Bipartisan Senators Urge CMS to Expand Access to Alzheimer's Treatments

Strategic Insights -

U.S. Senators Shelley Moore Capito (R-W.Va.) and Susan Collins (R-Maine) led a bipartisan group of 20 senators in sending a letter to the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) urging CMS to reconsider the Coverage with Evidence Development (CED) requirements for FDA-approved monoclonal antibodies treating Alzheimer's disease. The senators argue that the current coverage policies will limit access to disease-modifying therapies for Alzheimer's patients, resulting in irreversible disease progression and added burdens for caregivers and loved ones.

Key Takeaways:

  • The senators are calling on CMS to reconsider the Coverage with Evidence Development (CED) requirements for FDA-approved monoclonal antibodies treating Alzheimer's disease.
  • The current coverage policies will only cover monoclonal antibodies treating Alzheimer's and other dementia approved through the accelerated approval pathway for individuals enrolled in randomized clinical trials and treatments approved through the traditional approval pathway.
  • Unless CMS reconsiders the current national coverage determination (NCD), access to lecanemab and other disease-modifying therapies for Alzheimer's disease will be extremely limited.
  • The senators argue that processes that delay coverage decisions for several months can impose significant access delays, resulting in irreversible disease progression and added burdens for caregivers and loved ones.
  • According to the Alzheimer's Association, more than 2,000 individuals aged 65 or older transition per day from mild dementia due to Alzheimer's disease to moderate dementia due to Alzheimer's disease.
  • The effort is supported by the Alzheimer's Association, which estimates that by 2050, nearly 13 million Americans will live with Alzheimer's disease.

Statistics:

  • 44,000 individuals in West Virginia are expected to be living with Alzheimer's by 2025, and over 830 individuals will lose their life to the disease each year.
  • In 2022 alone, Alzheimer's and other dementia will cost the nation $321 billion.
  • Medicare and Medicaid bear much of this financial weight, as the programs are expected to cover about $239 billion, or 67%, of these costs in 2021.
  • Unless a treatment to slow, stop, or prevent the disease is approved and accessible to people, Alzheimer's is projected to reach a total cost of $1 trillion by 2050.

Sources:

  • Letter from Senator Shelley Moore Capito and 19 co-sponsors to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure.
  • Alzheimer's Association.
  • West Virginia Senator Shelley Moore Capito.