Alzheimer’s experts are warning against the Centers for Medicare and Medicaid Service (CMS)’s recent decision to restrict coverage of the first FDA-approved Alzheimer’s treatment, Aduhelm, saying it is “highly disappointing”, and worry it will “affect the exploration for new treatments for Alzheimer’s for years.”
Because of CMS’s severe restrictions, coverage for treatments that receive FDA’s gold standard of approval is still not guaranteed, putting the future of medical innovation at risk.
One medical company has already slowed its timeline of its experimental Alzheimer’s drug, which is terrible news for Alzheimer’s patients and those with other neurological or medical conditions such as Down Syndrome.
For the millions of Americans living with Alzheimer’s and their families, this is a devastating decision that could mean less exploration for new treatments:
- “CMS officials disagree with the FDA’s reasoning, and are likely worried about the cost of covering a medication for hundreds of thousands of beneficiaries who might seek the treatment if it was broadly covered by Medicare. While CMS’s concern for taxpayers is understandable, it’s the FDA — not CMS — that has the statutory authority and deep medical expertise to assess a drug for approval. And Aduhelm passed the FDA’s assessment.”
- “CMS arguably overstepped the bounds of its authority. Its decision is a huge blow to millions of Americans living with Alzheimer’s and their families. They are the losers in CMS’s decision, not only from the severe restriction on access to Aduhelm but also from its chilling effect on the development of other disease-modifying agents for people with Alzheimer’s. If CMS won’t pay for a treatment after the FDA legally approves it, why should a company bother pursuing this pathway?”
CLICK HERE to read the full op-ed.
“This overreach means an entire class of cures may never make it to market,” Ways and Means Republican Leader Rep. Kevin Brady (R-TX) and Energy and Commerce Republican Leader Rep. Cathy McMorris Rodgers (R-WA) cautioned in a joint statement.
Ways and Means Republicans recently examined the devastating decision by Democrats to deny coverage for cures and treatments, and to find solutions to lower costs for patients without sacrificing cures.