On Friday, a bipartisan group of U.S. senators urged Medicare to expand its coverage of Alzheimer’s treatments approved by the Food and Drug Administration (FDA), citing concerns that current restrictions delay crucial care for patients as their condition worsens.
In a letter addressed to Health and Human Services Secretary Xavier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure, the group of 18 Republicans and two Democrats, led by Sens.
Susan Collins (R-Maine) and Shelley Moore Capito (R-W.V.), emphasized the urgent need to ensure immediate access to FDA-approved treatments for Alzheimer’s patients, when deemed appropriate by clinicians.
The senators highlighted projections that Alzheimer’s disease could cost the nation $1 trillion by 2050 if decisive action is not taken. They noted that the population of seniors, who are most affected by the disease, is expected to grow by over 50% to 86 million over the next 30 years, according to Census Bureau estimates.
Pressure on Medicare has intensified following the FDA’s accelerated approval of Leqembi, a treatment developed by Eisai and Biogen targeting brain plaque associated with early Alzheimer’s disease. Leqembi has demonstrated a 27% reduction in cognitive decline in late-stage clinical trials, but it also carries risks such as brain swelling and bleeding.
Currently, Medicare’s coverage of Alzheimer’s treatments like Leqembi, priced at $26,500 per year by Eisai, is limited to individuals participating in FDA- and NIH-approved clinical trials. However, as Eisai has completed its late-stage trial and stopped enrolling participants, access to the drug under Medicare has become extremely limited.
Ivan Cheung, CEO of Eisai in the U.S., stated that the company is unaware of any seniors who have successfully obtained Medicare coverage for Leqembi.
The senators expressed concern that delays in Medicare coverage decisions could lead to irreversible disease progression and impose additional burdens on caregivers and families.
“Processes that may delay coverage decisions by several months can impose significant access delays, resulting in irreversible disease progression and added burdens for caregivers and loved ones,” the senators wrote to CMS.
Their call to action follows a similar appeal from over 70 House lawmakers who raised concerns that current restrictions disadvantage rural communities where clinical trials are less accessible.
The Alzheimer’s Association and the American Academy of Neurology have also advocated for broader Medicare coverage of Leqembi, stressing the treatment’s potential benefits supported by clinical data.
Eisai anticipates receiving full FDA approval for Leqembi as early as summer 2024. Upon such approval, Medicare’s policy would likely expand to provide broader coverage for individuals participating in approved research studies.
Medicare Administrator Chiquita Brooks-LaSure acknowledged the ongoing dialogue, indicating openness to new data and emphasizing the importance of evidence in making coverage decisions.
Eisai’s Cheung suggested that with robust evidence supporting Leqembi’s benefits, Medicare should consider minimal or no restrictions on coverage to ensure broad and straightforward access for beneficiaries.
Medicare’s cautious approach stems partly from controversy surrounding another Alzheimer’s treatment, Aduhelm, which received accelerated FDA approval despite objections from independent advisors who questioned its clinical benefits.
