A new class of Alzheimer’s drugs will be available to patients on Medicare – but only if the medicine has received “traditional approval” and the patient participates in a registry.
If one of these Alzheimer’s drugs has received “traditional approval” from the U.S. Food and Drug Administration (FDA), Medicare will cover the drug “in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare,” Centers for Medicare and Medicaid Services (CMS) announced on June 1.
Biogen’s Aduhelm and Eisai’s LEQEMBI, which fall into this class of drugs, both received accelerated approval. LEQEMBI could receive traditional approval soon; the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is due to discuss the results of a trial later this week. A potential decision on traditional approval is thought to be possible within weeks.
To be covered for these drugs, according to CMS, a patient needs to be enrolled in Medicare, to be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s disease, and to have a qualified physician participating in a registry.
An ‘unnecessary barrier’
The Alzheimer’s Association says requiring a registry as a condition of coverage is an “unnecessary barrier.”
“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 an FDA-approved treatment,” the organization said in a statement.
This policy is consistent with CMS’ restrictive National Coverage Determination and, rather than increase access, seems to only reinforce the idea that accelerated approval is “less than” traditional approval.
What is a registry?
A registry is when a physician and a clinical team take part in a project to collect evidence about how drugs work outside of the lab. They submit their findings through a U.S.-wide site, which is subject to robust privacy protections in accordance with federal law. Researchers access information to carry out studies, broadening knowledge on how these drugs can potentially help people. Registries are commonly used and there has become a strong precedent for using registries to gather more information on a newly-approved treatment. More registries are expected to be coming online soon.