In a rare moment of solidarity among fierce competitors, Biogen’s peers Roche and Eli Lilly are rallying behind the company’s troubled Alzheimer’s disease therapy, Aduhelm, in an effort to change the Centers for Medicare & Medicaid Services’ (CMS') restrictive ruling against monoclonal antibodies for the condition.
CMS just closed a comment period on a proposal to limit Medicare coverage of Aduhelm to only patients enrolled in approved clinical trials. If the decision passes as currently written, the ruling would also apply to other monoclonal antibodies, or mAbs, in development that target amyloid like Aduhelm, including those by Lilly and Roche’s Genentech.
Lilly’s Brandy Matthews, medical launch leader for the company’s candidate donanemab, urged the agency to consider mAbs individually based on the evidence for each candidate, rather than restricting all amyloid-clearing therapies in the class. She advocated for the one drug that has already been approved, Aduhelm, and those to come to be covered for the populations studied in their respective clinical trials. Any future changes in covered patient populations can then be informed by the FDA's labeling updates or based on evidence presented in peer-reviewed published studies.
“We urge CMS to ensure that its coverage decision does not intentionally or unintentionally limit access to future therapies,” Matthews said.
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CMS' proposal to limit coverage also got plenty of support, however. Some argued that the therapy was too expensive for full coverage considering the FDA approved it without definitive evidence of efficacy. Others said that patients need access to existing treatments now, but coverage should be restricted to ensure patients and their caregivers have a sound understanding of the benefits and risks. Still more commenters urged CMS to not cover Aduhelm and other mAbs at all and that the FDA should not have approved it in the first place.
The Indianapolis Big Pharma said last week during an earnings call that the completion of an accelerated approval application for donanemab would be pushed back to later this year in light of the CMS decision. The company is hoping to have some data on clinical efficacy available to support the application.
Matthews urged CMS to examine Lilly's therapy based on the evidence presented with the application for accelerated approval, rather than lumping it into a category and denying full coverage automatically.
Genentech echoed the concerns in support of its candidates gantenerumab and crenezumab. Similar to Lilly, Genentech wants to deliver on efficacy data to prove once and for all that the drugs work. Both candidates are in various stages of clinical testing, with gantenerumab leading the way. A critical readout for the therapy is expected in the second half of this year.
“We believe that by including anti-amyloid therapies still undergoing phase 3 clinical trials within the scope of this policy, CMS is jeopardizing individuals' access to products that may be approved in the future and that might be appropriate for their specific treatment needs, without even considering the evidence for those products,” wrote Genentech’s David Burt, executive director of federal government affairs.
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Genentech also noted that limiting coverage to just approved clinical trials will hamper the development of real-world evidence, which can inform future innovations. Burt argued that this will set back advancements in research and clinical practice in Alzheimer’s. Biogen and Eisai similarly argued this point in their comments.
Burt also noted that the restrictions will disadvantage people living in more rural areas or underserved communities. The types of trials that CMS is proposing to limit coverage to are traditionally conducted in urban academic medical centers that have long struggled to address diversity in clinical trials.
Eisai and Biogen also argued against the broad ban on the anti-amyloid mAbs class, both in an effort to rescue Aduhelm and for their next Alzheimer's candidate.
“In its current proposal, CMS would hold FDA-approved therapies for Alzheimer’s disease to a different standard than it has previously applied to therapies in any other disease states, including other accelerated approval drugs,” Biogen said.
Also backing up the individual Big Pharmas were the industry groups PhRMA and BIO, which represent pharmaceutical companies and biotechs, respectively.
“It is imperative that CMS does not worsen existing disparities in treatment for Alzheimer’s by limiting access to this class of treatments,” argued PhRMA, noting that the disease disproportionately affects Black Americans and Hispanics.
BIO, meanwhile, expressed a long-standing concern about CMS’ push to restrict coverage of new FDA-approved drugs and “impose new coverage barriers.”
CMS is expected to issue its final ruling in April.