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Taking a global leap into GI technology
Sharmila Anandasabapathy, MD, knew she wanted to focus on endoscopy when she first started her career.
While leading an endoscopy unit in New York City, Dr. Anandasabapathy began developing endoscopic and imaging technologies for underresourced and underserved areas. These technologies eventually made their way into global clinical trials.
“We’ve gone to clinical trial in over 2,000 patients worldwide. When I made that jump into global GI, I was able to make that jump into global health in general,” said Dr. Anandasabapathy.
As vice president for global programs at Baylor College of Medicine in Houston, Dr. Anandasabapathy currently focuses on clinical and translational research.
“We’re looking at the development of new, low-cost devices for early cancer detection in GI globally. I oversee our global programs across the whole college, so it’s GI, it’s surgery, it’s anesthesia, it’s obstetrics, it’s everything.”
In an interview, Dr. Anandasabapathy discussed what attracted her to gastroenterology and why she always takes the time to smile at her patients.
Q: Why did you choose GI?
A: There’s two questions in there: Why I chose GI and why I chose endoscopy.
I chose GI because when I was in my internal medicine training, they seemed like the happiest people in the hospital. They liked what they did. You could make a meaningful impact even at 3 a.m. if you were coming in for a variceal bleed. Everybody seemed happy with their choice of specialty. I was ready to be an oncologist, and I ended up becoming a gastroenterologist.
I chose endoscopy because it was where I wanted to be when I woke up in the morning. I was happy there. I love the procedures; I love the hand-eye coordination. I liked the fact that these were relatively shorter procedures, that it was technology based, and there was infinite growth.
Q: Was there a time when you really helped a patient by doing that endoscopy, preventing Barrett’s esophagus or even cancer?
A: I can think of several times where we had early cancers and it was a question between endoscopic treatment or surgery. It was always discussed with the surgeons. We made the decision within a multidisciplinary group and with the patient, but we usually went with the endoscopic options and the patients have done great. We’ve given them a greater quality of life, and I think that’s really rewarding.
Q: What gives you the most joy in your day-to-day practice?
A: My patients. I work with Barrett’s esophagus patients, and they tend to be well informed about the research and the science. I’m lucky to have a patient population that is really interested and willing to participate in that. I also like my students, my junior faculty. I like teaching and the global application of teaching.
Q: What fears did you have to push past to get to where you are in your career?
A: That I would never become an independent researcher and do it alone. I was able to, over time. The ability to transition from being independent to teaching others and making them independent is a wonderful one.
Early on when I was doing GI, I remember looking at my division, and there were about 58 gastroenterologists and only 2 women. I thought at the time, “Well, can I do it? Is this a field that is conducive with being a woman and having a family?” It turned out that it is. Today, I’m really gratified to see that there are more women in GI than there ever were before.
Q: Have you ever received advice that you’ve ignored?A: Yes. Early in my training in internal medicine, I was told that I smiled too much and that my personality was such that patients and others would think I was too glib. Medicine was a serious business, and you shouldn’t be smiling. That’s not my personality – I’m not Eeyore. I think it’s served me well to be positive, and it’s served me well with patients to be smiling. Especially when you’re dealing with patients who have precancer or dysplasia and are scared – they want reassurance and they want a level of confidence. I’m glad I ignored that advice.
Q: What would be your advice to medical students?
A: Think about where you want to be when you wake up in the morning. If it’s either in a GI practice or doing GI research or doing endoscopy, then you should absolutely do it.
Lightning round
Cat person or dog person
Dog
Favorite sport
Tennis
What song do you have to sing along with when you hear it?
Dancing Queen
Favorite music genre
1980s pop
Favorite movie, show, or book
Wuthering Heights
Dr. Anandasabapathy is on LinkedIn and on Twitter at @anandasabapathy , @bcmglobalhealth , and @bcm_gihep .
Sharmila Anandasabapathy, MD, knew she wanted to focus on endoscopy when she first started her career.
While leading an endoscopy unit in New York City, Dr. Anandasabapathy began developing endoscopic and imaging technologies for underresourced and underserved areas. These technologies eventually made their way into global clinical trials.
“We’ve gone to clinical trial in over 2,000 patients worldwide. When I made that jump into global GI, I was able to make that jump into global health in general,” said Dr. Anandasabapathy.
As vice president for global programs at Baylor College of Medicine in Houston, Dr. Anandasabapathy currently focuses on clinical and translational research.
“We’re looking at the development of new, low-cost devices for early cancer detection in GI globally. I oversee our global programs across the whole college, so it’s GI, it’s surgery, it’s anesthesia, it’s obstetrics, it’s everything.”
In an interview, Dr. Anandasabapathy discussed what attracted her to gastroenterology and why she always takes the time to smile at her patients.
Q: Why did you choose GI?
A: There’s two questions in there: Why I chose GI and why I chose endoscopy.
I chose GI because when I was in my internal medicine training, they seemed like the happiest people in the hospital. They liked what they did. You could make a meaningful impact even at 3 a.m. if you were coming in for a variceal bleed. Everybody seemed happy with their choice of specialty. I was ready to be an oncologist, and I ended up becoming a gastroenterologist.
I chose endoscopy because it was where I wanted to be when I woke up in the morning. I was happy there. I love the procedures; I love the hand-eye coordination. I liked the fact that these were relatively shorter procedures, that it was technology based, and there was infinite growth.
Q: Was there a time when you really helped a patient by doing that endoscopy, preventing Barrett’s esophagus or even cancer?
A: I can think of several times where we had early cancers and it was a question between endoscopic treatment or surgery. It was always discussed with the surgeons. We made the decision within a multidisciplinary group and with the patient, but we usually went with the endoscopic options and the patients have done great. We’ve given them a greater quality of life, and I think that’s really rewarding.
Q: What gives you the most joy in your day-to-day practice?
A: My patients. I work with Barrett’s esophagus patients, and they tend to be well informed about the research and the science. I’m lucky to have a patient population that is really interested and willing to participate in that. I also like my students, my junior faculty. I like teaching and the global application of teaching.
Q: What fears did you have to push past to get to where you are in your career?
A: That I would never become an independent researcher and do it alone. I was able to, over time. The ability to transition from being independent to teaching others and making them independent is a wonderful one.
Early on when I was doing GI, I remember looking at my division, and there were about 58 gastroenterologists and only 2 women. I thought at the time, “Well, can I do it? Is this a field that is conducive with being a woman and having a family?” It turned out that it is. Today, I’m really gratified to see that there are more women in GI than there ever were before.
Q: Have you ever received advice that you’ve ignored?A: Yes. Early in my training in internal medicine, I was told that I smiled too much and that my personality was such that patients and others would think I was too glib. Medicine was a serious business, and you shouldn’t be smiling. That’s not my personality – I’m not Eeyore. I think it’s served me well to be positive, and it’s served me well with patients to be smiling. Especially when you’re dealing with patients who have precancer or dysplasia and are scared – they want reassurance and they want a level of confidence. I’m glad I ignored that advice.
Q: What would be your advice to medical students?
A: Think about where you want to be when you wake up in the morning. If it’s either in a GI practice or doing GI research or doing endoscopy, then you should absolutely do it.
Lightning round
Cat person or dog person
Dog
Favorite sport
Tennis
What song do you have to sing along with when you hear it?
Dancing Queen
Favorite music genre
1980s pop
Favorite movie, show, or book
Wuthering Heights
Dr. Anandasabapathy is on LinkedIn and on Twitter at @anandasabapathy , @bcmglobalhealth , and @bcm_gihep .
Sharmila Anandasabapathy, MD, knew she wanted to focus on endoscopy when she first started her career.
While leading an endoscopy unit in New York City, Dr. Anandasabapathy began developing endoscopic and imaging technologies for underresourced and underserved areas. These technologies eventually made their way into global clinical trials.
“We’ve gone to clinical trial in over 2,000 patients worldwide. When I made that jump into global GI, I was able to make that jump into global health in general,” said Dr. Anandasabapathy.
As vice president for global programs at Baylor College of Medicine in Houston, Dr. Anandasabapathy currently focuses on clinical and translational research.
“We’re looking at the development of new, low-cost devices for early cancer detection in GI globally. I oversee our global programs across the whole college, so it’s GI, it’s surgery, it’s anesthesia, it’s obstetrics, it’s everything.”
In an interview, Dr. Anandasabapathy discussed what attracted her to gastroenterology and why she always takes the time to smile at her patients.
Q: Why did you choose GI?
A: There’s two questions in there: Why I chose GI and why I chose endoscopy.
I chose GI because when I was in my internal medicine training, they seemed like the happiest people in the hospital. They liked what they did. You could make a meaningful impact even at 3 a.m. if you were coming in for a variceal bleed. Everybody seemed happy with their choice of specialty. I was ready to be an oncologist, and I ended up becoming a gastroenterologist.
I chose endoscopy because it was where I wanted to be when I woke up in the morning. I was happy there. I love the procedures; I love the hand-eye coordination. I liked the fact that these were relatively shorter procedures, that it was technology based, and there was infinite growth.
Q: Was there a time when you really helped a patient by doing that endoscopy, preventing Barrett’s esophagus or even cancer?
A: I can think of several times where we had early cancers and it was a question between endoscopic treatment or surgery. It was always discussed with the surgeons. We made the decision within a multidisciplinary group and with the patient, but we usually went with the endoscopic options and the patients have done great. We’ve given them a greater quality of life, and I think that’s really rewarding.
Q: What gives you the most joy in your day-to-day practice?
A: My patients. I work with Barrett’s esophagus patients, and they tend to be well informed about the research and the science. I’m lucky to have a patient population that is really interested and willing to participate in that. I also like my students, my junior faculty. I like teaching and the global application of teaching.
Q: What fears did you have to push past to get to where you are in your career?
A: That I would never become an independent researcher and do it alone. I was able to, over time. The ability to transition from being independent to teaching others and making them independent is a wonderful one.
Early on when I was doing GI, I remember looking at my division, and there were about 58 gastroenterologists and only 2 women. I thought at the time, “Well, can I do it? Is this a field that is conducive with being a woman and having a family?” It turned out that it is. Today, I’m really gratified to see that there are more women in GI than there ever were before.
Q: Have you ever received advice that you’ve ignored?A: Yes. Early in my training in internal medicine, I was told that I smiled too much and that my personality was such that patients and others would think I was too glib. Medicine was a serious business, and you shouldn’t be smiling. That’s not my personality – I’m not Eeyore. I think it’s served me well to be positive, and it’s served me well with patients to be smiling. Especially when you’re dealing with patients who have precancer or dysplasia and are scared – they want reassurance and they want a level of confidence. I’m glad I ignored that advice.
Q: What would be your advice to medical students?
A: Think about where you want to be when you wake up in the morning. If it’s either in a GI practice or doing GI research or doing endoscopy, then you should absolutely do it.
Lightning round
Cat person or dog person
Dog
Favorite sport
Tennis
What song do you have to sing along with when you hear it?
Dancing Queen
Favorite music genre
1980s pop
Favorite movie, show, or book
Wuthering Heights
Dr. Anandasabapathy is on LinkedIn and on Twitter at @anandasabapathy , @bcmglobalhealth , and @bcm_gihep .
GI lends itself to multiple career paths, says Boston physician
Daniel Leffler, MD, MS, AGAF, has some advice for young physicians starting out in their careers: Don’t be afraid of change.
“Just because you’re a doctor doesn’t mean you have to spend the rest of your career doing patient care. We don’t teach that in medical school as well as we should,” said Dr. Leffler. “If you’re interested in a skill set and move in a different direction, that’s totally okay. Many people have major career shifts, whether it’s early, mid- or late career.”
Dr. Leffler followed his own advice in 2016 when he left his longtime job as an associate professor at Harvard Medical School and accepted a position with Takeda Pharmaceuticals. As its medical director, he had a specific goal: To find more therapeutic options for patients with celiac disease.
“Gastroenterology is a fantastic field of medicine, and it somehow continues to get more and more exciting,” said Dr. Leffler, who continues to see patients at Beth Israel Deaconess Medical Center in Boston. “There are just so many careers you can have within gastroenterology, whether you are a full-time endoscopist, in a teaching career, or doing lab work.”
He discussed the events that led to this career change in an interview with GI & Hepatology News.
Q: Why did you choose GI?
Dr. Leffler: I think for a lot of people GI is just an incredibly diverse field where you can see all types of patients and you have an unusually wide armamentarium of diagnostic and therapeutic options. Our ability to see inside in the GI tract relatively easily and obtain tissue and do functional studies is unique. It makes it a very dynamic field.
Q: What gives you the most joy in your day-to-day practice?
Dr. Leffler: I think it’s taking a fresh look at somebody whose symptoms have been incorrectly diagnosed or diagnosed preliminarily as one thing and opening different options and working with the patient to hopefully find a more targeted therapy based on a more definitive diagnosis.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Leffler: There are two challenges. For celiac disease, all I have is a gluten-free diet. It would be nice to have other options, the same way we do with almost every other GI disease, whether it’s acid-related disorders or chronic constipation or inflammatory bowel disease. We have a range of therapies we can pick and choose from, tailoring those to the individual. We are not there yet, unfortunately, in celiac disease, so that’s a huge challenge.
Another challenge is awareness of celiac disease. It’s not what it should be. We see a lot of patients who either were misdiagnosed or went many years without getting a proper diagnosis or got diagnosed and did not have proper education or follow up.
Q: How has your job changed since you first began your career? Perhaps we could discuss your switch from Harvard/Beth Israel Deaconess to Takeda Pharmaceuticals.
Dr. Leffler: I became convinced some years ago that the next big thing for celiac disease was an effective therapy beyond the gluten-free diet. Takeda had acquired rights to two of the therapies that I was most interested in, even though they were very early. There was a new glutenase, TAK-062, and a new immune-tolerizing molecule that became TAK-101. Takeda had moved its research center to Boston, and they were looking for someone to work on their celiac program. Moving from an academic position, which I loved, was a really difficult decision.
I didn’t leave without a conversation with the division chief at the time, Tom Lamont, MD. I basically said, “If this doesn’t work out, will you take me back?” I wasn’t sure how much I’d like working in industry. The other thing, on both sides, was that I was allowed to keep a clinic. I still see patients on Fridays and really, to me, I have the best of both worlds.
Q: What teacher or mentor had the greatest impact on you?
Dr. Leffler: I really think of Ciaran Kelly, MD at Beth Israel Deaconess, Detlef Schuppan, MD, who also was at Beth Israel Deaconess, but is now at the University of Mainz in Germany. And Peter Green, MD at Columbia University. These three are the physicians I’ve interacted with the most and learned the most from.
Q: What habits have you established that have benefited your career most?
Dr. Leffler: I do try to focus on being a good collaborator. Playing that long game of working for the good of the project and not necessarily what is next for you, has served me very well over the years.
Lightening round
Superpower?
Optimism
Favorite movie to quote?
The Big Lebowski
What is your favorite form of exercise?
Elliptical
Name one thing on your bucket list.
Ethiopia travel
How many cups of coffee do you drink per day?
Two-ish
Dr. Leffler is on LinkedIn.
Daniel Leffler, MD, MS, AGAF, has some advice for young physicians starting out in their careers: Don’t be afraid of change.
“Just because you’re a doctor doesn’t mean you have to spend the rest of your career doing patient care. We don’t teach that in medical school as well as we should,” said Dr. Leffler. “If you’re interested in a skill set and move in a different direction, that’s totally okay. Many people have major career shifts, whether it’s early, mid- or late career.”
Dr. Leffler followed his own advice in 2016 when he left his longtime job as an associate professor at Harvard Medical School and accepted a position with Takeda Pharmaceuticals. As its medical director, he had a specific goal: To find more therapeutic options for patients with celiac disease.
“Gastroenterology is a fantastic field of medicine, and it somehow continues to get more and more exciting,” said Dr. Leffler, who continues to see patients at Beth Israel Deaconess Medical Center in Boston. “There are just so many careers you can have within gastroenterology, whether you are a full-time endoscopist, in a teaching career, or doing lab work.”
He discussed the events that led to this career change in an interview with GI & Hepatology News.
Q: Why did you choose GI?
Dr. Leffler: I think for a lot of people GI is just an incredibly diverse field where you can see all types of patients and you have an unusually wide armamentarium of diagnostic and therapeutic options. Our ability to see inside in the GI tract relatively easily and obtain tissue and do functional studies is unique. It makes it a very dynamic field.
Q: What gives you the most joy in your day-to-day practice?
Dr. Leffler: I think it’s taking a fresh look at somebody whose symptoms have been incorrectly diagnosed or diagnosed preliminarily as one thing and opening different options and working with the patient to hopefully find a more targeted therapy based on a more definitive diagnosis.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Leffler: There are two challenges. For celiac disease, all I have is a gluten-free diet. It would be nice to have other options, the same way we do with almost every other GI disease, whether it’s acid-related disorders or chronic constipation or inflammatory bowel disease. We have a range of therapies we can pick and choose from, tailoring those to the individual. We are not there yet, unfortunately, in celiac disease, so that’s a huge challenge.
Another challenge is awareness of celiac disease. It’s not what it should be. We see a lot of patients who either were misdiagnosed or went many years without getting a proper diagnosis or got diagnosed and did not have proper education or follow up.
Q: How has your job changed since you first began your career? Perhaps we could discuss your switch from Harvard/Beth Israel Deaconess to Takeda Pharmaceuticals.
Dr. Leffler: I became convinced some years ago that the next big thing for celiac disease was an effective therapy beyond the gluten-free diet. Takeda had acquired rights to two of the therapies that I was most interested in, even though they were very early. There was a new glutenase, TAK-062, and a new immune-tolerizing molecule that became TAK-101. Takeda had moved its research center to Boston, and they were looking for someone to work on their celiac program. Moving from an academic position, which I loved, was a really difficult decision.
I didn’t leave without a conversation with the division chief at the time, Tom Lamont, MD. I basically said, “If this doesn’t work out, will you take me back?” I wasn’t sure how much I’d like working in industry. The other thing, on both sides, was that I was allowed to keep a clinic. I still see patients on Fridays and really, to me, I have the best of both worlds.
Q: What teacher or mentor had the greatest impact on you?
Dr. Leffler: I really think of Ciaran Kelly, MD at Beth Israel Deaconess, Detlef Schuppan, MD, who also was at Beth Israel Deaconess, but is now at the University of Mainz in Germany. And Peter Green, MD at Columbia University. These three are the physicians I’ve interacted with the most and learned the most from.
Q: What habits have you established that have benefited your career most?
Dr. Leffler: I do try to focus on being a good collaborator. Playing that long game of working for the good of the project and not necessarily what is next for you, has served me very well over the years.
Lightening round
Superpower?
Optimism
Favorite movie to quote?
The Big Lebowski
What is your favorite form of exercise?
Elliptical
Name one thing on your bucket list.
Ethiopia travel
How many cups of coffee do you drink per day?
Two-ish
Dr. Leffler is on LinkedIn.
Daniel Leffler, MD, MS, AGAF, has some advice for young physicians starting out in their careers: Don’t be afraid of change.
“Just because you’re a doctor doesn’t mean you have to spend the rest of your career doing patient care. We don’t teach that in medical school as well as we should,” said Dr. Leffler. “If you’re interested in a skill set and move in a different direction, that’s totally okay. Many people have major career shifts, whether it’s early, mid- or late career.”
Dr. Leffler followed his own advice in 2016 when he left his longtime job as an associate professor at Harvard Medical School and accepted a position with Takeda Pharmaceuticals. As its medical director, he had a specific goal: To find more therapeutic options for patients with celiac disease.
“Gastroenterology is a fantastic field of medicine, and it somehow continues to get more and more exciting,” said Dr. Leffler, who continues to see patients at Beth Israel Deaconess Medical Center in Boston. “There are just so many careers you can have within gastroenterology, whether you are a full-time endoscopist, in a teaching career, or doing lab work.”
He discussed the events that led to this career change in an interview with GI & Hepatology News.
Q: Why did you choose GI?
Dr. Leffler: I think for a lot of people GI is just an incredibly diverse field where you can see all types of patients and you have an unusually wide armamentarium of diagnostic and therapeutic options. Our ability to see inside in the GI tract relatively easily and obtain tissue and do functional studies is unique. It makes it a very dynamic field.
Q: What gives you the most joy in your day-to-day practice?
Dr. Leffler: I think it’s taking a fresh look at somebody whose symptoms have been incorrectly diagnosed or diagnosed preliminarily as one thing and opening different options and working with the patient to hopefully find a more targeted therapy based on a more definitive diagnosis.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Leffler: There are two challenges. For celiac disease, all I have is a gluten-free diet. It would be nice to have other options, the same way we do with almost every other GI disease, whether it’s acid-related disorders or chronic constipation or inflammatory bowel disease. We have a range of therapies we can pick and choose from, tailoring those to the individual. We are not there yet, unfortunately, in celiac disease, so that’s a huge challenge.
Another challenge is awareness of celiac disease. It’s not what it should be. We see a lot of patients who either were misdiagnosed or went many years without getting a proper diagnosis or got diagnosed and did not have proper education or follow up.
Q: How has your job changed since you first began your career? Perhaps we could discuss your switch from Harvard/Beth Israel Deaconess to Takeda Pharmaceuticals.
Dr. Leffler: I became convinced some years ago that the next big thing for celiac disease was an effective therapy beyond the gluten-free diet. Takeda had acquired rights to two of the therapies that I was most interested in, even though they were very early. There was a new glutenase, TAK-062, and a new immune-tolerizing molecule that became TAK-101. Takeda had moved its research center to Boston, and they were looking for someone to work on their celiac program. Moving from an academic position, which I loved, was a really difficult decision.
I didn’t leave without a conversation with the division chief at the time, Tom Lamont, MD. I basically said, “If this doesn’t work out, will you take me back?” I wasn’t sure how much I’d like working in industry. The other thing, on both sides, was that I was allowed to keep a clinic. I still see patients on Fridays and really, to me, I have the best of both worlds.
Q: What teacher or mentor had the greatest impact on you?
Dr. Leffler: I really think of Ciaran Kelly, MD at Beth Israel Deaconess, Detlef Schuppan, MD, who also was at Beth Israel Deaconess, but is now at the University of Mainz in Germany. And Peter Green, MD at Columbia University. These three are the physicians I’ve interacted with the most and learned the most from.
Q: What habits have you established that have benefited your career most?
Dr. Leffler: I do try to focus on being a good collaborator. Playing that long game of working for the good of the project and not necessarily what is next for you, has served me very well over the years.
Lightening round
Superpower?
Optimism
Favorite movie to quote?
The Big Lebowski
What is your favorite form of exercise?
Elliptical
Name one thing on your bucket list.
Ethiopia travel
How many cups of coffee do you drink per day?
Two-ish
Dr. Leffler is on LinkedIn.
Biosimilars and patients: Discussions should address safety, cost, and anxiety about change
Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.
“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.
The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”
He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”
The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.
It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.
Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
Insurance often drives the conversation
The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.
Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.
Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.
Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”
However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.
This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.
But not all physicians are quick to prescribe biosimilars.
Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”
Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
Conversations about cost
Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.
If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.
Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.
Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”
Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.
“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.
Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”
For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.
Biosimilars 101: Familiarizing patients
Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.
Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.
Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar. 
As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.
When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.
Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.
In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
A village approach to education
When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.
The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar.
This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”
Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”
Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.
No consensus on interchangeability
Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.
If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.
The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.
In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).
“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.
Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”
Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.
“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
Resources for physicians, patients
The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.
The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.
Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.
“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.
Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.
Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.
A version of this article originally appeared on Medscape.com.
Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.
“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.
The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”
He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”
The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.
It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.
Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
Insurance often drives the conversation
The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.
Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.
Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.
Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”
However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.
This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.
But not all physicians are quick to prescribe biosimilars.
Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”
Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
Conversations about cost
Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.
If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.
Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.
Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”
Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.
“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.
Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”
For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.
Biosimilars 101: Familiarizing patients
Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.
Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.
Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar.
As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.
When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.
Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.
In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
A village approach to education
When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.
The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar.
This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”
Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”
Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.
No consensus on interchangeability
Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.
If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.
The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.
In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).
“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.
Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”
Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.
“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
Resources for physicians, patients
The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.
The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.
Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.
“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.
Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.
Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.
A version of this article originally appeared on Medscape.com.
Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.
“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.
The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”
He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”
The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.
It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.
Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
Insurance often drives the conversation
The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.
Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.
Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.
Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”
However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.
This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.
But not all physicians are quick to prescribe biosimilars.
Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”
Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
Conversations about cost
Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.
If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.
Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.
Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”
Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.
“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.
Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”
For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.
Biosimilars 101: Familiarizing patients
Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.
Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.
Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar.
As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.
When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.
Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.
In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
A village approach to education
When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.
The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar.
This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”
Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”
Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.
No consensus on interchangeability
Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.
If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.
The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.
In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).
“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.
Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”
Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.
“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
Resources for physicians, patients
The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.
The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.
Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.
“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.
Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.
Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.
A version of this article originally appeared on Medscape.com.
Culinary medicine guides rural GI doctor’s career
Someone once told Christina Tennyson, MD, that clinical medicine was a grind. Instead of veering away from the profession, she dove in. Medicine will always have its frustrations, she acknowledged.
However, “finding areas that interest me and incorporating those into clinical practice has really helped me enjoy the practice of medicine,” said Dr. Tennyson, who works at Augusta Health in Fishersville, Va.
It has also inspired her to think outside the box in her gastroenterology practice. What her patients eat and the lifestyle choices they make is a central focus of her work.
Q: Why did you choose GI?
Dr. Tennyson: I always had an interest in nutrition. During training at medical school at NYU [New York University], I also really loved learning all I could about internal medicine. I worked with a great surgical team as a student and enjoyed being in the operating room. Although I knew I didn’t want to enter surgery, the experience encouraged me to pursue gastroenterology as it involved nutrition, internal medicine, and procedures as well as my favorite organ, the small bowel. I worked with some great mentors in gastroenterology, such as Dr. David Metz and Dr. Dave Katzka, at the University of Pennsylvania as a resident. I enjoyed taking care of patients with both acute and chronic conditions as well as the mix of doing procedures and seeing patients in the office. It also provided me the opportunity to incorporate nutrition into my clinical practice.
Q: What gives you the most joy in your day-to-day practice?
Dr. Tennyson: I enjoy helping my patients make meaningful lifestyle changes that can positively impact digestive health and well-being. I try to address topics related to lifestyle medicine in most of my clinical visits including eating more fiber/plants, exercise, positive relationships, and stress management. Many of the conditions we treat as gastroenterologists can benefit from addressing aspects of lifestyle along with our conventional medical therapies. I reinforce that attention to these areas can make a difference. I enjoy sharing recipes, books, and websites that I have found helpful.
Q: How has your job changed since you first began your career?
Dr. Tennyson: After fellowship, I joined the faculty at Columbia University and worked at the Celiac Disease Center seeing patients, teaching, and performing clinical research under the mentorship of Peter Green, MD, and Suzanne Lewis, MD. It was a great opportunity to learn and practice in a tertiary center. I later switched roles and joined a general multispecialty community practice in Brooklyn [N.Y.] affiliated with an academic medical center. After practicing in New York for 10 years, I left my clinical practice and performed locums work for several years in underserved rural areas. I enjoyed working in rural areas and took a permanent position at a community hospital in Virginia’s Shenandoah Valley.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Tennyson: The small, rural community hospital where I currently work does not have the same resources and staffing as urban tertiary centers. While we are taking care of the community in our general gastroenterology practice, we’ve also launched an integrated care model in our hospital. We have collaborated with behavioral health, dietitians, nurses, health coaches, exercise physiologists as well as other members of the community, including farmers and a chef. We have performed some innovative, engaging programs, including fermentation workshops, cooking classes, farm walks, and mindfulness programs.
Q: What are you most proud of accomplishing?
Dr. Tennyson: I am proud that I took a nontraditional path after training to do what I enjoy and find rewarding. I received certification during GI fellowship at Mount Sinai [N.Y.] as a physician nutrition specialist. I later completed a fellowship in integrative medicine at the University of Arizona, received certification in lifestyle medicine, and completed coursework in culinary medicine. I really enjoyed doing locums work taking care of patients in other parts of the country, like Mississippi or Maine. I’ve enjoyed working in more rural areas and bringing some innovative programs to the community.
Q: What teacher or mentor had the greatest impact on you?
Dr. Tennyson: Dr. Anthony Grieco while I was a student at NYU. He is an astute clinician, always listened to his patients, loved clinical medicine, and had an endless fund of knowledge. I wanted to be a doctor like him. During my fellowship at Mount Sinai, I was also exposed to many great mentors including Dr. Lloyd Mayer, Dr. Jerome Waye, Dr. Steve Itzkowitz, and Dr. Blair Lewis who encouraged my interest in nutrition and small bowel diseases.
Lightning round
What's your superpower?
Finding fun in mundane things
Favorite movie to quote?
The Princess Bride
What is your favorite form of exercise?
A hike in the woods
Name one thing on your bucket list.
Galapagos Islands trip before my kids grow up
Cats or dogs?
Dogs
Summer or winter?
Summer
Someone once told Christina Tennyson, MD, that clinical medicine was a grind. Instead of veering away from the profession, she dove in. Medicine will always have its frustrations, she acknowledged.
However, “finding areas that interest me and incorporating those into clinical practice has really helped me enjoy the practice of medicine,” said Dr. Tennyson, who works at Augusta Health in Fishersville, Va.
It has also inspired her to think outside the box in her gastroenterology practice. What her patients eat and the lifestyle choices they make is a central focus of her work.
Q: Why did you choose GI?
Dr. Tennyson: I always had an interest in nutrition. During training at medical school at NYU [New York University], I also really loved learning all I could about internal medicine. I worked with a great surgical team as a student and enjoyed being in the operating room. Although I knew I didn’t want to enter surgery, the experience encouraged me to pursue gastroenterology as it involved nutrition, internal medicine, and procedures as well as my favorite organ, the small bowel. I worked with some great mentors in gastroenterology, such as Dr. David Metz and Dr. Dave Katzka, at the University of Pennsylvania as a resident. I enjoyed taking care of patients with both acute and chronic conditions as well as the mix of doing procedures and seeing patients in the office. It also provided me the opportunity to incorporate nutrition into my clinical practice.
Q: What gives you the most joy in your day-to-day practice?
Dr. Tennyson: I enjoy helping my patients make meaningful lifestyle changes that can positively impact digestive health and well-being. I try to address topics related to lifestyle medicine in most of my clinical visits including eating more fiber/plants, exercise, positive relationships, and stress management. Many of the conditions we treat as gastroenterologists can benefit from addressing aspects of lifestyle along with our conventional medical therapies. I reinforce that attention to these areas can make a difference. I enjoy sharing recipes, books, and websites that I have found helpful.
Q: How has your job changed since you first began your career?
Dr. Tennyson: After fellowship, I joined the faculty at Columbia University and worked at the Celiac Disease Center seeing patients, teaching, and performing clinical research under the mentorship of Peter Green, MD, and Suzanne Lewis, MD. It was a great opportunity to learn and practice in a tertiary center. I later switched roles and joined a general multispecialty community practice in Brooklyn [N.Y.] affiliated with an academic medical center. After practicing in New York for 10 years, I left my clinical practice and performed locums work for several years in underserved rural areas. I enjoyed working in rural areas and took a permanent position at a community hospital in Virginia’s Shenandoah Valley.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Tennyson: The small, rural community hospital where I currently work does not have the same resources and staffing as urban tertiary centers. While we are taking care of the community in our general gastroenterology practice, we’ve also launched an integrated care model in our hospital. We have collaborated with behavioral health, dietitians, nurses, health coaches, exercise physiologists as well as other members of the community, including farmers and a chef. We have performed some innovative, engaging programs, including fermentation workshops, cooking classes, farm walks, and mindfulness programs.
Q: What are you most proud of accomplishing?
Dr. Tennyson: I am proud that I took a nontraditional path after training to do what I enjoy and find rewarding. I received certification during GI fellowship at Mount Sinai [N.Y.] as a physician nutrition specialist. I later completed a fellowship in integrative medicine at the University of Arizona, received certification in lifestyle medicine, and completed coursework in culinary medicine. I really enjoyed doing locums work taking care of patients in other parts of the country, like Mississippi or Maine. I’ve enjoyed working in more rural areas and bringing some innovative programs to the community.
Q: What teacher or mentor had the greatest impact on you?
Dr. Tennyson: Dr. Anthony Grieco while I was a student at NYU. He is an astute clinician, always listened to his patients, loved clinical medicine, and had an endless fund of knowledge. I wanted to be a doctor like him. During my fellowship at Mount Sinai, I was also exposed to many great mentors including Dr. Lloyd Mayer, Dr. Jerome Waye, Dr. Steve Itzkowitz, and Dr. Blair Lewis who encouraged my interest in nutrition and small bowel diseases.
Lightning round
What's your superpower?
Finding fun in mundane things
Favorite movie to quote?
The Princess Bride
What is your favorite form of exercise?
A hike in the woods
Name one thing on your bucket list.
Galapagos Islands trip before my kids grow up
Cats or dogs?
Dogs
Summer or winter?
Summer
Someone once told Christina Tennyson, MD, that clinical medicine was a grind. Instead of veering away from the profession, she dove in. Medicine will always have its frustrations, she acknowledged.
However, “finding areas that interest me and incorporating those into clinical practice has really helped me enjoy the practice of medicine,” said Dr. Tennyson, who works at Augusta Health in Fishersville, Va.
It has also inspired her to think outside the box in her gastroenterology practice. What her patients eat and the lifestyle choices they make is a central focus of her work.
Q: Why did you choose GI?
Dr. Tennyson: I always had an interest in nutrition. During training at medical school at NYU [New York University], I also really loved learning all I could about internal medicine. I worked with a great surgical team as a student and enjoyed being in the operating room. Although I knew I didn’t want to enter surgery, the experience encouraged me to pursue gastroenterology as it involved nutrition, internal medicine, and procedures as well as my favorite organ, the small bowel. I worked with some great mentors in gastroenterology, such as Dr. David Metz and Dr. Dave Katzka, at the University of Pennsylvania as a resident. I enjoyed taking care of patients with both acute and chronic conditions as well as the mix of doing procedures and seeing patients in the office. It also provided me the opportunity to incorporate nutrition into my clinical practice.
Q: What gives you the most joy in your day-to-day practice?
Dr. Tennyson: I enjoy helping my patients make meaningful lifestyle changes that can positively impact digestive health and well-being. I try to address topics related to lifestyle medicine in most of my clinical visits including eating more fiber/plants, exercise, positive relationships, and stress management. Many of the conditions we treat as gastroenterologists can benefit from addressing aspects of lifestyle along with our conventional medical therapies. I reinforce that attention to these areas can make a difference. I enjoy sharing recipes, books, and websites that I have found helpful.
Q: How has your job changed since you first began your career?
Dr. Tennyson: After fellowship, I joined the faculty at Columbia University and worked at the Celiac Disease Center seeing patients, teaching, and performing clinical research under the mentorship of Peter Green, MD, and Suzanne Lewis, MD. It was a great opportunity to learn and practice in a tertiary center. I later switched roles and joined a general multispecialty community practice in Brooklyn [N.Y.] affiliated with an academic medical center. After practicing in New York for 10 years, I left my clinical practice and performed locums work for several years in underserved rural areas. I enjoyed working in rural areas and took a permanent position at a community hospital in Virginia’s Shenandoah Valley.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Tennyson: The small, rural community hospital where I currently work does not have the same resources and staffing as urban tertiary centers. While we are taking care of the community in our general gastroenterology practice, we’ve also launched an integrated care model in our hospital. We have collaborated with behavioral health, dietitians, nurses, health coaches, exercise physiologists as well as other members of the community, including farmers and a chef. We have performed some innovative, engaging programs, including fermentation workshops, cooking classes, farm walks, and mindfulness programs.
Q: What are you most proud of accomplishing?
Dr. Tennyson: I am proud that I took a nontraditional path after training to do what I enjoy and find rewarding. I received certification during GI fellowship at Mount Sinai [N.Y.] as a physician nutrition specialist. I later completed a fellowship in integrative medicine at the University of Arizona, received certification in lifestyle medicine, and completed coursework in culinary medicine. I really enjoyed doing locums work taking care of patients in other parts of the country, like Mississippi or Maine. I’ve enjoyed working in more rural areas and bringing some innovative programs to the community.
Q: What teacher or mentor had the greatest impact on you?
Dr. Tennyson: Dr. Anthony Grieco while I was a student at NYU. He is an astute clinician, always listened to his patients, loved clinical medicine, and had an endless fund of knowledge. I wanted to be a doctor like him. During my fellowship at Mount Sinai, I was also exposed to many great mentors including Dr. Lloyd Mayer, Dr. Jerome Waye, Dr. Steve Itzkowitz, and Dr. Blair Lewis who encouraged my interest in nutrition and small bowel diseases.
Lightning round
What's your superpower?
Finding fun in mundane things
Favorite movie to quote?
The Princess Bride
What is your favorite form of exercise?
A hike in the woods
Name one thing on your bucket list.
Galapagos Islands trip before my kids grow up
Cats or dogs?
Dogs
Summer or winter?
Summer
New influx of Humira biosimilars may not drive immediate change
Gastroenterologists in 2023 will have more tools in their arsenal to treat patients with Crohn’s disease or ulcerative colitis. As many as 8-10 adalimumab biosimilars are anticipated to come on the market this year, giving mainstay drug Humira some vigorous competition.
Three scenarios will drive adalimumab biosimilar initiation: Insurance preference for the initial treatment of a newly diagnosed condition, a change in a patient’s insurance plan, or an insurance-mandated switch, said Edward C. Oldfield IV, MD, assistant professor at Eastern Virginia Medical School’s division of gastroenterology in Norfolk.
“Outside of these scenarios, I would encourage patients to remain on their current biologic so long as cost and accessibility remain stable,” said Dr. Oldfield.
Many factors will contribute to the success of biosimilars. Will physicians be prescribing them? How are biosimilars placed on formularies and will they be given preferred status? How will manufacturers price their biosimilars? “We have to wait and see to get the answers to these questions,” said Steven Newmark, JD, MPA, chief legal officer and director of policy, Global Healthy Living Foundation/CreakyJoints, a nonprofit advocacy organization based in New York.
Prescribing biosimilars is no different than prescribing originator biologics, so providers should know how to use them, said Mr. Newmark. “Most important will be the availability of patient-friendly resources that providers can share with their patients to provide education about and confidence in using biosimilars,” he added.
Overall, biosimilars are a good thing, said Dr. Oldfield. “In the long run they should bring down costs and increase access to medications for our patients.”
Others are skeptical that the adalimumab biosimilars will save patients much money.
Biosimilar laws were created to lower costs. However, if a patient with insurance pays only $5 a month out of pocket for Humira – a drug that normally costs $7,000 without coverage – it’s unlikely they would want to switch unless there’s comparable savings from the biosimilar, said Stephen B. Hanauer, MD, medical director of the Digestive Health Center and professor of medicine at Northwestern Medicine, Northwestern University, Evanston, Ill.
Like generics, Humira biosimilars may face some initial backlash, said Dr. Hanauer.
2023 broadens scope of adalimumab treatments
The American Gastroenterological Association describes a biosimilar as something that’s “highly similar to, but not an exact copy of, a biologic reference product already approved” by the Food and Drug Administration. Congress under the 2010 Affordable Care Act created a special, abbreviated pathway to approval for biosimilars.
AbbVie’s Humira, the global revenue for which exceeded $20 billion in 2021, has long dominated the U.S. market on injectable treatments for autoimmune diseases. The popular drug faces some competition in 2023, however, following a series of legal settlements that allowed AbbVie competitors to release their own adalimumab biosimilars.
“So far, we haven’t seen biosimilars live up to their potential in the U.S. in the inflammatory space,” said Mr. Newmark. This may change, however. Previously, biosimilars have required infusion, which demanded more time, commitment, and travel from patients. “The new set of forthcoming Humira biosimilars are injectables, an administration method preferred by patients,” he said.
The FDA will approve a biosimilar if it determines that the biological product is highly similar to the reference product, and that there are no clinically meaningful differences between the biological and reference product in terms of the safety, purity, and potency of the product.
The agency to date has approved 8 adalimumab biosimilars. These include: Idacio (adalimumab-aacf, Fresenius Kabi); Amjevita (adalimumab-atto, Amgen); Hadlima (adalimumab-bwwd, Organon); Cyltezo (adalimumab-adbm, Boehringer Ingelheim); Yusimry (adalimumab-aqvh from Coherus BioSciences); Hulio (adalimumab-fkjp; Mylan/Fujifilm Kyowa Kirin Biologics); Hyrimoz (adalimumab-adaz, Sandoz), and Abrilada (adalimumab-afzb, Pfizer).
“While FDA doesn’t formally track when products come to market, we know based on published reports that application holders for many of the currently FDA-approved biosimilars plan to market this year, starting with Amjevita being the first adalimumab biosimilar launched” in January, said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the agency.
At press time, two other companies (Celltrion and Alvotech/Teva) were awaiting FDA approval for their adalimumab biosimilar drugs.
Among the eight approved drugs, Cyltezo is the only one that has a designation for interchangeability with Humira.
An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the prescriber – much like generics are substituted, depending on state laws, said Dr. Yim. “However, in terms of safety and effectiveness, FDA’s standards for approval mean that biosimilar or interchangeable biosimilar products can be used in place of the reference product they were compared to.”
FDA-approved biosimilars undergo a rigorous evaluation for safety, effectiveness, and quality for their approved conditions of use, she continued. “Therefore, patients and health care providers can rely on a biosimilar to be as safe and effective for its approved uses as the original biological product.”
Remicade as a yardstick
Gastroenterologists dealt with this situation once before, when Remicade (infliximab) biosimilars came on the market in 2016, noted Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic.
Remicade and Humira are both tumor necrosis factor inhibitors with the same mechanism of action and many of the same indications. “We already had that experience with Remicade and biosimilar switch 2 or 3 years ago. Now we’re talking about Humira,” said Dr. Regueiro.
Most GI doctors have prescribed one of the more common infliximab biosimilars (Inflectra or Renflexis), noted Dr. Oldfield.
Cardinal Health, which recently surveyed 300 gastroenterologists, rheumatologists, and dermatologists about adalimumab biosimilars, found that gastroenterologists had the highest comfort level in prescribing them. Their top concern, however, was changing a patient from adalimumab to an adalimumab biosimilar.
For most patients, Dr. Oldfield sees the Humira reference biologic and biosimilar as equivalent.
However, he said he would change a patient’s drug only if there were a good reason or if his hand was forced by insurance. He would not make the change for a patient who recently began induction with the reference biologic or a patient with highly active clinical disease.
“While there is limited data to support this, I would also have some qualms about changing a patient from reference biologic to a biosimilar if they previously had immune-mediated pharmacokinetic failure due to antibody development with a biologic and were currently doing well on their new biologic,” he said.
Those with a new ulcerative colitis or Crohn’s diagnosis who are initiating a biologic for the first time might consider a biosimilar. If a patient is transitioning from a reference biologic to a biosimilar, “I would want to make that change during a time of stable remission and with the recognition that the switch is not a temporary switch, but a long-term switch,” he continued.
A paper that reviewed 23 observational studies of adalimumab and other biosimilars found that switching biosimilars was safe and effective. But if possible, patients should minimize the number of switches until more robust long-term data are available, added Dr. Oldfield.
If a patient is apprehensive about switching to a new therapy, “one may need to be cognizant of the ‘nocebo’ effect in which there is an unexplained or unfavorable therapeutic effect after switching,” he said.
Other gastroenterologists voiced similar reservations about switching. “I won’t use an adalimumab biosimilar unless the patient requests it, the insurance requires it, or there is a cost advantage for the patient such that they prefer it,” said Doug Wolf, MD, an Atlanta gastroenterologist.
“There is no medical treatment advantage to a biosimilar, especially if switching from Humira,” added Dr. Wolf.
Insurance will guide treatment
Once a drug is approved for use by the FDA, that drug will be available in all 50 states. “Different private insurance formularies, as well as state Medicaid formularies, might affect the actual ability of patients to receive such drugs,” said Mr. Newmark.
Patients should consult with their providers and insurance companies to see what therapies are available, he advised.
Dr. Hanauer anticipates some headaches arising for patients and doctors alike when negotiating for a specific drug.
Cyltezo may be the only biosimilar interchangeable with Humira, but the third-party pharmacy benefit manager (PBM) could negotiate for one of the noninterchangeable ones. “On a yearly basis they could switch their preference,” said Dr. Hanauer.
In the Cardinal Health survey, more than 60% of respondents said they would feel comfortable prescribing an adalimumab biosimilar only with an interchangeability designation.
A PBM may offer a patient Cyltezo if it’s cheaper than Humira. If the patient insists on staying on Humira, then they’ll have to pay more for that drug on their payer’s formulary, said Dr. Hanauer. In a worst-case scenario, a physician may have to appeal on a patient’s behalf to get Humira if the insurer offers only the biosimilar.
Taking that step to appeal is a major hassle for the physician, and leads to extra back door costs as well, said Dr. Hanauer.
Humira manufacturer AbbVie, in turn, may offer discounts and rebates to the PBMs to put Humira on their formulary. “That’s the AbbVie negotiating power. It’s not that the cost is going to be that much different. It’s going to be that there are rebates and discounts that are going to make the cost different,” he added.
As a community physician, Dr. Oldfield has specific concerns about accessibility.
The ever-increasing burden of insurance documentation and prior authorization means it can take weeks or months to get these medications approved. “The addition of new biosimilars is a welcome entrance if it can get patients the medications they need when they need it,” he said.
When it comes to prescribing biologics, many physicians rely on ancillary staff for assistance. It’s a team effort to sift through all the paperwork, observed Dr. Oldfield.
“While many community GI practices have specialized staff to deal with prior authorizations, they are still a far cry from the IBD [inflammatory bowel disease] academic centers where there are often pharmacists, nursing specialists, and home-monitoring programs to check in on patients,” he explained.
Landscape on cost is uncertain
At present, little is known about the cost of the biosimilars and impact on future drug pricing, said Dr. Oldfield.
At least for Medicare, Humira biosimilars will be considered Medicare Part D drugs if used for a medically accepted indication, said a spokesperson for the Centers for Medicare and Medicaid Services.
Part D sponsors (pharmacy and therapeutic committees) “will make the determination as to whether Amjevita and other products will be added to their formularies,” said the spokesperson.
Patients never saw a significant cost savings with Remicade biosimilars. “I imagine the same would be true with biosimilars for Humira,” said Dr. Regueiro. Patients may see greater access to these drugs, however, because the insurance plan or the pharmacy plan will make them more readily available, he added.
The hope is that, as biosimilars are introduced, the price of the originator biologic will go down, said Mr. Newmark. “Therefore, we can expect Humira to be offered at a lower price as it faces competition. Where it will sit in comparison to the forthcoming biosimilars will depend on how much biosimilar companies drop their price and how much pressure will be on PBMs and insurers to cover the lowest list price drug,” he said.
AbbVie did not respond to several requests for comment.
Charitable patient assistance programs for biosimilars or biologics can help offset the price of copayments, Mr. Newmark offered.
Ideally, insurers will offer designated biosimilars at a reduced or even no out-of-pocket expense on their formularies. This should lead to a decreased administrative burden for approval with streamlined (or even removal) of prior authorizations for certain medications, said Dr. Oldfield.
Without insurance or medication assistance programs, the cost of biosimilars is prohibitively expensive, he added.
“Biosimilars have higher research, development, and manufacturing costs than what people conventionally think of [for] a generic medication.”
Educating, advising patients
Dr. Oldfield advised that gastroenterologists refer to biologics by the generic name rather than branded name when initiating therapy unless there is a very specific reason not to. “This approach should make the process more streamlined and less subjected to quick denials for brand-only requests as biosimilars start to assume a larger market share,” he said.
Uptake of the Humira biosimilars also will depend on proper education of physicians and patients and their comfort level with the biosimilars, said Dr. Regueiro. Cleveland Clinic uses a team approach to educate on this topic, relying on pharmacists, clinicians, and nurses to explain that there’s no real difference between the reference drug and its biosimilars, based on efficacy and safety data.
Physicians can also direct patients to patient-friendly resources, said Mr. Newmark. “By starting the conversation early, it ensures that when/if the time comes that your patient is switched to or chooses a biosimilar they will feel more confident because they have the knowledge to make decisions about their care.”
The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars , is a free resource for patients, he added.
It’s important that doctors also understand these products so they can explain to their patients what to expect, said the FDA’s Dr. Yim. The FDA provides educational materials on its website, including a comprehensive curriculum toolkit.
Dr. Hanauer has served as a consultant for AbbVie, Amgen, American College of Gastroenterology, GlaxoSmithKline, American Gastroenterological Association, Pfizer, and a host of other companies . Dr. Regueiro has served on advisory boards and as a consultant for Abbvie, Janssen, UCB, Takeda, Pfizer, BMS, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET Pharma Solutions,Trellis, and Boehringer Ingelheim Pharmaceuticals. Dr. Wolf, Dr. Yim, Dr. Oldfield, and Mr. Newmark have no financial conflicts of interest.
Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars .
Gastroenterologists in 2023 will have more tools in their arsenal to treat patients with Crohn’s disease or ulcerative colitis. As many as 8-10 adalimumab biosimilars are anticipated to come on the market this year, giving mainstay drug Humira some vigorous competition.
Three scenarios will drive adalimumab biosimilar initiation: Insurance preference for the initial treatment of a newly diagnosed condition, a change in a patient’s insurance plan, or an insurance-mandated switch, said Edward C. Oldfield IV, MD, assistant professor at Eastern Virginia Medical School’s division of gastroenterology in Norfolk.
“Outside of these scenarios, I would encourage patients to remain on their current biologic so long as cost and accessibility remain stable,” said Dr. Oldfield.
Many factors will contribute to the success of biosimilars. Will physicians be prescribing them? How are biosimilars placed on formularies and will they be given preferred status? How will manufacturers price their biosimilars? “We have to wait and see to get the answers to these questions,” said Steven Newmark, JD, MPA, chief legal officer and director of policy, Global Healthy Living Foundation/CreakyJoints, a nonprofit advocacy organization based in New York.
Prescribing biosimilars is no different than prescribing originator biologics, so providers should know how to use them, said Mr. Newmark. “Most important will be the availability of patient-friendly resources that providers can share with their patients to provide education about and confidence in using biosimilars,” he added.
Overall, biosimilars are a good thing, said Dr. Oldfield. “In the long run they should bring down costs and increase access to medications for our patients.”
Others are skeptical that the adalimumab biosimilars will save patients much money.
Biosimilar laws were created to lower costs. However, if a patient with insurance pays only $5 a month out of pocket for Humira – a drug that normally costs $7,000 without coverage – it’s unlikely they would want to switch unless there’s comparable savings from the biosimilar, said Stephen B. Hanauer, MD, medical director of the Digestive Health Center and professor of medicine at Northwestern Medicine, Northwestern University, Evanston, Ill.
Like generics, Humira biosimilars may face some initial backlash, said Dr. Hanauer.
2023 broadens scope of adalimumab treatments
The American Gastroenterological Association describes a biosimilar as something that’s “highly similar to, but not an exact copy of, a biologic reference product already approved” by the Food and Drug Administration. Congress under the 2010 Affordable Care Act created a special, abbreviated pathway to approval for biosimilars.
AbbVie’s Humira, the global revenue for which exceeded $20 billion in 2021, has long dominated the U.S. market on injectable treatments for autoimmune diseases. The popular drug faces some competition in 2023, however, following a series of legal settlements that allowed AbbVie competitors to release their own adalimumab biosimilars.
“So far, we haven’t seen biosimilars live up to their potential in the U.S. in the inflammatory space,” said Mr. Newmark. This may change, however. Previously, biosimilars have required infusion, which demanded more time, commitment, and travel from patients. “The new set of forthcoming Humira biosimilars are injectables, an administration method preferred by patients,” he said.
The FDA will approve a biosimilar if it determines that the biological product is highly similar to the reference product, and that there are no clinically meaningful differences between the biological and reference product in terms of the safety, purity, and potency of the product.
The agency to date has approved 8 adalimumab biosimilars. These include: Idacio (adalimumab-aacf, Fresenius Kabi); Amjevita (adalimumab-atto, Amgen); Hadlima (adalimumab-bwwd, Organon); Cyltezo (adalimumab-adbm, Boehringer Ingelheim); Yusimry (adalimumab-aqvh from Coherus BioSciences); Hulio (adalimumab-fkjp; Mylan/Fujifilm Kyowa Kirin Biologics); Hyrimoz (adalimumab-adaz, Sandoz), and Abrilada (adalimumab-afzb, Pfizer).
“While FDA doesn’t formally track when products come to market, we know based on published reports that application holders for many of the currently FDA-approved biosimilars plan to market this year, starting with Amjevita being the first adalimumab biosimilar launched” in January, said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the agency.
At press time, two other companies (Celltrion and Alvotech/Teva) were awaiting FDA approval for their adalimumab biosimilar drugs.
Among the eight approved drugs, Cyltezo is the only one that has a designation for interchangeability with Humira.
An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the prescriber – much like generics are substituted, depending on state laws, said Dr. Yim. “However, in terms of safety and effectiveness, FDA’s standards for approval mean that biosimilar or interchangeable biosimilar products can be used in place of the reference product they were compared to.”
FDA-approved biosimilars undergo a rigorous evaluation for safety, effectiveness, and quality for their approved conditions of use, she continued. “Therefore, patients and health care providers can rely on a biosimilar to be as safe and effective for its approved uses as the original biological product.”
Remicade as a yardstick
Gastroenterologists dealt with this situation once before, when Remicade (infliximab) biosimilars came on the market in 2016, noted Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic.
Remicade and Humira are both tumor necrosis factor inhibitors with the same mechanism of action and many of the same indications. “We already had that experience with Remicade and biosimilar switch 2 or 3 years ago. Now we’re talking about Humira,” said Dr. Regueiro.
Most GI doctors have prescribed one of the more common infliximab biosimilars (Inflectra or Renflexis), noted Dr. Oldfield.
Cardinal Health, which recently surveyed 300 gastroenterologists, rheumatologists, and dermatologists about adalimumab biosimilars, found that gastroenterologists had the highest comfort level in prescribing them. Their top concern, however, was changing a patient from adalimumab to an adalimumab biosimilar.
For most patients, Dr. Oldfield sees the Humira reference biologic and biosimilar as equivalent.
However, he said he would change a patient’s drug only if there were a good reason or if his hand was forced by insurance. He would not make the change for a patient who recently began induction with the reference biologic or a patient with highly active clinical disease.
“While there is limited data to support this, I would also have some qualms about changing a patient from reference biologic to a biosimilar if they previously had immune-mediated pharmacokinetic failure due to antibody development with a biologic and were currently doing well on their new biologic,” he said.
Those with a new ulcerative colitis or Crohn’s diagnosis who are initiating a biologic for the first time might consider a biosimilar. If a patient is transitioning from a reference biologic to a biosimilar, “I would want to make that change during a time of stable remission and with the recognition that the switch is not a temporary switch, but a long-term switch,” he continued.
A paper that reviewed 23 observational studies of adalimumab and other biosimilars found that switching biosimilars was safe and effective. But if possible, patients should minimize the number of switches until more robust long-term data are available, added Dr. Oldfield.
If a patient is apprehensive about switching to a new therapy, “one may need to be cognizant of the ‘nocebo’ effect in which there is an unexplained or unfavorable therapeutic effect after switching,” he said.
Other gastroenterologists voiced similar reservations about switching. “I won’t use an adalimumab biosimilar unless the patient requests it, the insurance requires it, or there is a cost advantage for the patient such that they prefer it,” said Doug Wolf, MD, an Atlanta gastroenterologist.
“There is no medical treatment advantage to a biosimilar, especially if switching from Humira,” added Dr. Wolf.
Insurance will guide treatment
Once a drug is approved for use by the FDA, that drug will be available in all 50 states. “Different private insurance formularies, as well as state Medicaid formularies, might affect the actual ability of patients to receive such drugs,” said Mr. Newmark.
Patients should consult with their providers and insurance companies to see what therapies are available, he advised.
Dr. Hanauer anticipates some headaches arising for patients and doctors alike when negotiating for a specific drug.
Cyltezo may be the only biosimilar interchangeable with Humira, but the third-party pharmacy benefit manager (PBM) could negotiate for one of the noninterchangeable ones. “On a yearly basis they could switch their preference,” said Dr. Hanauer.
In the Cardinal Health survey, more than 60% of respondents said they would feel comfortable prescribing an adalimumab biosimilar only with an interchangeability designation.
A PBM may offer a patient Cyltezo if it’s cheaper than Humira. If the patient insists on staying on Humira, then they’ll have to pay more for that drug on their payer’s formulary, said Dr. Hanauer. In a worst-case scenario, a physician may have to appeal on a patient’s behalf to get Humira if the insurer offers only the biosimilar.
Taking that step to appeal is a major hassle for the physician, and leads to extra back door costs as well, said Dr. Hanauer.
Humira manufacturer AbbVie, in turn, may offer discounts and rebates to the PBMs to put Humira on their formulary. “That’s the AbbVie negotiating power. It’s not that the cost is going to be that much different. It’s going to be that there are rebates and discounts that are going to make the cost different,” he added.
As a community physician, Dr. Oldfield has specific concerns about accessibility.
The ever-increasing burden of insurance documentation and prior authorization means it can take weeks or months to get these medications approved. “The addition of new biosimilars is a welcome entrance if it can get patients the medications they need when they need it,” he said.
When it comes to prescribing biologics, many physicians rely on ancillary staff for assistance. It’s a team effort to sift through all the paperwork, observed Dr. Oldfield.
“While many community GI practices have specialized staff to deal with prior authorizations, they are still a far cry from the IBD [inflammatory bowel disease] academic centers where there are often pharmacists, nursing specialists, and home-monitoring programs to check in on patients,” he explained.
Landscape on cost is uncertain
At present, little is known about the cost of the biosimilars and impact on future drug pricing, said Dr. Oldfield.
At least for Medicare, Humira biosimilars will be considered Medicare Part D drugs if used for a medically accepted indication, said a spokesperson for the Centers for Medicare and Medicaid Services.
Part D sponsors (pharmacy and therapeutic committees) “will make the determination as to whether Amjevita and other products will be added to their formularies,” said the spokesperson.
Patients never saw a significant cost savings with Remicade biosimilars. “I imagine the same would be true with biosimilars for Humira,” said Dr. Regueiro. Patients may see greater access to these drugs, however, because the insurance plan or the pharmacy plan will make them more readily available, he added.
The hope is that, as biosimilars are introduced, the price of the originator biologic will go down, said Mr. Newmark. “Therefore, we can expect Humira to be offered at a lower price as it faces competition. Where it will sit in comparison to the forthcoming biosimilars will depend on how much biosimilar companies drop their price and how much pressure will be on PBMs and insurers to cover the lowest list price drug,” he said.
AbbVie did not respond to several requests for comment.
Charitable patient assistance programs for biosimilars or biologics can help offset the price of copayments, Mr. Newmark offered.
Ideally, insurers will offer designated biosimilars at a reduced or even no out-of-pocket expense on their formularies. This should lead to a decreased administrative burden for approval with streamlined (or even removal) of prior authorizations for certain medications, said Dr. Oldfield.
Without insurance or medication assistance programs, the cost of biosimilars is prohibitively expensive, he added.
“Biosimilars have higher research, development, and manufacturing costs than what people conventionally think of [for] a generic medication.”
Educating, advising patients
Dr. Oldfield advised that gastroenterologists refer to biologics by the generic name rather than branded name when initiating therapy unless there is a very specific reason not to. “This approach should make the process more streamlined and less subjected to quick denials for brand-only requests as biosimilars start to assume a larger market share,” he said.
Uptake of the Humira biosimilars also will depend on proper education of physicians and patients and their comfort level with the biosimilars, said Dr. Regueiro. Cleveland Clinic uses a team approach to educate on this topic, relying on pharmacists, clinicians, and nurses to explain that there’s no real difference between the reference drug and its biosimilars, based on efficacy and safety data.
Physicians can also direct patients to patient-friendly resources, said Mr. Newmark. “By starting the conversation early, it ensures that when/if the time comes that your patient is switched to or chooses a biosimilar they will feel more confident because they have the knowledge to make decisions about their care.”
The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars , is a free resource for patients, he added.
It’s important that doctors also understand these products so they can explain to their patients what to expect, said the FDA’s Dr. Yim. The FDA provides educational materials on its website, including a comprehensive curriculum toolkit.
Dr. Hanauer has served as a consultant for AbbVie, Amgen, American College of Gastroenterology, GlaxoSmithKline, American Gastroenterological Association, Pfizer, and a host of other companies . Dr. Regueiro has served on advisory boards and as a consultant for Abbvie, Janssen, UCB, Takeda, Pfizer, BMS, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET Pharma Solutions,Trellis, and Boehringer Ingelheim Pharmaceuticals. Dr. Wolf, Dr. Yim, Dr. Oldfield, and Mr. Newmark have no financial conflicts of interest.
Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars .
Gastroenterologists in 2023 will have more tools in their arsenal to treat patients with Crohn’s disease or ulcerative colitis. As many as 8-10 adalimumab biosimilars are anticipated to come on the market this year, giving mainstay drug Humira some vigorous competition.
Three scenarios will drive adalimumab biosimilar initiation: Insurance preference for the initial treatment of a newly diagnosed condition, a change in a patient’s insurance plan, or an insurance-mandated switch, said Edward C. Oldfield IV, MD, assistant professor at Eastern Virginia Medical School’s division of gastroenterology in Norfolk.
“Outside of these scenarios, I would encourage patients to remain on their current biologic so long as cost and accessibility remain stable,” said Dr. Oldfield.
Many factors will contribute to the success of biosimilars. Will physicians be prescribing them? How are biosimilars placed on formularies and will they be given preferred status? How will manufacturers price their biosimilars? “We have to wait and see to get the answers to these questions,” said Steven Newmark, JD, MPA, chief legal officer and director of policy, Global Healthy Living Foundation/CreakyJoints, a nonprofit advocacy organization based in New York.
Prescribing biosimilars is no different than prescribing originator biologics, so providers should know how to use them, said Mr. Newmark. “Most important will be the availability of patient-friendly resources that providers can share with their patients to provide education about and confidence in using biosimilars,” he added.
Overall, biosimilars are a good thing, said Dr. Oldfield. “In the long run they should bring down costs and increase access to medications for our patients.”
Others are skeptical that the adalimumab biosimilars will save patients much money.
Biosimilar laws were created to lower costs. However, if a patient with insurance pays only $5 a month out of pocket for Humira – a drug that normally costs $7,000 without coverage – it’s unlikely they would want to switch unless there’s comparable savings from the biosimilar, said Stephen B. Hanauer, MD, medical director of the Digestive Health Center and professor of medicine at Northwestern Medicine, Northwestern University, Evanston, Ill.
Like generics, Humira biosimilars may face some initial backlash, said Dr. Hanauer.
2023 broadens scope of adalimumab treatments
The American Gastroenterological Association describes a biosimilar as something that’s “highly similar to, but not an exact copy of, a biologic reference product already approved” by the Food and Drug Administration. Congress under the 2010 Affordable Care Act created a special, abbreviated pathway to approval for biosimilars.
AbbVie’s Humira, the global revenue for which exceeded $20 billion in 2021, has long dominated the U.S. market on injectable treatments for autoimmune diseases. The popular drug faces some competition in 2023, however, following a series of legal settlements that allowed AbbVie competitors to release their own adalimumab biosimilars.
“So far, we haven’t seen biosimilars live up to their potential in the U.S. in the inflammatory space,” said Mr. Newmark. This may change, however. Previously, biosimilars have required infusion, which demanded more time, commitment, and travel from patients. “The new set of forthcoming Humira biosimilars are injectables, an administration method preferred by patients,” he said.
The FDA will approve a biosimilar if it determines that the biological product is highly similar to the reference product, and that there are no clinically meaningful differences between the biological and reference product in terms of the safety, purity, and potency of the product.
The agency to date has approved 8 adalimumab biosimilars. These include: Idacio (adalimumab-aacf, Fresenius Kabi); Amjevita (adalimumab-atto, Amgen); Hadlima (adalimumab-bwwd, Organon); Cyltezo (adalimumab-adbm, Boehringer Ingelheim); Yusimry (adalimumab-aqvh from Coherus BioSciences); Hulio (adalimumab-fkjp; Mylan/Fujifilm Kyowa Kirin Biologics); Hyrimoz (adalimumab-adaz, Sandoz), and Abrilada (adalimumab-afzb, Pfizer).
“While FDA doesn’t formally track when products come to market, we know based on published reports that application holders for many of the currently FDA-approved biosimilars plan to market this year, starting with Amjevita being the first adalimumab biosimilar launched” in January, said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the agency.
At press time, two other companies (Celltrion and Alvotech/Teva) were awaiting FDA approval for their adalimumab biosimilar drugs.
Among the eight approved drugs, Cyltezo is the only one that has a designation for interchangeability with Humira.
An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the prescriber – much like generics are substituted, depending on state laws, said Dr. Yim. “However, in terms of safety and effectiveness, FDA’s standards for approval mean that biosimilar or interchangeable biosimilar products can be used in place of the reference product they were compared to.”
FDA-approved biosimilars undergo a rigorous evaluation for safety, effectiveness, and quality for their approved conditions of use, she continued. “Therefore, patients and health care providers can rely on a biosimilar to be as safe and effective for its approved uses as the original biological product.”
Remicade as a yardstick
Gastroenterologists dealt with this situation once before, when Remicade (infliximab) biosimilars came on the market in 2016, noted Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic.
Remicade and Humira are both tumor necrosis factor inhibitors with the same mechanism of action and many of the same indications. “We already had that experience with Remicade and biosimilar switch 2 or 3 years ago. Now we’re talking about Humira,” said Dr. Regueiro.
Most GI doctors have prescribed one of the more common infliximab biosimilars (Inflectra or Renflexis), noted Dr. Oldfield.
Cardinal Health, which recently surveyed 300 gastroenterologists, rheumatologists, and dermatologists about adalimumab biosimilars, found that gastroenterologists had the highest comfort level in prescribing them. Their top concern, however, was changing a patient from adalimumab to an adalimumab biosimilar.
For most patients, Dr. Oldfield sees the Humira reference biologic and biosimilar as equivalent.
However, he said he would change a patient’s drug only if there were a good reason or if his hand was forced by insurance. He would not make the change for a patient who recently began induction with the reference biologic or a patient with highly active clinical disease.
“While there is limited data to support this, I would also have some qualms about changing a patient from reference biologic to a biosimilar if they previously had immune-mediated pharmacokinetic failure due to antibody development with a biologic and were currently doing well on their new biologic,” he said.
Those with a new ulcerative colitis or Crohn’s diagnosis who are initiating a biologic for the first time might consider a biosimilar. If a patient is transitioning from a reference biologic to a biosimilar, “I would want to make that change during a time of stable remission and with the recognition that the switch is not a temporary switch, but a long-term switch,” he continued.
A paper that reviewed 23 observational studies of adalimumab and other biosimilars found that switching biosimilars was safe and effective. But if possible, patients should minimize the number of switches until more robust long-term data are available, added Dr. Oldfield.
If a patient is apprehensive about switching to a new therapy, “one may need to be cognizant of the ‘nocebo’ effect in which there is an unexplained or unfavorable therapeutic effect after switching,” he said.
Other gastroenterologists voiced similar reservations about switching. “I won’t use an adalimumab biosimilar unless the patient requests it, the insurance requires it, or there is a cost advantage for the patient such that they prefer it,” said Doug Wolf, MD, an Atlanta gastroenterologist.
“There is no medical treatment advantage to a biosimilar, especially if switching from Humira,” added Dr. Wolf.
Insurance will guide treatment
Once a drug is approved for use by the FDA, that drug will be available in all 50 states. “Different private insurance formularies, as well as state Medicaid formularies, might affect the actual ability of patients to receive such drugs,” said Mr. Newmark.
Patients should consult with their providers and insurance companies to see what therapies are available, he advised.
Dr. Hanauer anticipates some headaches arising for patients and doctors alike when negotiating for a specific drug.
Cyltezo may be the only biosimilar interchangeable with Humira, but the third-party pharmacy benefit manager (PBM) could negotiate for one of the noninterchangeable ones. “On a yearly basis they could switch their preference,” said Dr. Hanauer.
In the Cardinal Health survey, more than 60% of respondents said they would feel comfortable prescribing an adalimumab biosimilar only with an interchangeability designation.
A PBM may offer a patient Cyltezo if it’s cheaper than Humira. If the patient insists on staying on Humira, then they’ll have to pay more for that drug on their payer’s formulary, said Dr. Hanauer. In a worst-case scenario, a physician may have to appeal on a patient’s behalf to get Humira if the insurer offers only the biosimilar.
Taking that step to appeal is a major hassle for the physician, and leads to extra back door costs as well, said Dr. Hanauer.
Humira manufacturer AbbVie, in turn, may offer discounts and rebates to the PBMs to put Humira on their formulary. “That’s the AbbVie negotiating power. It’s not that the cost is going to be that much different. It’s going to be that there are rebates and discounts that are going to make the cost different,” he added.
As a community physician, Dr. Oldfield has specific concerns about accessibility.
The ever-increasing burden of insurance documentation and prior authorization means it can take weeks or months to get these medications approved. “The addition of new biosimilars is a welcome entrance if it can get patients the medications they need when they need it,” he said.
When it comes to prescribing biologics, many physicians rely on ancillary staff for assistance. It’s a team effort to sift through all the paperwork, observed Dr. Oldfield.
“While many community GI practices have specialized staff to deal with prior authorizations, they are still a far cry from the IBD [inflammatory bowel disease] academic centers where there are often pharmacists, nursing specialists, and home-monitoring programs to check in on patients,” he explained.
Landscape on cost is uncertain
At present, little is known about the cost of the biosimilars and impact on future drug pricing, said Dr. Oldfield.
At least for Medicare, Humira biosimilars will be considered Medicare Part D drugs if used for a medically accepted indication, said a spokesperson for the Centers for Medicare and Medicaid Services.
Part D sponsors (pharmacy and therapeutic committees) “will make the determination as to whether Amjevita and other products will be added to their formularies,” said the spokesperson.
Patients never saw a significant cost savings with Remicade biosimilars. “I imagine the same would be true with biosimilars for Humira,” said Dr. Regueiro. Patients may see greater access to these drugs, however, because the insurance plan or the pharmacy plan will make them more readily available, he added.
The hope is that, as biosimilars are introduced, the price of the originator biologic will go down, said Mr. Newmark. “Therefore, we can expect Humira to be offered at a lower price as it faces competition. Where it will sit in comparison to the forthcoming biosimilars will depend on how much biosimilar companies drop their price and how much pressure will be on PBMs and insurers to cover the lowest list price drug,” he said.
AbbVie did not respond to several requests for comment.
Charitable patient assistance programs for biosimilars or biologics can help offset the price of copayments, Mr. Newmark offered.
Ideally, insurers will offer designated biosimilars at a reduced or even no out-of-pocket expense on their formularies. This should lead to a decreased administrative burden for approval with streamlined (or even removal) of prior authorizations for certain medications, said Dr. Oldfield.
Without insurance or medication assistance programs, the cost of biosimilars is prohibitively expensive, he added.
“Biosimilars have higher research, development, and manufacturing costs than what people conventionally think of [for] a generic medication.”
Educating, advising patients
Dr. Oldfield advised that gastroenterologists refer to biologics by the generic name rather than branded name when initiating therapy unless there is a very specific reason not to. “This approach should make the process more streamlined and less subjected to quick denials for brand-only requests as biosimilars start to assume a larger market share,” he said.
Uptake of the Humira biosimilars also will depend on proper education of physicians and patients and their comfort level with the biosimilars, said Dr. Regueiro. Cleveland Clinic uses a team approach to educate on this topic, relying on pharmacists, clinicians, and nurses to explain that there’s no real difference between the reference drug and its biosimilars, based on efficacy and safety data.
Physicians can also direct patients to patient-friendly resources, said Mr. Newmark. “By starting the conversation early, it ensures that when/if the time comes that your patient is switched to or chooses a biosimilar they will feel more confident because they have the knowledge to make decisions about their care.”
The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars , is a free resource for patients, he added.
It’s important that doctors also understand these products so they can explain to their patients what to expect, said the FDA’s Dr. Yim. The FDA provides educational materials on its website, including a comprehensive curriculum toolkit.
Dr. Hanauer has served as a consultant for AbbVie, Amgen, American College of Gastroenterology, GlaxoSmithKline, American Gastroenterological Association, Pfizer, and a host of other companies . Dr. Regueiro has served on advisory boards and as a consultant for Abbvie, Janssen, UCB, Takeda, Pfizer, BMS, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET Pharma Solutions,Trellis, and Boehringer Ingelheim Pharmaceuticals. Dr. Wolf, Dr. Yim, Dr. Oldfield, and Mr. Newmark have no financial conflicts of interest.
Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars .
New influx of Humira biosimilars may not drive immediate change
Gastroenterologists in 2023 will have more tools in their arsenal to treat patients with Crohn’s disease or ulcerative colitis. As many as 8-10 adalimumab biosimilars are anticipated to come on the market this year, giving mainstay drug Humira some vigorous competition.
Three scenarios will drive adalimumab biosimilar initiation: Insurance preference for the initial treatment of a newly diagnosed condition, a change in a patient’s insurance plan, or an insurance-mandated switch, said Edward C. Oldfield IV, MD, assistant professor at Eastern Virginia Medical School’s division of gastroenterology in Norfolk.
“Outside of these scenarios, I would encourage patients to remain on their current biologic so long as cost and accessibility remain stable,” said Dr. Oldfield.
Many factors will contribute to the success of biosimilars. Will physicians be prescribing them? How are biosimilars placed on formularies and will they be given preferred status? How will manufacturers price their biosimilars? “We have to wait and see to get the answers to these questions,” said Steven Newmark, JD, MPA, chief legal officer and director of policy, Global Healthy Living Foundation/CreakyJoints, a nonprofit advocacy organization based in New York.
Prescribing biosimilars is no different than prescribing originator biologics, so providers should know how to use them, said Mr. Newmark. “Most important will be the availability of patient-friendly resources that providers can share with their patients to provide education about and confidence in using biosimilars,” he added.
Overall, biosimilars are a good thing, said Dr. Oldfield. “In the long run they should bring down costs and increase access to medications for our patients.”
Others are skeptical that the adalimumab biosimilars will save patients much money.
Biosimilar laws were created to lower costs. However, if a patient with insurance pays only $5 a month out of pocket for Humira – a drug that normally costs $7,000 without coverage – it’s unlikely they would want to switch unless there’s comparable savings from the biosimilar, said Stephen B. Hanauer, MD, medical director of the Digestive Health Center and professor of medicine at Northwestern Medicine, Northwestern University, Evanston, Ill.
Like generics, Humira biosimilars may face some initial backlash, said Dr. Hanauer.
2023 broadens scope of adalimumab treatments
The American Gastroenterological Association describes a biosimilar as something that’s “highly similar to, but not an exact copy of, a biologic reference product already approved” by the Food and Drug Administration. Congress under the 2010 Affordable Care Act created a special, abbreviated pathway to approval for biosimilars.
AbbVie’s Humira, the global revenue for which exceeded $20 billion in 2021, has long dominated the U.S. market on injectable treatments for autoimmune diseases. The popular drug faces some competition in 2023, however, following a series of legal settlements that allowed AbbVie competitors to release their own adalimumab biosimilars.
“So far, we haven’t seen biosimilars live up to their potential in the U.S. in the inflammatory space,” said Mr. Newmark. This may change, however. Previously, biosimilars have required infusion, which demanded more time, commitment, and travel from patients. “The new set of forthcoming Humira biosimilars are injectables, an administration method preferred by patients,” he said.
The FDA will approve a biosimilar if it determines that the biological product is highly similar to the reference product, and that there are no clinically meaningful differences between the biological and reference product in terms of the safety, purity, and potency of the product.
The agency to date has approved 8 adalimumab biosimilars. These include: Idacio (adalimumab-aacf, Fresenius Kabi); Amjevita (adalimumab-atto, Amgen); Hadlima (adalimumab-bwwd, Organon); Cyltezo (adalimumab-adbm, Boehringer Ingelheim); Yusimry (adalimumab-aqvh from Coherus BioSciences); Hulio (adalimumab-fkjp; Mylan/Fujifilm Kyowa Kirin Biologics); Hyrimoz (adalimumab-adaz, Sandoz), and Abrilada (adalimumab-afzb, Pfizer).
“While FDA doesn’t formally track when products come to market, we know based on published reports that application holders for many of the currently FDA-approved biosimilars plan to market this year, starting with Amjevita being the first adalimumab biosimilar launched” in January, said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the agency.
At press time, two other companies (Celltrion and Alvotech/Teva) were awaiting FDA approval for their adalimumab biosimilar drugs.
Among the eight approved drugs, Cyltezo is the only one that has a designation for interchangeability with Humira.
An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the prescriber – much like generics are substituted, depending on state laws, said Dr. Yim. “However, in terms of safety and effectiveness, FDA’s standards for approval mean that biosimilar or interchangeable biosimilar products can be used in place of the reference product they were compared to.”
FDA-approved biosimilars undergo a rigorous evaluation for safety, effectiveness, and quality for their approved conditions of use, she continued. “Therefore, patients and health care providers can rely on a biosimilar to be as safe and effective for its approved uses as the original biological product.”
Remicade as a yard stick
Gastroenterologists dealt with this situation once before, when Remicade (infliximab) biosimilars came on the market in 2016, noted Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic.
Remicade and Humira are both tumor necrosis factor inhibitors with the same mechanism of action and many of the same indications. “We already had that experience with Remicade and biosimilar switch 2 or 3 years ago. Now we’re talking about Humira,” said Dr. Regueiro.
Most GI doctors have prescribed one of the more common infliximab biosimilars (Inflectra or Renflexis), noted Dr. Oldfield.
Cardinal Health, which recently surveyed 300 gastroenterologists, rheumatologists, and dermatologists about adalimumab biosimilars, found that gastroenterologists had the highest comfort level in prescribing them. Their top concern, however, was changing a patient from adalimumab to an adalimumab biosimilar.
For most patients, Dr. Oldfield sees the Humira reference biologic and biosimilar as equivalent.
However, he said he would change a patient’s drug only if there were a good reason or if his hand was forced by insurance. He would not make the change for a patient who recently began induction with the reference biologic or a patient with highly active clinical disease.
“While there is limited data to support this, I would also have some qualms about changing a patient from reference biologic to a biosimilar if they previously had immune-mediated pharmacokinetic failure due to antibody development with a biologic and were currently doing well on their new biologic,” he said.
Those with a new ulcerative colitis or Crohn’s diagnosis who are initiating a biologic for the first time might consider a biosimilar. If a patient is transitioning from a reference biologic to a biosimilar, “I would want to make that change during a time of stable remission and with the recognition that the switch is not a temporary switch, but a long-term switch,” he continued.
A paper that reviewed 23 observational studies of adalimumab and other biosimilars found that switching biosimilars was safe and effective. But if possible, patients should minimize the number of switches until more robust long-term data are available, added Dr. Oldfield.
If a patient is apprehensive about switching to a new therapy, “one may need to be cognizant of the ‘nocebo’ effect in which there is an unexplained or unfavorable therapeutic effect after switching,” he said.
Other gastroenterologists voiced similar reservations about switching. “I won’t use an adalimumab biosimilar unless the patient requests it, the insurance requires it, or there is a cost advantage for the patient such that they prefer it,” said Doug Wolf, MD, an Atlanta gastroenterologist.
“There is no medical treatment advantage to a biosimilar, especially if switching from Humira,” added Dr. Wolf.
Insurance will guide treatment
Once a drug is approved for use by the FDA, that drug will be available in all 50 states. “Different private insurance formularies, as well as state Medicaid formularies, might affect the actual ability of patients to receive such drugs,” said Mr. Newmark.
Patients should consult with their providers and insurance companies to see what therapies are available, he advised.
Dr. Hanauer anticipates some headaches arising for patients and doctors alike when negotiating for a specific drug.
Cyltezo may be the only biosimilar interchangeable with Humira, but the third-party pharmacy benefit manager (PBM) could negotiate for one of the noninterchangeable ones. “On a yearly basis they could switch their preference,” said Dr. Hanauer.
In the Cardinal Health survey, more than 60% of respondents said they would feel comfortable prescribing an adalimumab biosimilar only with an interchangeability designation.
A PBM may offer a patient Cyltezo if it’s cheaper than Humira. If the patient insists on staying on Humira, then they’ll have to pay more for that drug on their payer’s formulary, said Dr. Hanauer. In a worst-case scenario, a physician may have to appeal on a patient’s behalf to get Humira if the insurer offers only the biosimilar.
Taking that step to appeal is a major hassle for the physician, and leads to extra back door costs as well, said Dr. Hanauer.
Humira manufacturer AbbVie, in turn, may offer discounts and rebates to the PBMs to put Humira on their formulary. “That’s the AbbVie negotiating power. It’s not that the cost is going to be that much different. It’s going to be that there are rebates and discounts that are going to make the cost different,” he added.
As a community physician, Dr. Oldfield has specific concerns about accessibility.
The ever-increasing burden of insurance documentation and prior authorization means it can take weeks or months to get these medications approved. “The addition of new biosimilars is a welcome entrance if it can get patients the medications they need when they need it,” he said.
When it comes to prescribing biologics, many physicians rely on ancillary staff for assistance. It’s a team effort to sift through all the paperwork, observed Dr. Oldfield.
“While many community GI practices have specialized staff to deal with prior authorizations, they are still a far cry from the IBD [inflammatory bowel disease] academic centers where there are often pharmacists, nursing specialists, and home-monitoring programs to check in on patients,” he explained.
Landscape on cost is uncertain
At present, little is known about the cost of the biosimilars and impact on future drug pricing, said Dr. Oldfield.
At least for Medicare, Humira biosimilars will be considered Medicare Part D drugs if used for a medically accepted indication, said a spokesperson for the Centers for Medicare and Medicaid Services.
Part D sponsors (pharmacy and therapeutic committees) “will make the determination as to whether Amjevita and other products will be added to their formularies,” said the spokesperson.
Patients never saw a significant cost savings with Remicade biosimilars. “I imagine the same would be true with biosimilars for Humira,” said Dr. Regueiro. Patients may see greater access to these drugs, however, because the insurance plan or the pharmacy plan will make them more readily available, he added.
The hope is that, as biosimilars are introduced, the price of the originator biologic will go down, said Mr. Newmark. “Therefore, we can expect Humira to be offered at a lower price as it faces competition. Where it will sit in comparison to the forthcoming biosimilars will depend on how much biosimilar companies drop their price and how much pressure will be on PBMs and insurers to cover the lowest list price drug,” he said.
AbbVie did not respond to several requests for comment.
Charitable patient assistance programs for biosimilars or biologics can help offset the price of copayments, Mr. Newmark offered.
Ideally, insurers will offer designated biosimilars at a reduced or even no out-of-pocket expense on their formularies. This should lead to a decreased administrative burden for approval with streamlined (or even removal) of prior authorizations for certain medications, said Dr. Oldfield.
Without insurance or medication assistance programs, the cost of biosimilars is prohibitively expensive, he added.
“Biosimilars have higher research, development, and manufacturing costs than what people conventionally think of [for] a generic medication.”
Educating, advising patients
Dr. Oldfield advised that gastroenterologists refer to biologics by the generic name rather than branded name when initiating therapy unless there is a very specific reason not to. “This approach should make the process more streamlined and less subjected to quick denials for brand-only requests as biosimilars start to assume a larger market share,” he said.
Uptake of the Humira biosimilars also will depend on proper education of physicians and patients and their comfort level with the biosimilars, said Dr. Regueiro. Cleveland Clinic uses a team approach to educate on this topic, relying on pharmacists, clinicians, and nurses to explain that there’s no real difference between the reference drug and its biosimilars, based on efficacy and safety data.
Physicians can also direct patients to patient-friendly resources, said Mr. Newmark. “By starting the conversation early, it ensures that when/if the time comes that your patient is switched to or chooses a biosimilar they will feel more confident because they have the knowledge to make decisions about their care.”
The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars , is a free resource for patients, he added.
It’s important that doctors also understand these products so they can explain to their patients what to expect, said the FDA’s Dr. Yim. The FDA provides educational materials on its website, including a comprehensive curriculum toolkit.
Dr. Hanauer has served as a consultant for AbbVie, Amgen, American College of Gastroenterology, GlaxoSmithKline, American Gastroenterological Association, Pfizer, and a host of other companies . Dr. Regueiro has served on advisory boards and as a consultant for Abbvie, Janssen, UCB, Takeda, Pfizer, BMS, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET Pharma Solutions,Trellis, and Boehringer Ingelheim Pharmaceuticals. Dr. Wolf, Dr. Yim, Dr. Oldfield, and Mr. Newmark have no financial conflicts of interest.
Gastroenterologists in 2023 will have more tools in their arsenal to treat patients with Crohn’s disease or ulcerative colitis. As many as 8-10 adalimumab biosimilars are anticipated to come on the market this year, giving mainstay drug Humira some vigorous competition.
Three scenarios will drive adalimumab biosimilar initiation: Insurance preference for the initial treatment of a newly diagnosed condition, a change in a patient’s insurance plan, or an insurance-mandated switch, said Edward C. Oldfield IV, MD, assistant professor at Eastern Virginia Medical School’s division of gastroenterology in Norfolk.
“Outside of these scenarios, I would encourage patients to remain on their current biologic so long as cost and accessibility remain stable,” said Dr. Oldfield.
Many factors will contribute to the success of biosimilars. Will physicians be prescribing them? How are biosimilars placed on formularies and will they be given preferred status? How will manufacturers price their biosimilars? “We have to wait and see to get the answers to these questions,” said Steven Newmark, JD, MPA, chief legal officer and director of policy, Global Healthy Living Foundation/CreakyJoints, a nonprofit advocacy organization based in New York.
Prescribing biosimilars is no different than prescribing originator biologics, so providers should know how to use them, said Mr. Newmark. “Most important will be the availability of patient-friendly resources that providers can share with their patients to provide education about and confidence in using biosimilars,” he added.
Overall, biosimilars are a good thing, said Dr. Oldfield. “In the long run they should bring down costs and increase access to medications for our patients.”
Others are skeptical that the adalimumab biosimilars will save patients much money.
Biosimilar laws were created to lower costs. However, if a patient with insurance pays only $5 a month out of pocket for Humira – a drug that normally costs $7,000 without coverage – it’s unlikely they would want to switch unless there’s comparable savings from the biosimilar, said Stephen B. Hanauer, MD, medical director of the Digestive Health Center and professor of medicine at Northwestern Medicine, Northwestern University, Evanston, Ill.
Like generics, Humira biosimilars may face some initial backlash, said Dr. Hanauer.
2023 broadens scope of adalimumab treatments
The American Gastroenterological Association describes a biosimilar as something that’s “highly similar to, but not an exact copy of, a biologic reference product already approved” by the Food and Drug Administration. Congress under the 2010 Affordable Care Act created a special, abbreviated pathway to approval for biosimilars.
AbbVie’s Humira, the global revenue for which exceeded $20 billion in 2021, has long dominated the U.S. market on injectable treatments for autoimmune diseases. The popular drug faces some competition in 2023, however, following a series of legal settlements that allowed AbbVie competitors to release their own adalimumab biosimilars.
“So far, we haven’t seen biosimilars live up to their potential in the U.S. in the inflammatory space,” said Mr. Newmark. This may change, however. Previously, biosimilars have required infusion, which demanded more time, commitment, and travel from patients. “The new set of forthcoming Humira biosimilars are injectables, an administration method preferred by patients,” he said.
The FDA will approve a biosimilar if it determines that the biological product is highly similar to the reference product, and that there are no clinically meaningful differences between the biological and reference product in terms of the safety, purity, and potency of the product.
The agency to date has approved 8 adalimumab biosimilars. These include: Idacio (adalimumab-aacf, Fresenius Kabi); Amjevita (adalimumab-atto, Amgen); Hadlima (adalimumab-bwwd, Organon); Cyltezo (adalimumab-adbm, Boehringer Ingelheim); Yusimry (adalimumab-aqvh from Coherus BioSciences); Hulio (adalimumab-fkjp; Mylan/Fujifilm Kyowa Kirin Biologics); Hyrimoz (adalimumab-adaz, Sandoz), and Abrilada (adalimumab-afzb, Pfizer).
“While FDA doesn’t formally track when products come to market, we know based on published reports that application holders for many of the currently FDA-approved biosimilars plan to market this year, starting with Amjevita being the first adalimumab biosimilar launched” in January, said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the agency.
At press time, two other companies (Celltrion and Alvotech/Teva) were awaiting FDA approval for their adalimumab biosimilar drugs.
Among the eight approved drugs, Cyltezo is the only one that has a designation for interchangeability with Humira.
An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the prescriber – much like generics are substituted, depending on state laws, said Dr. Yim. “However, in terms of safety and effectiveness, FDA’s standards for approval mean that biosimilar or interchangeable biosimilar products can be used in place of the reference product they were compared to.”
FDA-approved biosimilars undergo a rigorous evaluation for safety, effectiveness, and quality for their approved conditions of use, she continued. “Therefore, patients and health care providers can rely on a biosimilar to be as safe and effective for its approved uses as the original biological product.”
Remicade as a yard stick
Gastroenterologists dealt with this situation once before, when Remicade (infliximab) biosimilars came on the market in 2016, noted Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic.
Remicade and Humira are both tumor necrosis factor inhibitors with the same mechanism of action and many of the same indications. “We already had that experience with Remicade and biosimilar switch 2 or 3 years ago. Now we’re talking about Humira,” said Dr. Regueiro.
Most GI doctors have prescribed one of the more common infliximab biosimilars (Inflectra or Renflexis), noted Dr. Oldfield.
Cardinal Health, which recently surveyed 300 gastroenterologists, rheumatologists, and dermatologists about adalimumab biosimilars, found that gastroenterologists had the highest comfort level in prescribing them. Their top concern, however, was changing a patient from adalimumab to an adalimumab biosimilar.
For most patients, Dr. Oldfield sees the Humira reference biologic and biosimilar as equivalent.
However, he said he would change a patient’s drug only if there were a good reason or if his hand was forced by insurance. He would not make the change for a patient who recently began induction with the reference biologic or a patient with highly active clinical disease.
“While there is limited data to support this, I would also have some qualms about changing a patient from reference biologic to a biosimilar if they previously had immune-mediated pharmacokinetic failure due to antibody development with a biologic and were currently doing well on their new biologic,” he said.
Those with a new ulcerative colitis or Crohn’s diagnosis who are initiating a biologic for the first time might consider a biosimilar. If a patient is transitioning from a reference biologic to a biosimilar, “I would want to make that change during a time of stable remission and with the recognition that the switch is not a temporary switch, but a long-term switch,” he continued.
A paper that reviewed 23 observational studies of adalimumab and other biosimilars found that switching biosimilars was safe and effective. But if possible, patients should minimize the number of switches until more robust long-term data are available, added Dr. Oldfield.
If a patient is apprehensive about switching to a new therapy, “one may need to be cognizant of the ‘nocebo’ effect in which there is an unexplained or unfavorable therapeutic effect after switching,” he said.
Other gastroenterologists voiced similar reservations about switching. “I won’t use an adalimumab biosimilar unless the patient requests it, the insurance requires it, or there is a cost advantage for the patient such that they prefer it,” said Doug Wolf, MD, an Atlanta gastroenterologist.
“There is no medical treatment advantage to a biosimilar, especially if switching from Humira,” added Dr. Wolf.
Insurance will guide treatment
Once a drug is approved for use by the FDA, that drug will be available in all 50 states. “Different private insurance formularies, as well as state Medicaid formularies, might affect the actual ability of patients to receive such drugs,” said Mr. Newmark.
Patients should consult with their providers and insurance companies to see what therapies are available, he advised.
Dr. Hanauer anticipates some headaches arising for patients and doctors alike when negotiating for a specific drug.
Cyltezo may be the only biosimilar interchangeable with Humira, but the third-party pharmacy benefit manager (PBM) could negotiate for one of the noninterchangeable ones. “On a yearly basis they could switch their preference,” said Dr. Hanauer.
In the Cardinal Health survey, more than 60% of respondents said they would feel comfortable prescribing an adalimumab biosimilar only with an interchangeability designation.
A PBM may offer a patient Cyltezo if it’s cheaper than Humira. If the patient insists on staying on Humira, then they’ll have to pay more for that drug on their payer’s formulary, said Dr. Hanauer. In a worst-case scenario, a physician may have to appeal on a patient’s behalf to get Humira if the insurer offers only the biosimilar.
Taking that step to appeal is a major hassle for the physician, and leads to extra back door costs as well, said Dr. Hanauer.
Humira manufacturer AbbVie, in turn, may offer discounts and rebates to the PBMs to put Humira on their formulary. “That’s the AbbVie negotiating power. It’s not that the cost is going to be that much different. It’s going to be that there are rebates and discounts that are going to make the cost different,” he added.
As a community physician, Dr. Oldfield has specific concerns about accessibility.
The ever-increasing burden of insurance documentation and prior authorization means it can take weeks or months to get these medications approved. “The addition of new biosimilars is a welcome entrance if it can get patients the medications they need when they need it,” he said.
When it comes to prescribing biologics, many physicians rely on ancillary staff for assistance. It’s a team effort to sift through all the paperwork, observed Dr. Oldfield.
“While many community GI practices have specialized staff to deal with prior authorizations, they are still a far cry from the IBD [inflammatory bowel disease] academic centers where there are often pharmacists, nursing specialists, and home-monitoring programs to check in on patients,” he explained.
Landscape on cost is uncertain
At present, little is known about the cost of the biosimilars and impact on future drug pricing, said Dr. Oldfield.
At least for Medicare, Humira biosimilars will be considered Medicare Part D drugs if used for a medically accepted indication, said a spokesperson for the Centers for Medicare and Medicaid Services.
Part D sponsors (pharmacy and therapeutic committees) “will make the determination as to whether Amjevita and other products will be added to their formularies,” said the spokesperson.
Patients never saw a significant cost savings with Remicade biosimilars. “I imagine the same would be true with biosimilars for Humira,” said Dr. Regueiro. Patients may see greater access to these drugs, however, because the insurance plan or the pharmacy plan will make them more readily available, he added.
The hope is that, as biosimilars are introduced, the price of the originator biologic will go down, said Mr. Newmark. “Therefore, we can expect Humira to be offered at a lower price as it faces competition. Where it will sit in comparison to the forthcoming biosimilars will depend on how much biosimilar companies drop their price and how much pressure will be on PBMs and insurers to cover the lowest list price drug,” he said.
AbbVie did not respond to several requests for comment.
Charitable patient assistance programs for biosimilars or biologics can help offset the price of copayments, Mr. Newmark offered.
Ideally, insurers will offer designated biosimilars at a reduced or even no out-of-pocket expense on their formularies. This should lead to a decreased administrative burden for approval with streamlined (or even removal) of prior authorizations for certain medications, said Dr. Oldfield.
Without insurance or medication assistance programs, the cost of biosimilars is prohibitively expensive, he added.
“Biosimilars have higher research, development, and manufacturing costs than what people conventionally think of [for] a generic medication.”
Educating, advising patients
Dr. Oldfield advised that gastroenterologists refer to biologics by the generic name rather than branded name when initiating therapy unless there is a very specific reason not to. “This approach should make the process more streamlined and less subjected to quick denials for brand-only requests as biosimilars start to assume a larger market share,” he said.
Uptake of the Humira biosimilars also will depend on proper education of physicians and patients and their comfort level with the biosimilars, said Dr. Regueiro. Cleveland Clinic uses a team approach to educate on this topic, relying on pharmacists, clinicians, and nurses to explain that there’s no real difference between the reference drug and its biosimilars, based on efficacy and safety data.
Physicians can also direct patients to patient-friendly resources, said Mr. Newmark. “By starting the conversation early, it ensures that when/if the time comes that your patient is switched to or chooses a biosimilar they will feel more confident because they have the knowledge to make decisions about their care.”
The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars , is a free resource for patients, he added.
It’s important that doctors also understand these products so they can explain to their patients what to expect, said the FDA’s Dr. Yim. The FDA provides educational materials on its website, including a comprehensive curriculum toolkit.
Dr. Hanauer has served as a consultant for AbbVie, Amgen, American College of Gastroenterology, GlaxoSmithKline, American Gastroenterological Association, Pfizer, and a host of other companies . Dr. Regueiro has served on advisory boards and as a consultant for Abbvie, Janssen, UCB, Takeda, Pfizer, BMS, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET Pharma Solutions,Trellis, and Boehringer Ingelheim Pharmaceuticals. Dr. Wolf, Dr. Yim, Dr. Oldfield, and Mr. Newmark have no financial conflicts of interest.
Gastroenterologists in 2023 will have more tools in their arsenal to treat patients with Crohn’s disease or ulcerative colitis. As many as 8-10 adalimumab biosimilars are anticipated to come on the market this year, giving mainstay drug Humira some vigorous competition.
Three scenarios will drive adalimumab biosimilar initiation: Insurance preference for the initial treatment of a newly diagnosed condition, a change in a patient’s insurance plan, or an insurance-mandated switch, said Edward C. Oldfield IV, MD, assistant professor at Eastern Virginia Medical School’s division of gastroenterology in Norfolk.
“Outside of these scenarios, I would encourage patients to remain on their current biologic so long as cost and accessibility remain stable,” said Dr. Oldfield.
Many factors will contribute to the success of biosimilars. Will physicians be prescribing them? How are biosimilars placed on formularies and will they be given preferred status? How will manufacturers price their biosimilars? “We have to wait and see to get the answers to these questions,” said Steven Newmark, JD, MPA, chief legal officer and director of policy, Global Healthy Living Foundation/CreakyJoints, a nonprofit advocacy organization based in New York.
Prescribing biosimilars is no different than prescribing originator biologics, so providers should know how to use them, said Mr. Newmark. “Most important will be the availability of patient-friendly resources that providers can share with their patients to provide education about and confidence in using biosimilars,” he added.
Overall, biosimilars are a good thing, said Dr. Oldfield. “In the long run they should bring down costs and increase access to medications for our patients.”
Others are skeptical that the adalimumab biosimilars will save patients much money.
Biosimilar laws were created to lower costs. However, if a patient with insurance pays only $5 a month out of pocket for Humira – a drug that normally costs $7,000 without coverage – it’s unlikely they would want to switch unless there’s comparable savings from the biosimilar, said Stephen B. Hanauer, MD, medical director of the Digestive Health Center and professor of medicine at Northwestern Medicine, Northwestern University, Evanston, Ill.
Like generics, Humira biosimilars may face some initial backlash, said Dr. Hanauer.
2023 broadens scope of adalimumab treatments
The American Gastroenterological Association describes a biosimilar as something that’s “highly similar to, but not an exact copy of, a biologic reference product already approved” by the Food and Drug Administration. Congress under the 2010 Affordable Care Act created a special, abbreviated pathway to approval for biosimilars.
AbbVie’s Humira, the global revenue for which exceeded $20 billion in 2021, has long dominated the U.S. market on injectable treatments for autoimmune diseases. The popular drug faces some competition in 2023, however, following a series of legal settlements that allowed AbbVie competitors to release their own adalimumab biosimilars.
“So far, we haven’t seen biosimilars live up to their potential in the U.S. in the inflammatory space,” said Mr. Newmark. This may change, however. Previously, biosimilars have required infusion, which demanded more time, commitment, and travel from patients. “The new set of forthcoming Humira biosimilars are injectables, an administration method preferred by patients,” he said.
The FDA will approve a biosimilar if it determines that the biological product is highly similar to the reference product, and that there are no clinically meaningful differences between the biological and reference product in terms of the safety, purity, and potency of the product.
The agency to date has approved 8 adalimumab biosimilars. These include: Idacio (adalimumab-aacf, Fresenius Kabi); Amjevita (adalimumab-atto, Amgen); Hadlima (adalimumab-bwwd, Organon); Cyltezo (adalimumab-adbm, Boehringer Ingelheim); Yusimry (adalimumab-aqvh from Coherus BioSciences); Hulio (adalimumab-fkjp; Mylan/Fujifilm Kyowa Kirin Biologics); Hyrimoz (adalimumab-adaz, Sandoz), and Abrilada (adalimumab-afzb, Pfizer).
“While FDA doesn’t formally track when products come to market, we know based on published reports that application holders for many of the currently FDA-approved biosimilars plan to market this year, starting with Amjevita being the first adalimumab biosimilar launched” in January, said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars at the agency.
At press time, two other companies (Celltrion and Alvotech/Teva) were awaiting FDA approval for their adalimumab biosimilar drugs.
Among the eight approved drugs, Cyltezo is the only one that has a designation for interchangeability with Humira.
An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the prescriber – much like generics are substituted, depending on state laws, said Dr. Yim. “However, in terms of safety and effectiveness, FDA’s standards for approval mean that biosimilar or interchangeable biosimilar products can be used in place of the reference product they were compared to.”
FDA-approved biosimilars undergo a rigorous evaluation for safety, effectiveness, and quality for their approved conditions of use, she continued. “Therefore, patients and health care providers can rely on a biosimilar to be as safe and effective for its approved uses as the original biological product.”
Remicade as a yard stick
Gastroenterologists dealt with this situation once before, when Remicade (infliximab) biosimilars came on the market in 2016, noted Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic.
Remicade and Humira are both tumor necrosis factor inhibitors with the same mechanism of action and many of the same indications. “We already had that experience with Remicade and biosimilar switch 2 or 3 years ago. Now we’re talking about Humira,” said Dr. Regueiro.
Most GI doctors have prescribed one of the more common infliximab biosimilars (Inflectra or Renflexis), noted Dr. Oldfield.
Cardinal Health, which recently surveyed 300 gastroenterologists, rheumatologists, and dermatologists about adalimumab biosimilars, found that gastroenterologists had the highest comfort level in prescribing them. Their top concern, however, was changing a patient from adalimumab to an adalimumab biosimilar.
For most patients, Dr. Oldfield sees the Humira reference biologic and biosimilar as equivalent.
However, he said he would change a patient’s drug only if there were a good reason or if his hand was forced by insurance. He would not make the change for a patient who recently began induction with the reference biologic or a patient with highly active clinical disease.
“While there is limited data to support this, I would also have some qualms about changing a patient from reference biologic to a biosimilar if they previously had immune-mediated pharmacokinetic failure due to antibody development with a biologic and were currently doing well on their new biologic,” he said.
Those with a new ulcerative colitis or Crohn’s diagnosis who are initiating a biologic for the first time might consider a biosimilar. If a patient is transitioning from a reference biologic to a biosimilar, “I would want to make that change during a time of stable remission and with the recognition that the switch is not a temporary switch, but a long-term switch,” he continued.
A paper that reviewed 23 observational studies of adalimumab and other biosimilars found that switching biosimilars was safe and effective. But if possible, patients should minimize the number of switches until more robust long-term data are available, added Dr. Oldfield.
If a patient is apprehensive about switching to a new therapy, “one may need to be cognizant of the ‘nocebo’ effect in which there is an unexplained or unfavorable therapeutic effect after switching,” he said.
Other gastroenterologists voiced similar reservations about switching. “I won’t use an adalimumab biosimilar unless the patient requests it, the insurance requires it, or there is a cost advantage for the patient such that they prefer it,” said Doug Wolf, MD, an Atlanta gastroenterologist.
“There is no medical treatment advantage to a biosimilar, especially if switching from Humira,” added Dr. Wolf.
Insurance will guide treatment
Once a drug is approved for use by the FDA, that drug will be available in all 50 states. “Different private insurance formularies, as well as state Medicaid formularies, might affect the actual ability of patients to receive such drugs,” said Mr. Newmark.
Patients should consult with their providers and insurance companies to see what therapies are available, he advised.
Dr. Hanauer anticipates some headaches arising for patients and doctors alike when negotiating for a specific drug.
Cyltezo may be the only biosimilar interchangeable with Humira, but the third-party pharmacy benefit manager (PBM) could negotiate for one of the noninterchangeable ones. “On a yearly basis they could switch their preference,” said Dr. Hanauer.
In the Cardinal Health survey, more than 60% of respondents said they would feel comfortable prescribing an adalimumab biosimilar only with an interchangeability designation.
A PBM may offer a patient Cyltezo if it’s cheaper than Humira. If the patient insists on staying on Humira, then they’ll have to pay more for that drug on their payer’s formulary, said Dr. Hanauer. In a worst-case scenario, a physician may have to appeal on a patient’s behalf to get Humira if the insurer offers only the biosimilar.
Taking that step to appeal is a major hassle for the physician, and leads to extra back door costs as well, said Dr. Hanauer.
Humira manufacturer AbbVie, in turn, may offer discounts and rebates to the PBMs to put Humira on their formulary. “That’s the AbbVie negotiating power. It’s not that the cost is going to be that much different. It’s going to be that there are rebates and discounts that are going to make the cost different,” he added.
As a community physician, Dr. Oldfield has specific concerns about accessibility.
The ever-increasing burden of insurance documentation and prior authorization means it can take weeks or months to get these medications approved. “The addition of new biosimilars is a welcome entrance if it can get patients the medications they need when they need it,” he said.
When it comes to prescribing biologics, many physicians rely on ancillary staff for assistance. It’s a team effort to sift through all the paperwork, observed Dr. Oldfield.
“While many community GI practices have specialized staff to deal with prior authorizations, they are still a far cry from the IBD [inflammatory bowel disease] academic centers where there are often pharmacists, nursing specialists, and home-monitoring programs to check in on patients,” he explained.
Landscape on cost is uncertain
At present, little is known about the cost of the biosimilars and impact on future drug pricing, said Dr. Oldfield.
At least for Medicare, Humira biosimilars will be considered Medicare Part D drugs if used for a medically accepted indication, said a spokesperson for the Centers for Medicare and Medicaid Services.
Part D sponsors (pharmacy and therapeutic committees) “will make the determination as to whether Amjevita and other products will be added to their formularies,” said the spokesperson.
Patients never saw a significant cost savings with Remicade biosimilars. “I imagine the same would be true with biosimilars for Humira,” said Dr. Regueiro. Patients may see greater access to these drugs, however, because the insurance plan or the pharmacy plan will make them more readily available, he added.
The hope is that, as biosimilars are introduced, the price of the originator biologic will go down, said Mr. Newmark. “Therefore, we can expect Humira to be offered at a lower price as it faces competition. Where it will sit in comparison to the forthcoming biosimilars will depend on how much biosimilar companies drop their price and how much pressure will be on PBMs and insurers to cover the lowest list price drug,” he said.
AbbVie did not respond to several requests for comment.
Charitable patient assistance programs for biosimilars or biologics can help offset the price of copayments, Mr. Newmark offered.
Ideally, insurers will offer designated biosimilars at a reduced or even no out-of-pocket expense on their formularies. This should lead to a decreased administrative burden for approval with streamlined (or even removal) of prior authorizations for certain medications, said Dr. Oldfield.
Without insurance or medication assistance programs, the cost of biosimilars is prohibitively expensive, he added.
“Biosimilars have higher research, development, and manufacturing costs than what people conventionally think of [for] a generic medication.”
Educating, advising patients
Dr. Oldfield advised that gastroenterologists refer to biologics by the generic name rather than branded name when initiating therapy unless there is a very specific reason not to. “This approach should make the process more streamlined and less subjected to quick denials for brand-only requests as biosimilars start to assume a larger market share,” he said.
Uptake of the Humira biosimilars also will depend on proper education of physicians and patients and their comfort level with the biosimilars, said Dr. Regueiro. Cleveland Clinic uses a team approach to educate on this topic, relying on pharmacists, clinicians, and nurses to explain that there’s no real difference between the reference drug and its biosimilars, based on efficacy and safety data.
Physicians can also direct patients to patient-friendly resources, said Mr. Newmark. “By starting the conversation early, it ensures that when/if the time comes that your patient is switched to or chooses a biosimilar they will feel more confident because they have the knowledge to make decisions about their care.”
The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars , is a free resource for patients, he added.
It’s important that doctors also understand these products so they can explain to their patients what to expect, said the FDA’s Dr. Yim. The FDA provides educational materials on its website, including a comprehensive curriculum toolkit.
Dr. Hanauer has served as a consultant for AbbVie, Amgen, American College of Gastroenterology, GlaxoSmithKline, American Gastroenterological Association, Pfizer, and a host of other companies . Dr. Regueiro has served on advisory boards and as a consultant for Abbvie, Janssen, UCB, Takeda, Pfizer, BMS, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET Pharma Solutions,Trellis, and Boehringer Ingelheim Pharmaceuticals. Dr. Wolf, Dr. Yim, Dr. Oldfield, and Mr. Newmark have no financial conflicts of interest.
Setting higher standards for digital health technologies
“It’s influenced the way I see medicine and the work that I do around identifying quality, not in the conventional context in a hospital or a clinic, but applying that lens to the world of technology,” said Dr. Mathews, assistant professor of medicine at Johns Hopkins Medicine in Baltimore.
Bringing greater visibility to digital health technologies is part of his life’s work.
“There is now an expectation that high quality must be part of the development process of these new technologies,” said Dr. Mathews.
In particular, he’d like to see noninvasive diagnostic technologies in the gastroenterology world become more patient-centric.
Bringing somebody into the hospital is often inconvenient and disruptive. The field is heading toward technologies that can be used in the home or in an outpatient setting. “I have some research in that area, and I’d love to see it ultimately reach the patient at the bedside, if possible.”
Dr. Mathews is a member of the AGA Center for GI Innovation and Technology and a previous mentee in the Future Leaders Program.
In an interview, Dr. Mathews discussed his push to validate health technologies in the GI field and to make them more transparent to physicians and patients.
Question: Why did you choose GI?
Answer: I think the world of gastroenterology offers a tremendous amount of diversity in the way we manage and treat patients. There’s a huge spectrum of disease. There’s also the procedural aspect, which is very different from a lot of other medical specialties. For me particularly, there’s the opportunity to work on technology as it relates to GI, as well as research in that space.
Q: It seems like gastroenterology involves a lot of detective work. Would you say that’s true?
A: When you think of something like abdominal pain or GI symptoms, any place in the body can cause those symptoms to be present. You have to think broadly about all of the contributing factors, the whole patient as it relates to travel, pets, exposures, food, diet. You really can’t be myopic when you think about all the potential causes.
The name of the game is to provide answers whenever possible, but I will settle for getting someone feeling better, even if we don’t have the answer etched in stone.
Q: What gives you the most joy in your day-to-day practice?
A: I work in an academic institution at Johns Hopkins. I really enjoy the direct connection with patients. I’ve switched mostly to a hospital-based practice, which means I’m getting patients at their sickest. It’s really a privilege to provide an opportunity for improvement or support in that context. I also enjoy the teaching and training of the next generation of folks that are going into this field. There’s so much to learn, and I think trying to set that example and teach by doing is a great opportunity, and I really enjoy that as well.
Q: Describe your biggest practice-related challenge and what you’re doing to address it.A: One of my focus areas on the research front is about providing greater transparency and validation around health technologies. How do patients know which health technologies to use? How do doctors know which ones to recommend or advocate for?
Q: Can you give an example of a technology of concern?
A: Looking at oncology and mobile apps, one study I coauthored in 2021 found that well over half did not meet physician or patient expectations. These were the most popular and highest rated apps available at the time. It shows that there’s a real disconnect between what the end users – the doctors and the patients – want from these solutions and what’s actually being provided.
There’s a flood of different solutions that are out there, and there really isn’t a streamlined way to know, as a clinician or as a patient, which ones really make a difference clinically and which ones are going to be helpful for you. And that’s been the focus of my research – understanding ways to evaluate technologies that are not so burdensome as to be purely in the realm of academics, but to be pragmatic.
Q: Who has had the strongest influence on your life?
A: I would say my spouse. She’s an academic physician at Hopkins. One of the things she has shown me is the importance of finding alignment in what you do professionally with the sort of goals that you have or the values that you hold as an individual. That’s why I’ve done some nontraditional things in my academic career. It’s really been in search of finding that alignment that matches my interests and goals, as opposed to just doing something because it’s a popular thing to do.
Lightning Round
Favorite sport: Soccer
What song do you have to sing along with when you hear it? 80s pop music
Introvert or extrovert? Introvert
Favorite holiday: Christmas
Optimist or pessimist? Realist
Dr. Mathews is on LinkedIn . His health tech blog is Digital Differential.
“It’s influenced the way I see medicine and the work that I do around identifying quality, not in the conventional context in a hospital or a clinic, but applying that lens to the world of technology,” said Dr. Mathews, assistant professor of medicine at Johns Hopkins Medicine in Baltimore.
Bringing greater visibility to digital health technologies is part of his life’s work.
“There is now an expectation that high quality must be part of the development process of these new technologies,” said Dr. Mathews.
In particular, he’d like to see noninvasive diagnostic technologies in the gastroenterology world become more patient-centric.
Bringing somebody into the hospital is often inconvenient and disruptive. The field is heading toward technologies that can be used in the home or in an outpatient setting. “I have some research in that area, and I’d love to see it ultimately reach the patient at the bedside, if possible.”
Dr. Mathews is a member of the AGA Center for GI Innovation and Technology and a previous mentee in the Future Leaders Program.
In an interview, Dr. Mathews discussed his push to validate health technologies in the GI field and to make them more transparent to physicians and patients.
Question: Why did you choose GI?
Answer: I think the world of gastroenterology offers a tremendous amount of diversity in the way we manage and treat patients. There’s a huge spectrum of disease. There’s also the procedural aspect, which is very different from a lot of other medical specialties. For me particularly, there’s the opportunity to work on technology as it relates to GI, as well as research in that space.
Q: It seems like gastroenterology involves a lot of detective work. Would you say that’s true?
A: When you think of something like abdominal pain or GI symptoms, any place in the body can cause those symptoms to be present. You have to think broadly about all of the contributing factors, the whole patient as it relates to travel, pets, exposures, food, diet. You really can’t be myopic when you think about all the potential causes.
The name of the game is to provide answers whenever possible, but I will settle for getting someone feeling better, even if we don’t have the answer etched in stone.
Q: What gives you the most joy in your day-to-day practice?
A: I work in an academic institution at Johns Hopkins. I really enjoy the direct connection with patients. I’ve switched mostly to a hospital-based practice, which means I’m getting patients at their sickest. It’s really a privilege to provide an opportunity for improvement or support in that context. I also enjoy the teaching and training of the next generation of folks that are going into this field. There’s so much to learn, and I think trying to set that example and teach by doing is a great opportunity, and I really enjoy that as well.
Q: Describe your biggest practice-related challenge and what you’re doing to address it.A: One of my focus areas on the research front is about providing greater transparency and validation around health technologies. How do patients know which health technologies to use? How do doctors know which ones to recommend or advocate for?
Q: Can you give an example of a technology of concern?
A: Looking at oncology and mobile apps, one study I coauthored in 2021 found that well over half did not meet physician or patient expectations. These were the most popular and highest rated apps available at the time. It shows that there’s a real disconnect between what the end users – the doctors and the patients – want from these solutions and what’s actually being provided.
There’s a flood of different solutions that are out there, and there really isn’t a streamlined way to know, as a clinician or as a patient, which ones really make a difference clinically and which ones are going to be helpful for you. And that’s been the focus of my research – understanding ways to evaluate technologies that are not so burdensome as to be purely in the realm of academics, but to be pragmatic.
Q: Who has had the strongest influence on your life?
A: I would say my spouse. She’s an academic physician at Hopkins. One of the things she has shown me is the importance of finding alignment in what you do professionally with the sort of goals that you have or the values that you hold as an individual. That’s why I’ve done some nontraditional things in my academic career. It’s really been in search of finding that alignment that matches my interests and goals, as opposed to just doing something because it’s a popular thing to do.
Lightning Round
Favorite sport: Soccer
What song do you have to sing along with when you hear it? 80s pop music
Introvert or extrovert? Introvert
Favorite holiday: Christmas
Optimist or pessimist? Realist
Dr. Mathews is on LinkedIn . His health tech blog is Digital Differential.
“It’s influenced the way I see medicine and the work that I do around identifying quality, not in the conventional context in a hospital or a clinic, but applying that lens to the world of technology,” said Dr. Mathews, assistant professor of medicine at Johns Hopkins Medicine in Baltimore.
Bringing greater visibility to digital health technologies is part of his life’s work.
“There is now an expectation that high quality must be part of the development process of these new technologies,” said Dr. Mathews.
In particular, he’d like to see noninvasive diagnostic technologies in the gastroenterology world become more patient-centric.
Bringing somebody into the hospital is often inconvenient and disruptive. The field is heading toward technologies that can be used in the home or in an outpatient setting. “I have some research in that area, and I’d love to see it ultimately reach the patient at the bedside, if possible.”
Dr. Mathews is a member of the AGA Center for GI Innovation and Technology and a previous mentee in the Future Leaders Program.
In an interview, Dr. Mathews discussed his push to validate health technologies in the GI field and to make them more transparent to physicians and patients.
Question: Why did you choose GI?
Answer: I think the world of gastroenterology offers a tremendous amount of diversity in the way we manage and treat patients. There’s a huge spectrum of disease. There’s also the procedural aspect, which is very different from a lot of other medical specialties. For me particularly, there’s the opportunity to work on technology as it relates to GI, as well as research in that space.
Q: It seems like gastroenterology involves a lot of detective work. Would you say that’s true?
A: When you think of something like abdominal pain or GI symptoms, any place in the body can cause those symptoms to be present. You have to think broadly about all of the contributing factors, the whole patient as it relates to travel, pets, exposures, food, diet. You really can’t be myopic when you think about all the potential causes.
The name of the game is to provide answers whenever possible, but I will settle for getting someone feeling better, even if we don’t have the answer etched in stone.
Q: What gives you the most joy in your day-to-day practice?
A: I work in an academic institution at Johns Hopkins. I really enjoy the direct connection with patients. I’ve switched mostly to a hospital-based practice, which means I’m getting patients at their sickest. It’s really a privilege to provide an opportunity for improvement or support in that context. I also enjoy the teaching and training of the next generation of folks that are going into this field. There’s so much to learn, and I think trying to set that example and teach by doing is a great opportunity, and I really enjoy that as well.
Q: Describe your biggest practice-related challenge and what you’re doing to address it.A: One of my focus areas on the research front is about providing greater transparency and validation around health technologies. How do patients know which health technologies to use? How do doctors know which ones to recommend or advocate for?
Q: Can you give an example of a technology of concern?
A: Looking at oncology and mobile apps, one study I coauthored in 2021 found that well over half did not meet physician or patient expectations. These were the most popular and highest rated apps available at the time. It shows that there’s a real disconnect between what the end users – the doctors and the patients – want from these solutions and what’s actually being provided.
There’s a flood of different solutions that are out there, and there really isn’t a streamlined way to know, as a clinician or as a patient, which ones really make a difference clinically and which ones are going to be helpful for you. And that’s been the focus of my research – understanding ways to evaluate technologies that are not so burdensome as to be purely in the realm of academics, but to be pragmatic.
Q: Who has had the strongest influence on your life?
A: I would say my spouse. She’s an academic physician at Hopkins. One of the things she has shown me is the importance of finding alignment in what you do professionally with the sort of goals that you have or the values that you hold as an individual. That’s why I’ve done some nontraditional things in my academic career. It’s really been in search of finding that alignment that matches my interests and goals, as opposed to just doing something because it’s a popular thing to do.
Lightning Round
Favorite sport: Soccer
What song do you have to sing along with when you hear it? 80s pop music
Introvert or extrovert? Introvert
Favorite holiday: Christmas
Optimist or pessimist? Realist
Dr. Mathews is on LinkedIn . His health tech blog is Digital Differential.
Teamwork guides cardio-rheumatology clinics that care for unique patient population
Clinical cardiologist Heba Wassif, MD, MPH, knows the value of working with her fellow rheumatologists, surgeons, and other clinicians to establish a care plan for her patients with cardiac conditions and autoimmune diseases.
She is the cofounder of the Cleveland Clinic’s new cardio-rheumatology program, which places an emphasis on multidisciplinary care. In her role, Dr. Wassif closely follows her patients, and if she sees any inflammation or any other condition that requires the rheumatologist, she reaches out to her colleagues to adjust medications if needed.
Collaboration with a rheumatologist was important when a patient with valvular disease was prepping for surgery. The patient was on significant immunosuppressants and the surgery had to be timed appropriately, accounting for any decreases in her immunosuppression, explained Dr. Wassif, director of inpatient clinical cardiology at Cleveland Clinic in Ohio.
Cardio-rheumatology programs are “the newest child” in a series of cardiology offshoots focusing on different populations. Cardio-oncology and cardio-obstetrics took off about 6 years ago, with cardio-rheumatology clinics and interested physicians rising in number over the last several years, Dr. Wassif noted.
The relationship between cardiovascular diseases and rheumatologic conditions is certainly recognized more often, “which means more literature is being published to discuss the link,” according to Rekha Mankad, MD, a trailblazer of this model of care. She directs the Women’s Heart Clinic at Mayo Clinic in Rochester, Minn., which was one of the earliest adopters of a cardio-rheumatology clinic.
Ten years ago, “nobody was talking about the link between rheumatologic conditions and cardiovascular disease,” Dr. Mankad said. “I’ve been asked to speak on this topic, and programs have asked me to speak about establishing cardio-rheumatology practices. So, there’s been an evolution as far as a recognition that these two conditions overlap.”
Patients have come to her independent of internal referrals, which means they have done Google searches on cardiology and rheumatology. “I think that it has made a splash, at least in the world of cardiology,” Dr. Mankad observed in an interview.
Other institutions such as NYU-Langone, Yale, Stanford, Brigham and Women’s Hospital in Boston, and Women’s College Hospital in Toronto have formed similar clinics whose focus is to address the specific needs of rheumatology patients with cardiac conditions through a teamwork approach.
Challenges of treating cardiac, rheumatologic conditions
The rise in clinics addresses the longstanding connection between autoimmune disorders and cardiac conditions.
Cardiologists have known that there is an element of inflammation that contributes to atherosclerosis, said Dr. Wassif, who has researched this topic extensively. A recent study she led found a strong association between rheumatic immune-mediated inflammatory diseases (IMIDs) and high risk of acute coronary syndrome in Medicare patients.
“This particular population has a very clear increased risk for cardiovascular conditions, including valve disease and heart failure,” she emphasized.
Patients with rheumatoid arthritis and lupus have up to a twofold and eightfold higher risk of heart disease, respectively, noted Michael S. Garshick, MD, a cardiovascular disease specialist who directs the cardio-rheumatology program at NYU-Langone Health, in New York. Cardiologists “have really developed an understanding that the immune system can impact the heart, and that there’s a need for people to understand the nuance behind how the immune system can affect them and what to do about it,” Dr. Garshick said.
Caring for patients with both afflictions comes with specific challenges. Many physicians are not well trained on managing and treating patients with these dual conditions.
The “lipid paradox,” in which lipids are reduced with active inflammation in some rheumatologic conditions, can make treatment more nuanced. In addition, the traditional ASCVD (atherosclerotic cardiovascular disease) score often underestimates the cardiovascular risk of these patients, noted cardiologist Margaret Furman, MD, MPH, assistant professor and codirector of Yale’s Cardio-Rheumatology Program, New Haven, Conn.
Newer biologic medications used to treat rheumatologic diseases can alter a patient’s lipid profile, she said in an interview.
“It can be difficult to assess each individual patient’s cardiovascular risk as their disease state and treatment can vary throughout their lifetime based on their degree of inflammation. The importance of aggressive lipid management is often underestimated,” Dr. Furman added.
Cardiology and rheumatology partnerships can address gaps in care of this unique group of patients, said Vaidehi R. Chowdhary, MBBS, MD, clinical chief of the Yale Section of Rheumatology, Allergy, and Immunology at Yale University.
“The role of the rheumatologist in this dyad is to educate patients on this risk, work toward adequate control of inflammation, and minimize use of medications that contribute to increased cardiovascular risks,” said Dr. Chowdhary, who cofounded Yale’s cardio-rheumatology program with Dr. Furman.
Cardiologists in turn can assert their knowledge about medications and their impact on lipids and inflammation, Dr. Wassif said.
Many anti-inflammatory therapies are now within the cardiologist’s purview, Dr. Garshick noted. “For example, specifically with pericarditis, there’s [Food and Drug Administration]–approved anti-inflammatories or biologics. We’re the ones who feel the most comfortable giving them right now.” Cardiologists quite often are consulted about medications that are efficacious in rheumatologic conditions but could negatively impact the cardiovascular system, such as Janus kinase inhibitors, he added.
‘Reading the tea leaves’
Each program has its own unique story. For the Cleveland Clinic, the concept of a cardio-rheumatology program began during the COVID-19 pandemic in 2020. Developing such a concept and gaining institutional acceptance is always a work in process, Dr. Wassif said. “It’s not that you decide one day that you’re going to build a center, and that center is going to come into fruition overnight. You first gauge interest within your division. Who are the individuals that are interested in this area?”
Cleveland Clinic’s center is seeking to build relations between medical disciplines while spotlighting the concept of cardio-rheumatology, said Dr. Wassif, who has been providing education within the clinic and at other health institutions to ensure that patients receive appropriate attention early.
NYU-Langone launched its program amid this heightened awareness that the immune system could affect atherosclerosis, “kind of reading of the tea leaves, so to speak,” Dr. Garshick said.
Several clinical trials served as a catalyst for this movement. “A lot of clinical cardiologists were never 100% convinced that targeting the immune system reduced cardiovascular disease,” he said. Then the CANTOS clinical trial came along and showed for the first time that a therapeutic monoclonal antibody targeting interleukin-1beta, a cytokine central to inflammatory response, could in fact reduce cardiovascular disease.
Trials like this, along with epidemiologic literature connecting the rheumatologic and the autoimmune conditions with cardiovascular disease, pushed this concept to the forefront, Dr. Garshick said.
The notion that a clinic could successfully address cardiac problems in patients with rheumatic diseases yielded promising returns at Women’s College Hospital in Toronto, according to a report presented at the 2018 American College of Rheumatology annual meeting. Researchers reported that patients with rheumatologic conditions who attended a cardio-rheumatology clinic at this center saw improvements in care. The clinic identified increased cardiovascular risk and early atherosclerosis, and 53.8% of patients altered their medications after being seen in the clinic.
A total of 39.7% and 32.1% received lipid lowering and antiplatelet therapies, respectively, and 14% received antihypertensive therapy. A small percentage were treated for heart failure or placed on lifelong anticoagulation therapy for atrial fibrillation, and one patient received a percutaneous coronary stent.
Ins and outs of the referral process
Initially designed for preventive cardiac risk assessment, Yale’s program evolved into a multidisciplinary, patient-centered approach for the management of complex cardiovascular conditions in patients with autoimmune rheumatologic diseases.
The program is open to anyone who carries a diagnosis of rheumatologic disease or has elevated inflammatory markers. “Every patient, regardless of the reason for the referral, receives a cardiovascular risk assessment,” Dr. Furman said.
Most referrals come from rheumatologists, although cardiology colleagues and pulmonologists have also sent referrals. A pulmonologist, for example, may want to rule out a cardiac cause to shortness of breath. The patient’s workup, care, and follow-up are based on the reason for referral.
“We are currently referring patients with established cardiac disease, traditional risk factors, or for better risk assessment for primary prevention of coronary artery disease,” Dr. Chowdhary said. “We communicate very frequently about medication changes, and patients are aware of goals of care from both sides.”
Dr. Furman works closely with several of the rheumatology specialists taking care of patients with rheumatoid arthritis, systemic lupus erythematosus, and scleroderma.
Rheumatology follows patients every 3-6 months or more frequently based on their disease activity.
Dr. Mankad uses her sleuthing skills at Mayo Clinic to determine what the patients need. If they come in for a preventive assessment, she looks more closely at their cardiovascular risks and may order additional imaging to look for subclinical atherosclerosis. “We’re more aggressive with statin therapy in this population because of that,” she said.
If it’s valve disease, she pays extra attention to the patients’ valves in the echocardiograms and follows them a bit more regularly than someone without a rheumatologic condition and valve disease.
For patients with heart failure signs or symptoms, “it depends on how symptomatic they are,” Dr. Mankad said. In some instances, she may look for evidence of heart failure with preserved ejection fraction in patients who have rheumatoid arthritis who happen to be short of breath. “There’s so many different manifestations that patients with rheumatologic conditions can have as far as what could be affected in the heart,” she noted.
Quite frequently, Dr. Mankad identifies subclinical disease in her patients with rheumatoid arthritis. “I’ve seen many patients whose risk scores would not dictate statin therapy. But I went looking for subclinical disease by either doing coronary assessment or carotid assessment and have found atherosclerosis that would be enough to warrant statin therapy.”
A personalized assessment to reduce cardiac risk
NYU-Langone’s program offers opportunities to educate patients about the link between cardiac and rheumatologic disease.
“Their rheumatologist or their dermatologist will say, ‘Hey, have you heard about the connection between psoriasis, psoriatic or rheumatoid arthritis, and heart disease and the risk of heart attack or stroke?’ ” Dr. Garshick said.
The patients will often say they know nothing about these connections and want to learn more about how to treat it.
“We’ll say, ‘we have someone here that can help you.’ They’ll send them to myself or other colleagues like me across the country. We’ll assess blood pressure, weight, lipids, hemoglobin A1c, and other serologic and oftentimes imaging biomarkers of cardiovascular risk.” The patients will receive a personalized assessment, listing things they can do to lower their risk, whether it’s diet, exercise, or lifestyle. “Many times it can involve medications to reduce heart disease risk,” said Dr. Garshick.
In some instances, a rheumatologist or dermatologist may be concerned about starting a patient on a specific medication for the disease such as a JAK inhibitor. “We’ll help assess their risk because there’s been a lot of literature out in the rheumatology world about the risk of JAK inhibitors and heart disease and blood clots,” said Dr. Garshick.
Dr. Garshick also sees patients with rheumatologic conditions who have a specific cardiovascular concern or complaint such as shortness of breath or chest pain. “We’ll work that up with a specific knowledge of the underlying immune condition and how that may impact their heart,” he said.
Advances in research
As they continue to see patients and devise specific care plans, developers of cardio-rheumatology programs have been supplementing their work with ongoing research.
Yale’s clinic is expanding this year to include a new attending physician, Attila Feher, MD, PhD, who has conducted research in autoimmunity and microcirculation using molecular imaging and multimodality imaging techniques. Prevalence of coronary microvascular dysfunction appears to be increased in this patient population, Dr. Furman said.
Dr. Wassif recently coauthored a paper that examined patients with underlying rheumatologic conditions who undergo valvular and aortic valve replacement. “To our surprise, there was really no difference between patients with autoimmune conditions and others with nonautoimmune conditions,” she said, adding that the study had its limitations.
Other work includes data on Medicare patients with ST- and non-ST-elevation myocardial infarctions who have an underlying autoimmune disorder. Dr. Wassif and her colleagues found that their long-term outcomes are worse than those of patients without these conditions. “It’s unclear if worse outcomes are related to complications of autoimmunity versus the extent of their underlying disease. This is a work in progress and certainly an area that is ripe for research.”
Dr. Garshick and other collaborators at NYU have been focusing on the endothelium, specifically platelet biology in patients with psoriasis, psoriatic arthritis, and lupus. “We’re about to start the same research with gout as well,” he said.
“The process we’re most interested in is understanding how these diseases impact the early stages of cholesterol. And the way we’re doing that is evaluating the vasculature, specifically the endothelium,” he said.
He has finished two clinical trials that evaluate how standard heart disease medications such as aspirin and statins impact or can potentially benefit patients with psoriasis and/or psoriatic arthritis. “We have a whole list of other trials in the pipeline with other institutions across the country.”
Through a grant, Dr. Mankad is assessing whether a PET scan could detect inflammation in the hearts of rheumatoid arthritis patients. “We’re looking to see if the reason these patients have heart failure later in life is because their heart muscle actually shows evidence of inflammation, even when they have no symptoms,” she explained.
Other tests such as echocardiogram and CT scans will be used to evaluate coronary disease in about 40-50 patients. The goal of using these multiple imaging tools is to find markers indicating that the heart is affected by rheumatoid arthritis, which may indicate a higher likelihood of developing heart failure, she said.
Clinics are popping up
Through these new clinics, some collaborations have emerged. Dr. Garshick works closely with Brigham and Women’s Hospital, which has a similar cardio-rheumatology program, run by Brittany Weber, MD, to exchange ideas, discuss challenging cases, and collaborate.
“There are a lot of clinics like us popping up across the country,” he observed. Every so often, he hears from other institutions that are interested in starting their own cardio-rheumatology programs. “They ask us: How do you start, what should we look for?”
It’s an education process for both patients and providers, Dr. Garshick emphasized. “I also think it’s a bandwidth issue. Many of our rheumatology and dermatology colleagues are acutely aware of the connection, but there may not be enough time at a clinic visit to really go in depth” with these dual conditions, he said.
NYU-Langone Health for the past several years has been holding a symposium to educate people on the cardio-rheumatology connection and treating inflammation in cardiovascular disease. This year’s symposium, held in conjunction with Brigham and Women’s Hospital, is scheduled for April 28. For more information, visit the course website: nyulmc.org/cvinflammationcme.
“What we’re trying to do is help [other institutions] get that bandwidth” to adequately help and serve these patients, he said.
Dr. Garshick has received consultant fees from Abbvie and Horizon therapeutics and an unrestricted research grant from Pfizer. No other sources had relevant financial disclosures.
Clinical cardiologist Heba Wassif, MD, MPH, knows the value of working with her fellow rheumatologists, surgeons, and other clinicians to establish a care plan for her patients with cardiac conditions and autoimmune diseases.
She is the cofounder of the Cleveland Clinic’s new cardio-rheumatology program, which places an emphasis on multidisciplinary care. In her role, Dr. Wassif closely follows her patients, and if she sees any inflammation or any other condition that requires the rheumatologist, she reaches out to her colleagues to adjust medications if needed.
Collaboration with a rheumatologist was important when a patient with valvular disease was prepping for surgery. The patient was on significant immunosuppressants and the surgery had to be timed appropriately, accounting for any decreases in her immunosuppression, explained Dr. Wassif, director of inpatient clinical cardiology at Cleveland Clinic in Ohio.
Cardio-rheumatology programs are “the newest child” in a series of cardiology offshoots focusing on different populations. Cardio-oncology and cardio-obstetrics took off about 6 years ago, with cardio-rheumatology clinics and interested physicians rising in number over the last several years, Dr. Wassif noted.
The relationship between cardiovascular diseases and rheumatologic conditions is certainly recognized more often, “which means more literature is being published to discuss the link,” according to Rekha Mankad, MD, a trailblazer of this model of care. She directs the Women’s Heart Clinic at Mayo Clinic in Rochester, Minn., which was one of the earliest adopters of a cardio-rheumatology clinic.
Ten years ago, “nobody was talking about the link between rheumatologic conditions and cardiovascular disease,” Dr. Mankad said. “I’ve been asked to speak on this topic, and programs have asked me to speak about establishing cardio-rheumatology practices. So, there’s been an evolution as far as a recognition that these two conditions overlap.”
Patients have come to her independent of internal referrals, which means they have done Google searches on cardiology and rheumatology. “I think that it has made a splash, at least in the world of cardiology,” Dr. Mankad observed in an interview.
Other institutions such as NYU-Langone, Yale, Stanford, Brigham and Women’s Hospital in Boston, and Women’s College Hospital in Toronto have formed similar clinics whose focus is to address the specific needs of rheumatology patients with cardiac conditions through a teamwork approach.
Challenges of treating cardiac, rheumatologic conditions
The rise in clinics addresses the longstanding connection between autoimmune disorders and cardiac conditions.
Cardiologists have known that there is an element of inflammation that contributes to atherosclerosis, said Dr. Wassif, who has researched this topic extensively. A recent study she led found a strong association between rheumatic immune-mediated inflammatory diseases (IMIDs) and high risk of acute coronary syndrome in Medicare patients.
“This particular population has a very clear increased risk for cardiovascular conditions, including valve disease and heart failure,” she emphasized.
Patients with rheumatoid arthritis and lupus have up to a twofold and eightfold higher risk of heart disease, respectively, noted Michael S. Garshick, MD, a cardiovascular disease specialist who directs the cardio-rheumatology program at NYU-Langone Health, in New York. Cardiologists “have really developed an understanding that the immune system can impact the heart, and that there’s a need for people to understand the nuance behind how the immune system can affect them and what to do about it,” Dr. Garshick said.
Caring for patients with both afflictions comes with specific challenges. Many physicians are not well trained on managing and treating patients with these dual conditions.
The “lipid paradox,” in which lipids are reduced with active inflammation in some rheumatologic conditions, can make treatment more nuanced. In addition, the traditional ASCVD (atherosclerotic cardiovascular disease) score often underestimates the cardiovascular risk of these patients, noted cardiologist Margaret Furman, MD, MPH, assistant professor and codirector of Yale’s Cardio-Rheumatology Program, New Haven, Conn.
Newer biologic medications used to treat rheumatologic diseases can alter a patient’s lipid profile, she said in an interview.
“It can be difficult to assess each individual patient’s cardiovascular risk as their disease state and treatment can vary throughout their lifetime based on their degree of inflammation. The importance of aggressive lipid management is often underestimated,” Dr. Furman added.
Cardiology and rheumatology partnerships can address gaps in care of this unique group of patients, said Vaidehi R. Chowdhary, MBBS, MD, clinical chief of the Yale Section of Rheumatology, Allergy, and Immunology at Yale University.
“The role of the rheumatologist in this dyad is to educate patients on this risk, work toward adequate control of inflammation, and minimize use of medications that contribute to increased cardiovascular risks,” said Dr. Chowdhary, who cofounded Yale’s cardio-rheumatology program with Dr. Furman.
Cardiologists in turn can assert their knowledge about medications and their impact on lipids and inflammation, Dr. Wassif said.
Many anti-inflammatory therapies are now within the cardiologist’s purview, Dr. Garshick noted. “For example, specifically with pericarditis, there’s [Food and Drug Administration]–approved anti-inflammatories or biologics. We’re the ones who feel the most comfortable giving them right now.” Cardiologists quite often are consulted about medications that are efficacious in rheumatologic conditions but could negatively impact the cardiovascular system, such as Janus kinase inhibitors, he added.
‘Reading the tea leaves’
Each program has its own unique story. For the Cleveland Clinic, the concept of a cardio-rheumatology program began during the COVID-19 pandemic in 2020. Developing such a concept and gaining institutional acceptance is always a work in process, Dr. Wassif said. “It’s not that you decide one day that you’re going to build a center, and that center is going to come into fruition overnight. You first gauge interest within your division. Who are the individuals that are interested in this area?”
Cleveland Clinic’s center is seeking to build relations between medical disciplines while spotlighting the concept of cardio-rheumatology, said Dr. Wassif, who has been providing education within the clinic and at other health institutions to ensure that patients receive appropriate attention early.
NYU-Langone launched its program amid this heightened awareness that the immune system could affect atherosclerosis, “kind of reading of the tea leaves, so to speak,” Dr. Garshick said.
Several clinical trials served as a catalyst for this movement. “A lot of clinical cardiologists were never 100% convinced that targeting the immune system reduced cardiovascular disease,” he said. Then the CANTOS clinical trial came along and showed for the first time that a therapeutic monoclonal antibody targeting interleukin-1beta, a cytokine central to inflammatory response, could in fact reduce cardiovascular disease.
Trials like this, along with epidemiologic literature connecting the rheumatologic and the autoimmune conditions with cardiovascular disease, pushed this concept to the forefront, Dr. Garshick said.
The notion that a clinic could successfully address cardiac problems in patients with rheumatic diseases yielded promising returns at Women’s College Hospital in Toronto, according to a report presented at the 2018 American College of Rheumatology annual meeting. Researchers reported that patients with rheumatologic conditions who attended a cardio-rheumatology clinic at this center saw improvements in care. The clinic identified increased cardiovascular risk and early atherosclerosis, and 53.8% of patients altered their medications after being seen in the clinic.
A total of 39.7% and 32.1% received lipid lowering and antiplatelet therapies, respectively, and 14% received antihypertensive therapy. A small percentage were treated for heart failure or placed on lifelong anticoagulation therapy for atrial fibrillation, and one patient received a percutaneous coronary stent.
Ins and outs of the referral process
Initially designed for preventive cardiac risk assessment, Yale’s program evolved into a multidisciplinary, patient-centered approach for the management of complex cardiovascular conditions in patients with autoimmune rheumatologic diseases.
The program is open to anyone who carries a diagnosis of rheumatologic disease or has elevated inflammatory markers. “Every patient, regardless of the reason for the referral, receives a cardiovascular risk assessment,” Dr. Furman said.
Most referrals come from rheumatologists, although cardiology colleagues and pulmonologists have also sent referrals. A pulmonologist, for example, may want to rule out a cardiac cause to shortness of breath. The patient’s workup, care, and follow-up are based on the reason for referral.
“We are currently referring patients with established cardiac disease, traditional risk factors, or for better risk assessment for primary prevention of coronary artery disease,” Dr. Chowdhary said. “We communicate very frequently about medication changes, and patients are aware of goals of care from both sides.”
Dr. Furman works closely with several of the rheumatology specialists taking care of patients with rheumatoid arthritis, systemic lupus erythematosus, and scleroderma.
Rheumatology follows patients every 3-6 months or more frequently based on their disease activity.
Dr. Mankad uses her sleuthing skills at Mayo Clinic to determine what the patients need. If they come in for a preventive assessment, she looks more closely at their cardiovascular risks and may order additional imaging to look for subclinical atherosclerosis. “We’re more aggressive with statin therapy in this population because of that,” she said.
If it’s valve disease, she pays extra attention to the patients’ valves in the echocardiograms and follows them a bit more regularly than someone without a rheumatologic condition and valve disease.
For patients with heart failure signs or symptoms, “it depends on how symptomatic they are,” Dr. Mankad said. In some instances, she may look for evidence of heart failure with preserved ejection fraction in patients who have rheumatoid arthritis who happen to be short of breath. “There’s so many different manifestations that patients with rheumatologic conditions can have as far as what could be affected in the heart,” she noted.
Quite frequently, Dr. Mankad identifies subclinical disease in her patients with rheumatoid arthritis. “I’ve seen many patients whose risk scores would not dictate statin therapy. But I went looking for subclinical disease by either doing coronary assessment or carotid assessment and have found atherosclerosis that would be enough to warrant statin therapy.”
A personalized assessment to reduce cardiac risk
NYU-Langone’s program offers opportunities to educate patients about the link between cardiac and rheumatologic disease.
“Their rheumatologist or their dermatologist will say, ‘Hey, have you heard about the connection between psoriasis, psoriatic or rheumatoid arthritis, and heart disease and the risk of heart attack or stroke?’ ” Dr. Garshick said.
The patients will often say they know nothing about these connections and want to learn more about how to treat it.
“We’ll say, ‘we have someone here that can help you.’ They’ll send them to myself or other colleagues like me across the country. We’ll assess blood pressure, weight, lipids, hemoglobin A1c, and other serologic and oftentimes imaging biomarkers of cardiovascular risk.” The patients will receive a personalized assessment, listing things they can do to lower their risk, whether it’s diet, exercise, or lifestyle. “Many times it can involve medications to reduce heart disease risk,” said Dr. Garshick.
In some instances, a rheumatologist or dermatologist may be concerned about starting a patient on a specific medication for the disease such as a JAK inhibitor. “We’ll help assess their risk because there’s been a lot of literature out in the rheumatology world about the risk of JAK inhibitors and heart disease and blood clots,” said Dr. Garshick.
Dr. Garshick also sees patients with rheumatologic conditions who have a specific cardiovascular concern or complaint such as shortness of breath or chest pain. “We’ll work that up with a specific knowledge of the underlying immune condition and how that may impact their heart,” he said.
Advances in research
As they continue to see patients and devise specific care plans, developers of cardio-rheumatology programs have been supplementing their work with ongoing research.
Yale’s clinic is expanding this year to include a new attending physician, Attila Feher, MD, PhD, who has conducted research in autoimmunity and microcirculation using molecular imaging and multimodality imaging techniques. Prevalence of coronary microvascular dysfunction appears to be increased in this patient population, Dr. Furman said.
Dr. Wassif recently coauthored a paper that examined patients with underlying rheumatologic conditions who undergo valvular and aortic valve replacement. “To our surprise, there was really no difference between patients with autoimmune conditions and others with nonautoimmune conditions,” she said, adding that the study had its limitations.
Other work includes data on Medicare patients with ST- and non-ST-elevation myocardial infarctions who have an underlying autoimmune disorder. Dr. Wassif and her colleagues found that their long-term outcomes are worse than those of patients without these conditions. “It’s unclear if worse outcomes are related to complications of autoimmunity versus the extent of their underlying disease. This is a work in progress and certainly an area that is ripe for research.”
Dr. Garshick and other collaborators at NYU have been focusing on the endothelium, specifically platelet biology in patients with psoriasis, psoriatic arthritis, and lupus. “We’re about to start the same research with gout as well,” he said.
“The process we’re most interested in is understanding how these diseases impact the early stages of cholesterol. And the way we’re doing that is evaluating the vasculature, specifically the endothelium,” he said.
He has finished two clinical trials that evaluate how standard heart disease medications such as aspirin and statins impact or can potentially benefit patients with psoriasis and/or psoriatic arthritis. “We have a whole list of other trials in the pipeline with other institutions across the country.”
Through a grant, Dr. Mankad is assessing whether a PET scan could detect inflammation in the hearts of rheumatoid arthritis patients. “We’re looking to see if the reason these patients have heart failure later in life is because their heart muscle actually shows evidence of inflammation, even when they have no symptoms,” she explained.
Other tests such as echocardiogram and CT scans will be used to evaluate coronary disease in about 40-50 patients. The goal of using these multiple imaging tools is to find markers indicating that the heart is affected by rheumatoid arthritis, which may indicate a higher likelihood of developing heart failure, she said.
Clinics are popping up
Through these new clinics, some collaborations have emerged. Dr. Garshick works closely with Brigham and Women’s Hospital, which has a similar cardio-rheumatology program, run by Brittany Weber, MD, to exchange ideas, discuss challenging cases, and collaborate.
“There are a lot of clinics like us popping up across the country,” he observed. Every so often, he hears from other institutions that are interested in starting their own cardio-rheumatology programs. “They ask us: How do you start, what should we look for?”
It’s an education process for both patients and providers, Dr. Garshick emphasized. “I also think it’s a bandwidth issue. Many of our rheumatology and dermatology colleagues are acutely aware of the connection, but there may not be enough time at a clinic visit to really go in depth” with these dual conditions, he said.
NYU-Langone Health for the past several years has been holding a symposium to educate people on the cardio-rheumatology connection and treating inflammation in cardiovascular disease. This year’s symposium, held in conjunction with Brigham and Women’s Hospital, is scheduled for April 28. For more information, visit the course website: nyulmc.org/cvinflammationcme.
“What we’re trying to do is help [other institutions] get that bandwidth” to adequately help and serve these patients, he said.
Dr. Garshick has received consultant fees from Abbvie and Horizon therapeutics and an unrestricted research grant from Pfizer. No other sources had relevant financial disclosures.
Clinical cardiologist Heba Wassif, MD, MPH, knows the value of working with her fellow rheumatologists, surgeons, and other clinicians to establish a care plan for her patients with cardiac conditions and autoimmune diseases.
She is the cofounder of the Cleveland Clinic’s new cardio-rheumatology program, which places an emphasis on multidisciplinary care. In her role, Dr. Wassif closely follows her patients, and if she sees any inflammation or any other condition that requires the rheumatologist, she reaches out to her colleagues to adjust medications if needed.
Collaboration with a rheumatologist was important when a patient with valvular disease was prepping for surgery. The patient was on significant immunosuppressants and the surgery had to be timed appropriately, accounting for any decreases in her immunosuppression, explained Dr. Wassif, director of inpatient clinical cardiology at Cleveland Clinic in Ohio.
Cardio-rheumatology programs are “the newest child” in a series of cardiology offshoots focusing on different populations. Cardio-oncology and cardio-obstetrics took off about 6 years ago, with cardio-rheumatology clinics and interested physicians rising in number over the last several years, Dr. Wassif noted.
The relationship between cardiovascular diseases and rheumatologic conditions is certainly recognized more often, “which means more literature is being published to discuss the link,” according to Rekha Mankad, MD, a trailblazer of this model of care. She directs the Women’s Heart Clinic at Mayo Clinic in Rochester, Minn., which was one of the earliest adopters of a cardio-rheumatology clinic.
Ten years ago, “nobody was talking about the link between rheumatologic conditions and cardiovascular disease,” Dr. Mankad said. “I’ve been asked to speak on this topic, and programs have asked me to speak about establishing cardio-rheumatology practices. So, there’s been an evolution as far as a recognition that these two conditions overlap.”
Patients have come to her independent of internal referrals, which means they have done Google searches on cardiology and rheumatology. “I think that it has made a splash, at least in the world of cardiology,” Dr. Mankad observed in an interview.
Other institutions such as NYU-Langone, Yale, Stanford, Brigham and Women’s Hospital in Boston, and Women’s College Hospital in Toronto have formed similar clinics whose focus is to address the specific needs of rheumatology patients with cardiac conditions through a teamwork approach.
Challenges of treating cardiac, rheumatologic conditions
The rise in clinics addresses the longstanding connection between autoimmune disorders and cardiac conditions.
Cardiologists have known that there is an element of inflammation that contributes to atherosclerosis, said Dr. Wassif, who has researched this topic extensively. A recent study she led found a strong association between rheumatic immune-mediated inflammatory diseases (IMIDs) and high risk of acute coronary syndrome in Medicare patients.
“This particular population has a very clear increased risk for cardiovascular conditions, including valve disease and heart failure,” she emphasized.
Patients with rheumatoid arthritis and lupus have up to a twofold and eightfold higher risk of heart disease, respectively, noted Michael S. Garshick, MD, a cardiovascular disease specialist who directs the cardio-rheumatology program at NYU-Langone Health, in New York. Cardiologists “have really developed an understanding that the immune system can impact the heart, and that there’s a need for people to understand the nuance behind how the immune system can affect them and what to do about it,” Dr. Garshick said.
Caring for patients with both afflictions comes with specific challenges. Many physicians are not well trained on managing and treating patients with these dual conditions.
The “lipid paradox,” in which lipids are reduced with active inflammation in some rheumatologic conditions, can make treatment more nuanced. In addition, the traditional ASCVD (atherosclerotic cardiovascular disease) score often underestimates the cardiovascular risk of these patients, noted cardiologist Margaret Furman, MD, MPH, assistant professor and codirector of Yale’s Cardio-Rheumatology Program, New Haven, Conn.
Newer biologic medications used to treat rheumatologic diseases can alter a patient’s lipid profile, she said in an interview.
“It can be difficult to assess each individual patient’s cardiovascular risk as their disease state and treatment can vary throughout their lifetime based on their degree of inflammation. The importance of aggressive lipid management is often underestimated,” Dr. Furman added.
Cardiology and rheumatology partnerships can address gaps in care of this unique group of patients, said Vaidehi R. Chowdhary, MBBS, MD, clinical chief of the Yale Section of Rheumatology, Allergy, and Immunology at Yale University.
“The role of the rheumatologist in this dyad is to educate patients on this risk, work toward adequate control of inflammation, and minimize use of medications that contribute to increased cardiovascular risks,” said Dr. Chowdhary, who cofounded Yale’s cardio-rheumatology program with Dr. Furman.
Cardiologists in turn can assert their knowledge about medications and their impact on lipids and inflammation, Dr. Wassif said.
Many anti-inflammatory therapies are now within the cardiologist’s purview, Dr. Garshick noted. “For example, specifically with pericarditis, there’s [Food and Drug Administration]–approved anti-inflammatories or biologics. We’re the ones who feel the most comfortable giving them right now.” Cardiologists quite often are consulted about medications that are efficacious in rheumatologic conditions but could negatively impact the cardiovascular system, such as Janus kinase inhibitors, he added.
‘Reading the tea leaves’
Each program has its own unique story. For the Cleveland Clinic, the concept of a cardio-rheumatology program began during the COVID-19 pandemic in 2020. Developing such a concept and gaining institutional acceptance is always a work in process, Dr. Wassif said. “It’s not that you decide one day that you’re going to build a center, and that center is going to come into fruition overnight. You first gauge interest within your division. Who are the individuals that are interested in this area?”
Cleveland Clinic’s center is seeking to build relations between medical disciplines while spotlighting the concept of cardio-rheumatology, said Dr. Wassif, who has been providing education within the clinic and at other health institutions to ensure that patients receive appropriate attention early.
NYU-Langone launched its program amid this heightened awareness that the immune system could affect atherosclerosis, “kind of reading of the tea leaves, so to speak,” Dr. Garshick said.
Several clinical trials served as a catalyst for this movement. “A lot of clinical cardiologists were never 100% convinced that targeting the immune system reduced cardiovascular disease,” he said. Then the CANTOS clinical trial came along and showed for the first time that a therapeutic monoclonal antibody targeting interleukin-1beta, a cytokine central to inflammatory response, could in fact reduce cardiovascular disease.
Trials like this, along with epidemiologic literature connecting the rheumatologic and the autoimmune conditions with cardiovascular disease, pushed this concept to the forefront, Dr. Garshick said.
The notion that a clinic could successfully address cardiac problems in patients with rheumatic diseases yielded promising returns at Women’s College Hospital in Toronto, according to a report presented at the 2018 American College of Rheumatology annual meeting. Researchers reported that patients with rheumatologic conditions who attended a cardio-rheumatology clinic at this center saw improvements in care. The clinic identified increased cardiovascular risk and early atherosclerosis, and 53.8% of patients altered their medications after being seen in the clinic.
A total of 39.7% and 32.1% received lipid lowering and antiplatelet therapies, respectively, and 14% received antihypertensive therapy. A small percentage were treated for heart failure or placed on lifelong anticoagulation therapy for atrial fibrillation, and one patient received a percutaneous coronary stent.
Ins and outs of the referral process
Initially designed for preventive cardiac risk assessment, Yale’s program evolved into a multidisciplinary, patient-centered approach for the management of complex cardiovascular conditions in patients with autoimmune rheumatologic diseases.
The program is open to anyone who carries a diagnosis of rheumatologic disease or has elevated inflammatory markers. “Every patient, regardless of the reason for the referral, receives a cardiovascular risk assessment,” Dr. Furman said.
Most referrals come from rheumatologists, although cardiology colleagues and pulmonologists have also sent referrals. A pulmonologist, for example, may want to rule out a cardiac cause to shortness of breath. The patient’s workup, care, and follow-up are based on the reason for referral.
“We are currently referring patients with established cardiac disease, traditional risk factors, or for better risk assessment for primary prevention of coronary artery disease,” Dr. Chowdhary said. “We communicate very frequently about medication changes, and patients are aware of goals of care from both sides.”
Dr. Furman works closely with several of the rheumatology specialists taking care of patients with rheumatoid arthritis, systemic lupus erythematosus, and scleroderma.
Rheumatology follows patients every 3-6 months or more frequently based on their disease activity.
Dr. Mankad uses her sleuthing skills at Mayo Clinic to determine what the patients need. If they come in for a preventive assessment, she looks more closely at their cardiovascular risks and may order additional imaging to look for subclinical atherosclerosis. “We’re more aggressive with statin therapy in this population because of that,” she said.
If it’s valve disease, she pays extra attention to the patients’ valves in the echocardiograms and follows them a bit more regularly than someone without a rheumatologic condition and valve disease.
For patients with heart failure signs or symptoms, “it depends on how symptomatic they are,” Dr. Mankad said. In some instances, she may look for evidence of heart failure with preserved ejection fraction in patients who have rheumatoid arthritis who happen to be short of breath. “There’s so many different manifestations that patients with rheumatologic conditions can have as far as what could be affected in the heart,” she noted.
Quite frequently, Dr. Mankad identifies subclinical disease in her patients with rheumatoid arthritis. “I’ve seen many patients whose risk scores would not dictate statin therapy. But I went looking for subclinical disease by either doing coronary assessment or carotid assessment and have found atherosclerosis that would be enough to warrant statin therapy.”
A personalized assessment to reduce cardiac risk
NYU-Langone’s program offers opportunities to educate patients about the link between cardiac and rheumatologic disease.
“Their rheumatologist or their dermatologist will say, ‘Hey, have you heard about the connection between psoriasis, psoriatic or rheumatoid arthritis, and heart disease and the risk of heart attack or stroke?’ ” Dr. Garshick said.
The patients will often say they know nothing about these connections and want to learn more about how to treat it.
“We’ll say, ‘we have someone here that can help you.’ They’ll send them to myself or other colleagues like me across the country. We’ll assess blood pressure, weight, lipids, hemoglobin A1c, and other serologic and oftentimes imaging biomarkers of cardiovascular risk.” The patients will receive a personalized assessment, listing things they can do to lower their risk, whether it’s diet, exercise, or lifestyle. “Many times it can involve medications to reduce heart disease risk,” said Dr. Garshick.
In some instances, a rheumatologist or dermatologist may be concerned about starting a patient on a specific medication for the disease such as a JAK inhibitor. “We’ll help assess their risk because there’s been a lot of literature out in the rheumatology world about the risk of JAK inhibitors and heart disease and blood clots,” said Dr. Garshick.
Dr. Garshick also sees patients with rheumatologic conditions who have a specific cardiovascular concern or complaint such as shortness of breath or chest pain. “We’ll work that up with a specific knowledge of the underlying immune condition and how that may impact their heart,” he said.
Advances in research
As they continue to see patients and devise specific care plans, developers of cardio-rheumatology programs have been supplementing their work with ongoing research.
Yale’s clinic is expanding this year to include a new attending physician, Attila Feher, MD, PhD, who has conducted research in autoimmunity and microcirculation using molecular imaging and multimodality imaging techniques. Prevalence of coronary microvascular dysfunction appears to be increased in this patient population, Dr. Furman said.
Dr. Wassif recently coauthored a paper that examined patients with underlying rheumatologic conditions who undergo valvular and aortic valve replacement. “To our surprise, there was really no difference between patients with autoimmune conditions and others with nonautoimmune conditions,” she said, adding that the study had its limitations.
Other work includes data on Medicare patients with ST- and non-ST-elevation myocardial infarctions who have an underlying autoimmune disorder. Dr. Wassif and her colleagues found that their long-term outcomes are worse than those of patients without these conditions. “It’s unclear if worse outcomes are related to complications of autoimmunity versus the extent of their underlying disease. This is a work in progress and certainly an area that is ripe for research.”
Dr. Garshick and other collaborators at NYU have been focusing on the endothelium, specifically platelet biology in patients with psoriasis, psoriatic arthritis, and lupus. “We’re about to start the same research with gout as well,” he said.
“The process we’re most interested in is understanding how these diseases impact the early stages of cholesterol. And the way we’re doing that is evaluating the vasculature, specifically the endothelium,” he said.
He has finished two clinical trials that evaluate how standard heart disease medications such as aspirin and statins impact or can potentially benefit patients with psoriasis and/or psoriatic arthritis. “We have a whole list of other trials in the pipeline with other institutions across the country.”
Through a grant, Dr. Mankad is assessing whether a PET scan could detect inflammation in the hearts of rheumatoid arthritis patients. “We’re looking to see if the reason these patients have heart failure later in life is because their heart muscle actually shows evidence of inflammation, even when they have no symptoms,” she explained.
Other tests such as echocardiogram and CT scans will be used to evaluate coronary disease in about 40-50 patients. The goal of using these multiple imaging tools is to find markers indicating that the heart is affected by rheumatoid arthritis, which may indicate a higher likelihood of developing heart failure, she said.
Clinics are popping up
Through these new clinics, some collaborations have emerged. Dr. Garshick works closely with Brigham and Women’s Hospital, which has a similar cardio-rheumatology program, run by Brittany Weber, MD, to exchange ideas, discuss challenging cases, and collaborate.
“There are a lot of clinics like us popping up across the country,” he observed. Every so often, he hears from other institutions that are interested in starting their own cardio-rheumatology programs. “They ask us: How do you start, what should we look for?”
It’s an education process for both patients and providers, Dr. Garshick emphasized. “I also think it’s a bandwidth issue. Many of our rheumatology and dermatology colleagues are acutely aware of the connection, but there may not be enough time at a clinic visit to really go in depth” with these dual conditions, he said.
NYU-Langone Health for the past several years has been holding a symposium to educate people on the cardio-rheumatology connection and treating inflammation in cardiovascular disease. This year’s symposium, held in conjunction with Brigham and Women’s Hospital, is scheduled for April 28. For more information, visit the course website: nyulmc.org/cvinflammationcme.
“What we’re trying to do is help [other institutions] get that bandwidth” to adequately help and serve these patients, he said.
Dr. Garshick has received consultant fees from Abbvie and Horizon therapeutics and an unrestricted research grant from Pfizer. No other sources had relevant financial disclosures.
Miami hepatologist leverages Golden Rule to balance work, family, address health equities
Hepatologist Patricia Denise Jones, MD, recollects the balancing act of going through medical training while caring for her four children.
“I had them at every stage: my first one as a medical student; twins when I was a resident, and my last one at the end of fellowship. It was challenging, trying to put their needs first while trying to be a great doctor, learning how to do research,” said Dr. Jones, an associate professor at the University of Miami Health system.
She has no regrets. “I think I’m a better doctor and colleague because I have children. Showing my kids how important it is to help and serve others is one of the best legacies I can leave them.”
If there’s anything she’d like to fix, it’s the healthcare delivery system for patients disproportionately affected by liver disease.
Dr. Jones was selected as 1 of 10 scholars in the inaugural cohort of the National Institutes of Health–funded program Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) where she participated in a 2-year program of leadership development, mentorship, and research skills development.
In an interview,
Q: Describe your current practice. What gives you the most joy in your day-to-day practice?
Dr. Jones: Being able to make a difference in the lives of patients. A lot of the patients that I take care of have difficulty navigating the health system. That’s the population I feel most inclined to serve. It’s always rewarding to help someone make a connection that they couldn’t make on their own or help them understand something that wasn’t clear. Knowing that you’re helping someone to live a healthier life is deeply gratifying.
Q: Tell me about your patient population.
Dr. Jones: My focus is patients with liver cancer, hepatocellular carcinoma specifically, and cirrhosis patients. They tend to be sick relative to most Americans. I also take care of people who have other forms of liver disease like fatty liver and viral hepatitis. I live in Miami, so most of the patients that I take care of are going to be Hispanic. A good percentage are immigrants with limited health literacy.
Q: What is your biggest practice-related challenge? What are you doing to address it?
Dr. Jones: Lack of insurance and underinsurance. One patient of mine with Medicare and Humana has a carve out: She can see me and some of my colleagues but not the oncologist or a radiation oncologist. For her to be seen in our center, she would have to get a referral from a doctor in a different county. This makes no sense. It’s a hard problem to solve. To me, that’s the most challenging thing – not being able to help when something is beyond my control, beyond what I understand, and translating it into action.
Q: What general principles guide you in your professional and personal life?
Dr. Jones: I try to think of the Golden Rule in every encounter with a person, either in clinic or in real life, as if they were my mother or sister. If I’m frustrated or having a bad day, what would I want that person’s experience to be with their doctor? I also try to assume the best possible intent with people.
Q: What teacher, mentor, or other influences had the greatest impact on you?
Dr. Jones: My father. He started out as a salesman, worked in legislation, and then retired early to focus on and build up our community, making sure that we were better off than we were before. In terms of my professional life, Robert Sandler, MD is one of my greatest mentors. He is at the University of North Carolina and was the division chief of gastroenterology. He saw potential in me and supports me to this day. If you need something, he’s there. If you need him to comment on your draft, he’s very reliable and gives you great, critical feedback.
Q: In 10 years, what do you hope you are doing or what do you hope you have accomplished?
Dr. Jones: In 10 years, I hope that my efforts will have revolutionized our approach to delivering care to vulnerable populations. Much of the work that has been done thus far in the field of disparities and liver disease has focused on describing the inequities. However, I have just started working in health equity. This will require partnering with patients and caregivers to get a better understanding of their needs and collaborating with legislators to increase funding directed towards building the infrastructure necessary to deliver health care to those who have been forgotten.
Lightning round questions
Favorite movie, show, or book
Forrest Gump, Blackish, anything by Toni Morrison
Favorite music genre
Hip Hop
Favorite food
Seafood
Favorite travel destination
Tanzania
Your ideal type of pet
Dog
Optimist or pessimist?
Optimist!
Dr. Jones is on Twitter @DrLiverPatty.
Hepatologist Patricia Denise Jones, MD, recollects the balancing act of going through medical training while caring for her four children.
“I had them at every stage: my first one as a medical student; twins when I was a resident, and my last one at the end of fellowship. It was challenging, trying to put their needs first while trying to be a great doctor, learning how to do research,” said Dr. Jones, an associate professor at the University of Miami Health system.
She has no regrets. “I think I’m a better doctor and colleague because I have children. Showing my kids how important it is to help and serve others is one of the best legacies I can leave them.”
If there’s anything she’d like to fix, it’s the healthcare delivery system for patients disproportionately affected by liver disease.
Dr. Jones was selected as 1 of 10 scholars in the inaugural cohort of the National Institutes of Health–funded program Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) where she participated in a 2-year program of leadership development, mentorship, and research skills development.
In an interview,
Q: Describe your current practice. What gives you the most joy in your day-to-day practice?
Dr. Jones: Being able to make a difference in the lives of patients. A lot of the patients that I take care of have difficulty navigating the health system. That’s the population I feel most inclined to serve. It’s always rewarding to help someone make a connection that they couldn’t make on their own or help them understand something that wasn’t clear. Knowing that you’re helping someone to live a healthier life is deeply gratifying.
Q: Tell me about your patient population.
Dr. Jones: My focus is patients with liver cancer, hepatocellular carcinoma specifically, and cirrhosis patients. They tend to be sick relative to most Americans. I also take care of people who have other forms of liver disease like fatty liver and viral hepatitis. I live in Miami, so most of the patients that I take care of are going to be Hispanic. A good percentage are immigrants with limited health literacy.
Q: What is your biggest practice-related challenge? What are you doing to address it?
Dr. Jones: Lack of insurance and underinsurance. One patient of mine with Medicare and Humana has a carve out: She can see me and some of my colleagues but not the oncologist or a radiation oncologist. For her to be seen in our center, she would have to get a referral from a doctor in a different county. This makes no sense. It’s a hard problem to solve. To me, that’s the most challenging thing – not being able to help when something is beyond my control, beyond what I understand, and translating it into action.
Q: What general principles guide you in your professional and personal life?
Dr. Jones: I try to think of the Golden Rule in every encounter with a person, either in clinic or in real life, as if they were my mother or sister. If I’m frustrated or having a bad day, what would I want that person’s experience to be with their doctor? I also try to assume the best possible intent with people.
Q: What teacher, mentor, or other influences had the greatest impact on you?
Dr. Jones: My father. He started out as a salesman, worked in legislation, and then retired early to focus on and build up our community, making sure that we were better off than we were before. In terms of my professional life, Robert Sandler, MD is one of my greatest mentors. He is at the University of North Carolina and was the division chief of gastroenterology. He saw potential in me and supports me to this day. If you need something, he’s there. If you need him to comment on your draft, he’s very reliable and gives you great, critical feedback.
Q: In 10 years, what do you hope you are doing or what do you hope you have accomplished?
Dr. Jones: In 10 years, I hope that my efforts will have revolutionized our approach to delivering care to vulnerable populations. Much of the work that has been done thus far in the field of disparities and liver disease has focused on describing the inequities. However, I have just started working in health equity. This will require partnering with patients and caregivers to get a better understanding of their needs and collaborating with legislators to increase funding directed towards building the infrastructure necessary to deliver health care to those who have been forgotten.
Lightning round questions
Favorite movie, show, or book
Forrest Gump, Blackish, anything by Toni Morrison
Favorite music genre
Hip Hop
Favorite food
Seafood
Favorite travel destination
Tanzania
Your ideal type of pet
Dog
Optimist or pessimist?
Optimist!
Dr. Jones is on Twitter @DrLiverPatty.
Hepatologist Patricia Denise Jones, MD, recollects the balancing act of going through medical training while caring for her four children.
“I had them at every stage: my first one as a medical student; twins when I was a resident, and my last one at the end of fellowship. It was challenging, trying to put their needs first while trying to be a great doctor, learning how to do research,” said Dr. Jones, an associate professor at the University of Miami Health system.
She has no regrets. “I think I’m a better doctor and colleague because I have children. Showing my kids how important it is to help and serve others is one of the best legacies I can leave them.”
If there’s anything she’d like to fix, it’s the healthcare delivery system for patients disproportionately affected by liver disease.
Dr. Jones was selected as 1 of 10 scholars in the inaugural cohort of the National Institutes of Health–funded program Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) where she participated in a 2-year program of leadership development, mentorship, and research skills development.
In an interview,
Q: Describe your current practice. What gives you the most joy in your day-to-day practice?
Dr. Jones: Being able to make a difference in the lives of patients. A lot of the patients that I take care of have difficulty navigating the health system. That’s the population I feel most inclined to serve. It’s always rewarding to help someone make a connection that they couldn’t make on their own or help them understand something that wasn’t clear. Knowing that you’re helping someone to live a healthier life is deeply gratifying.
Q: Tell me about your patient population.
Dr. Jones: My focus is patients with liver cancer, hepatocellular carcinoma specifically, and cirrhosis patients. They tend to be sick relative to most Americans. I also take care of people who have other forms of liver disease like fatty liver and viral hepatitis. I live in Miami, so most of the patients that I take care of are going to be Hispanic. A good percentage are immigrants with limited health literacy.
Q: What is your biggest practice-related challenge? What are you doing to address it?
Dr. Jones: Lack of insurance and underinsurance. One patient of mine with Medicare and Humana has a carve out: She can see me and some of my colleagues but not the oncologist or a radiation oncologist. For her to be seen in our center, she would have to get a referral from a doctor in a different county. This makes no sense. It’s a hard problem to solve. To me, that’s the most challenging thing – not being able to help when something is beyond my control, beyond what I understand, and translating it into action.
Q: What general principles guide you in your professional and personal life?
Dr. Jones: I try to think of the Golden Rule in every encounter with a person, either in clinic or in real life, as if they were my mother or sister. If I’m frustrated or having a bad day, what would I want that person’s experience to be with their doctor? I also try to assume the best possible intent with people.
Q: What teacher, mentor, or other influences had the greatest impact on you?
Dr. Jones: My father. He started out as a salesman, worked in legislation, and then retired early to focus on and build up our community, making sure that we were better off than we were before. In terms of my professional life, Robert Sandler, MD is one of my greatest mentors. He is at the University of North Carolina and was the division chief of gastroenterology. He saw potential in me and supports me to this day. If you need something, he’s there. If you need him to comment on your draft, he’s very reliable and gives you great, critical feedback.
Q: In 10 years, what do you hope you are doing or what do you hope you have accomplished?
Dr. Jones: In 10 years, I hope that my efforts will have revolutionized our approach to delivering care to vulnerable populations. Much of the work that has been done thus far in the field of disparities and liver disease has focused on describing the inequities. However, I have just started working in health equity. This will require partnering with patients and caregivers to get a better understanding of their needs and collaborating with legislators to increase funding directed towards building the infrastructure necessary to deliver health care to those who have been forgotten.
Lightning round questions
Favorite movie, show, or book
Forrest Gump, Blackish, anything by Toni Morrison
Favorite music genre
Hip Hop
Favorite food
Seafood
Favorite travel destination
Tanzania
Your ideal type of pet
Dog
Optimist or pessimist?
Optimist!
Dr. Jones is on Twitter @DrLiverPatty.
Rheumatology Match Day follows same pattern as previous years
Rheumatology joined six other Medicine specialties that filled more than 95% of fellowship positions in 2022.
The National Resident Matching Program in its 2022 Medicine and Pediatric Specialties Match reported that rheumatology filled 123 of 127 certified programs (96.9%) along with 265 certified positions (97.8%).
Matched applicants for adult rheumatology programs included 40 U.S. foreign applicants (15.1%), 123 MD graduates (46.4%), 66 foreign (24.9%), and 36 DO graduates (13.6%).
A total of 352 applicants showed a preference for this specialty, and 75% matched to the specialty. Another 23% did not match to any program.
2022 was the first year that NRMP combined medical specialties, pediatric specialties, and adolescent medicine fellowship matches into the “Medicine and Pediatric Specialties Match.”
“We engaged the leadership of both pediatrics and internal medicine organizations to work with the NRMP to brainstorm solutions and were successful in combining pediatrics and internal medicine into one fellowship match,” said Jill Fussell, MD, immediate past chair of the Council of Pediatric Subspecialties in a statement. “It was an incredibly rewarding experience to work across pediatrics and internal medicine on behalf of resident well-being to make this collaborative change happen.”
Similar to 2021, pediatric rheumatology didn’t do as well as adult programs, filling just 18 of 32 certified programs (56.3%) and 27 out of 43 certified positions (62.8%). More than 66% of the applicants represented MD graduates. Eight were foreign, and one was a DO graduate.
The 2022 match was the largest on record, comprising 39 subspecialties in internal medicine, pediatrics, addiction, and multidisciplinary specialties. A total of 3,361 programs filled 7,648 (87.7%) of 8,724 positions in 2022. Three specialties – cardiovascular disease, interventional pulmonology, and oncology – filled all their positions offered in the match.
In addition to rheumatology, six other specialties filled 95% or more of their positions. This included clinical cardiac electrophysiology, critical care medicine, endocrinology, gastroenterology, hematology/oncology, and pulmonary/critical care medicine. Allergy and immunology, which accepts applicants from either internal medicine or pediatrics, also filled more than 95% of positions offered.
Matched applicants will start fellowship training in July 2023.
Rheumatology joined six other Medicine specialties that filled more than 95% of fellowship positions in 2022.
The National Resident Matching Program in its 2022 Medicine and Pediatric Specialties Match reported that rheumatology filled 123 of 127 certified programs (96.9%) along with 265 certified positions (97.8%).
Matched applicants for adult rheumatology programs included 40 U.S. foreign applicants (15.1%), 123 MD graduates (46.4%), 66 foreign (24.9%), and 36 DO graduates (13.6%).
A total of 352 applicants showed a preference for this specialty, and 75% matched to the specialty. Another 23% did not match to any program.
2022 was the first year that NRMP combined medical specialties, pediatric specialties, and adolescent medicine fellowship matches into the “Medicine and Pediatric Specialties Match.”
“We engaged the leadership of both pediatrics and internal medicine organizations to work with the NRMP to brainstorm solutions and were successful in combining pediatrics and internal medicine into one fellowship match,” said Jill Fussell, MD, immediate past chair of the Council of Pediatric Subspecialties in a statement. “It was an incredibly rewarding experience to work across pediatrics and internal medicine on behalf of resident well-being to make this collaborative change happen.”
Similar to 2021, pediatric rheumatology didn’t do as well as adult programs, filling just 18 of 32 certified programs (56.3%) and 27 out of 43 certified positions (62.8%). More than 66% of the applicants represented MD graduates. Eight were foreign, and one was a DO graduate.
The 2022 match was the largest on record, comprising 39 subspecialties in internal medicine, pediatrics, addiction, and multidisciplinary specialties. A total of 3,361 programs filled 7,648 (87.7%) of 8,724 positions in 2022. Three specialties – cardiovascular disease, interventional pulmonology, and oncology – filled all their positions offered in the match.
In addition to rheumatology, six other specialties filled 95% or more of their positions. This included clinical cardiac electrophysiology, critical care medicine, endocrinology, gastroenterology, hematology/oncology, and pulmonary/critical care medicine. Allergy and immunology, which accepts applicants from either internal medicine or pediatrics, also filled more than 95% of positions offered.
Matched applicants will start fellowship training in July 2023.
Rheumatology joined six other Medicine specialties that filled more than 95% of fellowship positions in 2022.
The National Resident Matching Program in its 2022 Medicine and Pediatric Specialties Match reported that rheumatology filled 123 of 127 certified programs (96.9%) along with 265 certified positions (97.8%).
Matched applicants for adult rheumatology programs included 40 U.S. foreign applicants (15.1%), 123 MD graduates (46.4%), 66 foreign (24.9%), and 36 DO graduates (13.6%).
A total of 352 applicants showed a preference for this specialty, and 75% matched to the specialty. Another 23% did not match to any program.
2022 was the first year that NRMP combined medical specialties, pediatric specialties, and adolescent medicine fellowship matches into the “Medicine and Pediatric Specialties Match.”
“We engaged the leadership of both pediatrics and internal medicine organizations to work with the NRMP to brainstorm solutions and were successful in combining pediatrics and internal medicine into one fellowship match,” said Jill Fussell, MD, immediate past chair of the Council of Pediatric Subspecialties in a statement. “It was an incredibly rewarding experience to work across pediatrics and internal medicine on behalf of resident well-being to make this collaborative change happen.”
Similar to 2021, pediatric rheumatology didn’t do as well as adult programs, filling just 18 of 32 certified programs (56.3%) and 27 out of 43 certified positions (62.8%). More than 66% of the applicants represented MD graduates. Eight were foreign, and one was a DO graduate.
The 2022 match was the largest on record, comprising 39 subspecialties in internal medicine, pediatrics, addiction, and multidisciplinary specialties. A total of 3,361 programs filled 7,648 (87.7%) of 8,724 positions in 2022. Three specialties – cardiovascular disease, interventional pulmonology, and oncology – filled all their positions offered in the match.
In addition to rheumatology, six other specialties filled 95% or more of their positions. This included clinical cardiac electrophysiology, critical care medicine, endocrinology, gastroenterology, hematology/oncology, and pulmonary/critical care medicine. Allergy and immunology, which accepts applicants from either internal medicine or pediatrics, also filled more than 95% of positions offered.
Matched applicants will start fellowship training in July 2023.