In a groundbreaking move, the Centers for Medicare and Medicaid Services (CMS) has announced its plans to offer Medicare coverage for Alzheimer-slowing drugs. This coverage is contingent upon these drugs receiving traditional approval from the Food and Drug Administration (FDA).
The move comes at a time when the global market for Alzheimer’s disease treatments is set to surpass a staggering $13 billion by 2030, largely due to the advent of groundbreaking therapies. Among the medications under consideration are Eisai’s Leqembi and Eli Lilly’s Donanemab, both of which are promising Alzheimer’s treatments set for review by the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
If FDA approval is secured, Medicare coverage for both will start immediately. This policy will also be applicable to other medications in the same class that gain FDA approval.
While the earlier approval of the Alzheimer’s treatment Aduhelm was surrounded by controversy, both Leqembi and Donanemab have demonstrated promising results in Phase III clinical trials. Both are predicted to be top-selling Alzheimer’s drugs by 2030.
One of the conditions of the CMS’ new policy is that physicians and clinical teams must participate in a registry that will gather real-world evidence regarding the efficacy of these drugs. The data is to be submitted through a CMS-facilitated nationwide portal. It is hoped that it will provide new avenues for researchers to study the potential benefits of these drugs. The CMS is also coordinating efforts with organizations planning to launch their own registries.
In the interest of protecting sensitive information, the CMS has ensured that the data collection process for this registry will strictly adhere to federal laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA).
To qualify for this Medicare coverage, individuals must be:
- Enrolled in Medicare Part B
- Diagnosed with mild cognitive impairment or early dementia due to Alzheimer’s
- Under the care of a physician participating in the registry along with a dedicated clinical team for follow-up care
Once Medicare coverage for these new Alzheimer’s treatments is made available, it may prompt private health insurers and employers to follow suit by including these drugs in their benefit plans, broadening the availability and accessibility of these potentially life-changing treatments.
Experience Care will continue to keep readers updated on this topic.
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