Celine Castronuovo, Bloomberg Law: January 13, 2022
Minority groups could have a harder time accessing Biogen Inc.’s Alzheimer’s drug under Medicare’s preliminary decision to limit coverage to patients enrolled in clinical trials, policy analysts say.
The draft coverage determination aims to allow for additional studies on the effectiveness of Biogen’s Aduhelm, which won FDA approval in June 2021 despite pushback from scientific advisers. But limiting Medicare coverage could be detrimental to Black people, Hispanics, and other groups that are typically underrepresented in drug studies, in part because they may not have easy access to them.
“If we’re going to require or make provisions that certain kinds of technology or innovations are available to those that participate in clinical trials,” then “we need to expand the potential for diverse patient populations to participate in those clinical trials,” Esther Krofah, executive director of FasterCures and the Center for Public Health at the Milken Institute, said.
The Centers for Medicare & Medicaid Services should use this new drug as an opportunity to promote diversity in enrollment and ensure that clinical trial populations are reflective of the communities most impacted by the memory-destroying disease, she said.
The proposal “is the result of robust evidence analysis conducted through a thorough review process that found while there may be the potential for promise with this treatment, there is also the potential for harm to patients,” Lee Fleisher, CMS chief medical officer and director of the Center for Clinical Standards and Quality, said in a statement.
The public has 30 days to comment on the proposed National Coverage Determination before the CMS makes a final decision. If the proposal is finalized, the CMS said it will determine which clinical trials and patients meet the agency’s coverage eligibility requirements on a case-by-case basis.
The FDA granted accelerated approval to Aduhelm even though two clinical trials offered mixed signals about the drug’s efficacy. A committee of outside scientific advisers to the agency said the drug shouldn’t have been approved. Three panelists have since resigned.
Medical research and insurance companies, citing continued uncertainty over the treatment’s efficacy and cost, welcomed the CMS decision on Aduhelm.
Compiling and analyzing additional data on Aduhelm “will provide much-needed insights into the drug’s safety and effectiveness,” Adam Myers, senior vice president and chief clinical transformation officer (CCTO) for the Blue Cross Blue Shield Association, said in a statement. Private insurers in the U.S. have mostly declined to cover the treatment due to questions on its efficacy and whether its benefits outweigh risks.
“We will continue working with the administration and the health care industry to advance affordable, clinically-appropriate treatments for incurable conditions, including Alzheimer’s disease,” added Myers, whose association represents dozens of health insurance companies providing coverage to millions of Americans.
Limiting coverage to clinical trial participants will “help ensure that patients and family members are aware that taking Aduhelm is part of an experiment, despite Aduhelm’s FDA approval,” said Diana Zuckerman, founder and president of the National Center for Health Research.
Broad coverage and access to a medication is more likely when “clinicians are convinced of an accelerated approval drug’s promise, such that they are willing to prescribe it,” and “payers are convinced the drug works and is a good value, such that they are willing to pay for it,” Holly Fernandez Lynch [a medical ethics professor at the University of Pennsylvania] said. “Neither of those are true for Aduhelm.”
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