The Centers for Medicare & Medicaid Services intends to evaluate and determine whether to cover Biogen’s new Alzheimer medication. However, the economic advantage of the medication currently unexplained. Its high price – $56,000 – might, without saying so, boost Medicare expenditure.
- The efficacy of the drug: The drug, which is only intended for patients with mild forms of the neurodegenerative disorder target 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 build-up of this protein will improve disease outcomes. The confirmatory clinical trial for the drug could take another eight years to complete.
- Treatment coverage: “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.”
- Scientific evidence: 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.
- Expenditure: 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.
- Global research: 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.”