The estimated cost of treating the average person with early Alzheimer’s disease in the U.S. with Leqembi for a year totals $26,500, according to Eisai, the drug’s manufacturer. Additional costs include a positron emission tomography (PET) scan or cerebrospinal fluid (CFS) test to identify amyloid plaques on the brain, as well as any other tests or clinical costs required by a health care provider.
Medicare currently covers only one PET scan for dementia per lifetime. Furthermore, coverage is limited to those involved in a “coverage with evidence development” (CED) Medicare registry, such as the one required for Leqembi coverage. However, the Centers for Medicare and Medicaid Services (CMS) is considering removing that limitation to allow more affordable access to tests needed to prescribe Leqembi.
How to Pay for Leqembi
One’s health insurance provider may cover Leqembi, depending on the specifics of their plan’s benefits. Medicare, Medicare Advantage and Medicare Supplement plans may cover all or part of the cost of Leqembi. People with Medicare Part B who don’t have supplemental coverage (such as a Medicare Advantage or Medigap plan) pay a 20% coinsurance cost after meeting their annual deductible.
However, Medicare beneficiaries must meet the following requirements to receive coverage under Medicare’s CED rules:
- They must be currently enrolled in Medicare.
- They must be diagnosed with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia.
- They must have a physician who participates in a CMS-facilitated CED registry and manages an appropriate clinical team to provide follow-up care.
Medicaid also covers Leqembi when it’s prescribed for a medically accepted indication. Unlike Medicare, Medicaid doesn’t have a CED registry requirement.
Medicare uses the CED registry to continue gathering data and evidence of Leqembi’s efficacy. However, the CED registry system could delay coverage and care for those who need the treatment, says Sue Peschin, president and CEO of the Alliance for Aging Research.
“The coverage criteria has some very specific requirements around the types of facilities and the types of medical teams that can participate,” says Peschin. “So there may be workforce issues. There may be issues with the number of specialists available.”
The Bureau of Labor Statistics estimates that there are currently about 11,000 neurologists in the U.S. However, there’s a shortage of neurologists in rural areas and for underserved populations.
Peschin says neurology access is underutilized by poorer, underserved communities—particularly in communities of color—even in urban areas. “So there are significant equity issues with CED registries as well,” she adds.
Peschin isn’t the only voice of dissent with the CED coverage requirement.
“Given the progressive nature of Alzheimer’s disease, early access to disease-modifying therapy is crucial,” wrote Joanne Pike, president and CEO of the Alzheimer’s Association, in a December 2022 letter to CMS urging the department to revise its CED requirements.
”Processes that may delay coverage decisions by several months can impose significant access delays, resulting in irreversible disease progression for beneficiaries living with Alzheimer’s [disease] and added burdens for their caregivers and loved ones,” she added.
Despite concerns regarding the CED registry, Dr. Pascual-Leone insists it’s a necessary tool to track results from Leqembi and learn more about the medication.
“A registry is extremely powerful because it allows us to gather a lot of data in a very short period of time and not rely on anecdotes but on scientific evidence,” says Dr. Pascual-Leone.