The Centers for Medicare & Medicaid Services announced Thursday a plan to cover a new class of Alzheimer’s disease drugs if they receive full approval from the US Food and Drug Administration – and with some limitations.
Alzheimer’s drugs that slow the progression of cognitive decline will be covered by Medicare as long as they’ve received traditional approval from the FDA and the clinical team gathers data for a registry of how the drugs work in the real world, CMS said.
“If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered,” CMS Administrator Chiquita Brooks-LaSure said in a statement.
CMS said there’s “strong precedent” for using registries to gather more information on a newly approved treatments.
The Alzheimer’s Association criticized the use of a registry, saying in a statement that it creates “an unnecessary barrier” and “should not be a requirement for coverage of a FDA-approved treatment.”
The pharmaceutical trade group PhRMA agreed, saying in its statement that “CMS is reaffirming their plan to severely restrict patient access.”
“Requiring use of a registry to receive these important treatment options significantly constrains access. For one, not all patients will be able or willing to participate in a such a registry,” the group says. “Additionally, patients can’t access treatments through any and every provider if they are required to participate in a registry, which means seniors seeking to access these treatments will potentially have to travel to a new provider to be treated.”
The FDA has granted accelerated approval to the Alzheimer’s medications lecanemab, marketed as Leqembi, and Aduhelm. The accelerated approval program is meant to fast-track drugs to “fill an unmet medical need,” even as the drugmakers continue clinical research to determine the drug’s effectiveness. Neither has received traditional approval.
Medicare restricted coverage of Aduhelm to those enrolled in qualifying clinical trials last year, saying at the time that the “significant of serious unknown factors could result in harm.”
Alzheimer’s disease is the most common form of dementia, which is a general term for the loss of memory and intellectual abilities. The US Centers for Disease Control and Prevention estimates that about 6 million people are living with the disease. Alzheimer’s disease is fatal, and there is no cure. It is a slow-moving disease that starts with memory loss and ends with severe brain damage.