Medicare Coverage for Alzheimer’s Drugs: An Ever-Changing and Complex Outlook

Medicare Coverage for Alzheimer’s Treatments and Medications

As the number of Americans living with Alzheimer’s disease continues to rise, there is a growing need for treatments and medications that can slow the progression of the disease. However, determining whether Medicare covers these treatments can be complicated. Let’s explore the coverage options available for Alzheimer’s drugs under Medicare.

Medicare and Alzheimer’s Drugs

While there is currently no cure for Alzheimer’s disease, Medicare Part D prescription drug plans provide coverage for five medications that treat cognitive symptoms. These medications can help manage memory loss, language difficulties, and other cognitive impairments associated with the disease.

The three cholinesterase inhibitors covered by Medicare are Aricept, Exelon, and Razadyne. These drugs have been approved by the FDA for the treatment of Alzheimer’s disease and are prescribed to alleviate symptoms related to memory, language, judgment, and other cognitive processes. Aricept is approved for all stages of Alzheimer’s, while Exelon and Razadyne are approved for mild to moderate disease.

Medicare also covers Namenda and Namzaric, which are approved for moderate to severe Alzheimer’s disease. Namenda is a glutamate regulator, and Namzaric is a combination cholinesterase inhibitor and glutamate regulator. Both medications help improve memory, language, and the ability to perform simple tasks.

Medicare Coverage for Adulhelm and Leqembi

Adulhelm and Leqembi are new types of Alzheimer’s treatments that have garnered significant attention due to their potential to slow the progression of the disease. Adulhelm is an anti-amyloid, antibody intravenous (IV) infusion therapy for early Alzheimer’s, while Leqembi is a similar treatment for slowing Alzheimer’s.

Medicare’s coverage for Adulhelm has been a subject of debate and scrutiny. In June 2021, the FDA granted accelerated approval for Adulhelm, but Medicare’s coverage decision was more complex. Initially, Medicare decided to cover Adulhelm for beneficiaries with Medicare Part B who were enrolled in an approved clinical trial. However, this coverage decision drew criticism from the Alzheimer’s Association, which argued that it limited access to treatment for the majority of patients.

Furthermore, some health care providers, including Cleveland Clinic, Mass General Brigham, and Mount Sinai of New York City, chose not to administer Adulhelm due to concerns about safety and effectiveness.

When Medicare does cover Adulhelm, it pays 80% of the cost, with beneficiaries responsible for the remaining amount. The cost of Adulhelm can be significant, with the average out-of-pocket expense exceeding the out-of-pocket limit for Medicare Advantage plans.

In January 2023, Leqembi received accelerated approval from the FDA, and the Veterans Health Administration started covering it for certain veterans over 65 in March 2023. However, Medicare’s coverage for Leqembi is yet to be determined.

Medicare’s Coverage Rules and Future Considerations

Medicare’s coverage decisions for Alzheimer’s treatments continue to evolve. In early June, CMS announced that if the FDA grants traditional approval to drugs that slow the progression of Alzheimer’s, Medicare will cover the cost for qualifying beneficiaries who have a participating doctor registered in a special registry.

Critics argue that a registry may create barriers for patients, particularly those in rural and underserved areas. The Alzheimer’s Association and other advocacy groups contend that Medicare coverage should be accessible to all eligible beneficiaries without the need for a registry.

The FDA is expected to make a decision regarding full approval for Leqembi by July 6. Following the FDA’s decision, Medicare will determine whether and how it will cover Leqembi, as well as review its coverage rules for Adulhelm.

Public Opinion and Future Outlook

A recent poll revealed that nearly nine in 10 voters support requiring Medicare to cover the cost of FDA-approved drugs that can slow the progression of Alzheimer’s. This reflects the growing public demand for increased access to effective Alzheimer’s treatments.

In the coming months, Medicare will also evaluate coverage for Lilly’s donanemab, another drug that has shown clinical benefit for early Alzheimer’s patients. Clinical trials have demonstrated that donanemab can slow Alzheimer’s progression by 35% compared to a placebo.

While the future of Medicare coverage for Alzheimer’s treatments remains somewhat uncertain, there is a growing sense of optimism among advocates and patients. However, it’s essential to consider the financial implications of expanded coverage, as the cost of medications like Leqembi and Adulhelm could put a significant strain on Medicare.

Ultimately, the goal is to ensure that Medicare coverage for Alzheimer’s treatments is accessible, equitable, and based on sound medical evidence.

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