Our work was suspended when ABIM announced the creation of a new longitudinal assessment option for maintenance of certification across all specialties.

GI society leaders are in touch with ABIM. Here’s an update on what we know:

• • The ABIM Board of Directors committed to evolve its program to provide a longitudinal assessment option for Maintenance of Certification (MOC), offering a self-paced pathway for physicians to acquire and demonstrate ongoing knowledge. The traditional, long-form assessment will also remain an option, as some physicians have expressed a preference for a point-in-time exam taken less frequently.

Our next steps include seeking clarity from ABIM including:

1. The milestones in the process to create the new pathway.

2. When the new pathway will be available to diplomates.

3. Consideration and integration of the GI societies’ principles in the development of the new pathway for recertification, including:

a. MOC needs to be simpler, less intrusive and less expensive.

b. We continue to support alternatives to the high-stakes, every-10-year recertification exam.

c. We do not support single source or time-limited assessments, as they do not represent the current realities of medicine in the digital age.

d. We support the concept that, for the many diplomates who specialize within certain areas of gastroenterology and hepatology, MOC should not include high-stakes assessments of areas in which the diplomate may not practice.

e. We support the principles of lifelong learning, as evidenced by ongoing CME activities, rather than lifelong testing.

4. The role the GI societies, as representatives for thousands of U.S. members who are ABIM diplomates, play in the creation and implementation of the new pathway.



AASLD, ACG, AGA and ASGE want to be fully informed and fully respected partners in an endeavor that touches upon one of the toughest challenges facing our members and the single issue we hear about most often requesting our help.

We will continue to update our members as we learn the answers to these questions from ABIM.

Together, our first priority on the MOC issue remains ensuring that GI diplomates have a pathway for recertification that meets your needs.

[email protected]

Our work was suspended when ABIM announced the creation of a new longitudinal assessment option for maintenance of certification across all specialties.

GI society leaders are in touch with ABIM. Here’s an update on what we know:

• • The ABIM Board of Directors committed to evolve its program to provide a longitudinal assessment option for Maintenance of Certification (MOC), offering a self-paced pathway for physicians to acquire and demonstrate ongoing knowledge. The traditional, long-form assessment will also remain an option, as some physicians have expressed a preference for a point-in-time exam taken less frequently.

Our next steps include seeking clarity from ABIM including:

1. The milestones in the process to create the new pathway.

2. When the new pathway will be available to diplomates.

3. Consideration and integration of the GI societies’ principles in the development of the new pathway for recertification, including:

a. MOC needs to be simpler, less intrusive and less expensive.

b. We continue to support alternatives to the high-stakes, every-10-year recertification exam.

c. We do not support single source or time-limited assessments, as they do not represent the current realities of medicine in the digital age.

d. We support the concept that, for the many diplomates who specialize within certain areas of gastroenterology and hepatology, MOC should not include high-stakes assessments of areas in which the diplomate may not practice.

e. We support the principles of lifelong learning, as evidenced by ongoing CME activities, rather than lifelong testing.

4. The role the GI societies, as representatives for thousands of U.S. members who are ABIM diplomates, play in the creation and implementation of the new pathway.



AASLD, ACG, AGA and ASGE want to be fully informed and fully respected partners in an endeavor that touches upon one of the toughest challenges facing our members and the single issue we hear about most often requesting our help.

We will continue to update our members as we learn the answers to these questions from ABIM.

Together, our first priority on the MOC issue remains ensuring that GI diplomates have a pathway for recertification that meets your needs.

[email protected]

Our work was suspended when ABIM announced the creation of a new longitudinal assessment option for maintenance of certification across all specialties.

GI society leaders are in touch with ABIM. Here’s an update on what we know:

• • The ABIM Board of Directors committed to evolve its program to provide a longitudinal assessment option for Maintenance of Certification (MOC), offering a self-paced pathway for physicians to acquire and demonstrate ongoing knowledge. The traditional, long-form assessment will also remain an option, as some physicians have expressed a preference for a point-in-time exam taken less frequently.

Our next steps include seeking clarity from ABIM including:

1. The milestones in the process to create the new pathway.

2. When the new pathway will be available to diplomates.

3. Consideration and integration of the GI societies’ principles in the development of the new pathway for recertification, including:

a. MOC needs to be simpler, less intrusive and less expensive.

b. We continue to support alternatives to the high-stakes, every-10-year recertification exam.

c. We do not support single source or time-limited assessments, as they do not represent the current realities of medicine in the digital age.

d. We support the concept that, for the many diplomates who specialize within certain areas of gastroenterology and hepatology, MOC should not include high-stakes assessments of areas in which the diplomate may not practice.

e. We support the principles of lifelong learning, as evidenced by ongoing CME activities, rather than lifelong testing.

4. The role the GI societies, as representatives for thousands of U.S. members who are ABIM diplomates, play in the creation and implementation of the new pathway.



AASLD, ACG, AGA and ASGE want to be fully informed and fully respected partners in an endeavor that touches upon one of the toughest challenges facing our members and the single issue we hear about most often requesting our help.

We will continue to update our members as we learn the answers to these questions from ABIM.

Together, our first priority on the MOC issue remains ensuring that GI diplomates have a pathway for recertification that meets your needs.

[email protected]

Anil Rustgi, MD, AGAF, and Raymond DuBois, MD, PhD, AGAF, were elected to the National Academy of Medicine, considered one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.

[email protected]

Anil Rustgi, MD, AGAF, and Raymond DuBois, MD, PhD, AGAF, were elected to the National Academy of Medicine, considered one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.

[email protected]

Anil Rustgi, MD, AGAF, and Raymond DuBois, MD, PhD, AGAF, were elected to the National Academy of Medicine, considered one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.

[email protected]

The benefit of rituximab maintenance therapy in follicular lymphoma is long lasting and evident out to at least 9 years, according to the final efficacy analysis of the PRIMA phase 3, randomized, controlled trial.

Patho/Wikimedia Commons/CC BY-SA 3.0(http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons

Previously reported results of this pivotal trial showed prolongation of progression-free survival and time to next treatment with rituximab maintenance at a follow-up of 3 years and 6 years.

“Rituximab maintenance is now widely recommended for patients with follicular lymphoma responding to first-line rituximab-based immunochemotherapy,” Emmanuel Bachy, MD, PhD, of Institut National de la Santé et de la Recherche Médicale in Pierre-Bénite, France, and colleagues reported in the Journal of Clinical Oncology.

In PRIMA, patients with previously untreated high–tumor burden follicular lymphoma received any of three immunochemotherapy induction regimens. The 1,018 patients having a response were then randomly assigned to receive 2 years of rituximab (Rituxan) maintenance or observation only.

Dr. Bachy and colleagues performed the trial’s final efficacy analyses, now at a median follow-up of 9 years.

Among the 607 patients consenting to the extended follow-up, median progression-free survival was 10.5 years in the rituximab-maintenance group, compared with 4.1 years in the observation group (hazard ratio, 0.61; P less than .001).

“Subgroup analyses showed the substantial progression-free survival improvement associated with rituximab maintenance was independent of age, sex, induction immunochemotherapy regimen, response to induction, or [Follicular Lymphoma International Prognostic Index] risk score,” the investigators wrote.

Rituximab maintenance also prolonged the median time to next antilymphoma treatment (not reached vs. 6.1 years; hazard ratio, 0.66; P less than .001) and time to next chemotherapy treatment (not reached vs. 9.3 years; hazard ratio, 0.71; P less than .001).

But there was no significant difference in overall survival. Median overall survival was not reached in either group (hazard ratio, 1.04; P = .7948). The estimated 10-year overall survival rate was about 80% in both groups.

“This 9-year follow-up of the PRIMA study demonstrates that rituximab maintenance after induction immunochemotherapy provides a significant long-term [progression-free survival] benefit over observation,” the investigators wrote. “Despite the lack of [overall survival] advantage, it is noteworthy that more than half of the patients in the rituximab maintenance arm remain free of disease progression and have not required new antilymphoma treatment beyond 10 years.”

The trial was sponsored by the Lymphoma Study Association and supported by F. Hoffmann–La Roche and Biogen. Dr. Bachy reported financial disclosures related to Roche and other companies.

SOURCE: Bachy E et al. J Clin Oncol. 2019 Nov 1;37(31):2815-24.

The benefit of rituximab maintenance therapy in follicular lymphoma is long lasting and evident out to at least 9 years, according to the final efficacy analysis of the PRIMA phase 3, randomized, controlled trial.

Patho/Wikimedia Commons/CC BY-SA 3.0(http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons

Previously reported results of this pivotal trial showed prolongation of progression-free survival and time to next treatment with rituximab maintenance at a follow-up of 3 years and 6 years.

“Rituximab maintenance is now widely recommended for patients with follicular lymphoma responding to first-line rituximab-based immunochemotherapy,” Emmanuel Bachy, MD, PhD, of Institut National de la Santé et de la Recherche Médicale in Pierre-Bénite, France, and colleagues reported in the Journal of Clinical Oncology.

In PRIMA, patients with previously untreated high–tumor burden follicular lymphoma received any of three immunochemotherapy induction regimens. The 1,018 patients having a response were then randomly assigned to receive 2 years of rituximab (Rituxan) maintenance or observation only.

Dr. Bachy and colleagues performed the trial’s final efficacy analyses, now at a median follow-up of 9 years.

Among the 607 patients consenting to the extended follow-up, median progression-free survival was 10.5 years in the rituximab-maintenance group, compared with 4.1 years in the observation group (hazard ratio, 0.61; P less than .001).

“Subgroup analyses showed the substantial progression-free survival improvement associated with rituximab maintenance was independent of age, sex, induction immunochemotherapy regimen, response to induction, or [Follicular Lymphoma International Prognostic Index] risk score,” the investigators wrote.

Rituximab maintenance also prolonged the median time to next antilymphoma treatment (not reached vs. 6.1 years; hazard ratio, 0.66; P less than .001) and time to next chemotherapy treatment (not reached vs. 9.3 years; hazard ratio, 0.71; P less than .001).

But there was no significant difference in overall survival. Median overall survival was not reached in either group (hazard ratio, 1.04; P = .7948). The estimated 10-year overall survival rate was about 80% in both groups.

“This 9-year follow-up of the PRIMA study demonstrates that rituximab maintenance after induction immunochemotherapy provides a significant long-term [progression-free survival] benefit over observation,” the investigators wrote. “Despite the lack of [overall survival] advantage, it is noteworthy that more than half of the patients in the rituximab maintenance arm remain free of disease progression and have not required new antilymphoma treatment beyond 10 years.”

The trial was sponsored by the Lymphoma Study Association and supported by F. Hoffmann–La Roche and Biogen. Dr. Bachy reported financial disclosures related to Roche and other companies.

SOURCE: Bachy E et al. J Clin Oncol. 2019 Nov 1;37(31):2815-24.

The benefit of rituximab maintenance therapy in follicular lymphoma is long lasting and evident out to at least 9 years, according to the final efficacy analysis of the PRIMA phase 3, randomized, controlled trial.

Patho/Wikimedia Commons/CC BY-SA 3.0(http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons

Previously reported results of this pivotal trial showed prolongation of progression-free survival and time to next treatment with rituximab maintenance at a follow-up of 3 years and 6 years.

“Rituximab maintenance is now widely recommended for patients with follicular lymphoma responding to first-line rituximab-based immunochemotherapy,” Emmanuel Bachy, MD, PhD, of Institut National de la Santé et de la Recherche Médicale in Pierre-Bénite, France, and colleagues reported in the Journal of Clinical Oncology.

In PRIMA, patients with previously untreated high–tumor burden follicular lymphoma received any of three immunochemotherapy induction regimens. The 1,018 patients having a response were then randomly assigned to receive 2 years of rituximab (Rituxan) maintenance or observation only.

Dr. Bachy and colleagues performed the trial’s final efficacy analyses, now at a median follow-up of 9 years.

Among the 607 patients consenting to the extended follow-up, median progression-free survival was 10.5 years in the rituximab-maintenance group, compared with 4.1 years in the observation group (hazard ratio, 0.61; P less than .001).

“Subgroup analyses showed the substantial progression-free survival improvement associated with rituximab maintenance was independent of age, sex, induction immunochemotherapy regimen, response to induction, or [Follicular Lymphoma International Prognostic Index] risk score,” the investigators wrote.

Rituximab maintenance also prolonged the median time to next antilymphoma treatment (not reached vs. 6.1 years; hazard ratio, 0.66; P less than .001) and time to next chemotherapy treatment (not reached vs. 9.3 years; hazard ratio, 0.71; P less than .001).

But there was no significant difference in overall survival. Median overall survival was not reached in either group (hazard ratio, 1.04; P = .7948). The estimated 10-year overall survival rate was about 80% in both groups.

“This 9-year follow-up of the PRIMA study demonstrates that rituximab maintenance after induction immunochemotherapy provides a significant long-term [progression-free survival] benefit over observation,” the investigators wrote. “Despite the lack of [overall survival] advantage, it is noteworthy that more than half of the patients in the rituximab maintenance arm remain free of disease progression and have not required new antilymphoma treatment beyond 10 years.”

The trial was sponsored by the Lymphoma Study Association and supported by F. Hoffmann–La Roche and Biogen. Dr. Bachy reported financial disclosures related to Roche and other companies.

SOURCE: Bachy E et al. J Clin Oncol. 2019 Nov 1;37(31):2815-24.

BOSTON – Some of the most notable abstracts presented here at the annual meeting of the American Association for the Study of Liver Diseases dealt with key topics including the natural history of hepatitis B virus, novel treatment approaches, and prevention, according to Marc Ghany, MD.

Andrew Bowser/MDedge News

During a special hepatitis debriefing session held on the last day of the conference, Dr. Ghany reviewed his key selections in hepatitis B virus (HBV) research, including the following:
 

Natural history

Steatohepatitis may worsen HBV-related liver injury, according to results of an analysis of liver biopsies from adult patients enrolled in a North American cohort study (Abstract 162). Investigators found that steatohepatitis was associated with a 1.6-fold increased risk of advanced fibrosis.

“For all patients with hepatitis B, I think it’s important to screen and manage metabolic abnormalities to prevent liver disease progression,” said Dr. Ghany, who is with the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md.

Risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B was evaluated in two notable studies, Dr. Ghany said, including one that found no difference in risk of HCC development among white patients who received long-term entecavir versus those who received long-term tenofovir (Abstract 454). This stands in contrast to a previous and controversial finding, according to investigators, that HCC incidence was lower in Asian patients treated with tenofovir versus those treated with entecavir.

In the other study, investigators found that dual-antiplatelet therapy (DAPT) was associated with a lower risk of HCC versus aspirin monotherapy in patients with chronic hepatitis B (Abstract 934). Antiplatelet therapy was associated with a near 20% reduction in HCC risk, while DAPT as compared with aspirin monotherapy was linked to a near 30% reduction. “These are very provocative findings,” Dr. Ghany said. “Of course they need to be confirmed, but if so, may open new avenues of HCC chemoprevention.”
 

Novel therapies

Several new and promising drugs are undergoing clinical trials, including JNJ-64530440 (JNJ-0440), a novel class N capsid assembly modulator. In phase 1a data presented here at The Liver Meeting, the treatment was safe, well tolerated, and resulted in potent inhibition of viral replication (Abstract 0089). “We await further studies on its effect on functional cure,” Dr. Ghany told attendees.

Another treatment to watch is GSK3389404 (GSK404), a liver-targeted antisense oligonucleotide; in a phase 2 placebo-controlled study in patients with chronic hepatitis B on stable nucleos(t)ide therapy, this treatment had acceptable safety and produced dose-dependent declines in hepatitis B surface antigen (HBsAg), according to investigators (Abstract 0695). Dr. Ghany said this constitutes “proof of principle” that antisense oligonucleotides can decrease HBsAg levels.

In a phase 2 randomized, placebo-controlled study in virally suppressed adults with chronic hepatitis B, the toll-like receptor 8 (TLR8) agonist GS-9688 was safe and well tolerated, and resulted in dose-dependent pharmacodynamic changes, with 5% of patients experiencing a 1 log₁₀ IU/mL or greater decline in HBsAg levels or an HBsAg loss by week 24 (Abstract 0697). This is a “promising approach” that merits further study, according to Dr. Ghany.
 

Prevention: Vaccination and screening

A trivalent HBV vaccine is superior to monovalent vaccine, according to results from the double-blind, randomized, controlled, phase 3 PROTECT study presented here at the meeting (Abstract LP13). Known as Sci-B-Vac, the mammalian cell-derived trivalent vaccine had higher response rates versus the recombinant monovalent vaccine Engerix-B in difficult-to-vaccinate populations, according to Dr. Ghany.

A separate report based on a national health insurance cohort study in Korea demonstrated that regular follow-up, that is to say, every 3-6 months, significantly reduced liver cancer–related mortality (Abstract 0159). Patients compliant with screening in the study not only had a 44% reduction in risk of death from HCC, but also were more likely to receive curative treatments (23.1% versus 15.1%). “Notwithstanding the limitations or cohort studies, I think these data reinforce the need to screen patients with chronic hepatitis B,” Dr. Ghany said.

He provided no disclosures in his presentation.

BOSTON – Some of the most notable abstracts presented here at the annual meeting of the American Association for the Study of Liver Diseases dealt with key topics including the natural history of hepatitis B virus, novel treatment approaches, and prevention, according to Marc Ghany, MD.

Andrew Bowser/MDedge News

During a special hepatitis debriefing session held on the last day of the conference, Dr. Ghany reviewed his key selections in hepatitis B virus (HBV) research, including the following:
 

Natural history

Steatohepatitis may worsen HBV-related liver injury, according to results of an analysis of liver biopsies from adult patients enrolled in a North American cohort study (Abstract 162). Investigators found that steatohepatitis was associated with a 1.6-fold increased risk of advanced fibrosis.

“For all patients with hepatitis B, I think it’s important to screen and manage metabolic abnormalities to prevent liver disease progression,” said Dr. Ghany, who is with the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md.

Risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B was evaluated in two notable studies, Dr. Ghany said, including one that found no difference in risk of HCC development among white patients who received long-term entecavir versus those who received long-term tenofovir (Abstract 454). This stands in contrast to a previous and controversial finding, according to investigators, that HCC incidence was lower in Asian patients treated with tenofovir versus those treated with entecavir.

In the other study, investigators found that dual-antiplatelet therapy (DAPT) was associated with a lower risk of HCC versus aspirin monotherapy in patients with chronic hepatitis B (Abstract 934). Antiplatelet therapy was associated with a near 20% reduction in HCC risk, while DAPT as compared with aspirin monotherapy was linked to a near 30% reduction. “These are very provocative findings,” Dr. Ghany said. “Of course they need to be confirmed, but if so, may open new avenues of HCC chemoprevention.”
 

Novel therapies

Several new and promising drugs are undergoing clinical trials, including JNJ-64530440 (JNJ-0440), a novel class N capsid assembly modulator. In phase 1a data presented here at The Liver Meeting, the treatment was safe, well tolerated, and resulted in potent inhibition of viral replication (Abstract 0089). “We await further studies on its effect on functional cure,” Dr. Ghany told attendees.

Another treatment to watch is GSK3389404 (GSK404), a liver-targeted antisense oligonucleotide; in a phase 2 placebo-controlled study in patients with chronic hepatitis B on stable nucleos(t)ide therapy, this treatment had acceptable safety and produced dose-dependent declines in hepatitis B surface antigen (HBsAg), according to investigators (Abstract 0695). Dr. Ghany said this constitutes “proof of principle” that antisense oligonucleotides can decrease HBsAg levels.

In a phase 2 randomized, placebo-controlled study in virally suppressed adults with chronic hepatitis B, the toll-like receptor 8 (TLR8) agonist GS-9688 was safe and well tolerated, and resulted in dose-dependent pharmacodynamic changes, with 5% of patients experiencing a 1 log₁₀ IU/mL or greater decline in HBsAg levels or an HBsAg loss by week 24 (Abstract 0697). This is a “promising approach” that merits further study, according to Dr. Ghany.
 

Prevention: Vaccination and screening

A trivalent HBV vaccine is superior to monovalent vaccine, according to results from the double-blind, randomized, controlled, phase 3 PROTECT study presented here at the meeting (Abstract LP13). Known as Sci-B-Vac, the mammalian cell-derived trivalent vaccine had higher response rates versus the recombinant monovalent vaccine Engerix-B in difficult-to-vaccinate populations, according to Dr. Ghany.

A separate report based on a national health insurance cohort study in Korea demonstrated that regular follow-up, that is to say, every 3-6 months, significantly reduced liver cancer–related mortality (Abstract 0159). Patients compliant with screening in the study not only had a 44% reduction in risk of death from HCC, but also were more likely to receive curative treatments (23.1% versus 15.1%). “Notwithstanding the limitations or cohort studies, I think these data reinforce the need to screen patients with chronic hepatitis B,” Dr. Ghany said.

He provided no disclosures in his presentation.

BOSTON – Some of the most notable abstracts presented here at the annual meeting of the American Association for the Study of Liver Diseases dealt with key topics including the natural history of hepatitis B virus, novel treatment approaches, and prevention, according to Marc Ghany, MD.

Andrew Bowser/MDedge News

During a special hepatitis debriefing session held on the last day of the conference, Dr. Ghany reviewed his key selections in hepatitis B virus (HBV) research, including the following:
 

Natural history

Steatohepatitis may worsen HBV-related liver injury, according to results of an analysis of liver biopsies from adult patients enrolled in a North American cohort study (Abstract 162). Investigators found that steatohepatitis was associated with a 1.6-fold increased risk of advanced fibrosis.

“For all patients with hepatitis B, I think it’s important to screen and manage metabolic abnormalities to prevent liver disease progression,” said Dr. Ghany, who is with the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md.

Risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B was evaluated in two notable studies, Dr. Ghany said, including one that found no difference in risk of HCC development among white patients who received long-term entecavir versus those who received long-term tenofovir (Abstract 454). This stands in contrast to a previous and controversial finding, according to investigators, that HCC incidence was lower in Asian patients treated with tenofovir versus those treated with entecavir.

In the other study, investigators found that dual-antiplatelet therapy (DAPT) was associated with a lower risk of HCC versus aspirin monotherapy in patients with chronic hepatitis B (Abstract 934). Antiplatelet therapy was associated with a near 20% reduction in HCC risk, while DAPT as compared with aspirin monotherapy was linked to a near 30% reduction. “These are very provocative findings,” Dr. Ghany said. “Of course they need to be confirmed, but if so, may open new avenues of HCC chemoprevention.”
 

Novel therapies

Several new and promising drugs are undergoing clinical trials, including JNJ-64530440 (JNJ-0440), a novel class N capsid assembly modulator. In phase 1a data presented here at The Liver Meeting, the treatment was safe, well tolerated, and resulted in potent inhibition of viral replication (Abstract 0089). “We await further studies on its effect on functional cure,” Dr. Ghany told attendees.

Another treatment to watch is GSK3389404 (GSK404), a liver-targeted antisense oligonucleotide; in a phase 2 placebo-controlled study in patients with chronic hepatitis B on stable nucleos(t)ide therapy, this treatment had acceptable safety and produced dose-dependent declines in hepatitis B surface antigen (HBsAg), according to investigators (Abstract 0695). Dr. Ghany said this constitutes “proof of principle” that antisense oligonucleotides can decrease HBsAg levels.

In a phase 2 randomized, placebo-controlled study in virally suppressed adults with chronic hepatitis B, the toll-like receptor 8 (TLR8) agonist GS-9688 was safe and well tolerated, and resulted in dose-dependent pharmacodynamic changes, with 5% of patients experiencing a 1 log₁₀ IU/mL or greater decline in HBsAg levels or an HBsAg loss by week 24 (Abstract 0697). This is a “promising approach” that merits further study, according to Dr. Ghany.
 

Prevention: Vaccination and screening

A trivalent HBV vaccine is superior to monovalent vaccine, according to results from the double-blind, randomized, controlled, phase 3 PROTECT study presented here at the meeting (Abstract LP13). Known as Sci-B-Vac, the mammalian cell-derived trivalent vaccine had higher response rates versus the recombinant monovalent vaccine Engerix-B in difficult-to-vaccinate populations, according to Dr. Ghany.

A separate report based on a national health insurance cohort study in Korea demonstrated that regular follow-up, that is to say, every 3-6 months, significantly reduced liver cancer–related mortality (Abstract 0159). Patients compliant with screening in the study not only had a 44% reduction in risk of death from HCC, but also were more likely to receive curative treatments (23.1% versus 15.1%). “Notwithstanding the limitations or cohort studies, I think these data reinforce the need to screen patients with chronic hepatitis B,” Dr. Ghany said.

He provided no disclosures in his presentation.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Severe lower GI bleed (http://ow.ly/iTrS30pOKaP) – A 15-year-old male patient was sent to the ER with severe lower GI bleed after a general physical exam revealed he was experiencing hypotension and tachycardia. The GI community discusses diagnostic possibilities for severe lower GI bleed at such young age and management options.

2. Refractory nausea and vomiting in a transgender patient (http://ow.ly/Di9C30pOKbq) – In this case of a 45-year-old transgender male-to-female patient, the community deliberates on several clinical issues, including a non-binary gender option on patient identification forms, treatment options for the patient and if hormonal therapy is contributing to GI symptoms.

3. Multidisciplinary guidelines (http://ow.ly/BtUK30pOKC8) – Are multidisciplinary guidelines with related specialty societies “the need of the hour” or too rare and short-lived for the effort?

Also in the forum: The AGA Clinical Practice Updates Committee is soliciting topics for future clinical expert review and commentaries commissioned by AGA. Share your ideas with the GI community (http://ow.ly/siV930pOJS1).

Access these clinical cases and more discussions at https://community.gastro.org/discussions.
 

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Severe lower GI bleed (http://ow.ly/iTrS30pOKaP) – A 15-year-old male patient was sent to the ER with severe lower GI bleed after a general physical exam revealed he was experiencing hypotension and tachycardia. The GI community discusses diagnostic possibilities for severe lower GI bleed at such young age and management options.

2. Refractory nausea and vomiting in a transgender patient (http://ow.ly/Di9C30pOKbq) – In this case of a 45-year-old transgender male-to-female patient, the community deliberates on several clinical issues, including a non-binary gender option on patient identification forms, treatment options for the patient and if hormonal therapy is contributing to GI symptoms.

3. Multidisciplinary guidelines (http://ow.ly/BtUK30pOKC8) – Are multidisciplinary guidelines with related specialty societies “the need of the hour” or too rare and short-lived for the effort?

Also in the forum: The AGA Clinical Practice Updates Committee is soliciting topics for future clinical expert review and commentaries commissioned by AGA. Share your ideas with the GI community (http://ow.ly/siV930pOJS1).

Access these clinical cases and more discussions at https://community.gastro.org/discussions.
 

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Severe lower GI bleed (http://ow.ly/iTrS30pOKaP) – A 15-year-old male patient was sent to the ER with severe lower GI bleed after a general physical exam revealed he was experiencing hypotension and tachycardia. The GI community discusses diagnostic possibilities for severe lower GI bleed at such young age and management options.

2. Refractory nausea and vomiting in a transgender patient (http://ow.ly/Di9C30pOKbq) – In this case of a 45-year-old transgender male-to-female patient, the community deliberates on several clinical issues, including a non-binary gender option on patient identification forms, treatment options for the patient and if hormonal therapy is contributing to GI symptoms.

3. Multidisciplinary guidelines (http://ow.ly/BtUK30pOKC8) – Are multidisciplinary guidelines with related specialty societies “the need of the hour” or too rare and short-lived for the effort?

Also in the forum: The AGA Clinical Practice Updates Committee is soliciting topics for future clinical expert review and commentaries commissioned by AGA. Share your ideas with the GI community (http://ow.ly/siV930pOJS1).

Access these clinical cases and more discussions at https://community.gastro.org/discussions.
 

Rep. Donald Payne Jr., D-N.J., has been representing the 10th congressional district of New Jersey which includes the Newark area and the thriving life-sciences community in the region since 2012. Rep. Payne Jr. ran to serve in the seat that his father, the late Rep.

AGA Institute

Donald M. Payne, D-N.J., held for eleven terms until his untimely death in March 2012. The elder Payne succumbed to colon cancer 1 month after his initial diagnosis, and Rep. Payne Jr. has made it his personal mission since assuming his father’s seat to increase awareness of colorectal cancer screenings. In fact, shortly after entering office, Rep. Payne Jr. wrote an op-ed with AGA member Carla Ginsburg, MD, MPH, AGAF, on the importance of screening, relaying in deeply personal terms the cost of not getting screened.

Rep. Payne Jr. also made it a top priority to push national awareness of colon cancer screening beyond the halls of Congress. To that end, Rep. Payne Jr. successfully lobbied the Obama administration in 2014 to designate March as National Colorectal Cancer Awareness Month – the first colorectal cancer presidential proclamation in over than a decade. The presidential proclamation was subsequently reissued in both 2015 and 2016 by the Obama administration and in 2018 and 2019 by the Trump administration. Additionally, Rep. Payne Jr. introduces a resolution in the House of Representatives every year to designate March as National Colorectal Cancer Awareness Month in an effort to further promote awareness and educational activities of colorectal cancer screening in the chamber.

Most importantly, Rep. Payne Jr. is the lead champion of legislative efforts in the House to increase access to colorectal cancer screenings. Specifically, Rep. Payne Jr. is the lead sponsor of H.R. 1570, the Removing Barriers to Colorectal Cancer Screening Act, legislation that has been one of AGA’s top policy priorities. The legislation, which enjoys broad bipartisan support with over 300 cosponsors in the House, would correct the Medicare beneficiary coinsurance issue when a screening colonoscopy becomes therapeutic. He also is a strong supporter of biomedical research funding, noting in an op-ed with former Rep. Charlie Dent, R-Pa., that “scientists need stable, consistent, and robust funding to ensure that we can continue ... breakthroughs for the colorectal cancer community and beyond.”

AGA looks forward to continuing to work with Rep. Payne Jr. and his office in the 116th Congress on these critical issues and on policies affecting our patients and the field of gastroenterology.
 

[email protected]

Rep. Donald Payne Jr., D-N.J., has been representing the 10th congressional district of New Jersey which includes the Newark area and the thriving life-sciences community in the region since 2012. Rep. Payne Jr. ran to serve in the seat that his father, the late Rep.

AGA Institute

Donald M. Payne, D-N.J., held for eleven terms until his untimely death in March 2012. The elder Payne succumbed to colon cancer 1 month after his initial diagnosis, and Rep. Payne Jr. has made it his personal mission since assuming his father’s seat to increase awareness of colorectal cancer screenings. In fact, shortly after entering office, Rep. Payne Jr. wrote an op-ed with AGA member Carla Ginsburg, MD, MPH, AGAF, on the importance of screening, relaying in deeply personal terms the cost of not getting screened.

Rep. Payne Jr. also made it a top priority to push national awareness of colon cancer screening beyond the halls of Congress. To that end, Rep. Payne Jr. successfully lobbied the Obama administration in 2014 to designate March as National Colorectal Cancer Awareness Month – the first colorectal cancer presidential proclamation in over than a decade. The presidential proclamation was subsequently reissued in both 2015 and 2016 by the Obama administration and in 2018 and 2019 by the Trump administration. Additionally, Rep. Payne Jr. introduces a resolution in the House of Representatives every year to designate March as National Colorectal Cancer Awareness Month in an effort to further promote awareness and educational activities of colorectal cancer screening in the chamber.

Most importantly, Rep. Payne Jr. is the lead champion of legislative efforts in the House to increase access to colorectal cancer screenings. Specifically, Rep. Payne Jr. is the lead sponsor of H.R. 1570, the Removing Barriers to Colorectal Cancer Screening Act, legislation that has been one of AGA’s top policy priorities. The legislation, which enjoys broad bipartisan support with over 300 cosponsors in the House, would correct the Medicare beneficiary coinsurance issue when a screening colonoscopy becomes therapeutic. He also is a strong supporter of biomedical research funding, noting in an op-ed with former Rep. Charlie Dent, R-Pa., that “scientists need stable, consistent, and robust funding to ensure that we can continue ... breakthroughs for the colorectal cancer community and beyond.”

AGA looks forward to continuing to work with Rep. Payne Jr. and his office in the 116th Congress on these critical issues and on policies affecting our patients and the field of gastroenterology.
 

[email protected]

Rep. Donald Payne Jr., D-N.J., has been representing the 10th congressional district of New Jersey which includes the Newark area and the thriving life-sciences community in the region since 2012. Rep. Payne Jr. ran to serve in the seat that his father, the late Rep.

AGA Institute

Donald M. Payne, D-N.J., held for eleven terms until his untimely death in March 2012. The elder Payne succumbed to colon cancer 1 month after his initial diagnosis, and Rep. Payne Jr. has made it his personal mission since assuming his father’s seat to increase awareness of colorectal cancer screenings. In fact, shortly after entering office, Rep. Payne Jr. wrote an op-ed with AGA member Carla Ginsburg, MD, MPH, AGAF, on the importance of screening, relaying in deeply personal terms the cost of not getting screened.

Rep. Payne Jr. also made it a top priority to push national awareness of colon cancer screening beyond the halls of Congress. To that end, Rep. Payne Jr. successfully lobbied the Obama administration in 2014 to designate March as National Colorectal Cancer Awareness Month – the first colorectal cancer presidential proclamation in over than a decade. The presidential proclamation was subsequently reissued in both 2015 and 2016 by the Obama administration and in 2018 and 2019 by the Trump administration. Additionally, Rep. Payne Jr. introduces a resolution in the House of Representatives every year to designate March as National Colorectal Cancer Awareness Month in an effort to further promote awareness and educational activities of colorectal cancer screening in the chamber.

Most importantly, Rep. Payne Jr. is the lead champion of legislative efforts in the House to increase access to colorectal cancer screenings. Specifically, Rep. Payne Jr. is the lead sponsor of H.R. 1570, the Removing Barriers to Colorectal Cancer Screening Act, legislation that has been one of AGA’s top policy priorities. The legislation, which enjoys broad bipartisan support with over 300 cosponsors in the House, would correct the Medicare beneficiary coinsurance issue when a screening colonoscopy becomes therapeutic. He also is a strong supporter of biomedical research funding, noting in an op-ed with former Rep. Charlie Dent, R-Pa., that “scientists need stable, consistent, and robust funding to ensure that we can continue ... breakthroughs for the colorectal cancer community and beyond.”

AGA looks forward to continuing to work with Rep. Payne Jr. and his office in the 116th Congress on these critical issues and on policies affecting our patients and the field of gastroenterology.
 

[email protected]

BOSTON – For patients with hepatitis C virus infection who achieve sustained virologic response to interferon-free therapy, changes in hepatic venous pressure gradient (HVPG) predict clinical benefit, according to investigators.

Will Pass/MDedge News

This finding will allow investigators to use HVPG as a surrogate endpoint for etiologic therapies, which could accelerate future research, reported lead author Mattias Mandorfer, MD, PhD, of the Medical University of Vienna and colleagues.

“Sustained virologic response to interferon-free therapies ameliorates portal hypertension,” Dr. Mandorfer said during a presentation at the annual meeting of the American Association for the Study of Liver Diseases. “[Previous research has shown that] nearly two-thirds of patients with pretreatment clinically significant portal hypertension had an HVPG decrease above or equal to 10%, which denotes a clinically meaningful change according to current recommendations. However, evidence is limited to studies evaluating the impact of HVPG response to nonselective beta-blockers, and nonselective beta-blockers have a completely different mode of action than etiological therapies. Accordingly, it is unclear whether a decrease in HVPG after the cure of hepatitis C translates into the same clinical benefit.”

To find out, the investigators enrolled 90 patients with hepatitis C virus who had an elevated HVPG of 6 mm Hg or higher prior to sustained virologic response. Before and after interferon-free therapy, patients underwent paired HVPG measurement. In addition, to evaluate noninvasive methods of HVPG assessment, transient elastography and von Willebrand factor to platelet count ratio testing were performed.

Analysis showed that HVPG measurements after, but not before, interferon-free therapy predicted liver decompensation. Specifically, HVPG was associated with an 18% increased risk of hepatic decompensation per mm Hg. After 3 years, 40.1% of patients with posttherapy HVPG measurements of 16 mm Hg or more developed hepatic decompensation, an event that occurred in none of the patients with a posttherapy HVPG of 9 mm Hg or less. Among patients who had a baseline HVPG of 10 mm Hg or more, which is considered a clinically significant level of portal hypertension, a decrease in HVPG of least 10% after therapy was associated with a similar level of protection against decompensation, compared with those who had no such decrease (2.5% vs. 31.8%).

While the two noninvasive methods (transient elastography and von Willebrand factor to platelet count ratio) were able to detect clinically significant portal hypertension (at least 10 mm Hg), they were not accurate enough to detect the protective 10% drop in HVPG.

“These results support the concept of applying HVPG as a surrogate endpoint for interventions that primarily aim at decreasing intrahepatic resistance (e.g., etiological therapies),” the investigators concluded in their abstract.

Jaime Bosch, MD, PhD, of the University of Barcelona provided some expert insight into the findings.

“The significance of the work is very important,” Dr. Bosch said in a public comment. “This provides, for the first time, firm evidence that HVPG can be taken as a surrogate endpoint ... for studies involving portal hypertension and cirrhosis in general.”

In an interview, Dr. Bosch elaborated on this statement. “The problem is, it takes a long time to get rid of cirrhosis [after sustained virologic response], and meanwhile, as long as portal hypertension remains, there is a risk for decompensation, so the patients cannot be said to be cured. They are cured of the infection, of the consequences of the infection, but it may take 10 years or more [to resolve cirrhosis], so the patient needs clinical surveillance and treatment after curing the cause of the disease.

“An academic consequence of these findings is that they’ve proved that decreasing HVPG by means of achieving sustained virologic response is followed by an improvement in prognosis. ... And when you can influence prognosis, and the influence in prognosis is reflected by a measurement independent from the way that we achieve this effect on the measurement, it means that this measurement is robust and now has to be used as a surrogate marker of resolution of cirrhosis.”

The study was funded by the Medical Scientific Fund of the city of Vienna. The investigators disclosed relationships with AbbVie, Bristol-Myers Squibb, Gilead, and others.

SOURCE: Mandorfer M et al. The Liver Meeting 2019, Abstract 146.

BOSTON – For patients with hepatitis C virus infection who achieve sustained virologic response to interferon-free therapy, changes in hepatic venous pressure gradient (HVPG) predict clinical benefit, according to investigators.

Will Pass/MDedge News

This finding will allow investigators to use HVPG as a surrogate endpoint for etiologic therapies, which could accelerate future research, reported lead author Mattias Mandorfer, MD, PhD, of the Medical University of Vienna and colleagues.

“Sustained virologic response to interferon-free therapies ameliorates portal hypertension,” Dr. Mandorfer said during a presentation at the annual meeting of the American Association for the Study of Liver Diseases. “[Previous research has shown that] nearly two-thirds of patients with pretreatment clinically significant portal hypertension had an HVPG decrease above or equal to 10%, which denotes a clinically meaningful change according to current recommendations. However, evidence is limited to studies evaluating the impact of HVPG response to nonselective beta-blockers, and nonselective beta-blockers have a completely different mode of action than etiological therapies. Accordingly, it is unclear whether a decrease in HVPG after the cure of hepatitis C translates into the same clinical benefit.”

To find out, the investigators enrolled 90 patients with hepatitis C virus who had an elevated HVPG of 6 mm Hg or higher prior to sustained virologic response. Before and after interferon-free therapy, patients underwent paired HVPG measurement. In addition, to evaluate noninvasive methods of HVPG assessment, transient elastography and von Willebrand factor to platelet count ratio testing were performed.

Analysis showed that HVPG measurements after, but not before, interferon-free therapy predicted liver decompensation. Specifically, HVPG was associated with an 18% increased risk of hepatic decompensation per mm Hg. After 3 years, 40.1% of patients with posttherapy HVPG measurements of 16 mm Hg or more developed hepatic decompensation, an event that occurred in none of the patients with a posttherapy HVPG of 9 mm Hg or less. Among patients who had a baseline HVPG of 10 mm Hg or more, which is considered a clinically significant level of portal hypertension, a decrease in HVPG of least 10% after therapy was associated with a similar level of protection against decompensation, compared with those who had no such decrease (2.5% vs. 31.8%).

While the two noninvasive methods (transient elastography and von Willebrand factor to platelet count ratio) were able to detect clinically significant portal hypertension (at least 10 mm Hg), they were not accurate enough to detect the protective 10% drop in HVPG.

“These results support the concept of applying HVPG as a surrogate endpoint for interventions that primarily aim at decreasing intrahepatic resistance (e.g., etiological therapies),” the investigators concluded in their abstract.

Jaime Bosch, MD, PhD, of the University of Barcelona provided some expert insight into the findings.

“The significance of the work is very important,” Dr. Bosch said in a public comment. “This provides, for the first time, firm evidence that HVPG can be taken as a surrogate endpoint ... for studies involving portal hypertension and cirrhosis in general.”

In an interview, Dr. Bosch elaborated on this statement. “The problem is, it takes a long time to get rid of cirrhosis [after sustained virologic response], and meanwhile, as long as portal hypertension remains, there is a risk for decompensation, so the patients cannot be said to be cured. They are cured of the infection, of the consequences of the infection, but it may take 10 years or more [to resolve cirrhosis], so the patient needs clinical surveillance and treatment after curing the cause of the disease.

“An academic consequence of these findings is that they’ve proved that decreasing HVPG by means of achieving sustained virologic response is followed by an improvement in prognosis. ... And when you can influence prognosis, and the influence in prognosis is reflected by a measurement independent from the way that we achieve this effect on the measurement, it means that this measurement is robust and now has to be used as a surrogate marker of resolution of cirrhosis.”

The study was funded by the Medical Scientific Fund of the city of Vienna. The investigators disclosed relationships with AbbVie, Bristol-Myers Squibb, Gilead, and others.

SOURCE: Mandorfer M et al. The Liver Meeting 2019, Abstract 146.

BOSTON – For patients with hepatitis C virus infection who achieve sustained virologic response to interferon-free therapy, changes in hepatic venous pressure gradient (HVPG) predict clinical benefit, according to investigators.

Will Pass/MDedge News

This finding will allow investigators to use HVPG as a surrogate endpoint for etiologic therapies, which could accelerate future research, reported lead author Mattias Mandorfer, MD, PhD, of the Medical University of Vienna and colleagues.

“Sustained virologic response to interferon-free therapies ameliorates portal hypertension,” Dr. Mandorfer said during a presentation at the annual meeting of the American Association for the Study of Liver Diseases. “[Previous research has shown that] nearly two-thirds of patients with pretreatment clinically significant portal hypertension had an HVPG decrease above or equal to 10%, which denotes a clinically meaningful change according to current recommendations. However, evidence is limited to studies evaluating the impact of HVPG response to nonselective beta-blockers, and nonselective beta-blockers have a completely different mode of action than etiological therapies. Accordingly, it is unclear whether a decrease in HVPG after the cure of hepatitis C translates into the same clinical benefit.”

To find out, the investigators enrolled 90 patients with hepatitis C virus who had an elevated HVPG of 6 mm Hg or higher prior to sustained virologic response. Before and after interferon-free therapy, patients underwent paired HVPG measurement. In addition, to evaluate noninvasive methods of HVPG assessment, transient elastography and von Willebrand factor to platelet count ratio testing were performed.

Analysis showed that HVPG measurements after, but not before, interferon-free therapy predicted liver decompensation. Specifically, HVPG was associated with an 18% increased risk of hepatic decompensation per mm Hg. After 3 years, 40.1% of patients with posttherapy HVPG measurements of 16 mm Hg or more developed hepatic decompensation, an event that occurred in none of the patients with a posttherapy HVPG of 9 mm Hg or less. Among patients who had a baseline HVPG of 10 mm Hg or more, which is considered a clinically significant level of portal hypertension, a decrease in HVPG of least 10% after therapy was associated with a similar level of protection against decompensation, compared with those who had no such decrease (2.5% vs. 31.8%).

While the two noninvasive methods (transient elastography and von Willebrand factor to platelet count ratio) were able to detect clinically significant portal hypertension (at least 10 mm Hg), they were not accurate enough to detect the protective 10% drop in HVPG.

“These results support the concept of applying HVPG as a surrogate endpoint for interventions that primarily aim at decreasing intrahepatic resistance (e.g., etiological therapies),” the investigators concluded in their abstract.

Jaime Bosch, MD, PhD, of the University of Barcelona provided some expert insight into the findings.

“The significance of the work is very important,” Dr. Bosch said in a public comment. “This provides, for the first time, firm evidence that HVPG can be taken as a surrogate endpoint ... for studies involving portal hypertension and cirrhosis in general.”

In an interview, Dr. Bosch elaborated on this statement. “The problem is, it takes a long time to get rid of cirrhosis [after sustained virologic response], and meanwhile, as long as portal hypertension remains, there is a risk for decompensation, so the patients cannot be said to be cured. They are cured of the infection, of the consequences of the infection, but it may take 10 years or more [to resolve cirrhosis], so the patient needs clinical surveillance and treatment after curing the cause of the disease.

“An academic consequence of these findings is that they’ve proved that decreasing HVPG by means of achieving sustained virologic response is followed by an improvement in prognosis. ... And when you can influence prognosis, and the influence in prognosis is reflected by a measurement independent from the way that we achieve this effect on the measurement, it means that this measurement is robust and now has to be used as a surrogate marker of resolution of cirrhosis.”

The study was funded by the Medical Scientific Fund of the city of Vienna. The investigators disclosed relationships with AbbVie, Bristol-Myers Squibb, Gilead, and others.

SOURCE: Mandorfer M et al. The Liver Meeting 2019, Abstract 146.

The Oncology Care Model is a value-based payment approach aimed at encouraging coordinated cancer care through targeted bonus payments to practices. The payment experiment was launched by the Centers for Medicare & Medicaid Services in 2016 and now includes 175 practices and 10 payers. It is set to end in 2021. As agency officials consider whether to continue the program, Stephen S. Grubbs, MD, vice president for clinical affairs at the American Society of Clinical Oncology, weighs in on the model’s track record and its future.

utah778/Thinkstock

Question: How would you rate the Oncology Care Model in helping to drive practice transformation?

Dr. Grubbs: Participants in the Oncology Care Model (OCM) have demonstrated improved care coordination, psychosocial support, use of risk assessment tools, and other strategies to lower costs and adverse events. Over the past 2 years, ASCO has accepted numerous posters, articles, and abstracts from OCM participants on their outstanding work to advance cancer care delivery.

Question: Should the model be extended beyond 2021?

Dr. Grubbs: Changes to the model are necessary prior to a significant extension or expansion. Some have suggested that CMS extend OCM for an additional year with current participants. This would give CMS time to consider input from all stakeholders on its eventual replacement.

Question: What additional resources or payments do oncology practices need to be more successful in meeting the goals of the Oncology Care Model?

Dr. Grubbs: OCM has shown that by providing oncologists with payment for care management – OCM participants receive $160 per patient, per month – the results are better care coordination and reduced hospital and emergency department visits. If CMS chooses to expand payments to all oncology providers, we could expect to see improved care for cancer patients.

Question: ASCO has advanced its own Patient-Centered Oncology Payment model. What are the main elements of this strategy and how does it differ from the Oncology Care Model?

Dr. Grubbs: The Patient-Centered Oncology Payment (PCOP) model is the result of input from a wide group of stakeholders, including providers, employers, and managed care organizations. In the coming months, ASCO will publish an updated copy of the PCOP model.

Our review of OCM is that the included prediction model and two-sided risk options place small, rural, and certain other practices at considerable peril because of imprecise and inconsistent cost predictions. PCOP takes a different approach. Rather than requiring that practices take on actuarial risk for total cost of care, PCOP includes a three-part performance methodology. Practices are measured on adherence to clinical treatment pathways; electronically capturable quality measures; and select, targeted cost-of-care measures. Practices that perform well in PCOP’s performance methodology receive increased incentive payments to fund further advancements in care.

Question: The PCOP model includes payments to oncology practices for participation in clinical trials. How might that drive a change in behavior in a typical practice?

Dr. Grubbs: Practices that enroll patients in clinical trials have the same or greater storage and handling requirements as those treated with standard treatments, yet forgo revenue associated with the Medicare Part B average sales price methodology. PCOP ensures that such practices are not disadvantaged for supporting clinical research.

Question: Are there other areas – such as tumor biomarker tests – in which a tailored payment approach would improve the quality of care?

Dr. Grubbs: Recent studies have shown that not all patients receive the appropriate genomic profiling and other tests necessary to ensure that they benefit from personalized therapies. Clinical treatment pathways have the ability to inform and measure diagnostic completeness to improve the quality of care.

Question: What are the barriers that are keeping oncology practices from participating in alternative payment models designed to improve care?

Dr. Grubbs: Some alternative payment models, such as OCM, place a high administrative burden on their participants. Manual reporting of measures and clinical data, complicated billing requirements, and lack of support from electronic health record vendors create barriers for expanded participation. Practices are also concerned about the financial risks placed upon participants; it is impractical to expect that physicians hire actuaries in order to participate in a Medicare program.

ASCO has offered support for OCM practices through its PracticeNET benchmarking program, but we have also proposed PCOP as an appropriate alternative, applicable to practices of all types and sizes.

Dr. Grubbs joined ASCO in 2015 as the vice president of the newly launched clinical affairs department. Before joining ASCO, Dr. Grubbs worked as a community oncologist and managing partner at Medical Oncology Hematology Consultants in Newark, Del. Dr. Grubbs is a volunteer and the principal investigator of the Delaware Christiana Care National Cancer Institute Community Oncology Research Program. Dr. Grubbs reported having no financial disclosures.

The Oncology Care Model is a value-based payment approach aimed at encouraging coordinated cancer care through targeted bonus payments to practices. The payment experiment was launched by the Centers for Medicare & Medicaid Services in 2016 and now includes 175 practices and 10 payers. It is set to end in 2021. As agency officials consider whether to continue the program, Stephen S. Grubbs, MD, vice president for clinical affairs at the American Society of Clinical Oncology, weighs in on the model’s track record and its future.

utah778/Thinkstock

Question: How would you rate the Oncology Care Model in helping to drive practice transformation?

Dr. Grubbs: Participants in the Oncology Care Model (OCM) have demonstrated improved care coordination, psychosocial support, use of risk assessment tools, and other strategies to lower costs and adverse events. Over the past 2 years, ASCO has accepted numerous posters, articles, and abstracts from OCM participants on their outstanding work to advance cancer care delivery.

Question: Should the model be extended beyond 2021?

Dr. Grubbs: Changes to the model are necessary prior to a significant extension or expansion. Some have suggested that CMS extend OCM for an additional year with current participants. This would give CMS time to consider input from all stakeholders on its eventual replacement.

Question: What additional resources or payments do oncology practices need to be more successful in meeting the goals of the Oncology Care Model?

Dr. Grubbs: OCM has shown that by providing oncologists with payment for care management – OCM participants receive $160 per patient, per month – the results are better care coordination and reduced hospital and emergency department visits. If CMS chooses to expand payments to all oncology providers, we could expect to see improved care for cancer patients.

Question: ASCO has advanced its own Patient-Centered Oncology Payment model. What are the main elements of this strategy and how does it differ from the Oncology Care Model?

Dr. Grubbs: The Patient-Centered Oncology Payment (PCOP) model is the result of input from a wide group of stakeholders, including providers, employers, and managed care organizations. In the coming months, ASCO will publish an updated copy of the PCOP model.

Our review of OCM is that the included prediction model and two-sided risk options place small, rural, and certain other practices at considerable peril because of imprecise and inconsistent cost predictions. PCOP takes a different approach. Rather than requiring that practices take on actuarial risk for total cost of care, PCOP includes a three-part performance methodology. Practices are measured on adherence to clinical treatment pathways; electronically capturable quality measures; and select, targeted cost-of-care measures. Practices that perform well in PCOP’s performance methodology receive increased incentive payments to fund further advancements in care.

Question: The PCOP model includes payments to oncology practices for participation in clinical trials. How might that drive a change in behavior in a typical practice?

Dr. Grubbs: Practices that enroll patients in clinical trials have the same or greater storage and handling requirements as those treated with standard treatments, yet forgo revenue associated with the Medicare Part B average sales price methodology. PCOP ensures that such practices are not disadvantaged for supporting clinical research.

Question: Are there other areas – such as tumor biomarker tests – in which a tailored payment approach would improve the quality of care?

Dr. Grubbs: Recent studies have shown that not all patients receive the appropriate genomic profiling and other tests necessary to ensure that they benefit from personalized therapies. Clinical treatment pathways have the ability to inform and measure diagnostic completeness to improve the quality of care.

Question: What are the barriers that are keeping oncology practices from participating in alternative payment models designed to improve care?

Dr. Grubbs: Some alternative payment models, such as OCM, place a high administrative burden on their participants. Manual reporting of measures and clinical data, complicated billing requirements, and lack of support from electronic health record vendors create barriers for expanded participation. Practices are also concerned about the financial risks placed upon participants; it is impractical to expect that physicians hire actuaries in order to participate in a Medicare program.

ASCO has offered support for OCM practices through its PracticeNET benchmarking program, but we have also proposed PCOP as an appropriate alternative, applicable to practices of all types and sizes.

Dr. Grubbs joined ASCO in 2015 as the vice president of the newly launched clinical affairs department. Before joining ASCO, Dr. Grubbs worked as a community oncologist and managing partner at Medical Oncology Hematology Consultants in Newark, Del. Dr. Grubbs is a volunteer and the principal investigator of the Delaware Christiana Care National Cancer Institute Community Oncology Research Program. Dr. Grubbs reported having no financial disclosures.

The Oncology Care Model is a value-based payment approach aimed at encouraging coordinated cancer care through targeted bonus payments to practices. The payment experiment was launched by the Centers for Medicare & Medicaid Services in 2016 and now includes 175 practices and 10 payers. It is set to end in 2021. As agency officials consider whether to continue the program, Stephen S. Grubbs, MD, vice president for clinical affairs at the American Society of Clinical Oncology, weighs in on the model’s track record and its future.

utah778/Thinkstock

Question: How would you rate the Oncology Care Model in helping to drive practice transformation?

Dr. Grubbs: Participants in the Oncology Care Model (OCM) have demonstrated improved care coordination, psychosocial support, use of risk assessment tools, and other strategies to lower costs and adverse events. Over the past 2 years, ASCO has accepted numerous posters, articles, and abstracts from OCM participants on their outstanding work to advance cancer care delivery.

Question: Should the model be extended beyond 2021?

Dr. Grubbs: Changes to the model are necessary prior to a significant extension or expansion. Some have suggested that CMS extend OCM for an additional year with current participants. This would give CMS time to consider input from all stakeholders on its eventual replacement.

Question: What additional resources or payments do oncology practices need to be more successful in meeting the goals of the Oncology Care Model?

Dr. Grubbs: OCM has shown that by providing oncologists with payment for care management – OCM participants receive $160 per patient, per month – the results are better care coordination and reduced hospital and emergency department visits. If CMS chooses to expand payments to all oncology providers, we could expect to see improved care for cancer patients.

Question: ASCO has advanced its own Patient-Centered Oncology Payment model. What are the main elements of this strategy and how does it differ from the Oncology Care Model?

Dr. Grubbs: The Patient-Centered Oncology Payment (PCOP) model is the result of input from a wide group of stakeholders, including providers, employers, and managed care organizations. In the coming months, ASCO will publish an updated copy of the PCOP model.

Our review of OCM is that the included prediction model and two-sided risk options place small, rural, and certain other practices at considerable peril because of imprecise and inconsistent cost predictions. PCOP takes a different approach. Rather than requiring that practices take on actuarial risk for total cost of care, PCOP includes a three-part performance methodology. Practices are measured on adherence to clinical treatment pathways; electronically capturable quality measures; and select, targeted cost-of-care measures. Practices that perform well in PCOP’s performance methodology receive increased incentive payments to fund further advancements in care.

Question: The PCOP model includes payments to oncology practices for participation in clinical trials. How might that drive a change in behavior in a typical practice?

Dr. Grubbs: Practices that enroll patients in clinical trials have the same or greater storage and handling requirements as those treated with standard treatments, yet forgo revenue associated with the Medicare Part B average sales price methodology. PCOP ensures that such practices are not disadvantaged for supporting clinical research.

Question: Are there other areas – such as tumor biomarker tests – in which a tailored payment approach would improve the quality of care?

Dr. Grubbs: Recent studies have shown that not all patients receive the appropriate genomic profiling and other tests necessary to ensure that they benefit from personalized therapies. Clinical treatment pathways have the ability to inform and measure diagnostic completeness to improve the quality of care.

Question: What are the barriers that are keeping oncology practices from participating in alternative payment models designed to improve care?

Dr. Grubbs: Some alternative payment models, such as OCM, place a high administrative burden on their participants. Manual reporting of measures and clinical data, complicated billing requirements, and lack of support from electronic health record vendors create barriers for expanded participation. Practices are also concerned about the financial risks placed upon participants; it is impractical to expect that physicians hire actuaries in order to participate in a Medicare program.

ASCO has offered support for OCM practices through its PracticeNET benchmarking program, but we have also proposed PCOP as an appropriate alternative, applicable to practices of all types and sizes.

Dr. Grubbs joined ASCO in 2015 as the vice president of the newly launched clinical affairs department. Before joining ASCO, Dr. Grubbs worked as a community oncologist and managing partner at Medical Oncology Hematology Consultants in Newark, Del. Dr. Grubbs is a volunteer and the principal investigator of the Delaware Christiana Care National Cancer Institute Community Oncology Research Program. Dr. Grubbs reported having no financial disclosures.

BOSTON – Children who have recurrence of primary sclerosing cholangitis after liver transplant tend to be younger and have more rapidly progressive disease, based on an international retrospective analysis.

Will Pass/MDedge News

Within 5 years of transplant, the probability of primary sclerosing cholangitis (PSC) recurrence in pediatric patients is 26%, reported lead author Mercedes Martinez, MD, of Columbia University, New York, and colleagues.

“The aim of our study was to identify risk factors for primary sclerosing cholangitis recurrence following transplant,” Dr. Martinez said during a presentation at the annual meeting of the American Association for the Study of Liver Diseases. This may be the largest pediatric study evaluating recurrent PSC to date, she added.

The investigators drew data from 35 centers around the world via the Pediatric PSC Consortium database. Recurrence was defined by cholestatic biochemistry with nonanastomotic biliary strictures and beading of bile ducts on cholangiography. Recurrences caused by hepatic artery thrombosis or chronic rejection were excluded, as were any cases that recurred within 6 months of transplant.

The final analysis included 149 patients with a median age at diagnosis and liver transplant of 12 years and 15.4 years, respectively. Of these, 31 patients had recurrence after a median of 3.3 years. A closer look at the data showed that recurrence was linked with younger median age at time of transplant (13.2 vs. 16.2 years). In cases of recurrence, PSC was generally more aggressive prior to transplant, with a shorter interval between diagnosis and transplant (1.6 vs. 4.1 years), higher total bilirubin (7.8 vs. 3.8 mg/dL), and higher ALT (118 vs. 62 U/L). Furthermore, almost half of the patients (45%) who had recurrence also had pretransplant autoimmune hepatitis overlap, compared with approximately one-quarter of the patients (27%) who did not have recurrence, although this trend was not statistically significant (P = .06).

Recurrent PSC was also associated with poorer outcomes; almost half of those with recurrence (48%) were relisted for liver transplant, developed portal hypertension, or died within 2 years of diagnosis. Mean rejection rates were higher in recurrent versus nonrecurrent cases (3 vs. 1); recurrent cases also had shorter time until rejection (3 vs. 6 months) and greater prevalence of rejection that was refractory to steroids (23% vs. 12%). Moreover, a significantly greater proportion of patients with recurrence had Epstein-Barr viremia (41% vs. 21%).

Dr. Martinez noted that ongoing therapy involving mammalian target of rapamycin inhibition was associated with lower rates of recurrence and suggested that this deserves further investigation; however, owing to small population size, she urged a cautious interpretation of this finding.

“We have to do prospective research,” Dr. Martinez said, emphasizing that tissue immunophenotyping was needed, as a better understanding of underlying immune processes and disease subtypes may open doors to more effective therapies.

The investigators disclosed relationships with Gilead, Merck, Novartis, and others.

SOURCE: Martinez M et al. The Liver Meeting 2019, Abstract 44.

BOSTON – Children who have recurrence of primary sclerosing cholangitis after liver transplant tend to be younger and have more rapidly progressive disease, based on an international retrospective analysis.

Will Pass/MDedge News

Within 5 years of transplant, the probability of primary sclerosing cholangitis (PSC) recurrence in pediatric patients is 26%, reported lead author Mercedes Martinez, MD, of Columbia University, New York, and colleagues.

“The aim of our study was to identify risk factors for primary sclerosing cholangitis recurrence following transplant,” Dr. Martinez said during a presentation at the annual meeting of the American Association for the Study of Liver Diseases. This may be the largest pediatric study evaluating recurrent PSC to date, she added.

The investigators drew data from 35 centers around the world via the Pediatric PSC Consortium database. Recurrence was defined by cholestatic biochemistry with nonanastomotic biliary strictures and beading of bile ducts on cholangiography. Recurrences caused by hepatic artery thrombosis or chronic rejection were excluded, as were any cases that recurred within 6 months of transplant.

The final analysis included 149 patients with a median age at diagnosis and liver transplant of 12 years and 15.4 years, respectively. Of these, 31 patients had recurrence after a median of 3.3 years. A closer look at the data showed that recurrence was linked with younger median age at time of transplant (13.2 vs. 16.2 years). In cases of recurrence, PSC was generally more aggressive prior to transplant, with a shorter interval between diagnosis and transplant (1.6 vs. 4.1 years), higher total bilirubin (7.8 vs. 3.8 mg/dL), and higher ALT (118 vs. 62 U/L). Furthermore, almost half of the patients (45%) who had recurrence also had pretransplant autoimmune hepatitis overlap, compared with approximately one-quarter of the patients (27%) who did not have recurrence, although this trend was not statistically significant (P = .06).

Recurrent PSC was also associated with poorer outcomes; almost half of those with recurrence (48%) were relisted for liver transplant, developed portal hypertension, or died within 2 years of diagnosis. Mean rejection rates were higher in recurrent versus nonrecurrent cases (3 vs. 1); recurrent cases also had shorter time until rejection (3 vs. 6 months) and greater prevalence of rejection that was refractory to steroids (23% vs. 12%). Moreover, a significantly greater proportion of patients with recurrence had Epstein-Barr viremia (41% vs. 21%).

Dr. Martinez noted that ongoing therapy involving mammalian target of rapamycin inhibition was associated with lower rates of recurrence and suggested that this deserves further investigation; however, owing to small population size, she urged a cautious interpretation of this finding.

“We have to do prospective research,” Dr. Martinez said, emphasizing that tissue immunophenotyping was needed, as a better understanding of underlying immune processes and disease subtypes may open doors to more effective therapies.

The investigators disclosed relationships with Gilead, Merck, Novartis, and others.

SOURCE: Martinez M et al. The Liver Meeting 2019, Abstract 44.

BOSTON – Children who have recurrence of primary sclerosing cholangitis after liver transplant tend to be younger and have more rapidly progressive disease, based on an international retrospective analysis.

Will Pass/MDedge News

Within 5 years of transplant, the probability of primary sclerosing cholangitis (PSC) recurrence in pediatric patients is 26%, reported lead author Mercedes Martinez, MD, of Columbia University, New York, and colleagues.

“The aim of our study was to identify risk factors for primary sclerosing cholangitis recurrence following transplant,” Dr. Martinez said during a presentation at the annual meeting of the American Association for the Study of Liver Diseases. This may be the largest pediatric study evaluating recurrent PSC to date, she added.

The investigators drew data from 35 centers around the world via the Pediatric PSC Consortium database. Recurrence was defined by cholestatic biochemistry with nonanastomotic biliary strictures and beading of bile ducts on cholangiography. Recurrences caused by hepatic artery thrombosis or chronic rejection were excluded, as were any cases that recurred within 6 months of transplant.

The final analysis included 149 patients with a median age at diagnosis and liver transplant of 12 years and 15.4 years, respectively. Of these, 31 patients had recurrence after a median of 3.3 years. A closer look at the data showed that recurrence was linked with younger median age at time of transplant (13.2 vs. 16.2 years). In cases of recurrence, PSC was generally more aggressive prior to transplant, with a shorter interval between diagnosis and transplant (1.6 vs. 4.1 years), higher total bilirubin (7.8 vs. 3.8 mg/dL), and higher ALT (118 vs. 62 U/L). Furthermore, almost half of the patients (45%) who had recurrence also had pretransplant autoimmune hepatitis overlap, compared with approximately one-quarter of the patients (27%) who did not have recurrence, although this trend was not statistically significant (P = .06).

Recurrent PSC was also associated with poorer outcomes; almost half of those with recurrence (48%) were relisted for liver transplant, developed portal hypertension, or died within 2 years of diagnosis. Mean rejection rates were higher in recurrent versus nonrecurrent cases (3 vs. 1); recurrent cases also had shorter time until rejection (3 vs. 6 months) and greater prevalence of rejection that was refractory to steroids (23% vs. 12%). Moreover, a significantly greater proportion of patients with recurrence had Epstein-Barr viremia (41% vs. 21%).

Dr. Martinez noted that ongoing therapy involving mammalian target of rapamycin inhibition was associated with lower rates of recurrence and suggested that this deserves further investigation; however, owing to small population size, she urged a cautious interpretation of this finding.

“We have to do prospective research,” Dr. Martinez said, emphasizing that tissue immunophenotyping was needed, as a better understanding of underlying immune processes and disease subtypes may open doors to more effective therapies.

The investigators disclosed relationships with Gilead, Merck, Novartis, and others.

SOURCE: Martinez M et al. The Liver Meeting 2019, Abstract 44.

NATIONAL HARBOR, MD. – If the United States does not step up and create a thriving biosimilars market soon, it risks destroying the market not only domestically but internationally as well.

Gregory Twachtman/MDedge News

This was the warning Gillian Woollett, senior vice president at Avalere, provided to attendees at the annual meeting of the Academy of Managed Care Pharmacy.

She prefaced her warning by quoting Alex Azar, secretary of Health & Human Services, who said that those “trying to hold back biosimilars are simply on the wrong side of history,” though Ms. Woollett said they “may be on the right side of the current economic model in the United States.”

And despite the probusiness, procompetition philosophy of current HHS leadership, there has been very little movement on creating a competitive market for biosimilars in the United States, evidenced by the very expensive regulatory requirements that biosimilar manufacturers need to meet in order to get products to market.

“It’s not that we won’t have competition in the U.S.,” she said. “I think we will. We do have that innovation. ... It’s just that biosimilars may not ultimately be part of that competition. And for that, we will pay a price, and I actually think the whole world will pay a price because if we are not providing the [return on investment], I am not sure the other markets can sustain it.”

One issue biosimilars have is the lack of recognition of the value that they bring.

“That biosimilars offer the same clinical outcomes at a lower price is yet to be a recognized value,” she said. “To me that’s a really surprising situation in the United States.”

Ms. Woollett disclosed no relevant conflicts of interest.

To prepare for the entry of biosimilars to the market, AGA is taking the lead in educating health care providers and patients about biosimilars and how they can be used for IBD patient care. Learn more at www.gastro.org/biosimilars.

[email protected]

NATIONAL HARBOR, MD. – If the United States does not step up and create a thriving biosimilars market soon, it risks destroying the market not only domestically but internationally as well.

Gregory Twachtman/MDedge News

This was the warning Gillian Woollett, senior vice president at Avalere, provided to attendees at the annual meeting of the Academy of Managed Care Pharmacy.

She prefaced her warning by quoting Alex Azar, secretary of Health & Human Services, who said that those “trying to hold back biosimilars are simply on the wrong side of history,” though Ms. Woollett said they “may be on the right side of the current economic model in the United States.”

And despite the probusiness, procompetition philosophy of current HHS leadership, there has been very little movement on creating a competitive market for biosimilars in the United States, evidenced by the very expensive regulatory requirements that biosimilar manufacturers need to meet in order to get products to market.

“It’s not that we won’t have competition in the U.S.,” she said. “I think we will. We do have that innovation. ... It’s just that biosimilars may not ultimately be part of that competition. And for that, we will pay a price, and I actually think the whole world will pay a price because if we are not providing the [return on investment], I am not sure the other markets can sustain it.”

One issue biosimilars have is the lack of recognition of the value that they bring.

“That biosimilars offer the same clinical outcomes at a lower price is yet to be a recognized value,” she said. “To me that’s a really surprising situation in the United States.”

Ms. Woollett disclosed no relevant conflicts of interest.

To prepare for the entry of biosimilars to the market, AGA is taking the lead in educating health care providers and patients about biosimilars and how they can be used for IBD patient care. Learn more at www.gastro.org/biosimilars.

[email protected]

NATIONAL HARBOR, MD. – If the United States does not step up and create a thriving biosimilars market soon, it risks destroying the market not only domestically but internationally as well.

Gregory Twachtman/MDedge News

This was the warning Gillian Woollett, senior vice president at Avalere, provided to attendees at the annual meeting of the Academy of Managed Care Pharmacy.

She prefaced her warning by quoting Alex Azar, secretary of Health & Human Services, who said that those “trying to hold back biosimilars are simply on the wrong side of history,” though Ms. Woollett said they “may be on the right side of the current economic model in the United States.”

And despite the probusiness, procompetition philosophy of current HHS leadership, there has been very little movement on creating a competitive market for biosimilars in the United States, evidenced by the very expensive regulatory requirements that biosimilar manufacturers need to meet in order to get products to market.

“It’s not that we won’t have competition in the U.S.,” she said. “I think we will. We do have that innovation. ... It’s just that biosimilars may not ultimately be part of that competition. And for that, we will pay a price, and I actually think the whole world will pay a price because if we are not providing the [return on investment], I am not sure the other markets can sustain it.”

One issue biosimilars have is the lack of recognition of the value that they bring.

“That biosimilars offer the same clinical outcomes at a lower price is yet to be a recognized value,” she said. “To me that’s a really surprising situation in the United States.”

Ms. Woollett disclosed no relevant conflicts of interest.

To prepare for the entry of biosimilars to the market, AGA is taking the lead in educating health care providers and patients about biosimilars and how they can be used for IBD patient care. Learn more at www.gastro.org/biosimilars.

[email protected]