Aduhelm, the new Alzheimer’s drug, has a $56,000 per year price, but Medicare has launched a formal process to determine if it will include it in coverage. A final decision is not anticipated to be met until the Spring of 2022 from the Centers for Medicare and Medicaid Services (CMS), but a ruling could come as early as six months from now. A case-by-case determination will impact whether or not the drug will receive coverage.
Administrator of CMS, Chiquita Brooks-LaSure, says of the evaluation, “We want to consider Medicare coverage of new treatments very carefully in light of the evidence available…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.”
The investigation is currently in its 30-day public commentary period, which will be followed by two hearings to evaluate a wide range of opinions of Aduhelm’s approval. The decision will likely be determined by evidence that meets legal requirements for services and medications for the drug to be reasonable for diagnosis and treatment of illness.
The drug is on an Accelerated Approval Program, which allows drugs that treat serious conditions and fill an unmet medical need to be approved at a faster rate. Studies are still required from drug companies to assess their clinical benefit, which unfolds in a series of four phases in confirmatory trials. If the drug does provide clinical benefit, the FDA typically approves the drug.