The drug is intended for Alzheimer's patients in the early stages of the disease and will be limited to Medicare recipients who are participating in studies by the National Institutes of Health or in approved clinical trials, the Centers for Medicare and Medicaid Services said.
The drug is the first treatment approved in the country to slow cognitive decline in those living with the progressive disease. However, medical experts and doctors have refused to prescribe it given the lack of data and evidence about whether it actually slows memory loss.
Given the number of people who might qualify for the drug, health care officials were concerned it could strain Medicare's budget. Anticipation of the drug's costs, following a broad CMS coverage decision, led Medicare to increase premiums for this year.
"CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders," CMS Administrator Chiquita Brooks-LaSure said in a statement.
A final decision on the proposal is expected by April
The agency will accept public comments for 30 days, in hopes of hearing from Americans with Alzheimer's, their family members and caregivers, patient advocacy groups, medical experts and others. A final decision is expected by April 11.
News of the drug's coverage comes a day after Health and Human Services Secretary Xavier Becerra instructed CMS to reassess the recommendation for the 2022 Medicare Part B premium, given the dramatic price change of Aduhelm to $28,200 a year.
"With the 50% price drop of Aduhelm on January 1, there is a compelling basis for CMS to reexamine the previous recommendation," Becerra said in a statement.
Aduhelm is the first drug on the market able to remove amyloid, the sticky substance that builds up in the brains of Alzheimer's patients. It's also the first new Alzheimer's drug approved since 2003.
The Food and Drug Administration granted conditional approval of the drug last year — even though an advisory panel had recommended against allowing the drug on the market.
Since the drug's approval last year, sales have been much slower than many analysts expected. Biogen reported that in the three months following its approval in June 2021, Aduhelm brought in $300,000 — a very low number for the drug with a previous price tag of close to $60,000 a year.
When it comes to the drug, Atri added, "I think we need to figure out a way to present that option to [patients] in a way that's safe."