(Bloomberg) -- New Alzheimer’s drugs like Eisai Co.’s Leqembi will be covered by the US Medicare program as soon as they receive full regulatory approval, government health officials said.  

Eisai’s drug, one of the first in a new class that removes a toxic protein called amyloid from the brain’s of Alzheimer’s patients, received accelerated approval in January and is under review for full approval from the Food and Drug Administration. Medicare, which provides health coverage for elderly Americans, doesn’t currently cover the drug because of a controversial policy that calls for full US approval. 

Medicare has been under pressure from disease advocates and members of Congress to fully cover drugs like Leqembi for Alzheimer’s, the leading cause of dementia in the US. Explicit confirmation from the Centers for Medicare and Medicaid Services should reassure the Alzheimer’s community that hurdles to coverage are relatively insignificant, Robert W. Baird analyst Brian Skorney said in a note. 

“We continue to believe that the launch of Leqembi, once it receives full approval in early July, will be robust,” Skorney said. 

Eisai shares closed up 2.1% Thursday in Japan. Shares of its Alzheimer’s partner Biogen rose as much as 4% as of 10:43 a.m. in New York. 

In a statement, the agency said that Medicare will cover drugs like Leqembi with traditional FDA approval “when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry.” 

The agency didn’t provide many details about how the registry would work. The data-collection effort may present logistical challenges to rolling out the drug, Wedbush Securities analyst Laura Chico said in a note. 

The registry is an “unnecessary barrier” to coverage, the Alzheimer’s Association said in an emailed statement. “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 clarification of the CMS policy, while not unexpected, is good news for companies that make amyloid-removing drugs for Alzheimer’s, including Eisai and Biogen, as well as Eli Lilly & Co., which said last month that its experimental Alzheimer’s drug donanemab slowed the disease in a big trial.

Last year, Leqembi became the first drug to unambiguously slow the disease in a final-stage trial. The drug faces a key hearing before FDA advisers on June 9 that could pave the way for full approval in July.


(Updates with shares in fifth paragraph.)

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