CMS copies Aduhelm coverage plan for newly approved Alzheimer's drug

CMS said Feb. 22 it "is not reconsidering" its coverage plan for Alzheimer's drugs that target amyloids — meaning its Aduhelm-era decision will stay true for Leqembi.

The FDA approved Leqembi (lecanemab) on Jan. 6 — its third Alzheimer's drug approval in 30 years. Its predecessor became a blunder. 

Aduhelm, Biogen's other FDA-approved Alzheimer's drug, was swept into controversy amid questions of its overall efficacy and wide-label approval, which preceded the drugmaker CEO's resignation and a congressional report blaming both Biogen and the FDA.

CMS said in April 2022 that it would limit Aduhelm coverage to clinical trials only, which partly blocked the drugmaker's efforts to sell the drug it once deemed a blockbuster. Leqembi will be subject to the same coverage plan. 

"We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable," CMS said in a Feb. 22 statement. "After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration."

If "any new evidence" becomes available or an amyloid-targeting Alzheimer's drug receives traditional approval, CMS said it may reconsider its coverage decision.  

Here a four other notes about the newly approved drug:

1. Because of Leqembi's limited label use to early Alzheimer's stages, 1.5 million of the 6 million Americans with Alzheimer's could be eligible for the drug, according to The The New York Times

2. Based on its value and clinical benefit, Eisai — the drug's co-sponsor — said it will price an annual supply of Leqembi at $26,500, which equals a 200 milligram vial priced at $254.81 and a 500 milligram vial at $637.02. 

The cost is above what the Institute for Clinical and Economic Review listed it as: ICER said the product's "cost-effectiveness threshold" is between $8,500 and $20,600 for a year's supply.

3. The monoclonal antibody, which is intended to be infused every two weeks and be paired with frequent MRI scans in the first few months, noted a 27 percent slower cognitive decline in a phase 3 study. Three of the 2,000-plus study participants have died, but Biogen and Eisai have said the deaths aren't tied to Leqembi. 

4. The FDA approved Leqembi based on results from its phase 2 trial of 856 people with Alzheimer's disease.

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