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CMS Expands Leqembi Coverage After FDA’s Full Approval

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Medicare will cover Alzheimer’s drugs with full approval, including Leqembi — if the physician and patient participate in a real-world registry trial to gather additional data.

The Centers for Medicare & Medicaid Services announced that broader Medicare coverage is now available for the Alzheimer’s disease treatment Leqembi (lecanemab-irmb) after the FDA granted traditional approval. Now that the FDA has granted traditional approval, a CMS-facilitated registry is open for clinicians.

Leqembi had been granted accelerated approval in January 2023 and launched with a list price of $26,500 a year. CMS indicated that now that there is full approval, patients with original Medicare will pay a 20% coinsurance once they meet their Part B deductible. CMS has provided a new HCPCS claim code (Leqembi J0174) and requests that claims be submitted after July 25, 2023.

People enrolled in Medicare supplemental coverage (like a Medigap plan) or other secondary insurance, or those enrolled in a Medicare Advantage plan will be covered under those policies.

Leqembi is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in Alzheimer’s disease. The full approval was based on data from the phase 3 confirmatory Clarity AD clinical trial. In this study, Leqembi reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months.

Howard Fillit, M.D.

Howard Fillit, M.D.

“The approval of Leqembi will serve as a catalyst for driving further developments and investments in the Alzheimer’s pipeline,” Howard Fillit, M.D., co-founder and chief science officer of The Alzheimer’s Drug Discovery Foundation (ADDF) said in a statement. “We finally have clarity around amyloid’s modest effect on cognitive decline. Now, it is more important than ever to double down and widen our focus to developing the next generation of drugs based on the biology of aging that can lead to a combination therapy and precision medicine approach.”

The FDA also provided a warning on the drug’s label for patients and caregivers on the potential risks associated with amyloid-related imaging abnormalities (ARIA).

Eisai continues to work to “create broad and simple access to Leqembi for patients and to support diagnosis and treatment at the early stage of the disease,” Haruo Naito, chief executive officer at Eisai, said in a press release. Eisai has also established a patient assistance program to provide Leqembi at no cost for eligible uninsured and underinsured patients, including Medicare beneficiaries, who meet financial need and other program criteria. Additionally, Eisai provides patient navigators to help patients and their families understand their insurance coverage and options.

FDA accepted Eisai’s supplemental biologics license application (sBLA) for Leqembi in March under priority review.

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