By Rachel Cohrs

CMS Administrator Chiquita Brooks-LasureCHIP SOMODEVILLA/GETTY IMAGES

WASHINGTON — Despite pressure from Congress and advocates, Medicare isn’t changing its coverage plan for new Alzheimer’s drugs anytime soon.
Medicare on Thursday issued a statement reiterating its intent to require patient registries to collect data about how medications perform even after they gain full Food and Drug Administration approval. Eisai’s Leqembi could gain full approval within the next month, so time is running short for the agency to solidify details.
Right now, Leqembi and Biogen’s Aduhelm only have accelerated approval from the FDA, and are subject to even more restrictive coverage limits that require patients to be enrolled in a clinical trial to receive the medications. If Leqembi wins full approval, those restrictions will relax slightly, but providers would still need to collect data about all patients who receive the drugs in a patient registry. Medicare had previously announced that plan in April 2022.
Critics of the restrictions argue that no other medication faces similar restrictions. The Centers for Medicare and Medicaid Services looked to defend itself, writing that, “Registries are common tools in clinical settings that have successfully gathered information on patient outcomes for decades.”
The Alzheimer’s Association on Thursday called the registry an “unnecessary barrier” and said that more details are needed about how patients and physicians can enroll.
“Registries are important tools to gather much needed real-world evidence to transform and improve patient care. But, registries should not be a requirement for coverage of a FDA-approved treatment,” the association said in a written statement.
Lawmakers including Senate Finance Chair Ron Wyden (D-Ore.) and Rep. Anna Eshoo (D-Calif.) have urged the agency to at least clarify how providers could ensure they are set up with the data collection infrastructure to immediately begin giving the medication to patients if it receives full FDA approval. Some experts and stakeholders are concerned that requiring data collection through patient registries could cause some lower-income people and those in rural areas to miss out.
“Establishing a precedent where the agency can restrict coverage for new medicines, singling out groups of patients and exacerbating health disparities, is not in the best interest of patients,” said a spokesperson for Eli Lilly, which is developing its own Alzheimer’s treatment.
However, the agency offered few details on upcoming plans: “CMS is working with multiple organizations that are getting ready to open their own registries. More information will be released as they come on line,” CMS wrote. CMS said it would “facilitate” a nationwide portal for physicians to submit information, but provided no further information.
While Leqembi’s effectiveness data is promising, the medication has been plagued by patient safety concerns about brain swelling and potential connections to the deaths of three patients in clinical trials.
The agency contended that there is precedent for requiring a registry for a fully FDA-approved product by referencing a similar policy implemented for a transcatheter aortic valve replacement. However, that decision falls under the FDA’s authority to regulate medical devices, and is not a medication like Leqembi.
Sarah Owermohle contributed reporting.

Reference: https://www.statnews.com/2023/06/01/medicare-alzheimers-drug-policy/