FDA to decide on Eisai and Biogen’s treatment Leqembi in July

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The Food and Drug Administration will decide whether to fully approve Christian‘Sand biogenThe Alzheimer’s treatment will be available by July 6, the companies announced on Monday.

Lekambi is an antibody treatment that targets the brain plaques associated with the brain-robbing disease. It is administered intravenously twice a month and has slowed the progression of early Alzheimer’s disease by 27% in clinical trials. However, it also carries a risk of brain swelling and bleeding and costs $26,500 per year.

Although the FDA approved Lekembi on an expedited basis in January, access to the treatment doesn’t really exist yet. Medicare will only cover categories of drugs like Lekembi that receive expedited approval for people participating in clinical trials.

The Centers for Medicare and Medicaid Services said in January that it would provide broader coverage of Leqembi as soon as it receives full FDA approval.

Although coverage will be broad, the number of people who can access the drug is likely to be limited. Medicare has agreed to cover drugs like Lekenbi after it receives full approval, but only for people who participate in research studies, called registries, so Medicare can collect real-world data. .

Those studies will take time to establish; Health care providers and research institutions would have to enroll, and patients would also have to agree to participate. The health care system will need more capacity for the diagnostic tests and infusions needed to administer the drug.

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The Alzheimer’s Association asked CMS in December to provide unrestricted coverage to treatments such as LekMebi. Members of Congress have called for Medicare to provide broader coverage, arguing that the restrictions put people living in rural communities at a disadvantage because the providers participating in such studies are usually in large cities.

CMS last month rejected the Alzheimer’s Association’s request to provide unrestricted coverage, but the agency reiterated that it would cover Leqembi more broadly the day it receives full FDA approval.

“In order to provide coverage nationally, as defined in the statute, CMS is required to examine whether a drug is appropriate and necessary,” the agency said in its statement. “This standard differs from the criteria used by the FDA to assess whether drugs are safe and effective.”

The Alzheimer’s Association said it was “appalled” by CMS’s decision. The group estimates that 2,000 people aged 65 and older progress from mild dementia to a more advanced stage of the disease every day, making them ineligible for LekMebi.

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The role of a “CMS” is to provide health care coverage. Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate. Their role is to differentiate people living with Alzheimer’s. And it’s not to decide that their life, their liberty and their memory are not important,” said Joanne Pike, president of the association.

Eisai’s U.S. CEO Evan Cheung told CNBC last month that it’s possible that after Leqembi receives full approval, Medicare may agree to provide coverage without restrictions if CMS determines that it needs to support the treatment. There is high level of evidence.

“With a high level of evidence … the ban should be very limited, or maybe no ban at all, and that is Christian’s position,” Cheung said. “We believe that Medicare beneficiaries should have unfettered, comprehensive and simple access to Lakenby because the data meets those criteria,” Cheng said.

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