Key to expanding insurance coverage to US seniors in the early stages of mental deterioration, health advisors on Friday, June 10, unanimously endorsed the full clearance of a highly monitored Alzheimer's drug.
Early studies show that Leqembi may reduce the course of Alzheimer's by several months. In January, the Food and Drug Administration (FDA) granted the medicine provisional approval based on these findings. More conclusive data are now being reviewed by the FDA to see whether the medicine should earn the agency's complete support.
Notably, insurers have been reluctant to cover infusion therapy until it has received full FDA clearance, making this decision all the more crucial.
FDA Is Expected To Make a Final Decision on Clearance by July 6
A big company's research validated the drug's advantages for patients with moderate or early Alzheimer's. The FDA panel of outside experts voted 6-0 in favor of the study's conclusions. Full approval was recommended in a nonbinding vote, and the FDA is expected to make a final decision by July 6, as reported by CNBC.
Dr. Robert Alexander, the panel's chair from the University of Arizona, said, "There are adverse effects. But they're monitorable and I think the benefit is clear.."
Leqembi, marketed by Eisai and Biogen, was granted first approval from the FDA under the agency's expedited clearance procedure. This provides patients with early access to medications when laboratory or biological indicators show they may be helpful. The medication successfully removed a characteristic plaque in the brains of Alzheimer's patients.
More current data from a trial involving 1,800 patients were evaluated by the FDA panel, and it indicated that those taking the drug had a somewhat slower rate of deterioration in memory, judgment, and other cognitive tests.
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Insurers Have New Concerns About Leqembi's Price and Effectiveness
Experts, Congressmen, and health insurers have all expressed fresh worries over the cost and efficacy of novel plaque-targeting medications like Leqembi.
Prior to final FDA clearance, the Medicare health plan effectively barred coverage of Leqembi and a related medicine, Aduhelm. In a report by Medical Xpress, fears that Aduhelm's annual cost of $28,000 would increase Medicare spending led to the announcement of this unusual policy last year.
Most persons with Alzheimer's are covered by the government program, and commercial insurers often follow its lead.
Patients who have gotten Leqembi so far have mostly paid for it out of their own pockets at a yearly cost of $26,500.
Under pressure from Alzheimer's sufferers and activists, Medicare's administrator Chiquita Brooks-LaSure has said categorically that the program would begin covering the treatment immediately upon receiving FDA approval. But this week, she revealed additional conditions even after Medicare coverage begins.
Brooks-LaSure said all patients taking the said drug would need to be enrolled in a government registry to monitor Leqembi's safety and efficacy. Groups like the Alzheimer's Association, who have been pushing the government to cover the cost of medicine they think might assist thousands of people, have criticized the decision.
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