The Centers for Medicare and Medicaid Services (CMS) said in a statement Thursday that it will cover the medications once they are fully approved by the Food and Drug Administration, but will also require providers to collect data for patient registries about how the drugs perform in the real world.
That policy is in line with the commitment the CMS made in 2022 when it first announced its plans to restrict coverage.
The treatments in question are monoclonal antibody infusions that target brain plaque known as amyloid. The medications are intended for early stage Alzheimer’s patients, and are meant to slow the progression of memory loss, but are not a cure.
Currently, Medicare will only pay if a patient receives the treatment through a clinical trial.
Eisai’s Leqembi is one of two treatments that have already been granted accelerated approval. It costs $26,500 a year, and could get full approval within the next month.
Critics said no other medication has a similar requirement, and questioned whether coverage would really be able to start the same day a drug gets approved.
The Alzheimer’s Association in a statement called the registry an “unnecessary barrier” and pressed CMS to provide more details.
“What specific data will CMS require for the registry? What is the registry system and how accessible is it? What is the plan for clinician and health system education?” said Robert Egge, the group’s chief public policy officer.
Registries can be time consuming for physicians, and their practices need to have the right infrastructure to support CMS data collection requirements. Patients also need to be able or willing to participate.
“Every time burdens are placed on physicians, we know fewer will offer a treatment resulting in fewer in need having access to treatment,” Egge said. “Those in already underserved communities are the most likely to be impacted.”
CMS in its statement said registries are “common tools in clinical settings that have successfully gathered information on patient outcomes for decades. There is strong precedent for using registries to gather more information on a newly-approved treatment.”
