This Week in Managed Care: October 30, 2020

Updates on trials examining therapies and vaccine candidates for COVID-19, Managed Care Cast explores keeping physicians independent through value-based care, and an overview of the 2020 Community Oncology Alliance Virtual Payer Exchange Summit.

Welcome to This Week in Managed Care, I’m Matthew Gavidia.

Halted COVID-19 Trials to Resume, Eli Lilly’s Antibody Trial Cancelled

After halting clinical trials to investigate safety concerns of their respective vaccine candidates against SARS-CoV-2, the virus that causes COVID-19, both AstraZeneca and Johnson & Johnson announced plans to restart their studies.

The AstraZeneca trial was halted on September 6 after a study participant developed neurological symptoms that were reportedly found to be caused by transverse myelitis, a spinal cord condition. Johnson & Johnson, which halted its trial on October 11 after a reported stroke experienced by a study participant, has sent a final report of the case study to the FDA for review and could begin enrolling patients as early as next week.

In a separate phase 3 COVID-19 vaccine trial by Pfizer and collaborator BioNTech, enrollment has almost reached its max of 44,000 trial volunteers. Currently at the 95% mark for participants, close to 86% of this group have received both vaccine doses.

Scientists working on the trial are aiming for an immune system response from the messenger RNA the vaccine candidate contains, and they are currently awaiting an interim efficacy analysis from the data monitoring board. Pfizer previously commented that it won’t seek an emergency use authorization from the FDA until these data are available.

Also reported this week, Eli Lilly & Company announced it will be ending the clinical trial of its antibody drug bamlanivimab, in combination with remdesivir, a day after the National Institutes of Health, or NIH, found the combination therapy to exhibit no significant improvement among patients hospitalized with severe cases of COVID-19.

Initially paused by the pharmaceutical company on October 13 due to a potential safety concern, both Eli Lilly and the NIH still plan to pursue several additional trials involving the antibody drug, with the subsequent trials examining its efficacy among patients with less advanced stages of COVID-19.

For more on COVID-19 trial restarts, visit ajmc.com/link/4808. For more on Eli Lilly’s trial cancellation, visit ajmc.com/link/4809. For more on Pfizer’s trial, visit ajmc.com/link/4810.

Researchers Warn of Heightened Risk of HIV With Certain COVID-19 Vaccines

As the race to approve a safe and effective vaccine for COVID-19 continues, a group of researchers is warning that some of these vaccines could make patients more susceptible to contracting HIV.

Writing in The Lancet, researchers are urging caution when it comes to the use of adenovirus type-5, or Ad5, vectored vaccines for COVID-19, recalling their research from a decade ago on an Ad5 vectored vaccine in 2 HIV vaccine trials.

Stemming from the Step and Phambili phase 2b trials that studied the efficacy of an Ad5 vectored HIV-1 vaccine in preventing HIV, researchers found that the vaccine actually increased the risk of HIV among the vaccinated men.

The findings from the Phambili study, in particular, have important implications for the use of the vaccines in COVID-19, according to the researchers, as findings from this study showed that heterosexual men receiving the Ad5 vectored vaccine faced a consistently increased risk of HIV infection. Notably, this increased risk appeared to be limited to men, with women not having an observed increase of infection in the study.

“On the basis of these findings, we are concerned that use of an Ad5 vector for immunisation against SARS-CoV-2 could similarly increase the risk of HIV-1 acquisition among men who receive the vaccine,” wrote the researchers. “Both the HIV and COVID-19 pandemics disproportionately affect vulnerable populations globally. Roll-out of an effective SARS-CoV-2 vaccine globally could be given to populations at risk of HIV infection, which could potentially increase their risk of HIV-1 acquisition.”

There are several clinical trials assessing Ad5 vectored vaccine candidates underway, including by China’s CanSino Biologics and California-based ImmunityBio.

For more, visit ajmc.com.

Keeping Physicians Independent: Dr Patricia Salber Interviews Dr Farzad Mostashari

In this week’s Managed Care Cast, Dr Patricia Salber, of The Doctor Weighs In, spoke with Aledade co-founder, Dr Farzad Mostashari, about how his company is keeping physicians independent through value-based care.

Created 6 years ago to help physicians stay independent, Aledade implements a value-based care business model. Overall, the company has helped practices save $377 million and improved care by reducing hospitalizations and skilled nursing facility utilizations.

“In order to get sustained behavior change, you need to address the triple-strand DNA,” explains Mostashari, “which is the data and technology, the coaching, and a new economic model—that’s what Aledade does.”

For the full interview, visit ajmc.com.

COA 2020 Payer Exchange Summit

This week, the Community Oncology Alliance, or COA, presented its 2020 Payer Exchange Summit in a virtual format.

Known for its candid discussions of where progress is happening—or not happening—in payment reform, AJMC.com provided full coverage of the 2-day virtual event, which took place October 27-28.

In addition to written coverage of late-breaking sessions, AJMC.com has a wide array of video interviews with several key opinion leaders, including:

• Bo Gamble, director of Strategic Practice Initiatives for COA
• Dr Lucio Gordan, president and managing physician at Florida Cancer Specialists and Research Institute
• Dr Mark Fendrick, co-editor-in-chief of The American Journal of Managed Care®, and director of the University of Michigan Center for Value-Based Insurance Design
• And many more!

For full conference coverage, visit ajmc.com.

Paper of the Week

And now, our paper of the week, which looks back at some of the most important papers over the past 25 years of The American Journal of Managed Care^® and why they matter today.

Ten years ago, AJMC^® co-editor-in-chief Dr Mark Fendrick published “Value-Based Insurance Design for Diabetes Mellitus: Approaches to Optimal Pharmacoeconomic Implementation,” which was based on a roundtable presentation on emerging trends in bringing value-based concepts to diabetes care.

In the paper, which appeared shortly after passage of the Affordable Care Act, Dr Fendrick outlines the idea of reducing or eliminating copayments to increase medication adherence and thus reduce hospitalization and resulting costs.

For the paper, visit ajmc.com.

For all of us at AJMC^®, I’m Matthew Gavidia. Thanks for joining us!