Questions linger around how many patients will be able to access the drug with limited coverage from Medicare.
Now, the question becomes how many people will be able to access the drug, which is targeted at patients in the early stages of the debilitating disease. Medicare has said that it will reimburse the drug’s costs — more than $26,000 annually — only for beneficiaries enrolled in a nationwide registry that tracks patient side effects and outcomes over time.
The agency previously granted Leqembi, developed and manufactured by Eisai and Biogen, accelerated approval before evaluating late-stage clinical trial data earlier this year. The drug moderately slowed trial participants’ cognitive decline compared to a placebo, according to the data, but had potentially serious side effects, including brain swelling and bleeding.
Under accelerated approval, the Centers for Medicare and Medicaid Services said it would cover Leqembi only for those participating in a randomized clinical trial, of which none were enrolling. Medicare’s coverage determination was contrary to the Veterans Health Administration, which saidRoughly 6.7 million people in the U.S. have Alzheimer’s, and there are few treatments for the disease.
Lawmakers and advocacy groups have pressed CMS to reduce or eliminate coverage restrictions for Leqembi and drugs like it to ensure maximum patient uptake. In June, CMS said that it would make aon its website, and that it would ask physicians only for basic information about patients’ that they would typically collect — such as whether the patient is taking certain drugs that could increase the risk of side effects and how a patient’s cognition progresses over time.
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