The Centers for Medicare & Medicaid Services announced Thursday that they will fund new Alzheimer’s drugs that are fully approved by the Food and Drug Administration. However, doctors need to collect data on how well the drugs work in practice.
It is expected that more Alzheimer’s patients will be able to afford the new drugs.
The change, announced by CMS Administrator Chiquita Brooks-LaSure in a releaseis an asset to stakeholders, including the Alzheimer’s Association, seeking broader access to a newer class of drugs that clinical trials have shown evidence of slowing disease progression. Around 6.7 million people over the age of 65 have Alzheimer’s disease in the United States and may be eligible for Medicare coverage.
“Alzheimer’s disease takes a toll not only on those affected, but also on their families and caregivers in a way that few other diseases can match,” Brooks-LaSure said in a statement.
Previously, Medicare paid for these drugs — which received accelerated approval, known as accelerated approval — only if a patient was enrolled in a clinical trial. Two drugs have received accelerated approval: Biogen’s Aduhelm and Eisai’s Leqembi.
According to the FDA, the accelerated approval applies to drugs that “fill an unmet medical need”. In order to receive full approval, drug manufacturers must conduct additional clinical studies.
Doctors who prescribe the drugs must use a government registry to keep track of how well patients are doing. In a statement Thursday, the Alzheimer’s Association said requiring doctors to submit data to a registry was an “unnecessary hurdle.”
“We look forward to hearing more details from CMS and we are confident in the future of access to healthcare for our constituents,” the group said in a statement.
Thursday’s move comes ahead of an FDA advisory committee meeting on June 9, where an expert panel is expected to vote on whether the FDA should recommend full approval of Leqembi.
Clinical trials showed that the drug appeared to slow disease progression in people with early stages or with mild cognitive impairment.
The drug costs $26,500 per year, making it unaffordable for most people. But if the advisory committee meeting goes well and the FDA grants conventional approval, Medicare patients who need the drug should be able to get it under the new Medicare rules.Follow NBC HEALTH At Twitter & Facebook.