Access to Early Alzheimer's Treatments Limited by Payer Restrictions Despite FDA Approval
Key Insights
Medicare and other payers are creating barriers to access for FDA-approved early Alzheimer's treatments like Leqembi and Kisunla, despite their potential to delay disease progression.
The Centers for Medicare & Medicaid Services (search) (CMS) requires beneficiaries to enroll in clinical studies (Coverage with Evidence Development, CED) to access these therapies, limiting access.
TRICARE and private insurers like Cigna are also denying coverage, deeming the treatments "experimental" despite FDA approval, further restricting patient access.
The availability of new treatments for early Alzheimer's disease (search), such as Leqembi and Kisunla, is being hampered by restrictive coverage policies from Medicare and other payers in the United States, mirroring challenges seen in other countries like the United Kingdom. These restrictions are impacting access for the approximately 85% of patients who receive initial dementia diagnoses from geriatricians, family doctors, and primary care physicians.
Coverage with Evidence Development (CED) Policy
For over two years, Medicare has implemented a Coverage with Evidence Development (CED) policy, mandating that beneficiaries participate in clinical studies to gain access to these early Alzheimer's therapies. This policy imposes strict eligibility criteria on healthcare professionals and hospitals, resulting in limited access for Medicare beneficiaries, with communities of color often underrepresented in the required studies. A February 2023 report detailed the failures of CED in yielding meaningful evidence development or expanding timely access, yet CMS applied the policy to Alzheimer's medications in April 2022, marking the first time CED was applied to an on-label use of an FDA-approved drug.
Payer Restrictions and Their Impact
Other public and private payers have followed CMS's lead. TRICARE is denying beneficiary access to Leqembi, Kisunla, and all future drugs in the same class. Cigna has labeled Leqembi and Kisunla as "experimental, investigational, or unproven," denying coverage despite FDA approval. These coverage denials and complex guidelines deter utilization, limiting patient access to potentially beneficial treatments.
Clinical Benefits and Cost Considerations
Clinical trials of Leqembi and Kisunla have demonstrated effectiveness in delaying disease progression. A recent study modeled long-term scenarios and found that starting treatments in the early symptomatic stages of Alzheimer's could delay severe dementia by four to seven months, potentially up to two to four years. This delay is crucial for individuals in the early stages of the disease, as cognitive function and the ability to care for oneself gradually decline.
Despite the relatively low risk of side effects associated with Leqembi compared to other treatments like cancer drugs, Alzheimer's disease (search) remains underdiagnosed and undertreated, particularly among older adults. The annual list price for Leqembi, $26,500, has faced scrutiny, with CMS officials projecting inflated cost estimates. For example, CMS estimated Leqembi costs at $3.5 billion for 2025, a 536% increase from $550 million in 2024, implying a significant increase in the number of patients receiving the drug.
Medicare's Payment Policies
Medicare's payment policies further compound the issue. Medicare Part B pays clinicians 6% of the list price to administer medications. This creates a financial incentive for infusion centers to prioritize more expensive drugs, potentially placing early Alzheimer's disease (search) patients on waiting lists behind cancer patients receiving more lucrative CAR-T therapies. The combined impact of Medicare's CED policy and Part B payment scheme disadvantages Alzheimer's patients.
Call for Action
Ultimately, Medicare beneficiaries with early Alzheimer's are bearing the brunt of these restrictive policies. Treatments that could delay disease progression are available but remain out of reach due to Medicare's CED policy. There is a growing call for members of Congress to examine CMS's abuse of CED and oppose efforts to expand or codify it, especially in light of the Supreme Court's decision in Loper Bright Enterprises v. Raimondo, which eliminated the deference previously granted to CMS in its interpretation of Medicare law.