Medicare Rolls Out Alzheimer Patient Registry After FDA Approval

The Medicare agency officially launched its patient registry for the Alzheimer’s drug Leqembi on Thursday just minutes after the FDA granted traditional approval for the infusion therapy.

The Center for Medicare & Medicaid Services will now cover Eisai Co. and Biogen Inc.’s Leqembi for patients with a prescriber or clinical team participating in a patient registry, widening coverage for the drug that costs $26,500 for annual treatment. The agency had promised to expand coverage immediately after the Food and Drug Administration converted Leqembi’s approval from accelerated to traditional. The CMS previously only covered the drug for patients in clinical trials, citing the need for additional research on the amyloid-targeting treatment’s safety and efficacy.

Patients eligible to participate in the registry include Part B beneficiaries diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s disease. The registry will require providers to submit information on a patient’s clinical diagnosis, results from amyloid tests, and evidence of adverse events such as brain swelling or hemorrhage, among other facts.

Consistent with the CMS’ national coverage determination, Medicare will cover the drug when a physician and clinical team participate in the registry, designed to collect evidence about how the drug works in the real world.

“CMS today affirms our commitment to help people with Alzheimer’s disease have timely access to innovative treatments that may lead to improved care and better outcomes,” CMS Administrator Chiquita Brooks-LaSure said in a statement.

The registry also includes questions on whether the patient takes anticoagulants. The FDA’s approval Thursday includes prescribing information recommending caution when considering use of Leqembi in patients taking blood thinners or with other risk factors for intracerebral hemorrhage.

The drug’s label also includes a prominent black-box warning about the potential for swelling and bleeding in the brain, and notes patients with a certain gene mutation called APOE4 have a higher risk of such side effects.