Bipartisan Effort Urges CMS to Allow Access to Alzheimer's Treatments

Strategic Insights -

Over 45 U.S. representatives, led by Illinois Rep. Darin LaHood and New York Rep. Paul Tonko, are pushing the Centers for Medicare and Medicaid Services (CMS) to reconsider restrictions on access to FDA-approved treatments for early-stage Alzheimer's disease. The treatments, which have been shown to slow cognitive decline, are currently not available to Medicare beneficiaries due to the agency's coverage decision.

Key Takeaways:

  • The letter was signed by over 45 U.S. representatives, including Reps. Darin LaHood (IL-16) and Paul Tonko (NY-20), and urges CMS to reconsider the Coverage with Evidence Development (CED) requirements for FDA-approved monoclonal antibodies (mAbs) directed against amyloid for the treatment of Alzheimer's disease (AD).
  • The members express concern that the CED requirements have effectively prevented Medicare beneficiaries from accessing these therapies, resulting in significant access delays and irreversible disease progression for those living with Alzheimer's.
  • The Alzheimer's Association's Chief Public Policy Officer, Robert Egge, expressed support for the effort, stating that individuals living with early Alzheimer's deserve access to these treatments without barriers.
  • The letter highlights substantial new evidence published since the finalization of the National Coverage Determination (NCD) that warrants a reconsideration of the CED requirements.
  • The representatives request that CMS provide answers to several questions regarding the development of a registry for access to mAbs approved by the FDA under the traditional approval pathway.
  • The CMS standard for determining what treatments are "reasonable and necessary" for the Medicare population has been questioned, with representatives asking why CMS has held Alzheimer's treatments to a different standard than other diseases.

Statistics:

  • Over 6 million Americans are living with Alzheimer's disease (AD), and their families are facing significant access delays to FDA-approved treatments despite the progressive nature of this terminal disease.
  • It is estimated that treating Alzheimer's disease could provide patients with more time to participate in daily life, live independently, and have many more months of patients recognizing their loved ones.
  • The Phase 3 trial of Leqembi (lecanemab), a mAb for the treatment of mild cognitive impairment due to AD and early-stage AD, showed positive results in November 2022.

Sources:

  • Rep. Darin LaHood's office statement: U.S. Representatives Darin LaHood (IL-16) and Paul Tonko (NY-20) led a follow-up letter with over 45 colleagues to the Secretary of Health and Human Services (HHS) Xavier Becerra and the Administrator of the Centers for Medicare and Medicaid Services (CMS) Chiquita Brooks-LaSure.
  • Alzheimer's Association's statement: Robert Egge, Alzheimer's Association Chief Public Policy Officer and Alzheimer's Impact Movement (AIM) Executive Director, expressed support for the bipartisan effort.
  • June 16, 2023 letter from Reps. LaHood and Tonko to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure: U.S. Representatives Darin LaHood (IL-16) and Paul Tonko (NY-20), et al.