After the Centers for Medicare & Medicaid Services (CMS) proposed to limit coverage of Biogen’s Alzheimer’s disease drug Aduhelm to patients in approved clinical trials, the company and its partner Eisai have made their dissent official.
Biogen and Eisai on Thursday submitted formal comments to CMS in opposition of the centers’ draft coverage. The proposal, rolled out in January, “could effectively spell the end for Aduhelm,” RBC Capital Markets’ Brian Abrahams wrote in a note to clients last month.
A so-called coverage with evidence development (CED) policy, like the one CMS has proposed, would “significantly” limit and delay coverage for the anti-amyloid antibody class, Biogen argued. It would also place a “major burden” on providers, patients and CMS. The proposal, or any other CED, Biogen says, would also undermine the generation of new data that are required as part of Aduhelm's accelerated approval from the FDA.
The company said that generating real-world evidence on the med's risks and benefits "will only be possible if CMS provides coverage for Aduhelm … outside of a CED paradigm."
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Further, Biogen says restricting coverage to people enrolled in randomized clinical trials would deny “almost all Medicare beneficiaries access to Aduhelm” and other, future amyloid-directed antibodies. Alzheimer’s is a progressive disease, and delays in treatment access are “highly detrimental” to patients, the company explained.
Biogen also argued that the coverage proposal “mischaracterizes” existing data on amyloid-directed mAbs, “and Aduhelm specifically.”
“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 state, including other accelerated approval drugs,” Biogen said. Therefore, the company wants CMS to “reverse its position and issue a final NCD that provides coverage for FDA-approved uses of amyloid-directed mAbs."
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CMS’ final decision is expected in April. If the agency upholds its draft proposal, the Biogen launch would face a serious bottleneck as just a few thousand patients would likely be eligible for commercial therapy. Previously, Biogen has said that about 50,000 patients could begin treatment in 2022.
Biogen and Eisai aren’t the only ones up in arms about CMS’ decision. This week, a group of House Republicans, led by Cathy McMorris Rodgers, urged Department of Health and Human Services Secretary Xavier Becerra to “abandon and re-propose” CMS’ draft coverage. Meanwhile, more than 50 patient advocacy groups voiced their opposition in a letter to Becerra this week.
Aside from Aduhelm, Eli Lilly is advancing its own anti-amyloid antibody donanemab. Lilly now expects to complete its rolling application for that med sometime this year. The plan had originally been to complete the submission in the first quarter, but CMS’ decision prompted a change in strategy, Lilly’s chief scientific and medical officer, Dan Skovronsky, M.D., Ph.D., said on a recent earnings call.