The Centers for Medicare & Medicaid Services announced Thursday that they will pay for any new Alzheimer’s drug that is approved by the Food and Drug Administration. However, physicians will be required to collect data about how the drugs work in real life.
CMS Administrator Chiquita. Brooks-LaSure announced the change in a press release. This is a victory for groups like the Alzheimer’s Association that had been seeking greater access to newer medications that showed signs of slowing down the progression of Alzheimer’s in clinical trials. Around 6.7 millions people aged 65 and older suffer from Alzheimer’s disease in the U.S. They could be eligible for Medicare coverage.
Brooks-LaSure, in a recent statement, said that Alzheimer’s affects not only the person suffering from it but also their family members and caregivers.
Medicare used to only pay for these drugs if the patient had participated in a clinical study. Two drugs were granted accelerated approval. Biogen’s Aduhelm, and Eisai’s Leqembi.
FDA says that drugs “that fill an unmet medical needs” are eligible for accelerated approval. To gain full approval the drugmakers must conduct additional clinical studies.
The FDA advisory committee will meet on June 9, where a panel of experts will vote whether or not to recommend full FDA approval for Leqembi.
The drug was shown to slow down the progression of Alzheimer’s disease when administered to people with mild cognitive impairment or at an early stage.
Most people cannot afford the medication because it costs $26,500 per year. If the FDA approves the traditional approval and the advisory committee meeting is successful, then people on Medicare will be able to obtain the drug under the new Medicare rules.
