Medicare will cover drugs to treat Alzheimer's disease if they receive full FDA approval, the agency said June 1.
Though the agency plans to expand coverage, it will require physicians and clinicians to report "evidence about how these drugs work in the real world" to a registry, according to a June 1 CMS news release.
The policy is in-line with previous CMS guidance. The agency currently covers the pricey Alzheimer's treatments for patients participating in a clinical trial.
The FDA is expected to issue a full approval of Leqembi, Eisai and Biogen's medication targeting amyloid plaques in the brain, in the coming weeks.
"If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered. I'm pleased to make this announcement today as part of CMS' mission to help improve the lives of Americans we serve," CMS Administrator Chiquita Brooks-LaSure said in the release.
"I hope we see more private sector partners in this work making their own announcements soon," Ms. Brooks-LaSure added in the news release.
Since June 2022, most UnitedHealthcare plans have covered Aduhelm, Biogen's Alzhemier's treatment drug, only for patients in clinical trials who have received prior authorization. In September, Aetna said it would cover the drug if certain criteria are met, including obtaining prior authorization and receiving a prescription from a gerontologist, neurologist, psychiatrist or neuropsychiatrist.
Investigators have questioned Aduhelm's safety and efficacy, leading to the resignation of Biogen's CEO and a congressional report blaming the drug maker and FDA for a hasty approval process.
Leqembi could cost Medicare between $2 billion and $5 billion annually, according to a report in JAMA Internal Medicine.