The Centers for Medicare & Medicaid Services plans to review Biogen’s new Alzheimer’s disease drug and decide whether to cover it. The expensive drug’s benefit, however, is still uncertain.
On Monday, CMS opened a National Coverage Determination analysis, the process through which the agency determines Medicare coverage, for Biogen’s Aduhelm, the first new treatment for Alzheimer’s disease in decades. The drug won FDA approval through an accelerated pathway in early June.
The drug, which is only intended for patients with mild forms of the neurodegenerative disorder, targets the plaques of amyloid protein on the brains of patients. But the specific role of amyloid protein in Alzheimer’s disease is still unclear, and thus, it is not known if clearing away the buildup of this protein will improve disease outcomes. The confirmatory clinical trial for the drug could take another eight years to complete.
Despite the lack of proven benefit, the drug will cary a wholesale price of $56,000.
CMS usually makes coverage decisions without taking cost into consideration, but the high price tag of Aduhelm could significantly drive up Medicare spending, according to a Kaiser Family Foundation report.
If even a quarter of the nearly 2 million Medicare beneficiaries that used one of the available Alzheimer’s treatments covered by CMS in 2017 were prescribed Aduhelm, the total spending for the new drug in one year alone would be nearly $29 billion, the report shows. Comparatively, total Medicare spending for all Part B drugs was $37 billion in 2019.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“We want to consider Medicare coverage of new treatments very carefully in light of the evidence available,” said CMS Administrator Chiquita Brooks-LaSure in a news release. “That’s why our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of those living with this disease.”
After CMS has completed the National Coverage Determination analysis, which includes an examination of scientific evidence and public comments, CMS will post a proposed determination, which will be open to a second 30-day public comment period. The agency is expected to post a proposed decision within six months and a final decision within nine.
The Alzheimer’s Association, a nonprofit focused on accelerating global research, driving early detection and maximizing quality care, met the news with applause.
“We welcome today’s announcement of a National Coverage Determination (NCD) analysis, consistent with the Alzheimer’s Association position,” the association said in a statement posted to its website. “An NCD would help prevent regional and community level disparities due to barriers that would be difficult to overcome, particularly by those who have greater challenges accessing healthcare services.”
In particular, the association supports an NCD outcome that includes “Coverage with Evidence Development” to ensure confirmatory data is collected in a timeframe that can inform “decision making by policymakers, payers, healthcare providers, and patients and their families.”
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