Demand for Biogen’s (NSDQ:BIIB) monoclonal antibody Aduhelm (aducanumab) has been weak, leading the company to cut the wholesale cost of the drug in half to $28,200 for patients of average weight.
Now, Medicare officials reached a preliminary conclusion that federal coverage of the drug should be limited to clinical trial participants.
The agency went further, stating that coverage of the broader class of monoclonal antibodies targeting amyloid for Alzheimer’s would be limited to CMS-approved randomized controlled trials and trials supported by the NIH.
RBC Capital Markets analyst Brian Abrahams concluded that the news could “effectively spell the end for Aduhelm.”
U.S. officials appear to not be convinced regarding the efficacy of the drug despite the FDA approval of it.
“This proposed decision will enable researchers to collect crucial data to evaluate the clinical benefits of these drugs,” wrote Dr. Richard J. Hodes, director of the National Institute on Aging at NIH, in a statement.
In its preliminary conclusion, CMS intends to lay the groundwork for “an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders,” said CMS Administrator Chiquita Brooks-LaSure in a statement. “Before finalizing this proposal, we will have more opportunities to hear from people with Medicare living with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia, their family members and caregivers, as well as many other stakeholders, including patient advocacy groups, medical experts, states, payers, and industry professionals.”
Last week, Bloomberg published an op-ed recommending Medicare coverage of Aduhelm be constrained to clinical trial participants.
The Alzheimer’s Association railed against the decision. “CMS must change this draft decision. They must ensure equitable access for all who could benefit from FDA-approved treatments,” said Harry Johns, Alzheimer’s Association CEO, in a statement. “The Alzheimer’s Association calls on CMS to not only listen, but hear the needs of people living with dementia and their caregivers.”
In after-hours trading, BIIB shares fell 6.97% to $241.52. The stock is now trading lower than it was a year ago. BIIB shares were valued at $267.39 on Jan. 12, 2021, hitting a high of $414.71 on July 10, 2021. On Jan. 12, 2022, BIIB shares tumbled 7.31% to $223.86.
In advance of the Medicare decision, Biogen announced that it would host an analyst Q&A call on Jan. 13, 2022, at 8 a.m. ET.
Biogen released a statement saying that Medicare’s decision “denies the daily burden of people living with Alzheimer’s disease,” excluding “almost all patients who may benefit.”
CMS will open a 30-day public comment to obtain feedback regarding the preliminary decision.
CMS intends to reach its final decision by April 11, 2022.
Last year, an FDA advisory panel recommended against FDA approval of the drug. After the agency decided to conditionally approve aducanumab anyway, three of the committee members resigned.
Filed Under: Neurological Disease
