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Psoriatic arthritis treatment: “We’re not doing so well”
MAUI, HAWAII – Two recent Scandinavian studies highlight the considerable room for improvement that exists in psoriatic arthritis outcomes, according to speakers at the 2018 Rheumatology Winter Clinical Symposium.
“We’re not doing so well. I think that in general, ,” declared Arthur Kavanaugh, MD, program director for the symposium and professor of medicine at the University of California, San Diego.
“If you say that MDA is remission, a 23% remission rate is not good enough. And there are some people who are not on treatment. So I think we’re still seeing a lag in psoriatic arthritis. We’re not treating it as aggressively as we are rheumatoid arthritis,” said Dr. Kavanaugh, director of the Center for Innovative Therapy in the university’s division of rheumatology, allergy, and immunology.
“This study was a surprise,” he continued. “I think it’s like rheumatoid arthritis was years ago. If you asked docs how they were doing, they would say, ‘My patients are doing great!’ But then you go to the office and measure the patients and it’s like, ‘Well, not so much.’ ”
Another speaker, Eric M. Ruderman, MD, concurred.
That being said, it’s also clear that rheumatologists aren’t doing as well in managing psoriatic arthritis as dermatologists are with psoriasis, where skin clearance or almost-clear rates unimaginable just a few years ago are now routinely attainable, he added.
“In dermatology they’re getting better and better and better and better with each successive new cytokine target. We’re not. The ACR responses with risankizumab [an investigational anti-interleukin-23 p19 inhibitor] are very much like we saw with the tumor necrosis factor inhibitors. The interleukin-12/23 inhibitor responses are very much like we’ve seen with the interleukin-17 inhibitors. So each successive improvement in getting skin disease under control hasn’t really gotten us very much further with joint disease. I don’t know that we’ve cracked that yet,” Dr. Ruderman said.
Another recent Scandinavian psoriatic arthritis study that particularly impressed Dr. Kavanaugh was a Danish nationwide cohort registry study that shed new light upon the burdens imposed by the disease in terms of societal costs, comorbid conditions, and disability. The subjects were 10,525 Danes with psoriatic arthritis and nearly 21,000 matched general population controls evaluated during the period from 5 years prior to diagnosis of psoriatic arthritis through 10 years after.
The costs were impressive: an average of 10,641 euros more per year per psoriatic arthritis patient, compared with controls, during the 10-year period following diagnosis, with most of the difference attributed to higher health care costs and forgone earnings due to unemployment, early retirement, or receipt of a disability pension.
At the time of their diagnosis, psoriatic arthritis patients had a significantly higher burden of comorbid conditions than did controls, including a 1.7-fold higher likelihood of cardiovascular disease, a 1.73-fold increase in risk for pulmonary disease, a 2.03-fold greater likelihood of infectious diseases, and a 1.94-fold increased risk of hematologic disorders.
Five years prior to diagnosis of psoriatic arthritis, affected individuals were 1.36-fold more likely than were controls to be on a disability pension. At diagnosis, they were 1.6-fold more likely. Ten years after diagnosis of psoriatic arthritis, they were 2.69-fold more likely to be on a disability pension. Indeed, by that point, 21.8% of Danish psoriatic arthritis patients were on disability (Ann Rheum Dis. 2017 Sep;76([9]:1495-1501).
Health care costs began rising steeply at least 3 years prior to diagnosis of psoriatic arthritis, as well.
“We need to do better with our psoriatic arthritis patients. I think this beautiful study is a call to attention for us to make sure that we’re identifying people with psoriatic arthritis as early as we can,” Dr. Kavanaugh said.
As for the treat-to-target approach that has become so widespread in the management of rheumatoid arthritis, it has gained a toehold in the treatment of psoriatic arthritis. Dr. Kavanaugh was a member of an international task force that recently published treat-to-target recommendations for psoriatic arthritis and axial spondyloarthritis (Ann Rheum Dis. 2018 Jan;77[1]:3-17).
The recommendation for defining the target in psoriatic arthritis was to use the DAPSA or MDA. However, this was a controversial recommendation because of the dearth of evidence. It passed with 51.6% of the task force votes and a level of agreement of 7.9 on a 0-10 scale.
Despite the demonstrable room for improvement in psoriatic arthritis treatment outcomes, better times are likely to be coming for affected patients. A record-breaking number of publications on psoriatic arthritis was published in 2017, and three additional drugs received marketing approval for the disease.
Dr. Kavanaugh and Dr. Ruderman reported serving as consultants to and receiving research grants from numerous pharmaceutical companies.
MAUI, HAWAII – Two recent Scandinavian studies highlight the considerable room for improvement that exists in psoriatic arthritis outcomes, according to speakers at the 2018 Rheumatology Winter Clinical Symposium.
“We’re not doing so well. I think that in general, ,” declared Arthur Kavanaugh, MD, program director for the symposium and professor of medicine at the University of California, San Diego.
“If you say that MDA is remission, a 23% remission rate is not good enough. And there are some people who are not on treatment. So I think we’re still seeing a lag in psoriatic arthritis. We’re not treating it as aggressively as we are rheumatoid arthritis,” said Dr. Kavanaugh, director of the Center for Innovative Therapy in the university’s division of rheumatology, allergy, and immunology.
“This study was a surprise,” he continued. “I think it’s like rheumatoid arthritis was years ago. If you asked docs how they were doing, they would say, ‘My patients are doing great!’ But then you go to the office and measure the patients and it’s like, ‘Well, not so much.’ ”
Another speaker, Eric M. Ruderman, MD, concurred.
That being said, it’s also clear that rheumatologists aren’t doing as well in managing psoriatic arthritis as dermatologists are with psoriasis, where skin clearance or almost-clear rates unimaginable just a few years ago are now routinely attainable, he added.
“In dermatology they’re getting better and better and better and better with each successive new cytokine target. We’re not. The ACR responses with risankizumab [an investigational anti-interleukin-23 p19 inhibitor] are very much like we saw with the tumor necrosis factor inhibitors. The interleukin-12/23 inhibitor responses are very much like we’ve seen with the interleukin-17 inhibitors. So each successive improvement in getting skin disease under control hasn’t really gotten us very much further with joint disease. I don’t know that we’ve cracked that yet,” Dr. Ruderman said.
Another recent Scandinavian psoriatic arthritis study that particularly impressed Dr. Kavanaugh was a Danish nationwide cohort registry study that shed new light upon the burdens imposed by the disease in terms of societal costs, comorbid conditions, and disability. The subjects were 10,525 Danes with psoriatic arthritis and nearly 21,000 matched general population controls evaluated during the period from 5 years prior to diagnosis of psoriatic arthritis through 10 years after.
The costs were impressive: an average of 10,641 euros more per year per psoriatic arthritis patient, compared with controls, during the 10-year period following diagnosis, with most of the difference attributed to higher health care costs and forgone earnings due to unemployment, early retirement, or receipt of a disability pension.
At the time of their diagnosis, psoriatic arthritis patients had a significantly higher burden of comorbid conditions than did controls, including a 1.7-fold higher likelihood of cardiovascular disease, a 1.73-fold increase in risk for pulmonary disease, a 2.03-fold greater likelihood of infectious diseases, and a 1.94-fold increased risk of hematologic disorders.
Five years prior to diagnosis of psoriatic arthritis, affected individuals were 1.36-fold more likely than were controls to be on a disability pension. At diagnosis, they were 1.6-fold more likely. Ten years after diagnosis of psoriatic arthritis, they were 2.69-fold more likely to be on a disability pension. Indeed, by that point, 21.8% of Danish psoriatic arthritis patients were on disability (Ann Rheum Dis. 2017 Sep;76([9]:1495-1501).
Health care costs began rising steeply at least 3 years prior to diagnosis of psoriatic arthritis, as well.
“We need to do better with our psoriatic arthritis patients. I think this beautiful study is a call to attention for us to make sure that we’re identifying people with psoriatic arthritis as early as we can,” Dr. Kavanaugh said.
As for the treat-to-target approach that has become so widespread in the management of rheumatoid arthritis, it has gained a toehold in the treatment of psoriatic arthritis. Dr. Kavanaugh was a member of an international task force that recently published treat-to-target recommendations for psoriatic arthritis and axial spondyloarthritis (Ann Rheum Dis. 2018 Jan;77[1]:3-17).
The recommendation for defining the target in psoriatic arthritis was to use the DAPSA or MDA. However, this was a controversial recommendation because of the dearth of evidence. It passed with 51.6% of the task force votes and a level of agreement of 7.9 on a 0-10 scale.
Despite the demonstrable room for improvement in psoriatic arthritis treatment outcomes, better times are likely to be coming for affected patients. A record-breaking number of publications on psoriatic arthritis was published in 2017, and three additional drugs received marketing approval for the disease.
Dr. Kavanaugh and Dr. Ruderman reported serving as consultants to and receiving research grants from numerous pharmaceutical companies.
MAUI, HAWAII – Two recent Scandinavian studies highlight the considerable room for improvement that exists in psoriatic arthritis outcomes, according to speakers at the 2018 Rheumatology Winter Clinical Symposium.
“We’re not doing so well. I think that in general, ,” declared Arthur Kavanaugh, MD, program director for the symposium and professor of medicine at the University of California, San Diego.
“If you say that MDA is remission, a 23% remission rate is not good enough. And there are some people who are not on treatment. So I think we’re still seeing a lag in psoriatic arthritis. We’re not treating it as aggressively as we are rheumatoid arthritis,” said Dr. Kavanaugh, director of the Center for Innovative Therapy in the university’s division of rheumatology, allergy, and immunology.
“This study was a surprise,” he continued. “I think it’s like rheumatoid arthritis was years ago. If you asked docs how they were doing, they would say, ‘My patients are doing great!’ But then you go to the office and measure the patients and it’s like, ‘Well, not so much.’ ”
Another speaker, Eric M. Ruderman, MD, concurred.
That being said, it’s also clear that rheumatologists aren’t doing as well in managing psoriatic arthritis as dermatologists are with psoriasis, where skin clearance or almost-clear rates unimaginable just a few years ago are now routinely attainable, he added.
“In dermatology they’re getting better and better and better and better with each successive new cytokine target. We’re not. The ACR responses with risankizumab [an investigational anti-interleukin-23 p19 inhibitor] are very much like we saw with the tumor necrosis factor inhibitors. The interleukin-12/23 inhibitor responses are very much like we’ve seen with the interleukin-17 inhibitors. So each successive improvement in getting skin disease under control hasn’t really gotten us very much further with joint disease. I don’t know that we’ve cracked that yet,” Dr. Ruderman said.
Another recent Scandinavian psoriatic arthritis study that particularly impressed Dr. Kavanaugh was a Danish nationwide cohort registry study that shed new light upon the burdens imposed by the disease in terms of societal costs, comorbid conditions, and disability. The subjects were 10,525 Danes with psoriatic arthritis and nearly 21,000 matched general population controls evaluated during the period from 5 years prior to diagnosis of psoriatic arthritis through 10 years after.
The costs were impressive: an average of 10,641 euros more per year per psoriatic arthritis patient, compared with controls, during the 10-year period following diagnosis, with most of the difference attributed to higher health care costs and forgone earnings due to unemployment, early retirement, or receipt of a disability pension.
At the time of their diagnosis, psoriatic arthritis patients had a significantly higher burden of comorbid conditions than did controls, including a 1.7-fold higher likelihood of cardiovascular disease, a 1.73-fold increase in risk for pulmonary disease, a 2.03-fold greater likelihood of infectious diseases, and a 1.94-fold increased risk of hematologic disorders.
Five years prior to diagnosis of psoriatic arthritis, affected individuals were 1.36-fold more likely than were controls to be on a disability pension. At diagnosis, they were 1.6-fold more likely. Ten years after diagnosis of psoriatic arthritis, they were 2.69-fold more likely to be on a disability pension. Indeed, by that point, 21.8% of Danish psoriatic arthritis patients were on disability (Ann Rheum Dis. 2017 Sep;76([9]:1495-1501).
Health care costs began rising steeply at least 3 years prior to diagnosis of psoriatic arthritis, as well.
“We need to do better with our psoriatic arthritis patients. I think this beautiful study is a call to attention for us to make sure that we’re identifying people with psoriatic arthritis as early as we can,” Dr. Kavanaugh said.
As for the treat-to-target approach that has become so widespread in the management of rheumatoid arthritis, it has gained a toehold in the treatment of psoriatic arthritis. Dr. Kavanaugh was a member of an international task force that recently published treat-to-target recommendations for psoriatic arthritis and axial spondyloarthritis (Ann Rheum Dis. 2018 Jan;77[1]:3-17).
The recommendation for defining the target in psoriatic arthritis was to use the DAPSA or MDA. However, this was a controversial recommendation because of the dearth of evidence. It passed with 51.6% of the task force votes and a level of agreement of 7.9 on a 0-10 scale.
Despite the demonstrable room for improvement in psoriatic arthritis treatment outcomes, better times are likely to be coming for affected patients. A record-breaking number of publications on psoriatic arthritis was published in 2017, and three additional drugs received marketing approval for the disease.
Dr. Kavanaugh and Dr. Ruderman reported serving as consultants to and receiving research grants from numerous pharmaceutical companies.
EXPERT ANALYSIS FROM RWCS 2018
States strive to curb costs for a crucial – but exorbitant – hemophilia treatment
The child is well-known in the halls in which state bureaucrats oversee health care for millions of Californians – not by name, but by a number: $21 million.
His medications alone cost state taxpayers that much in a single year, not including other health care. The boy, whose identity has not been released, was California’s most expensive Medicaid patient in recent years. His case was singled out in a tweet last year by the state’s top health care official to highlight the public insurance program’s extraordinary obligations as a backstop for low-income patients.
How on earth can a single child’s treatment cost that much? The answer: He has hemophilia and needs large quantities of a pricey drug – known as clotting factor – that makes blood coagulate.
Hemophilia drugs are among the most costly drugs in the nation, and taxpayers are footing the bill for many patients on Medicaid who could never afford them on their own. Officials in California and other states are doing what they can to manage the costs, but it’s a daunting task that highlights the complexity and secrecy of prescription drug pricing.
Kaiser Health News is examining how America has become a “Medicaid Nation” – where tens of millions of poor and disabled people now rely on the support of the federal and state insurance program. Hemophilia is one those diseases that helps explain its burgeoning cost.
Medications for hemophilia are crucial to patients – overwhelmingly male – with the rare genetic condition that prevents clotting and puts them at great risk of bleeding to death, even from a minor injury. There is no question the drugs prolong and save lives, and state officials are not arguing that they should be withheld.
“It’s a highly vulnerable population,” said Ken Kizer, a veteran federal and state health administrator who formerly oversaw Medi-Cal, California’s version of Medicaid. “If anyone has seen a hemophiliac in crisis, you’re not going to say no.”
But drugmakers profit handsomely, competing vigorously for the limited number of patients.
The U.S. hemophilia market, which serves about 20,000 patients, is worth $4.6 billion a year, according to AllianceBernstein, a research and investment firm.
“There are millions being made out there on these kids – it’s a huge business,” said Doris Quon, MD, medical director of the Orthopaedic Hemophilia Treatment Center at the University of California, Los Angeles.
Contributing to the costs is the fact that there is no cure for hemophilia and no cheaper substitute for blood factor. Factor may be prescribed at high doses for a lifetime, even more so when a patient has an injury or complications.
Nationwide, a third of adults and children living with hemophilia are covered by Medicaid. And the Medicaid program’s three most expensive drugs per prescription are for hemophilia, according to an analysis by the Kaiser Family Foundation. (California Healthline is produced by Kaiser Health News, an editorially independent publication of the foundation.)
In 2015 alone, Medicaid paid about $353 million for prescriptions of Advate, the most commonly prescribed blood-clotting medication for hemophilia – a 273% increase from 2011.
Generally speaking, the price of hemophilia drugs rise as rival drugs hit the market. But, in addition, doctors are prescribing ever more clotting factor for prevention of joint-damaging bleeds and for improved long-term health. The increase in the cost of Advate, for example, was nearly all attributed to increased use.
Tab for 145 kids: $195 million
The California boy whose drugs cost $21 million in a single year was an extreme case, and the circumstances of his care have not been disclosed because of confidentiality protections. Still, medications to treat hemophilia on average annual cost more than $270,000 per patient, according to a 2015 Express Scripts report, and they can easily soar past $1 million annually.
In contrast to more common diseases like hepatitis C, hemophilia treatment is not a state “budget buster” per se: about 4,000 patients live in California. About 1,100 of them are covered by Medi-Cal or two other government-funded programs for chronically ill children in California, according to Jennifer Kent, director of the state Department of Health Care Services and author of last year’s tweet. But the amount of money spent per person dwarfs that spent on people with other serious diseases.
One Stanford University study of 34,000 California kids with severe chronic diseases found that the tiny portion of children who needed blood factor accounted for 41% of the state’s outpatient drug spending on this entire patient population. About $195 million was spent on just 145 kids over a 3-year period, although some of that money came back to the state in rebates from drug companies – a portion of the cost that Medicaid can recoup after purchase.
Caitlin Carroll, director of public affairs for PhRMA, the pharmaceutical industry lobbying group, said high development costs and the complicated and lengthy manufacturing process play a role in how hemophilia drugs are priced. She added that federally mandated rebates significantly reduce the cost of blood factor. They amount to 17% of the average manufacturer price per unit.
Manufacturers also note that some newer and more expensive hemophilia drugs last longer and do not need to be administered as frequently, so they can prove less costly to payers overall.
Even so, some patients require a monumental investment to survive.
‘Extremely fortunate’
Colleen Tuite’s son Kevin, a 7-year-old, has severe hemophilia with a complication known as an inhibitor – an antibody that makes his regular blood-factor infusions less effective. Inhibitors can dramatically increase the cost of care, because massive doses of blood factor or expensive, specialized blood products known as bypassing agents may be needed.
Ms. Tuite and her husband initially were Kevin’s foster parents, then adopted the boy as a toddler. Because he has been a foster child, Kevin qualifies for Medi-Cal until he is 26.
The Monrovia, Calif., family also has private health insurance, which pays for about half of Kevin’s medical bills. These can run upward of $200,000 per month, Ms. Tuite said.
“We definitely would not have been able to adopt him without the help of Medi-Cal,” Ms. Tuite said. “We’ve been extremely fortunate.”
With the support of drug manufacturers and hemophilia advocacy groups, patients and their families have significant political clout. Some experts say they also have a moral claim on public resources: In the early days of the AIDS epidemic, thousands of the nation’s hemophilia patients died after they contracted HIV through transfusions before the virus was eliminated from the blood supply.
State health officials say the costs of hemophilia are hard to anticipate and control, even with rebates.
“We do a really aggressive job of collecting rebates on our pharmacy costs,” said Ms. Kent, California’s top Medicaid official. “But there’s just not any way around blood factor. It is just a very, very expensive product. It’s nonnegotiable for people that require it.”
In 2016, California’s Medicaid program paid at least $205 million for medications used to treat hemophilia, according to a Kaiser Health News analysis of federal Medicaid data. That figure doesn’t account for the federal rebates.
States can negotiate “supplemental” rebates with drugmakers for individual medications – but those must be kept secret under federal and some state laws. Such secrecy is becoming increasingly controversial as states continue to confront spiraling drug prices.
Limited options for states
In 2016, Pfizer sued Texas’ state health agency for giving data on the drug company’s supplemental Medicaid rebates to state lawmakers who requested it. The drugmaker alleged that releasing the confidential information would undermine the company’s competitiveness and give away trade secrets, and warned that the discounts it gave Texas could disappear.
In early October, a judge ruled that lawmakers should be able to obtain some of that data, noting dryly that “in Pfizer’s view, legislators are not necessary to carry out the state’s Medicaid program.”
Instead of seeking additional rebates from manufacturers for blood factor, some states, including Washington and Oregon, have chosen to require patients to get their blood factor from federally designated Hemophilia Treatment Centers only. That allows state Medicaid programs to take advantage of a federal drug-discount program known as “340B.”
However, officials in California said they studied that option and determined it wouldn’t save them any more money than the rebates they negotiate with drugmakers.
Whatever their approach, state health officials say they are struggling against forces they are nearly powerless to change.
“There aren’t a lot of options available to Medicaid programs in terms of controlling costs, because we don’t set the initial costs,” said Deborah Weston, pharmacy program manager for Oregon’s Medicaid program.
Kaiser Health News data correspondent Sydney Lupkin contributed to this report. KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Heising-Simons Foundation. This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
The child is well-known in the halls in which state bureaucrats oversee health care for millions of Californians – not by name, but by a number: $21 million.
His medications alone cost state taxpayers that much in a single year, not including other health care. The boy, whose identity has not been released, was California’s most expensive Medicaid patient in recent years. His case was singled out in a tweet last year by the state’s top health care official to highlight the public insurance program’s extraordinary obligations as a backstop for low-income patients.
How on earth can a single child’s treatment cost that much? The answer: He has hemophilia and needs large quantities of a pricey drug – known as clotting factor – that makes blood coagulate.
Hemophilia drugs are among the most costly drugs in the nation, and taxpayers are footing the bill for many patients on Medicaid who could never afford them on their own. Officials in California and other states are doing what they can to manage the costs, but it’s a daunting task that highlights the complexity and secrecy of prescription drug pricing.
Kaiser Health News is examining how America has become a “Medicaid Nation” – where tens of millions of poor and disabled people now rely on the support of the federal and state insurance program. Hemophilia is one those diseases that helps explain its burgeoning cost.
Medications for hemophilia are crucial to patients – overwhelmingly male – with the rare genetic condition that prevents clotting and puts them at great risk of bleeding to death, even from a minor injury. There is no question the drugs prolong and save lives, and state officials are not arguing that they should be withheld.
“It’s a highly vulnerable population,” said Ken Kizer, a veteran federal and state health administrator who formerly oversaw Medi-Cal, California’s version of Medicaid. “If anyone has seen a hemophiliac in crisis, you’re not going to say no.”
But drugmakers profit handsomely, competing vigorously for the limited number of patients.
The U.S. hemophilia market, which serves about 20,000 patients, is worth $4.6 billion a year, according to AllianceBernstein, a research and investment firm.
“There are millions being made out there on these kids – it’s a huge business,” said Doris Quon, MD, medical director of the Orthopaedic Hemophilia Treatment Center at the University of California, Los Angeles.
Contributing to the costs is the fact that there is no cure for hemophilia and no cheaper substitute for blood factor. Factor may be prescribed at high doses for a lifetime, even more so when a patient has an injury or complications.
Nationwide, a third of adults and children living with hemophilia are covered by Medicaid. And the Medicaid program’s three most expensive drugs per prescription are for hemophilia, according to an analysis by the Kaiser Family Foundation. (California Healthline is produced by Kaiser Health News, an editorially independent publication of the foundation.)
In 2015 alone, Medicaid paid about $353 million for prescriptions of Advate, the most commonly prescribed blood-clotting medication for hemophilia – a 273% increase from 2011.
Generally speaking, the price of hemophilia drugs rise as rival drugs hit the market. But, in addition, doctors are prescribing ever more clotting factor for prevention of joint-damaging bleeds and for improved long-term health. The increase in the cost of Advate, for example, was nearly all attributed to increased use.
Tab for 145 kids: $195 million
The California boy whose drugs cost $21 million in a single year was an extreme case, and the circumstances of his care have not been disclosed because of confidentiality protections. Still, medications to treat hemophilia on average annual cost more than $270,000 per patient, according to a 2015 Express Scripts report, and they can easily soar past $1 million annually.
In contrast to more common diseases like hepatitis C, hemophilia treatment is not a state “budget buster” per se: about 4,000 patients live in California. About 1,100 of them are covered by Medi-Cal or two other government-funded programs for chronically ill children in California, according to Jennifer Kent, director of the state Department of Health Care Services and author of last year’s tweet. But the amount of money spent per person dwarfs that spent on people with other serious diseases.
One Stanford University study of 34,000 California kids with severe chronic diseases found that the tiny portion of children who needed blood factor accounted for 41% of the state’s outpatient drug spending on this entire patient population. About $195 million was spent on just 145 kids over a 3-year period, although some of that money came back to the state in rebates from drug companies – a portion of the cost that Medicaid can recoup after purchase.
Caitlin Carroll, director of public affairs for PhRMA, the pharmaceutical industry lobbying group, said high development costs and the complicated and lengthy manufacturing process play a role in how hemophilia drugs are priced. She added that federally mandated rebates significantly reduce the cost of blood factor. They amount to 17% of the average manufacturer price per unit.
Manufacturers also note that some newer and more expensive hemophilia drugs last longer and do not need to be administered as frequently, so they can prove less costly to payers overall.
Even so, some patients require a monumental investment to survive.
‘Extremely fortunate’
Colleen Tuite’s son Kevin, a 7-year-old, has severe hemophilia with a complication known as an inhibitor – an antibody that makes his regular blood-factor infusions less effective. Inhibitors can dramatically increase the cost of care, because massive doses of blood factor or expensive, specialized blood products known as bypassing agents may be needed.
Ms. Tuite and her husband initially were Kevin’s foster parents, then adopted the boy as a toddler. Because he has been a foster child, Kevin qualifies for Medi-Cal until he is 26.
The Monrovia, Calif., family also has private health insurance, which pays for about half of Kevin’s medical bills. These can run upward of $200,000 per month, Ms. Tuite said.
“We definitely would not have been able to adopt him without the help of Medi-Cal,” Ms. Tuite said. “We’ve been extremely fortunate.”
With the support of drug manufacturers and hemophilia advocacy groups, patients and their families have significant political clout. Some experts say they also have a moral claim on public resources: In the early days of the AIDS epidemic, thousands of the nation’s hemophilia patients died after they contracted HIV through transfusions before the virus was eliminated from the blood supply.
State health officials say the costs of hemophilia are hard to anticipate and control, even with rebates.
“We do a really aggressive job of collecting rebates on our pharmacy costs,” said Ms. Kent, California’s top Medicaid official. “But there’s just not any way around blood factor. It is just a very, very expensive product. It’s nonnegotiable for people that require it.”
In 2016, California’s Medicaid program paid at least $205 million for medications used to treat hemophilia, according to a Kaiser Health News analysis of federal Medicaid data. That figure doesn’t account for the federal rebates.
States can negotiate “supplemental” rebates with drugmakers for individual medications – but those must be kept secret under federal and some state laws. Such secrecy is becoming increasingly controversial as states continue to confront spiraling drug prices.
Limited options for states
In 2016, Pfizer sued Texas’ state health agency for giving data on the drug company’s supplemental Medicaid rebates to state lawmakers who requested it. The drugmaker alleged that releasing the confidential information would undermine the company’s competitiveness and give away trade secrets, and warned that the discounts it gave Texas could disappear.
In early October, a judge ruled that lawmakers should be able to obtain some of that data, noting dryly that “in Pfizer’s view, legislators are not necessary to carry out the state’s Medicaid program.”
Instead of seeking additional rebates from manufacturers for blood factor, some states, including Washington and Oregon, have chosen to require patients to get their blood factor from federally designated Hemophilia Treatment Centers only. That allows state Medicaid programs to take advantage of a federal drug-discount program known as “340B.”
However, officials in California said they studied that option and determined it wouldn’t save them any more money than the rebates they negotiate with drugmakers.
Whatever their approach, state health officials say they are struggling against forces they are nearly powerless to change.
“There aren’t a lot of options available to Medicaid programs in terms of controlling costs, because we don’t set the initial costs,” said Deborah Weston, pharmacy program manager for Oregon’s Medicaid program.
Kaiser Health News data correspondent Sydney Lupkin contributed to this report. KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Heising-Simons Foundation. This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
The child is well-known in the halls in which state bureaucrats oversee health care for millions of Californians – not by name, but by a number: $21 million.
His medications alone cost state taxpayers that much in a single year, not including other health care. The boy, whose identity has not been released, was California’s most expensive Medicaid patient in recent years. His case was singled out in a tweet last year by the state’s top health care official to highlight the public insurance program’s extraordinary obligations as a backstop for low-income patients.
How on earth can a single child’s treatment cost that much? The answer: He has hemophilia and needs large quantities of a pricey drug – known as clotting factor – that makes blood coagulate.
Hemophilia drugs are among the most costly drugs in the nation, and taxpayers are footing the bill for many patients on Medicaid who could never afford them on their own. Officials in California and other states are doing what they can to manage the costs, but it’s a daunting task that highlights the complexity and secrecy of prescription drug pricing.
Kaiser Health News is examining how America has become a “Medicaid Nation” – where tens of millions of poor and disabled people now rely on the support of the federal and state insurance program. Hemophilia is one those diseases that helps explain its burgeoning cost.
Medications for hemophilia are crucial to patients – overwhelmingly male – with the rare genetic condition that prevents clotting and puts them at great risk of bleeding to death, even from a minor injury. There is no question the drugs prolong and save lives, and state officials are not arguing that they should be withheld.
“It’s a highly vulnerable population,” said Ken Kizer, a veteran federal and state health administrator who formerly oversaw Medi-Cal, California’s version of Medicaid. “If anyone has seen a hemophiliac in crisis, you’re not going to say no.”
But drugmakers profit handsomely, competing vigorously for the limited number of patients.
The U.S. hemophilia market, which serves about 20,000 patients, is worth $4.6 billion a year, according to AllianceBernstein, a research and investment firm.
“There are millions being made out there on these kids – it’s a huge business,” said Doris Quon, MD, medical director of the Orthopaedic Hemophilia Treatment Center at the University of California, Los Angeles.
Contributing to the costs is the fact that there is no cure for hemophilia and no cheaper substitute for blood factor. Factor may be prescribed at high doses for a lifetime, even more so when a patient has an injury or complications.
Nationwide, a third of adults and children living with hemophilia are covered by Medicaid. And the Medicaid program’s three most expensive drugs per prescription are for hemophilia, according to an analysis by the Kaiser Family Foundation. (California Healthline is produced by Kaiser Health News, an editorially independent publication of the foundation.)
In 2015 alone, Medicaid paid about $353 million for prescriptions of Advate, the most commonly prescribed blood-clotting medication for hemophilia – a 273% increase from 2011.
Generally speaking, the price of hemophilia drugs rise as rival drugs hit the market. But, in addition, doctors are prescribing ever more clotting factor for prevention of joint-damaging bleeds and for improved long-term health. The increase in the cost of Advate, for example, was nearly all attributed to increased use.
Tab for 145 kids: $195 million
The California boy whose drugs cost $21 million in a single year was an extreme case, and the circumstances of his care have not been disclosed because of confidentiality protections. Still, medications to treat hemophilia on average annual cost more than $270,000 per patient, according to a 2015 Express Scripts report, and they can easily soar past $1 million annually.
In contrast to more common diseases like hepatitis C, hemophilia treatment is not a state “budget buster” per se: about 4,000 patients live in California. About 1,100 of them are covered by Medi-Cal or two other government-funded programs for chronically ill children in California, according to Jennifer Kent, director of the state Department of Health Care Services and author of last year’s tweet. But the amount of money spent per person dwarfs that spent on people with other serious diseases.
One Stanford University study of 34,000 California kids with severe chronic diseases found that the tiny portion of children who needed blood factor accounted for 41% of the state’s outpatient drug spending on this entire patient population. About $195 million was spent on just 145 kids over a 3-year period, although some of that money came back to the state in rebates from drug companies – a portion of the cost that Medicaid can recoup after purchase.
Caitlin Carroll, director of public affairs for PhRMA, the pharmaceutical industry lobbying group, said high development costs and the complicated and lengthy manufacturing process play a role in how hemophilia drugs are priced. She added that federally mandated rebates significantly reduce the cost of blood factor. They amount to 17% of the average manufacturer price per unit.
Manufacturers also note that some newer and more expensive hemophilia drugs last longer and do not need to be administered as frequently, so they can prove less costly to payers overall.
Even so, some patients require a monumental investment to survive.
‘Extremely fortunate’
Colleen Tuite’s son Kevin, a 7-year-old, has severe hemophilia with a complication known as an inhibitor – an antibody that makes his regular blood-factor infusions less effective. Inhibitors can dramatically increase the cost of care, because massive doses of blood factor or expensive, specialized blood products known as bypassing agents may be needed.
Ms. Tuite and her husband initially were Kevin’s foster parents, then adopted the boy as a toddler. Because he has been a foster child, Kevin qualifies for Medi-Cal until he is 26.
The Monrovia, Calif., family also has private health insurance, which pays for about half of Kevin’s medical bills. These can run upward of $200,000 per month, Ms. Tuite said.
“We definitely would not have been able to adopt him without the help of Medi-Cal,” Ms. Tuite said. “We’ve been extremely fortunate.”
With the support of drug manufacturers and hemophilia advocacy groups, patients and their families have significant political clout. Some experts say they also have a moral claim on public resources: In the early days of the AIDS epidemic, thousands of the nation’s hemophilia patients died after they contracted HIV through transfusions before the virus was eliminated from the blood supply.
State health officials say the costs of hemophilia are hard to anticipate and control, even with rebates.
“We do a really aggressive job of collecting rebates on our pharmacy costs,” said Ms. Kent, California’s top Medicaid official. “But there’s just not any way around blood factor. It is just a very, very expensive product. It’s nonnegotiable for people that require it.”
In 2016, California’s Medicaid program paid at least $205 million for medications used to treat hemophilia, according to a Kaiser Health News analysis of federal Medicaid data. That figure doesn’t account for the federal rebates.
States can negotiate “supplemental” rebates with drugmakers for individual medications – but those must be kept secret under federal and some state laws. Such secrecy is becoming increasingly controversial as states continue to confront spiraling drug prices.
Limited options for states
In 2016, Pfizer sued Texas’ state health agency for giving data on the drug company’s supplemental Medicaid rebates to state lawmakers who requested it. The drugmaker alleged that releasing the confidential information would undermine the company’s competitiveness and give away trade secrets, and warned that the discounts it gave Texas could disappear.
In early October, a judge ruled that lawmakers should be able to obtain some of that data, noting dryly that “in Pfizer’s view, legislators are not necessary to carry out the state’s Medicaid program.”
Instead of seeking additional rebates from manufacturers for blood factor, some states, including Washington and Oregon, have chosen to require patients to get their blood factor from federally designated Hemophilia Treatment Centers only. That allows state Medicaid programs to take advantage of a federal drug-discount program known as “340B.”
However, officials in California said they studied that option and determined it wouldn’t save them any more money than the rebates they negotiate with drugmakers.
Whatever their approach, state health officials say they are struggling against forces they are nearly powerless to change.
“There aren’t a lot of options available to Medicaid programs in terms of controlling costs, because we don’t set the initial costs,” said Deborah Weston, pharmacy program manager for Oregon’s Medicaid program.
Kaiser Health News data correspondent Sydney Lupkin contributed to this report. KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Heising-Simons Foundation. This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
HCT-CI score may predict mortality for nonmalignant disease
SALT LAKE CITY – Scores of 3 or higher on the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) are associated with an increased risk of posttransplant mortality in certain patients undergoing allogeneic HCT for nonmalignant disease, according to findings from a review of more than 4,000 patients.
The exception was in patients undergoing HCT for hemoglobinopathies, Larisa Broglie, MD, reported at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
The findings of the study, which is the largest to date to validate the usefulness of the HCT-CI for risk assessment in HCT patients with nonmalignant disease, have important implications for patient counseling and decision making, said Dr. Broglie of the Medical College of Wisconsin, Milwaukee.
Of 4,083 children and adults who underwent a first allogeneic HCT for a nonmalignant disease between 2007 and 2014 and who had sufficient follow-up (median, 39 months), 61% had an HCT-CI score of 0, 20% had a score of 1-2, and 19% had a score of 3 or higher.
After adjustment for age, disease, donor, graft source, recipient cytomegalovirus status, and performance status, scores of 3 or greater were associated with an overall increased hazard ratio for poor survival (HRs of 1.33 for scores of 3-4 and 2.31 for scores of 5 or greater, vs. 1.0 and 1.127 for scores of 0 or 1-2, respectively), she said.
Patients with an HCT-CI score of 0 had estimated 2-year overall survival of 82.7%, compared with 80.3% for scores 1-2, 74.0% for scores 3-4, and 55.8% for scores of 5 or greater.
Patients included in this study were identified from the Center for International Blood & Marrow Transplant Research database. They ranged in age from under 1 year to 77 years but most were young; the median age was 9 years and 78% of patients were under age 20.
HCT was performed for acquired aplastic anemia in 33% of patients, immune deficiencies in 19%, hemoglobinopathies in 16%, bone marrow failure in 12%, histiocytic disorders in 11%, metabolic disease in 9%, or autoimmune disease in less than 1%, she said, noting that the most frequent comorbidities seen within the entire cohort were moderate pulmonary disease, hepatic disease, and infection requiring ongoing treatment.
The effect of HCT-CI score on survival was present regardless of conditioning intensity and graft-versus-host disease prophylaxis, but scores predicted mortality risk differently based on underlying disease, and different comorbidities predominated in each disease category, she said, explaining that this was apparent when patients were stratified by the seven represented nonmalignant disease categories to account for disease heterogeneity.
For example, HCT-CI score predicted mortality risk in patients with aplastic anemia (HRs of 1.00, 1.19, and 2.06 for scores of 0, 1-2, and 3 or greater, respectively), and in patients with immune deficiency (HRs of 1.00, 1.37, and 1.87 for scores of 0, 1-2, and 3 or greater, respectively), and the distribution of comorbidities in patients in these two disease categories was similar to that of the overall cohort.
However, HCT-CI score did not predict mortality risk in those undergoing HCT for hemoglobinopathies (HRs of 1.00, 0.46, and 0.59 for scores of 0, 1-2, and 3 or greater, respectively), Dr. Broglie said, noting that these patients had overall high survival rates regardless of HCT-CI scores, and they had comorbidities that differed from the overall cohort.
HCT is a curative treatment strategy for many patients with nonmalignant diseases but transplant-related mortality remains a concern, she said. While HCT-CI has been shown to be useful for discriminating the risks of nonrelapse and overall survival among patients with hematologic malignancies who undergo allogeneic HCT, its usefulness in patients undergoing HCT for nonmalignant diseases has been less clear.
The distinction is important, as patients with nonmalignant diseases have different pretransplant exposures and may have comorbidities specific to their underlying disease. Furthermore, transplantation approaches – including conditioning regimens and intensities – differ, she said.
“And the HCT-CI was developed to predict risk of nonrelapse mortality, but relapse in nonmalignant diseases can often be difficult to define,” she added.
The current findings demonstrate the value of the HCT-CI in nonmalignant diseases, and “offer the potential to intervene with transplantation prior to the onset of comorbidities, or with efforts to prevent comorbidities prior to transplantation,” she said, concluding that “future efforts could focus on further refining pretransplant risk assessment for patients with nonmalignant diseases, especially for patients with hemoglobinopathies and HCT-CI scores of less than 3.”
Dr. Broglie reported having no financial disclosures.
SOURCE: Broglie L et al. Abstract 16.
SALT LAKE CITY – Scores of 3 or higher on the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) are associated with an increased risk of posttransplant mortality in certain patients undergoing allogeneic HCT for nonmalignant disease, according to findings from a review of more than 4,000 patients.
The exception was in patients undergoing HCT for hemoglobinopathies, Larisa Broglie, MD, reported at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
The findings of the study, which is the largest to date to validate the usefulness of the HCT-CI for risk assessment in HCT patients with nonmalignant disease, have important implications for patient counseling and decision making, said Dr. Broglie of the Medical College of Wisconsin, Milwaukee.
Of 4,083 children and adults who underwent a first allogeneic HCT for a nonmalignant disease between 2007 and 2014 and who had sufficient follow-up (median, 39 months), 61% had an HCT-CI score of 0, 20% had a score of 1-2, and 19% had a score of 3 or higher.
After adjustment for age, disease, donor, graft source, recipient cytomegalovirus status, and performance status, scores of 3 or greater were associated with an overall increased hazard ratio for poor survival (HRs of 1.33 for scores of 3-4 and 2.31 for scores of 5 or greater, vs. 1.0 and 1.127 for scores of 0 or 1-2, respectively), she said.
Patients with an HCT-CI score of 0 had estimated 2-year overall survival of 82.7%, compared with 80.3% for scores 1-2, 74.0% for scores 3-4, and 55.8% for scores of 5 or greater.
Patients included in this study were identified from the Center for International Blood & Marrow Transplant Research database. They ranged in age from under 1 year to 77 years but most were young; the median age was 9 years and 78% of patients were under age 20.
HCT was performed for acquired aplastic anemia in 33% of patients, immune deficiencies in 19%, hemoglobinopathies in 16%, bone marrow failure in 12%, histiocytic disorders in 11%, metabolic disease in 9%, or autoimmune disease in less than 1%, she said, noting that the most frequent comorbidities seen within the entire cohort were moderate pulmonary disease, hepatic disease, and infection requiring ongoing treatment.
The effect of HCT-CI score on survival was present regardless of conditioning intensity and graft-versus-host disease prophylaxis, but scores predicted mortality risk differently based on underlying disease, and different comorbidities predominated in each disease category, she said, explaining that this was apparent when patients were stratified by the seven represented nonmalignant disease categories to account for disease heterogeneity.
For example, HCT-CI score predicted mortality risk in patients with aplastic anemia (HRs of 1.00, 1.19, and 2.06 for scores of 0, 1-2, and 3 or greater, respectively), and in patients with immune deficiency (HRs of 1.00, 1.37, and 1.87 for scores of 0, 1-2, and 3 or greater, respectively), and the distribution of comorbidities in patients in these two disease categories was similar to that of the overall cohort.
However, HCT-CI score did not predict mortality risk in those undergoing HCT for hemoglobinopathies (HRs of 1.00, 0.46, and 0.59 for scores of 0, 1-2, and 3 or greater, respectively), Dr. Broglie said, noting that these patients had overall high survival rates regardless of HCT-CI scores, and they had comorbidities that differed from the overall cohort.
HCT is a curative treatment strategy for many patients with nonmalignant diseases but transplant-related mortality remains a concern, she said. While HCT-CI has been shown to be useful for discriminating the risks of nonrelapse and overall survival among patients with hematologic malignancies who undergo allogeneic HCT, its usefulness in patients undergoing HCT for nonmalignant diseases has been less clear.
The distinction is important, as patients with nonmalignant diseases have different pretransplant exposures and may have comorbidities specific to their underlying disease. Furthermore, transplantation approaches – including conditioning regimens and intensities – differ, she said.
“And the HCT-CI was developed to predict risk of nonrelapse mortality, but relapse in nonmalignant diseases can often be difficult to define,” she added.
The current findings demonstrate the value of the HCT-CI in nonmalignant diseases, and “offer the potential to intervene with transplantation prior to the onset of comorbidities, or with efforts to prevent comorbidities prior to transplantation,” she said, concluding that “future efforts could focus on further refining pretransplant risk assessment for patients with nonmalignant diseases, especially for patients with hemoglobinopathies and HCT-CI scores of less than 3.”
Dr. Broglie reported having no financial disclosures.
SOURCE: Broglie L et al. Abstract 16.
SALT LAKE CITY – Scores of 3 or higher on the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) are associated with an increased risk of posttransplant mortality in certain patients undergoing allogeneic HCT for nonmalignant disease, according to findings from a review of more than 4,000 patients.
The exception was in patients undergoing HCT for hemoglobinopathies, Larisa Broglie, MD, reported at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
The findings of the study, which is the largest to date to validate the usefulness of the HCT-CI for risk assessment in HCT patients with nonmalignant disease, have important implications for patient counseling and decision making, said Dr. Broglie of the Medical College of Wisconsin, Milwaukee.
Of 4,083 children and adults who underwent a first allogeneic HCT for a nonmalignant disease between 2007 and 2014 and who had sufficient follow-up (median, 39 months), 61% had an HCT-CI score of 0, 20% had a score of 1-2, and 19% had a score of 3 or higher.
After adjustment for age, disease, donor, graft source, recipient cytomegalovirus status, and performance status, scores of 3 or greater were associated with an overall increased hazard ratio for poor survival (HRs of 1.33 for scores of 3-4 and 2.31 for scores of 5 or greater, vs. 1.0 and 1.127 for scores of 0 or 1-2, respectively), she said.
Patients with an HCT-CI score of 0 had estimated 2-year overall survival of 82.7%, compared with 80.3% for scores 1-2, 74.0% for scores 3-4, and 55.8% for scores of 5 or greater.
Patients included in this study were identified from the Center for International Blood & Marrow Transplant Research database. They ranged in age from under 1 year to 77 years but most were young; the median age was 9 years and 78% of patients were under age 20.
HCT was performed for acquired aplastic anemia in 33% of patients, immune deficiencies in 19%, hemoglobinopathies in 16%, bone marrow failure in 12%, histiocytic disorders in 11%, metabolic disease in 9%, or autoimmune disease in less than 1%, she said, noting that the most frequent comorbidities seen within the entire cohort were moderate pulmonary disease, hepatic disease, and infection requiring ongoing treatment.
The effect of HCT-CI score on survival was present regardless of conditioning intensity and graft-versus-host disease prophylaxis, but scores predicted mortality risk differently based on underlying disease, and different comorbidities predominated in each disease category, she said, explaining that this was apparent when patients were stratified by the seven represented nonmalignant disease categories to account for disease heterogeneity.
For example, HCT-CI score predicted mortality risk in patients with aplastic anemia (HRs of 1.00, 1.19, and 2.06 for scores of 0, 1-2, and 3 or greater, respectively), and in patients with immune deficiency (HRs of 1.00, 1.37, and 1.87 for scores of 0, 1-2, and 3 or greater, respectively), and the distribution of comorbidities in patients in these two disease categories was similar to that of the overall cohort.
However, HCT-CI score did not predict mortality risk in those undergoing HCT for hemoglobinopathies (HRs of 1.00, 0.46, and 0.59 for scores of 0, 1-2, and 3 or greater, respectively), Dr. Broglie said, noting that these patients had overall high survival rates regardless of HCT-CI scores, and they had comorbidities that differed from the overall cohort.
HCT is a curative treatment strategy for many patients with nonmalignant diseases but transplant-related mortality remains a concern, she said. While HCT-CI has been shown to be useful for discriminating the risks of nonrelapse and overall survival among patients with hematologic malignancies who undergo allogeneic HCT, its usefulness in patients undergoing HCT for nonmalignant diseases has been less clear.
The distinction is important, as patients with nonmalignant diseases have different pretransplant exposures and may have comorbidities specific to their underlying disease. Furthermore, transplantation approaches – including conditioning regimens and intensities – differ, she said.
“And the HCT-CI was developed to predict risk of nonrelapse mortality, but relapse in nonmalignant diseases can often be difficult to define,” she added.
The current findings demonstrate the value of the HCT-CI in nonmalignant diseases, and “offer the potential to intervene with transplantation prior to the onset of comorbidities, or with efforts to prevent comorbidities prior to transplantation,” she said, concluding that “future efforts could focus on further refining pretransplant risk assessment for patients with nonmalignant diseases, especially for patients with hemoglobinopathies and HCT-CI scores of less than 3.”
Dr. Broglie reported having no financial disclosures.
SOURCE: Broglie L et al. Abstract 16.
REPORTING FROM THE 2018 BMT TANDEM MEETINGS
Key clinical point:
Major finding: Hazard ratios for poor survival were 1.33 for scores of 3-4 and 2.31 for scores of 5 or greater, compared with 1.0 and 1.127 for scores of 0 or 1-2, respectively.
Study details: A review of 4,083 patients from the CIBMTR database.
Disclosures: Dr. Broglie reported having no financial disclosures.
Source: Broglie L et al. Abstract 16.
ALT-70 score outperformed thermal imaging for cellulitis diagnosis
SAN DIEGO – A simple scoring system surpassed thermal imaging for diagnosing lower extremity cellulitis in a head-to-head, single-center comparison in 67 patients.
The ALT-70 score – which tallies points for asymmetry, leukocytosis, tachycardia, and age of at least 70 years – produced a positive predictive value for lower-extremity cellulitis (LEC) of 80.4% and a negative predictive value of 90.9%, compared with values of 75.5% and 57.1%, respectively, for thermal imaging when researchers applied both methods to 67 patients, said David G. Li, a clinical research fellow in the department of dermatology at Brigham and Women’s Hospital, Boston, where the study was conducted.
The senior author of Mr. Li’s report, Arash Mostaghimi, MD, director of the inpatient consultation service, department of dermatology at Brigham and Women’s, was also lead investigator for the team of dermatology researchers – from his center and from Massachusetts General Hospital in Boston – who recently devised the ALT-70 scoring system for diagnosing LEC (J Amer Acad Dermatol. 2017 April;76[4]:618-25.e2).
The four-item survey can generate a score of 0-7, with a score of 0-2 suggesting need for additional monitoring, a score of 3-4 initiating a dermatology consult, and a score of 5-7 triggering immediate treatment for cellulitis, Mr. Li said. The 2017 review of ALT-70 showed that among 259 patients, those with a score of 0-2 had an 83% likelihood of having pseudocellulitis, while patients with a score of 5-7 had an 82% likelihood of having true cellulitis.
The current study enrolled 67 patients who had a presumptive diagnosis of LEC while in the emergency department or inpatient wards during a 7-month period. In addition to undergoing blinded assessment by both thermal imaging and by ALT-70 scoring, all patients also underwent blinded assessment by a board-certified dermatologist, who provided the definitive diagnosis. The attending dermatologists determined that 46 of the patients had true LEC and 21 patients did not.
The calculated sensitivity of ALT-70 was 97.8%, compared with 87.0% for thermal imaging. Specificity was 47.6% for ALT-70 and 38.1% for thermal imaging, Mr. Li reported at the annual meeting of the American Academy of Dermatology.
He also presented an analysis of the results when he combined both methods, with a positive on both assessments required to produce a positive LEC diagnosis. This resulted in a positive predictive value of 86.7%, slightly higher than the 80.4% from ALT-70 alone, but the combination produced a negative predictive value of 68.2%, substantially less than the 90.9% rate with ALT-70 alone. This demonstrated the “marginal benefit” from combining the two methods, he said.
In a receiver operating characteristic curve analysis, in which the area under the curve (c-statistic) reflects a diagnostic test’s validity, ALT-70 produced a c-statistic of 0.85, thermal imaging had a c-statistic of 0.63, and when combined, the c-statistic was 0.88.
Mr. Li called for validation of the findings using larger and different patient populations.
He had no reported disclosures.
SOURCE: Li DG et al. AAD 18, Abstract 6744.
SAN DIEGO – A simple scoring system surpassed thermal imaging for diagnosing lower extremity cellulitis in a head-to-head, single-center comparison in 67 patients.
The ALT-70 score – which tallies points for asymmetry, leukocytosis, tachycardia, and age of at least 70 years – produced a positive predictive value for lower-extremity cellulitis (LEC) of 80.4% and a negative predictive value of 90.9%, compared with values of 75.5% and 57.1%, respectively, for thermal imaging when researchers applied both methods to 67 patients, said David G. Li, a clinical research fellow in the department of dermatology at Brigham and Women’s Hospital, Boston, where the study was conducted.
The senior author of Mr. Li’s report, Arash Mostaghimi, MD, director of the inpatient consultation service, department of dermatology at Brigham and Women’s, was also lead investigator for the team of dermatology researchers – from his center and from Massachusetts General Hospital in Boston – who recently devised the ALT-70 scoring system for diagnosing LEC (J Amer Acad Dermatol. 2017 April;76[4]:618-25.e2).
The four-item survey can generate a score of 0-7, with a score of 0-2 suggesting need for additional monitoring, a score of 3-4 initiating a dermatology consult, and a score of 5-7 triggering immediate treatment for cellulitis, Mr. Li said. The 2017 review of ALT-70 showed that among 259 patients, those with a score of 0-2 had an 83% likelihood of having pseudocellulitis, while patients with a score of 5-7 had an 82% likelihood of having true cellulitis.
The current study enrolled 67 patients who had a presumptive diagnosis of LEC while in the emergency department or inpatient wards during a 7-month period. In addition to undergoing blinded assessment by both thermal imaging and by ALT-70 scoring, all patients also underwent blinded assessment by a board-certified dermatologist, who provided the definitive diagnosis. The attending dermatologists determined that 46 of the patients had true LEC and 21 patients did not.
The calculated sensitivity of ALT-70 was 97.8%, compared with 87.0% for thermal imaging. Specificity was 47.6% for ALT-70 and 38.1% for thermal imaging, Mr. Li reported at the annual meeting of the American Academy of Dermatology.
He also presented an analysis of the results when he combined both methods, with a positive on both assessments required to produce a positive LEC diagnosis. This resulted in a positive predictive value of 86.7%, slightly higher than the 80.4% from ALT-70 alone, but the combination produced a negative predictive value of 68.2%, substantially less than the 90.9% rate with ALT-70 alone. This demonstrated the “marginal benefit” from combining the two methods, he said.
In a receiver operating characteristic curve analysis, in which the area under the curve (c-statistic) reflects a diagnostic test’s validity, ALT-70 produced a c-statistic of 0.85, thermal imaging had a c-statistic of 0.63, and when combined, the c-statistic was 0.88.
Mr. Li called for validation of the findings using larger and different patient populations.
He had no reported disclosures.
SOURCE: Li DG et al. AAD 18, Abstract 6744.
SAN DIEGO – A simple scoring system surpassed thermal imaging for diagnosing lower extremity cellulitis in a head-to-head, single-center comparison in 67 patients.
The ALT-70 score – which tallies points for asymmetry, leukocytosis, tachycardia, and age of at least 70 years – produced a positive predictive value for lower-extremity cellulitis (LEC) of 80.4% and a negative predictive value of 90.9%, compared with values of 75.5% and 57.1%, respectively, for thermal imaging when researchers applied both methods to 67 patients, said David G. Li, a clinical research fellow in the department of dermatology at Brigham and Women’s Hospital, Boston, where the study was conducted.
The senior author of Mr. Li’s report, Arash Mostaghimi, MD, director of the inpatient consultation service, department of dermatology at Brigham and Women’s, was also lead investigator for the team of dermatology researchers – from his center and from Massachusetts General Hospital in Boston – who recently devised the ALT-70 scoring system for diagnosing LEC (J Amer Acad Dermatol. 2017 April;76[4]:618-25.e2).
The four-item survey can generate a score of 0-7, with a score of 0-2 suggesting need for additional monitoring, a score of 3-4 initiating a dermatology consult, and a score of 5-7 triggering immediate treatment for cellulitis, Mr. Li said. The 2017 review of ALT-70 showed that among 259 patients, those with a score of 0-2 had an 83% likelihood of having pseudocellulitis, while patients with a score of 5-7 had an 82% likelihood of having true cellulitis.
The current study enrolled 67 patients who had a presumptive diagnosis of LEC while in the emergency department or inpatient wards during a 7-month period. In addition to undergoing blinded assessment by both thermal imaging and by ALT-70 scoring, all patients also underwent blinded assessment by a board-certified dermatologist, who provided the definitive diagnosis. The attending dermatologists determined that 46 of the patients had true LEC and 21 patients did not.
The calculated sensitivity of ALT-70 was 97.8%, compared with 87.0% for thermal imaging. Specificity was 47.6% for ALT-70 and 38.1% for thermal imaging, Mr. Li reported at the annual meeting of the American Academy of Dermatology.
He also presented an analysis of the results when he combined both methods, with a positive on both assessments required to produce a positive LEC diagnosis. This resulted in a positive predictive value of 86.7%, slightly higher than the 80.4% from ALT-70 alone, but the combination produced a negative predictive value of 68.2%, substantially less than the 90.9% rate with ALT-70 alone. This demonstrated the “marginal benefit” from combining the two methods, he said.
In a receiver operating characteristic curve analysis, in which the area under the curve (c-statistic) reflects a diagnostic test’s validity, ALT-70 produced a c-statistic of 0.85, thermal imaging had a c-statistic of 0.63, and when combined, the c-statistic was 0.88.
Mr. Li called for validation of the findings using larger and different patient populations.
He had no reported disclosures.
SOURCE: Li DG et al. AAD 18, Abstract 6744.
REPORTING FROM AAD 18
Key clinical point: The ALT-70 score surpassed thermal imaging for diagnosing lower-extremity cellulitis.
Major finding: Positive and negative predictive values were 80.4% and 90.9% for ALT-70 and 75.5% and 57.1% for thermal imaging.
Study details: A single-center study with 67 patients.
Disclosures: Mr. Li had no disclosures.
Source: Li DG et al. AAD 18, Abstract 6744.
HCV infection tied to premature ovarian senescence and a high miscarriage rate
Premenopausal women with hepatitis C virus (HCV) showed increased ovarian senescence, which was associated with a lower chance of live birth. Such women also had a greater risk of infertility, as reported in the Journal of Hepatology.
Researchers examined three cohort studies, which comprised an age-matched prospectively enrolled cohort study of 100 women who were HCV positive and had chronic liver disease, 50 women who were HBV positive and had CLD, and 100 healthy women; 1,998 HCV-infected women enrolled in the Platform for the Study of Viral Hepatitis Therapies (PITER) trial from Italy; and 6,085 women infected with HCV plus 20,415 uninfected women from a United States database, according to Aimilia Karampatou, MD, of the University of Bologna, Modena, Italy, and colleagues.
In the second group examined, the women from the PITER trial, miscarriages occurred in 42% of the HCV-infected women with 44.6% of these women experiencing multiple miscarriages. The total fertility rate, defined as the average number of children that would be born in a lifetime, was 0.7 for the HCV-infected women, compared with 1.37 in the general Italian population.
Infertility data from the large U.S. study was assessed from a total of 27,525 women (20,415 HCV negative and HIV negative; 6,805 HCV positive; and 305 HCV positive/HIV positive). Women with HCV showed a significantly higher probability of infertility compared with uninfected controls (odds ratio, 2.44), and those women dually infected with HCV and HIV were affected even more (OR, 3.64).
Primarily based on the observations of AMH, which in many of the HCV-positive women fell into the menopausal range, the researchers suggested that “the reduced reproductive capacity of women who are HCV positive is related to failing ovarian function and subsequent follicular depletion in the context of a more generalized dysfunction of other fertility-related factors.”
With regard to the effect of antiviral therapy, AMH levels remained stable in women who attained a sustained virologic response but continued to fall in those for whom the therapy was a failure.
“HCV infection significantly and negatively affects many aspects of fertility. It remains to be assessed whether antiviral therapy at a very early age can positively influence the occurrence of miscarriages and can prevent ovarian senescence because the latter has broader health implications than simply preserving fertility,” the researchers concluded.
The authors reported that they had no conflicts of interest.
AGA provides resources and education for your patients about hepatitis C at www.gastro.org/HCV
SOURCE: Karampatou A et al. J Hepatology. 2018;68:33-41.
Premenopausal women with hepatitis C virus (HCV) showed increased ovarian senescence, which was associated with a lower chance of live birth. Such women also had a greater risk of infertility, as reported in the Journal of Hepatology.
Researchers examined three cohort studies, which comprised an age-matched prospectively enrolled cohort study of 100 women who were HCV positive and had chronic liver disease, 50 women who were HBV positive and had CLD, and 100 healthy women; 1,998 HCV-infected women enrolled in the Platform for the Study of Viral Hepatitis Therapies (PITER) trial from Italy; and 6,085 women infected with HCV plus 20,415 uninfected women from a United States database, according to Aimilia Karampatou, MD, of the University of Bologna, Modena, Italy, and colleagues.
In the second group examined, the women from the PITER trial, miscarriages occurred in 42% of the HCV-infected women with 44.6% of these women experiencing multiple miscarriages. The total fertility rate, defined as the average number of children that would be born in a lifetime, was 0.7 for the HCV-infected women, compared with 1.37 in the general Italian population.
Infertility data from the large U.S. study was assessed from a total of 27,525 women (20,415 HCV negative and HIV negative; 6,805 HCV positive; and 305 HCV positive/HIV positive). Women with HCV showed a significantly higher probability of infertility compared with uninfected controls (odds ratio, 2.44), and those women dually infected with HCV and HIV were affected even more (OR, 3.64).
Primarily based on the observations of AMH, which in many of the HCV-positive women fell into the menopausal range, the researchers suggested that “the reduced reproductive capacity of women who are HCV positive is related to failing ovarian function and subsequent follicular depletion in the context of a more generalized dysfunction of other fertility-related factors.”
With regard to the effect of antiviral therapy, AMH levels remained stable in women who attained a sustained virologic response but continued to fall in those for whom the therapy was a failure.
“HCV infection significantly and negatively affects many aspects of fertility. It remains to be assessed whether antiviral therapy at a very early age can positively influence the occurrence of miscarriages and can prevent ovarian senescence because the latter has broader health implications than simply preserving fertility,” the researchers concluded.
The authors reported that they had no conflicts of interest.
AGA provides resources and education for your patients about hepatitis C at www.gastro.org/HCV
SOURCE: Karampatou A et al. J Hepatology. 2018;68:33-41.
Premenopausal women with hepatitis C virus (HCV) showed increased ovarian senescence, which was associated with a lower chance of live birth. Such women also had a greater risk of infertility, as reported in the Journal of Hepatology.
Researchers examined three cohort studies, which comprised an age-matched prospectively enrolled cohort study of 100 women who were HCV positive and had chronic liver disease, 50 women who were HBV positive and had CLD, and 100 healthy women; 1,998 HCV-infected women enrolled in the Platform for the Study of Viral Hepatitis Therapies (PITER) trial from Italy; and 6,085 women infected with HCV plus 20,415 uninfected women from a United States database, according to Aimilia Karampatou, MD, of the University of Bologna, Modena, Italy, and colleagues.
In the second group examined, the women from the PITER trial, miscarriages occurred in 42% of the HCV-infected women with 44.6% of these women experiencing multiple miscarriages. The total fertility rate, defined as the average number of children that would be born in a lifetime, was 0.7 for the HCV-infected women, compared with 1.37 in the general Italian population.
Infertility data from the large U.S. study was assessed from a total of 27,525 women (20,415 HCV negative and HIV negative; 6,805 HCV positive; and 305 HCV positive/HIV positive). Women with HCV showed a significantly higher probability of infertility compared with uninfected controls (odds ratio, 2.44), and those women dually infected with HCV and HIV were affected even more (OR, 3.64).
Primarily based on the observations of AMH, which in many of the HCV-positive women fell into the menopausal range, the researchers suggested that “the reduced reproductive capacity of women who are HCV positive is related to failing ovarian function and subsequent follicular depletion in the context of a more generalized dysfunction of other fertility-related factors.”
With regard to the effect of antiviral therapy, AMH levels remained stable in women who attained a sustained virologic response but continued to fall in those for whom the therapy was a failure.
“HCV infection significantly and negatively affects many aspects of fertility. It remains to be assessed whether antiviral therapy at a very early age can positively influence the occurrence of miscarriages and can prevent ovarian senescence because the latter has broader health implications than simply preserving fertility,” the researchers concluded.
The authors reported that they had no conflicts of interest.
AGA provides resources and education for your patients about hepatitis C at www.gastro.org/HCV
SOURCE: Karampatou A et al. J Hepatology. 2018;68:33-41.
FROM THE JOURNAL OF HEPATOLOGY
Key clinical point: HCV-positive women appear to undergo increased ovarian senescence.
Major finding: The fertility rate of HCV-positive women was 0.7 vs. 1.37 in the general population.
Study details: Three separate studies together comprising more than 30,000 HCV-infected and -uninfected women.
Disclosures: The authors reported that they had no conflicts of interest.
Source: Karampatou A et al. J Hepatology. 2018;68:33-41.
Young diabetics are at sevenfold increased risk of sudden cardiac death
ANAHEIM, CALIF. – Children and young adults with type 1 or type 2 diabetes have a 7.4-fold increased risk of sudden cardiac death, compared with nondiabetic, age-matched controls, according to a first-of-its-kind Danish national study.
“Luckily the absolute risk is low, but we hope these data will make [young patients with diabetes] think more about taking their insulin and following their physicians’ recommendations about treatment,” Jesper Svane said in presenting the study findings at the American Heart Association scientific sessions.
Sudden cardiac death (SCD) was the No. 1 cause of mortality in the diabetic cohort with a rate of 34.8 deaths/100,000 person-years, compared with 4.7 deaths/100,000 person-years in an age-matched nondiabetic cohort. That translates to a 7.4-fold increased risk of SCD in the diabetic cohort, noted Mr. Svane, a medical student at Copenhagen University.
When deaths caused by SCD were combined with those from other cardiac diseases, the young diabetic cohort had a rate of 68.3 deaths/100,000 person-years versus 8.2 deaths/100,000 person-years in age-matched controls, for an 8.3-fold increased risk. This observation underscores an important point: Monitoring cardiovascular risk needs to start early in young patients with diabetes.
“It’s important to pay attention when a young person with diabetes comes in complaining of chest pain or syncope,” Mr. Svane said.
The second and third most common causes of death in young Danish diabetic patients were pulmonary and endocrine diseases, which occurred at rates 7.2- and 79.2-fold greater in these patients, respectively, than in controls.
All-cause mortality occurred at a rate of 234.9 deaths/100,000 person-years in young patients with diabetes versus 50.9 deaths/100,000 person-years in matched controls, for a 4.6-fold increased risk.
Autopsies showed that the most common cause of death in diabetic persons aged 36-49 years was coronary artery disease, while in those up to age 35, it was sudden arrhythmic death syndrome, a label bestowed when a medical examiner can’t find an apparent cause of death.
Session moderator Robert H. Eckle, MD, a past AHA president, cautioned against routinely attributing the deaths without apparent cause at autopsy in young people with diabetes to sudden arrhythmic death syndrome. Given that the Danish registry data don’t include data on diabetic patients’ degree of metabolic control, it seems likely that an uncertain number of those deaths were really caused by hypoglycemia, observed Dr. Eckle, professor of medicine at the University of Colorado at Denver, Aurora.
Mr. Svane reported having no financial conflicts of interest.
SOURCE: Svane J. 2017 AHA Sessions.
ANAHEIM, CALIF. – Children and young adults with type 1 or type 2 diabetes have a 7.4-fold increased risk of sudden cardiac death, compared with nondiabetic, age-matched controls, according to a first-of-its-kind Danish national study.
“Luckily the absolute risk is low, but we hope these data will make [young patients with diabetes] think more about taking their insulin and following their physicians’ recommendations about treatment,” Jesper Svane said in presenting the study findings at the American Heart Association scientific sessions.
Sudden cardiac death (SCD) was the No. 1 cause of mortality in the diabetic cohort with a rate of 34.8 deaths/100,000 person-years, compared with 4.7 deaths/100,000 person-years in an age-matched nondiabetic cohort. That translates to a 7.4-fold increased risk of SCD in the diabetic cohort, noted Mr. Svane, a medical student at Copenhagen University.
When deaths caused by SCD were combined with those from other cardiac diseases, the young diabetic cohort had a rate of 68.3 deaths/100,000 person-years versus 8.2 deaths/100,000 person-years in age-matched controls, for an 8.3-fold increased risk. This observation underscores an important point: Monitoring cardiovascular risk needs to start early in young patients with diabetes.
“It’s important to pay attention when a young person with diabetes comes in complaining of chest pain or syncope,” Mr. Svane said.
The second and third most common causes of death in young Danish diabetic patients were pulmonary and endocrine diseases, which occurred at rates 7.2- and 79.2-fold greater in these patients, respectively, than in controls.
All-cause mortality occurred at a rate of 234.9 deaths/100,000 person-years in young patients with diabetes versus 50.9 deaths/100,000 person-years in matched controls, for a 4.6-fold increased risk.
Autopsies showed that the most common cause of death in diabetic persons aged 36-49 years was coronary artery disease, while in those up to age 35, it was sudden arrhythmic death syndrome, a label bestowed when a medical examiner can’t find an apparent cause of death.
Session moderator Robert H. Eckle, MD, a past AHA president, cautioned against routinely attributing the deaths without apparent cause at autopsy in young people with diabetes to sudden arrhythmic death syndrome. Given that the Danish registry data don’t include data on diabetic patients’ degree of metabolic control, it seems likely that an uncertain number of those deaths were really caused by hypoglycemia, observed Dr. Eckle, professor of medicine at the University of Colorado at Denver, Aurora.
Mr. Svane reported having no financial conflicts of interest.
SOURCE: Svane J. 2017 AHA Sessions.
ANAHEIM, CALIF. – Children and young adults with type 1 or type 2 diabetes have a 7.4-fold increased risk of sudden cardiac death, compared with nondiabetic, age-matched controls, according to a first-of-its-kind Danish national study.
“Luckily the absolute risk is low, but we hope these data will make [young patients with diabetes] think more about taking their insulin and following their physicians’ recommendations about treatment,” Jesper Svane said in presenting the study findings at the American Heart Association scientific sessions.
Sudden cardiac death (SCD) was the No. 1 cause of mortality in the diabetic cohort with a rate of 34.8 deaths/100,000 person-years, compared with 4.7 deaths/100,000 person-years in an age-matched nondiabetic cohort. That translates to a 7.4-fold increased risk of SCD in the diabetic cohort, noted Mr. Svane, a medical student at Copenhagen University.
When deaths caused by SCD were combined with those from other cardiac diseases, the young diabetic cohort had a rate of 68.3 deaths/100,000 person-years versus 8.2 deaths/100,000 person-years in age-matched controls, for an 8.3-fold increased risk. This observation underscores an important point: Monitoring cardiovascular risk needs to start early in young patients with diabetes.
“It’s important to pay attention when a young person with diabetes comes in complaining of chest pain or syncope,” Mr. Svane said.
The second and third most common causes of death in young Danish diabetic patients were pulmonary and endocrine diseases, which occurred at rates 7.2- and 79.2-fold greater in these patients, respectively, than in controls.
All-cause mortality occurred at a rate of 234.9 deaths/100,000 person-years in young patients with diabetes versus 50.9 deaths/100,000 person-years in matched controls, for a 4.6-fold increased risk.
Autopsies showed that the most common cause of death in diabetic persons aged 36-49 years was coronary artery disease, while in those up to age 35, it was sudden arrhythmic death syndrome, a label bestowed when a medical examiner can’t find an apparent cause of death.
Session moderator Robert H. Eckle, MD, a past AHA president, cautioned against routinely attributing the deaths without apparent cause at autopsy in young people with diabetes to sudden arrhythmic death syndrome. Given that the Danish registry data don’t include data on diabetic patients’ degree of metabolic control, it seems likely that an uncertain number of those deaths were really caused by hypoglycemia, observed Dr. Eckle, professor of medicine at the University of Colorado at Denver, Aurora.
Mr. Svane reported having no financial conflicts of interest.
SOURCE: Svane J. 2017 AHA Sessions.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point: Young persons with diabetes are 8.3-fold more likely to die of cardiac causes.
Major finding: In particular, the risk of sudden cardiac death in Danish children and young adults with diabetes was 7.4-fold greater than in age-matched controls.
Study details: This was a Danish national registry study of more than 14,000 children and young adults with diabetes and their rate of sudden cardiac death.
Disclosures: The study presenter reported having no financial conflicts.
Source: Svane J. 2017 AHA Sessions.
Breast cancer care delayed when patients have high deductibles
High-deductible health insurance plans may be bad for women’s health, suggest results of a new study.
An analysis of data on women without evidence of breast cancer who were covered for at least 1 year in a low annual deductible plan and then switched by their employers to high annual deductible plans showed that when women were forced to shell out substantially more money before their insurance kicked in, they were significantly more likely to have delays in diagnostic breast imaging, breast biopsy, and initiation of chemotherapy.
“Such delays might lead to adverse long-term breast cancer outcomes. Policymakers, health insurers, and employers should consider designing or incentivizing health insurance benefits that facilitate transitions through key steps along the cancer care pathway,” wrote J. Frank Wharam, MB, and colleagues at Harvard Medical School and Harvard Pilgrim Health Care Institute in Boston. The report was published in Journal of Clinical Oncology.
The investigators conducted a controlled pre-post study to measure the occurrence of outcomes both before and after women were switched from a low-deductible health plan, defined as a maximum annual deductible of $500 or less, to a high-deductible plan, defined as an annual deductible of $1,000 or more.
The study population comprised 273,499 women aged 25-64 years who had no evidence of breast cancer before they were included in the study. The women had all been enrolled in a low-deductible plan for at least 1 year, and were then switched by employer mandate to a high-deductible plan and followed for up to 4 additional years.
Controls included 2.4 million women matched by time of inclusion whose employers continued to offer only low-deductible health plans.
Although at baseline there were no differences between the study sample and the controls in time to first diagnostic breast imaging, breast biopsy, diagnosis of early stage breast cancer, or initiation of breast cancer chemotherapy, at follow-up the women who had been switched to the high-deductible plans had significant delays in all categories.
Compared with controls, the hazard ratios (HR) for each parameter were as follows:
Time to first diagnostic breast imaging: HR = 0.96 (95% confidence interval 0.94-0.96)
Time to first breast biopsy: HR = 0.92 (0.89-0.95)
Time to early stage breast cancer diagnosis: HR = 0.83 (0.78-0.90)
Time to breast cancer chemotherapy: HR = 0.79 (0.72-0.86)
“The findings imply that the high out-of-pocket obligations under HDHPs [high-deductible health plans] might be a barrier to timely receipt of essential breast cancer services. Women in HDHPs might either delay presenting for concerning symptoms or, if proceeding along the pathway from breast cancer screening to diagnostic testing to treatment, be hesitant to undergo subsequent (and generally more expensive) care,” the authors wrote.
They noted that initially modest delays in diagnostic imaging appeared to snowball into longer delays as women proceeded through stages of care.
They recommend a strategy whereby insurers carve out exemptions to high deductibles for services such as diagnostic imaging and breast biopsy.
SOURCE: Wharam et al. J Clin Oncol. 2018 Feb 28. doi: 10.1200/JCO.2017.75.2501.
High-deductible health insurance plans may be bad for women’s health, suggest results of a new study.
An analysis of data on women without evidence of breast cancer who were covered for at least 1 year in a low annual deductible plan and then switched by their employers to high annual deductible plans showed that when women were forced to shell out substantially more money before their insurance kicked in, they were significantly more likely to have delays in diagnostic breast imaging, breast biopsy, and initiation of chemotherapy.
“Such delays might lead to adverse long-term breast cancer outcomes. Policymakers, health insurers, and employers should consider designing or incentivizing health insurance benefits that facilitate transitions through key steps along the cancer care pathway,” wrote J. Frank Wharam, MB, and colleagues at Harvard Medical School and Harvard Pilgrim Health Care Institute in Boston. The report was published in Journal of Clinical Oncology.
The investigators conducted a controlled pre-post study to measure the occurrence of outcomes both before and after women were switched from a low-deductible health plan, defined as a maximum annual deductible of $500 or less, to a high-deductible plan, defined as an annual deductible of $1,000 or more.
The study population comprised 273,499 women aged 25-64 years who had no evidence of breast cancer before they were included in the study. The women had all been enrolled in a low-deductible plan for at least 1 year, and were then switched by employer mandate to a high-deductible plan and followed for up to 4 additional years.
Controls included 2.4 million women matched by time of inclusion whose employers continued to offer only low-deductible health plans.
Although at baseline there were no differences between the study sample and the controls in time to first diagnostic breast imaging, breast biopsy, diagnosis of early stage breast cancer, or initiation of breast cancer chemotherapy, at follow-up the women who had been switched to the high-deductible plans had significant delays in all categories.
Compared with controls, the hazard ratios (HR) for each parameter were as follows:
Time to first diagnostic breast imaging: HR = 0.96 (95% confidence interval 0.94-0.96)
Time to first breast biopsy: HR = 0.92 (0.89-0.95)
Time to early stage breast cancer diagnosis: HR = 0.83 (0.78-0.90)
Time to breast cancer chemotherapy: HR = 0.79 (0.72-0.86)
“The findings imply that the high out-of-pocket obligations under HDHPs [high-deductible health plans] might be a barrier to timely receipt of essential breast cancer services. Women in HDHPs might either delay presenting for concerning symptoms or, if proceeding along the pathway from breast cancer screening to diagnostic testing to treatment, be hesitant to undergo subsequent (and generally more expensive) care,” the authors wrote.
They noted that initially modest delays in diagnostic imaging appeared to snowball into longer delays as women proceeded through stages of care.
They recommend a strategy whereby insurers carve out exemptions to high deductibles for services such as diagnostic imaging and breast biopsy.
SOURCE: Wharam et al. J Clin Oncol. 2018 Feb 28. doi: 10.1200/JCO.2017.75.2501.
High-deductible health insurance plans may be bad for women’s health, suggest results of a new study.
An analysis of data on women without evidence of breast cancer who were covered for at least 1 year in a low annual deductible plan and then switched by their employers to high annual deductible plans showed that when women were forced to shell out substantially more money before their insurance kicked in, they were significantly more likely to have delays in diagnostic breast imaging, breast biopsy, and initiation of chemotherapy.
“Such delays might lead to adverse long-term breast cancer outcomes. Policymakers, health insurers, and employers should consider designing or incentivizing health insurance benefits that facilitate transitions through key steps along the cancer care pathway,” wrote J. Frank Wharam, MB, and colleagues at Harvard Medical School and Harvard Pilgrim Health Care Institute in Boston. The report was published in Journal of Clinical Oncology.
The investigators conducted a controlled pre-post study to measure the occurrence of outcomes both before and after women were switched from a low-deductible health plan, defined as a maximum annual deductible of $500 or less, to a high-deductible plan, defined as an annual deductible of $1,000 or more.
The study population comprised 273,499 women aged 25-64 years who had no evidence of breast cancer before they were included in the study. The women had all been enrolled in a low-deductible plan for at least 1 year, and were then switched by employer mandate to a high-deductible plan and followed for up to 4 additional years.
Controls included 2.4 million women matched by time of inclusion whose employers continued to offer only low-deductible health plans.
Although at baseline there were no differences between the study sample and the controls in time to first diagnostic breast imaging, breast biopsy, diagnosis of early stage breast cancer, or initiation of breast cancer chemotherapy, at follow-up the women who had been switched to the high-deductible plans had significant delays in all categories.
Compared with controls, the hazard ratios (HR) for each parameter were as follows:
Time to first diagnostic breast imaging: HR = 0.96 (95% confidence interval 0.94-0.96)
Time to first breast biopsy: HR = 0.92 (0.89-0.95)
Time to early stage breast cancer diagnosis: HR = 0.83 (0.78-0.90)
Time to breast cancer chemotherapy: HR = 0.79 (0.72-0.86)
“The findings imply that the high out-of-pocket obligations under HDHPs [high-deductible health plans] might be a barrier to timely receipt of essential breast cancer services. Women in HDHPs might either delay presenting for concerning symptoms or, if proceeding along the pathway from breast cancer screening to diagnostic testing to treatment, be hesitant to undergo subsequent (and generally more expensive) care,” the authors wrote.
They noted that initially modest delays in diagnostic imaging appeared to snowball into longer delays as women proceeded through stages of care.
They recommend a strategy whereby insurers carve out exemptions to high deductibles for services such as diagnostic imaging and breast biopsy.
SOURCE: Wharam et al. J Clin Oncol. 2018 Feb 28. doi: 10.1200/JCO.2017.75.2501.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Many women have high-deductible health plans that may discourage them from seeking essential care when needed.
Major finding: Women with an employer-mandated switch from a low- to high-deductible health plan had significant delays in diagnostic imaging, biopsy, diagnosis, and cancer care.
Study details: Controlled pre-post study of data on 273,499 women and 2.4 million controls.
Disclosures: The study was supported by National Cancer Institute and National Institute of Health grants. Dr. Wharam and three coauthors reported no conflicts of interest. Three coauthors reported honoraria and/or consulting/advisory roles with various companies.
Source: Wharam et al. J Clin Oncol. 2018 Feb 28. doi: 10.1200/JCO.2017.75.2501.
Prehospital antibiotics improved some aspects of sepsis care
SAN ANTONIO – according to results of a randomized trial.
Emergency medical service (EMS) personnel were able to recognize sepsis more quickly, obtain blood cultures, and give antibiotics after the training, reported investigator Prabath Nanayakkara, MD, PhD, FRCP, at the Society of Critical Care Medicine’s Critical Care Congress.
At 28 days, 120 patients (8%) in the prehospital antibiotics group had died, compared with 93 patients (8%) in the usual care group (relative risk, 0.95; 95% confidence interval, 0.74-1.24), according to the study’s results that were simultaneously published online in Lancet Respiratory Medicine.
The intervention group received antibiotics a median of 26 minutes prior to emergency department (ED) arrival. In the usual care group, median time to antibiotics after ED arrival was 70 minutes, versus 93 minutes prior to the sepsis recognition training (P = .142), the report further says.
“We do not advise prehospital antibiotics at the moment for patients with suspected sepsis,” Dr. Nanayakkara said, during his presentation at the conference.
Other countries might see different results, he cautioned.
In the Netherlands, ambulances reach the emergency scene within 15 minutes 93% of the time, and the average time from dispatch call to ED arrival is 40 minutes, Dr. Nanayakkara noted in the report.
“In part, due to the relatively short response times in the Netherlands, we don’t know if there are other countries with longer response times that would have other results, and whether they should use antibiotics in their ambulances,” Dr. Nanayakkara said in his presentation.
The study was the first-ever prospective randomized, controlled open-label trial to compare early prehospital antibiotics with standard care.
Before the study was started, EMS personnel at 10 large regional ambulance services serving 34 secondary or tertiary hospitals were trained in recognizing sepsis, the report says.
A total of 2,672 patients with suspected sepsis were included in the intention-to-treat analysis, of whom 1,535 were randomized to receive prehospital antibiotics and 1,137 to usual EMS care, which consisted of fluid resuscitation and supplementary oxygen.
The primary end point of the study was all-cause mortality at 28 days.
The negative mortality results of this trial are “not surprising,” given that the trial’s inclusion criteria allowed individuals with suspected infection but without organ dysfunction, said Jean-Louis Vincent, MD, PhD, of Erasmus Hospital, Brussels, in a related editorial appearing in the Lancet Respiratory Medicine (2018 Jan. doi: 10.1016/S2213-2600[17]30446-0).
Recent consensus definitions of sepsis recognize that sepsis is the association of an infection with some degree of organ dysfunction, according to Dr. Vincent.
“After this initial experience, I believe that a randomized, controlled trial could be done to assess the potential benefit of early antibiotic administration in the ambulance for patients with organ dysfunction associated with infection,” Dr. Vincent wrote in his editorial.
Dr. Nanayakkara and his coauthors declared no competing interests related to their study.
SOURCE: Alam N et al. Lancet Respir Med. 2018 Jan;6(1):40-50.
SAN ANTONIO – according to results of a randomized trial.
Emergency medical service (EMS) personnel were able to recognize sepsis more quickly, obtain blood cultures, and give antibiotics after the training, reported investigator Prabath Nanayakkara, MD, PhD, FRCP, at the Society of Critical Care Medicine’s Critical Care Congress.
At 28 days, 120 patients (8%) in the prehospital antibiotics group had died, compared with 93 patients (8%) in the usual care group (relative risk, 0.95; 95% confidence interval, 0.74-1.24), according to the study’s results that were simultaneously published online in Lancet Respiratory Medicine.
The intervention group received antibiotics a median of 26 minutes prior to emergency department (ED) arrival. In the usual care group, median time to antibiotics after ED arrival was 70 minutes, versus 93 minutes prior to the sepsis recognition training (P = .142), the report further says.
“We do not advise prehospital antibiotics at the moment for patients with suspected sepsis,” Dr. Nanayakkara said, during his presentation at the conference.
Other countries might see different results, he cautioned.
In the Netherlands, ambulances reach the emergency scene within 15 minutes 93% of the time, and the average time from dispatch call to ED arrival is 40 minutes, Dr. Nanayakkara noted in the report.
“In part, due to the relatively short response times in the Netherlands, we don’t know if there are other countries with longer response times that would have other results, and whether they should use antibiotics in their ambulances,” Dr. Nanayakkara said in his presentation.
The study was the first-ever prospective randomized, controlled open-label trial to compare early prehospital antibiotics with standard care.
Before the study was started, EMS personnel at 10 large regional ambulance services serving 34 secondary or tertiary hospitals were trained in recognizing sepsis, the report says.
A total of 2,672 patients with suspected sepsis were included in the intention-to-treat analysis, of whom 1,535 were randomized to receive prehospital antibiotics and 1,137 to usual EMS care, which consisted of fluid resuscitation and supplementary oxygen.
The primary end point of the study was all-cause mortality at 28 days.
The negative mortality results of this trial are “not surprising,” given that the trial’s inclusion criteria allowed individuals with suspected infection but without organ dysfunction, said Jean-Louis Vincent, MD, PhD, of Erasmus Hospital, Brussels, in a related editorial appearing in the Lancet Respiratory Medicine (2018 Jan. doi: 10.1016/S2213-2600[17]30446-0).
Recent consensus definitions of sepsis recognize that sepsis is the association of an infection with some degree of organ dysfunction, according to Dr. Vincent.
“After this initial experience, I believe that a randomized, controlled trial could be done to assess the potential benefit of early antibiotic administration in the ambulance for patients with organ dysfunction associated with infection,” Dr. Vincent wrote in his editorial.
Dr. Nanayakkara and his coauthors declared no competing interests related to their study.
SOURCE: Alam N et al. Lancet Respir Med. 2018 Jan;6(1):40-50.
SAN ANTONIO – according to results of a randomized trial.
Emergency medical service (EMS) personnel were able to recognize sepsis more quickly, obtain blood cultures, and give antibiotics after the training, reported investigator Prabath Nanayakkara, MD, PhD, FRCP, at the Society of Critical Care Medicine’s Critical Care Congress.
At 28 days, 120 patients (8%) in the prehospital antibiotics group had died, compared with 93 patients (8%) in the usual care group (relative risk, 0.95; 95% confidence interval, 0.74-1.24), according to the study’s results that were simultaneously published online in Lancet Respiratory Medicine.
The intervention group received antibiotics a median of 26 minutes prior to emergency department (ED) arrival. In the usual care group, median time to antibiotics after ED arrival was 70 minutes, versus 93 minutes prior to the sepsis recognition training (P = .142), the report further says.
“We do not advise prehospital antibiotics at the moment for patients with suspected sepsis,” Dr. Nanayakkara said, during his presentation at the conference.
Other countries might see different results, he cautioned.
In the Netherlands, ambulances reach the emergency scene within 15 minutes 93% of the time, and the average time from dispatch call to ED arrival is 40 minutes, Dr. Nanayakkara noted in the report.
“In part, due to the relatively short response times in the Netherlands, we don’t know if there are other countries with longer response times that would have other results, and whether they should use antibiotics in their ambulances,” Dr. Nanayakkara said in his presentation.
The study was the first-ever prospective randomized, controlled open-label trial to compare early prehospital antibiotics with standard care.
Before the study was started, EMS personnel at 10 large regional ambulance services serving 34 secondary or tertiary hospitals were trained in recognizing sepsis, the report says.
A total of 2,672 patients with suspected sepsis were included in the intention-to-treat analysis, of whom 1,535 were randomized to receive prehospital antibiotics and 1,137 to usual EMS care, which consisted of fluid resuscitation and supplementary oxygen.
The primary end point of the study was all-cause mortality at 28 days.
The negative mortality results of this trial are “not surprising,” given that the trial’s inclusion criteria allowed individuals with suspected infection but without organ dysfunction, said Jean-Louis Vincent, MD, PhD, of Erasmus Hospital, Brussels, in a related editorial appearing in the Lancet Respiratory Medicine (2018 Jan. doi: 10.1016/S2213-2600[17]30446-0).
Recent consensus definitions of sepsis recognize that sepsis is the association of an infection with some degree of organ dysfunction, according to Dr. Vincent.
“After this initial experience, I believe that a randomized, controlled trial could be done to assess the potential benefit of early antibiotic administration in the ambulance for patients with organ dysfunction associated with infection,” Dr. Vincent wrote in his editorial.
Dr. Nanayakkara and his coauthors declared no competing interests related to their study.
SOURCE: Alam N et al. Lancet Respir Med. 2018 Jan;6(1):40-50.
REPORTING FROM CCC47
Key clinical point: In patients with suspected sepsis, prehospital antibiotics delivered by EMS personnel improved some aspects of care, but did not reduce mortality.
Major finding: At 28 days, 120 patients (8%) in the prehospital antibiotics group had died, compared with 93 patients (8%) in the usual care group (relative risk, 0.95; 95% CI, 0.74-1.24).
Data source: Intention-to-treat analysis of 2,672 patients in a prospective randomized, controlled open-label trial comparing early prehospital antibiotics to standard care.
Disclosures: The study authors declared no competing interests related to the study.
Source: Alam N et al. Lancet Respir Med. 2018 Jan;6(1):40-50.
Ibrutinib linked to invasive fungal infections
The tyrosine kinase inhibitor ibrutinib (Imbruvica) may be associated with early-onset invasive fungal infections (IFI) in patients with hematologic malignancies, investigators caution.
French investigators identified 33 cases of invasive fungal infections occurring among patients who had been treated with ibrutinib as monotherapy or in combination with other agents. Of the 33 cases, 27 were invasive aspergillosis, and 40% of these were localized in the central nervous system. The findings were published in the journal Blood.
“IFI tend to occur within the first months of treatment and are infrequent thereafter. Whilst it seems difficult at this point to advocate for systematic antifungal prophylaxis in all patients, an increased awareness about the potential risk of IFI after initiating ibrutinib is warranted, especially when other predisposing factors are associated,” wrote David Ghez, MD, PhD, and colleagues at the Gustave Roussy Institute in Villejuif and other centers in France.
Although ibrutinib, an inhibitor of Bruton’s tyrosine kinase, is generally considered to be less immunosuppressive than other therapies, it was associated with five cases of Pneumocystis jirovecii pneumonia in patients with chronic lymphocytic leukemia (CLL) treated with ibrutinib monotherapy in a 2016 report (Blood. 2016;128:1940-3). Of these five patients, four were treatment naive, suggesting that ibrutinib itself could increase risk for invasive opportunistic infections, Dr. Ghez and his colleagues noted.
Based on this finding and on case reports of invasive infections in other patients being treated with ibrutinib, the authors conducted a retrospective survey of centers in the French Innovative Leukemia Organization CLL group.
They identified 33 cases, including 30 patients with CLL (15 of whom had deleterious 17p deletions), 1 with mantle cell lymphoma, and 2 with Waldenstrom macroglobulinemia.
Invasive aspergillosis accounted for 27 of the 33 cases, and 11 cases had CNS localization. There were four cases of disseminated cryptococcosis, and one each of mucormycosis and pneumocystis pneumonia.
The median time between the start of ibrutinib therapy and a diagnosis of invasive fungal infection was 3 months, with some cases occurring as early as 1 month, and others occurring 30 months out. However, the majority of cases – 28 – were diagnosed within 6 months of the start of therapy, including 20 that occurred within 3 months of ibrutinib initiation.
In 21 patients, the diagnosis of an invasive fungal infection led to drug discontinuation. In the remaining patients, the drug was either resumed after resolution of the IFI, or continued at a lower dose because of potential for interaction between ibrutinib and the antifungal agent voriconazole.
Dr. Ghez reported receiving a research grant from Janssen, and coauthor Loic Ysebaert, MD, PhD, reported consultancy fees from the company. All other authors declared no competing financial interests.
SOURCE: Ghez D et al., Blood. 2018 Feb 1. doi: 10.1182/blood-2017-11-818286.
The tyrosine kinase inhibitor ibrutinib (Imbruvica) may be associated with early-onset invasive fungal infections (IFI) in patients with hematologic malignancies, investigators caution.
French investigators identified 33 cases of invasive fungal infections occurring among patients who had been treated with ibrutinib as monotherapy or in combination with other agents. Of the 33 cases, 27 were invasive aspergillosis, and 40% of these were localized in the central nervous system. The findings were published in the journal Blood.
“IFI tend to occur within the first months of treatment and are infrequent thereafter. Whilst it seems difficult at this point to advocate for systematic antifungal prophylaxis in all patients, an increased awareness about the potential risk of IFI after initiating ibrutinib is warranted, especially when other predisposing factors are associated,” wrote David Ghez, MD, PhD, and colleagues at the Gustave Roussy Institute in Villejuif and other centers in France.
Although ibrutinib, an inhibitor of Bruton’s tyrosine kinase, is generally considered to be less immunosuppressive than other therapies, it was associated with five cases of Pneumocystis jirovecii pneumonia in patients with chronic lymphocytic leukemia (CLL) treated with ibrutinib monotherapy in a 2016 report (Blood. 2016;128:1940-3). Of these five patients, four were treatment naive, suggesting that ibrutinib itself could increase risk for invasive opportunistic infections, Dr. Ghez and his colleagues noted.
Based on this finding and on case reports of invasive infections in other patients being treated with ibrutinib, the authors conducted a retrospective survey of centers in the French Innovative Leukemia Organization CLL group.
They identified 33 cases, including 30 patients with CLL (15 of whom had deleterious 17p deletions), 1 with mantle cell lymphoma, and 2 with Waldenstrom macroglobulinemia.
Invasive aspergillosis accounted for 27 of the 33 cases, and 11 cases had CNS localization. There were four cases of disseminated cryptococcosis, and one each of mucormycosis and pneumocystis pneumonia.
The median time between the start of ibrutinib therapy and a diagnosis of invasive fungal infection was 3 months, with some cases occurring as early as 1 month, and others occurring 30 months out. However, the majority of cases – 28 – were diagnosed within 6 months of the start of therapy, including 20 that occurred within 3 months of ibrutinib initiation.
In 21 patients, the diagnosis of an invasive fungal infection led to drug discontinuation. In the remaining patients, the drug was either resumed after resolution of the IFI, or continued at a lower dose because of potential for interaction between ibrutinib and the antifungal agent voriconazole.
Dr. Ghez reported receiving a research grant from Janssen, and coauthor Loic Ysebaert, MD, PhD, reported consultancy fees from the company. All other authors declared no competing financial interests.
SOURCE: Ghez D et al., Blood. 2018 Feb 1. doi: 10.1182/blood-2017-11-818286.
The tyrosine kinase inhibitor ibrutinib (Imbruvica) may be associated with early-onset invasive fungal infections (IFI) in patients with hematologic malignancies, investigators caution.
French investigators identified 33 cases of invasive fungal infections occurring among patients who had been treated with ibrutinib as monotherapy or in combination with other agents. Of the 33 cases, 27 were invasive aspergillosis, and 40% of these were localized in the central nervous system. The findings were published in the journal Blood.
“IFI tend to occur within the first months of treatment and are infrequent thereafter. Whilst it seems difficult at this point to advocate for systematic antifungal prophylaxis in all patients, an increased awareness about the potential risk of IFI after initiating ibrutinib is warranted, especially when other predisposing factors are associated,” wrote David Ghez, MD, PhD, and colleagues at the Gustave Roussy Institute in Villejuif and other centers in France.
Although ibrutinib, an inhibitor of Bruton’s tyrosine kinase, is generally considered to be less immunosuppressive than other therapies, it was associated with five cases of Pneumocystis jirovecii pneumonia in patients with chronic lymphocytic leukemia (CLL) treated with ibrutinib monotherapy in a 2016 report (Blood. 2016;128:1940-3). Of these five patients, four were treatment naive, suggesting that ibrutinib itself could increase risk for invasive opportunistic infections, Dr. Ghez and his colleagues noted.
Based on this finding and on case reports of invasive infections in other patients being treated with ibrutinib, the authors conducted a retrospective survey of centers in the French Innovative Leukemia Organization CLL group.
They identified 33 cases, including 30 patients with CLL (15 of whom had deleterious 17p deletions), 1 with mantle cell lymphoma, and 2 with Waldenstrom macroglobulinemia.
Invasive aspergillosis accounted for 27 of the 33 cases, and 11 cases had CNS localization. There were four cases of disseminated cryptococcosis, and one each of mucormycosis and pneumocystis pneumonia.
The median time between the start of ibrutinib therapy and a diagnosis of invasive fungal infection was 3 months, with some cases occurring as early as 1 month, and others occurring 30 months out. However, the majority of cases – 28 – were diagnosed within 6 months of the start of therapy, including 20 that occurred within 3 months of ibrutinib initiation.
In 21 patients, the diagnosis of an invasive fungal infection led to drug discontinuation. In the remaining patients, the drug was either resumed after resolution of the IFI, or continued at a lower dose because of potential for interaction between ibrutinib and the antifungal agent voriconazole.
Dr. Ghez reported receiving a research grant from Janssen, and coauthor Loic Ysebaert, MD, PhD, reported consultancy fees from the company. All other authors declared no competing financial interests.
SOURCE: Ghez D et al., Blood. 2018 Feb 1. doi: 10.1182/blood-2017-11-818286.
FROM BLOOD
Key clinical point:
Major finding: Of 33 identified cases, 27 were invasive aspergillosis.
Study details: Retrospective review of case reports from 16 French centers.
Disclosures: Dr. Ghez reported receiving a research grant from Janssen, and coauthor Loic Ysebaert, MD, PhD, reported consultancy fees with the company. All other authors declared no competing financial interests.
Source: Ghez D et al. Blood. 2018 Feb 1. doi: 10.1182/blood-2017-11-818286.
Functional capacity, life skills critical for patients with schizophrenia
Improving the ability of people with schizophrenia to perform tasks that are important to daily functioning is a key component for any therapeutic intervention, a cross-sectional study of 740 patients shows.
“Our study confirms that [the four domains of] social cognition, neurocognition, resilience, and real-life functioning represent robust and independent constructs,” wrote Silvana Galderisi, MD, and her associates. The report was published in JAMA Psychiatry.
Dr. Galderisi and her associates recruited community-dwelling patients with schizophrenia as defined in the DSM-IV over an 18-month period. The patients were stabilized on antipsychotics and were seen in the outpatient units of 26 psychiatric clinics and/or mental health departments in Italy.
Several measures were administered, including the Brief Negative Symptom Scale (BNSS), the Calgary Depression Scale for Schizophrenia (CDSS), the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB), and the Positive and Negative Syndrome Scale (PANSS).
Using network analysis, the researchers analyzed the results found by the measures and the relationships between the four domains. “The study clearly shows that functional capacity and everyday life skills play a key role,” Dr. Galderisi and her associates wrote. “Functional capacity ... links neurocognition and social cognition with real-life functioning nodes, in particular with everyday life skills, such as household activities, handling of personal finances, and use of the telephone or public transportation.”
Dr. Galderisi and her associates said their findings show that patients with schizophrenia need treatment that goes beyond antipsychotics. “Therefore, with schizophrenia,” they wrote.
Read the full study in JAMA Psychiatry. 2018 Feb 14. doi: 10.1001/jamapsychiatry.2017.4607.
Improving the ability of people with schizophrenia to perform tasks that are important to daily functioning is a key component for any therapeutic intervention, a cross-sectional study of 740 patients shows.
“Our study confirms that [the four domains of] social cognition, neurocognition, resilience, and real-life functioning represent robust and independent constructs,” wrote Silvana Galderisi, MD, and her associates. The report was published in JAMA Psychiatry.
Dr. Galderisi and her associates recruited community-dwelling patients with schizophrenia as defined in the DSM-IV over an 18-month period. The patients were stabilized on antipsychotics and were seen in the outpatient units of 26 psychiatric clinics and/or mental health departments in Italy.
Several measures were administered, including the Brief Negative Symptom Scale (BNSS), the Calgary Depression Scale for Schizophrenia (CDSS), the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB), and the Positive and Negative Syndrome Scale (PANSS).
Using network analysis, the researchers analyzed the results found by the measures and the relationships between the four domains. “The study clearly shows that functional capacity and everyday life skills play a key role,” Dr. Galderisi and her associates wrote. “Functional capacity ... links neurocognition and social cognition with real-life functioning nodes, in particular with everyday life skills, such as household activities, handling of personal finances, and use of the telephone or public transportation.”
Dr. Galderisi and her associates said their findings show that patients with schizophrenia need treatment that goes beyond antipsychotics. “Therefore, with schizophrenia,” they wrote.
Read the full study in JAMA Psychiatry. 2018 Feb 14. doi: 10.1001/jamapsychiatry.2017.4607.
Improving the ability of people with schizophrenia to perform tasks that are important to daily functioning is a key component for any therapeutic intervention, a cross-sectional study of 740 patients shows.
“Our study confirms that [the four domains of] social cognition, neurocognition, resilience, and real-life functioning represent robust and independent constructs,” wrote Silvana Galderisi, MD, and her associates. The report was published in JAMA Psychiatry.
Dr. Galderisi and her associates recruited community-dwelling patients with schizophrenia as defined in the DSM-IV over an 18-month period. The patients were stabilized on antipsychotics and were seen in the outpatient units of 26 psychiatric clinics and/or mental health departments in Italy.
Several measures were administered, including the Brief Negative Symptom Scale (BNSS), the Calgary Depression Scale for Schizophrenia (CDSS), the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB), and the Positive and Negative Syndrome Scale (PANSS).
Using network analysis, the researchers analyzed the results found by the measures and the relationships between the four domains. “The study clearly shows that functional capacity and everyday life skills play a key role,” Dr. Galderisi and her associates wrote. “Functional capacity ... links neurocognition and social cognition with real-life functioning nodes, in particular with everyday life skills, such as household activities, handling of personal finances, and use of the telephone or public transportation.”
Dr. Galderisi and her associates said their findings show that patients with schizophrenia need treatment that goes beyond antipsychotics. “Therefore, with schizophrenia,” they wrote.
Read the full study in JAMA Psychiatry. 2018 Feb 14. doi: 10.1001/jamapsychiatry.2017.4607.
FROM JAMA PSYCHIATRY