- Medicare on Thursday gave more details on how it plans to cover new Alzheimer’s drugs once they receive full U.S. approval, emphasizing that a required patient registry will be free and easy to use.
- The additional guidance comes nearly a month after the Centers for Medicare and Medicaid Services affirmed its coverage policy on drugs like Eisai and Biogen’s Leqembi. The registry for tracking how the medicines work in the real world received pushback as an unnecessary hurdle to coverage.
- But Wall Street analysts said the registry portal as described Thursday could be easily handled by healthcare providers and shouldn’t overly hinder the launch of a new drug. Leqembi, now cleared on a conditional basis by the Food and Drug Administration, could receive a full approval in July.
CMS has faced pressure to relax its rules limiting coverage of Leqembi and Biogen’s earlier drug Aduhelm, both of which received conditional clearances, to patients enrolled in randomized clinical trials. The policy allows broader coverage via registries for drugs once they are fully approved.
Details released earlier this month confirmed that, following a traditional approval, Medicare will cover the drugs for patients who are enrolled in Medicare Part B, diagnosed with mild cognitive impairment or early dementia caused by the disease, and are treated by a physician who is participating in a registry.
Still, the nonprofit Alzheimer’s Association, which has been critical of Medicare’s policy, called the registry an unnecessary hurdle.
On Thursday, the agency that administers Medicare defended registries as a common tool clinicians have used for decades to measure patient outcomes.
“In facilitating the development of this registry, CMS is carefully balancing the need to collect information while keeping the registry as easy to use as possible,” the agency said, adding that healthcare providers will also be able to choose from other planned registries.
In a note to clients, Wall Street analyst Brian Skorney said the agency’s emphasis that the registry should be free and easy to use confirms his expectation the requirement won’t be a meaningful hurdle to a drug’s launch.
“We see this as a minimal barrier for physicians who treat Alzheimer's disease to prescribe Leqembi to their patients [and] reflects positively on the potential near-term success of Leqembi with the traditional approval decision set for early next month,” he wrote.
CMS said doctors will enter into the registry a patient’s diagnosis, whether the patient is taking blood thinners, results from scans or other tests measuring plaque levels, the specific antibody drug, any adverse events such as brain swelling or bleeding, and cognitive test results.