Analyst: CMS Decision Will “Significantly Limit" Biogen’s Aduhelm

CMS has proposed covering the anti-amyloid treatment only if the person taking it is enrolled in a clinical trial.

The Centers for Medicare and Medicaid Service’s (CMS) preliminary decision to only cover Biogen’s Aduhelm (aducanumab-avwa) with significant restrictions will greatly hamper sales of the controversial Alzheimer's treatment drug , according to an analyst.

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. That limitation could significantly limit access, said Rose Joachim, pharma analyst at GlobalData, in a statement.

“The Centers for Medicare & Medicaid Services (CMS) proposes to cover FDA approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (AD) under Coverage with Evidence Development (CED) in CMS approved randomized controlled trials…and in trials supported by the National Institutes of Health (NIH),” CMS said in the notice about the proposed coverage decision. . “All trials must be conducted in a hospital-based outpatient setting.”

“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.

Biogen executives are also concerned about the CMS decision, which denies “nearly all Medicare beneficiaries from accessing Aduhelm….as well as future amyloid-directed therapies,” Biogen said in a statement.

“It is imperative to change this draft decision to be aligned with reimbursement for other therapies for progressive diseases, where patients have immediate and equal access to medicines approved by the FDA,” Biogen said. “It is urgent to act. Thousands of patients progress each day from mild to moderate disease stages, where treatment may potentially no longer be an option.”

If CMS continues to require a RCT when it issues a final decision in April, it would likely take in excess of a year to begin enrolling patients, further delaying reimbursement for Medicare beneficiaries, Biogen said.

“It is also particularly concerning that this draft implies that some Medicare beneficiaries will receive a placebo instead of a treatment they are seeking,” the pharma maker added.

Aduhelm has been extremely controversial since its approval earlier this year. In July, some Blues plans said they would not cover Aduhelm and the Veterans Administration followed suit in August.

UnitedHealth and Humana said earlier this year they were waiting on the CMS decision on Aduhelm before setting their coverage policies.

Despite Aduhelm’s first-to-market advantage, the months of controversy following the drug’s approval were a “major setback,” Joachim said. “While CMS’s preliminary decision is yet another blow for the drug, the guidance can still potentially change, with a final decision expected in April."