
US starts national Medicare review for Biogen’s Alzheimer’s drug
pharmafile | July 14, 2021 | News story | Research and Development |
The US government has started a review process for national Medicare coverage of Biogen’s controversial Alzheimer’s drug, Aduhelm, that was recently approved by the FDA, despite the panel unanimously voting against its approval.
Aduhelm is priced at $56,000 per year, which means it would require significant spending for the government’s Medicare program for people aged 65 and older.
The Centres for Medicare and Medicaid Services (CMS) expects to give a proposed decision within six months and a final decision within nine months.
Currently, coverage for the drug is determined at the local level by Medicare administrative contractors, who represent 12 jurisdictions across the country.
CMS’s coverage decisions are based on an analysis of the benefits of a given therapy to Medicare beneficiaries.
This news comes shortly after the FDA acting commissioner decided to commence a review of of the drug approval.
In a letter on 9 July, Acting Commissioner Janet Woodcock asked the Health and Human Services Inspector General to review interactions between Biogen executives and agency officials during the review process, and to determine whether those contacts violated FDA rules.
There is also significant doubt amongst experts as to whether Aduhelm actually works, and Biogen recently amended their guidance on who is eligible for the drug.
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