CMS Aduhelm Decision Would “Significantly” Limit Anti-Amyloid Antibody Drugs

Under the proposed rule, CMS would cover Aduhelm and other monoclonal antibodies for Alzheimer’s disease patients only if they are participating in approved clinical trials.

The Centers for Medicare and Medicaid Service’s (CMS) preliminary decision to only cover Biogen’s Aduhelm (aducanumab-avwa) for patients in clinical trials is “arbitrary and capricious” and would significantly limit and delay coverage for the entire anti-amyloid antibody class, Biogen said in new comments submitted to the agency.

Under the proposed rule, CMS would cover Aduhelm and other monoclonal antibodies for Alzheimer’s disease patients only if they are participating in approved clinical trials.

In comments submitted to CMS, Priya Singhal, Biogen’s head of Research and Development, called the agency’s draft decision “arbitrary and capricious.”

The decision “does not consider the burden and harm of its proposed policy – including the effective denial of treatment to all but a few thousand Alzheimer’s disease patients for an unlimited period of time,” Singhal wrote.

The Alzheimer’s community has waited years for advances in therapies, Singhal wrote. “Confining coverage to beneficiaries enrolled in RCTs will effectively deny access for the vast majority of patients with Alzheimer’s Disease to the first FDA-approved treatment for Alzheimer’s disease in 20 years and…will not support generation of new data beyond existing efforts,” Singhal wrote.

“Narrow and complex coverage requirements that do not take into consideration a rapidly evolving clinical landscape could have the potential to stifle innovation and inappropriately limit access for beneficiaries living with Alzheimer’s disease today and in the future,” Singhal added.

In addition, CMS’s proposal effectively limits enrollment in the clinical trials to relatively healthy beneficiaries without disqualifying comorbidities, according to Singhal. “As such, the proposed CED would exclude many beneficiaries who would not meet the CED-compliant RCT criteria. Unfortunately, the draft coverage decision doesn’t explain how it would assure sufficient or equitable enrollment in the required trials given these limitations.”

Rose Joachim, pharma analyst at GlobalData, previously said in a statement that CMS’s decision will greatly hamper sales of the controversial Alzheimer's treatment drug.

“CMS’s decision to limit Medicare reimbursement of anti-amyloid mAb products to AD patients participating in randomized controlled trials (RCTs) will significantly delay and limit patient access to these products in the near term, with Biogen’s Aduhelm likely bearing the brunt of these troubles,” Joachim said.

Based on Aduhelm’s modest uptake, as well as Biogen's decision to cut the price of the drug by half, GlobalData estimates Aduhelm’s sales to reach $906.1 million in 2028— only a quarter of the sales GlobalData had previously forecast for that year.