Lawmakers worry Medicare Alzheimer's plan won't ensure access to new treatments
- Two Democratic lawmakers said Medicare has failed to answer basic questions about how its plan to cover Alzheimer's antibody treatments will work.
- Rep. Anna Eshoo, the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan said it is still "very unclear" how seniors will access the new treatments.
- Medicare has promised to cover Alzheimer's antibody treatments on the same day the medications receive full approval by Food and Drug Administration.
Two Democratic lawmakers are calling on Medicare to provide more information on how the program will make good on its promise to cover Alzheimer's treatments for seniors.
Rep. Anna Eshoo, the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan said Medicare has failed to answer basic questions about how its coverage plan will work.
The lawmakers told Chiquita Brooks-LaSure, who heads the Centers for Medicare and Medicaid Services (CMS), in a letter Monday that it is still "very unclear" how seniors will access the new treatments.
Medicare has promised to cover Alzheimer's antibody treatments on the same day the medications receive full approval by the Food and Drug Administration.
The federal health program will cover the treatments through Part B of the program for seniors. Part B typically covers treatments that seniors can't administer at home on their own, such as infusions.
Under this policy, seniors could receive coverage for Eisai and Biogen's antibody-infusion treatment Leqembi as soon as this summer. The FDA is expected to make a decision on Leqembi July 6.
Leqembi slowed cognitive declined by 27% in a clinical trial, though the treatment also carries risks of brain swelling and bleeding.
But Medicare will require patients to visit a doctor who participates in a so-called registry that collects real-world data on how the drug works.
Eshoo and Barragan told Brooks-LaSure that they are worried the registry could present a barrier to care.
Brooks-LaSure said last week that CMS will help set up a national registry to make it easy for doctors and clinicians to enter the required data on patients who are taking the drug.
But the lawmakers said CMS has published no details about how the required registry will actually work. The agency has not said when the registry will be live, what data must be collected, and how patients can find doctors who are participating in the system, Eshoo and Barragan said.
"At minimum, Congress, doctors, and patients deserve to have the answers to the above questions immediately," they said.
Medicare needs to clearly define how the registry will work and make sure the system is not burdensome to patients and doctors, they added.
The lawmakers called on CMS to ensure that the registry does not create disparities in access for Black, Hispanic and Native Americans as well as people living in rural areas.
What's more, Eshoo and Barragan said Medicare should consider dropping the registry requirement altogether.
"There needs to be clarity and transparency about the standards for coverage for FDA-approved treatments for deadly diseases with unmet medical needs," the lawmakers said. "Please do not allow CMS's demand for additional evidence generation be a barrier to patient care."