Alzheimer’s advocacy organizations have praised the Food and Drug Administration‘s approval of the new treatment for the debilitating disease, but they have equally condemned the Centers for Medicare and Medicaid Services for attaching significant burdens to access the care.
The Centers for Medicare and Medicaid Services announced on Thursday that, for Medicare to cover these expensive treatments, Medicare patients must be diagnosed with amyloid plaques on the brain and be treated by a physician who would be required to upload patient information into a federal database to monitor the real-world efficacy of the treatments.
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After granting accelerated pathway approval for Biogen and Eisai’s drug, Leqembi, in January, the FDA announced full approval of the infusion treatment that clinical trials demonstrate slows cognitive decline caused by Alzheimer’s disease progression in mild, early onset patients by 27%. Leqembi, which is called lecanemab-irmb generically, works by reducing amyloid plaques in the brain, which is a key feature of the disease.
As with many new drugs in high demand, the commercial cost of Leqembi is a staggering $26,500 annually for the drug itself. Added to this cost is the amount of time and travel costs to receive the treatment at licensed infusion centers. CMS promised earlier this year that it would explore coverage options upon the FDA granting full approval.
Coverage for Leqembi falls under Medicare Part B, as the treatment is administered in a facility, with a 20% patient co-pay depending upon the patient’s supplemental insurance, making the out-of-pocket costs for the treatment over $5,000 annually.
Testing for amyloid plaques also involves expensive, invasive procedures, both of which have serious complication risks. Although there are new advances in blood tests detecting the presence of amyloid plaques, existing protocols to test for these include functional PET brain scans or spinal taps to extract cerebral fluid.
The Alzheimer’s Association announced that, although it applauds the FDA’s approval of Leqembi and CMS’s steps to cover the drug, Medicare needs to do more to ease access to life-altering care for those with this terminal illness. Of chief concern is the mandatory participation in the federal registry.
“We were disappointed, however, that CMS did not take this opportunity to initiate the formal process to reconsider their National Coverage Determination policy. This reconsideration is extremely important and long overdue,” Robert Egge, the chief public policy officer of the Alzheimer’s Association, said.
“Registries — an important tool to gather much-needed real-world evidence to transform and improve patient care — should not be a requirement for coverage of a FDA-approved treatment,” read the Alzheimer’s Association press statement.
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“The scientists at FDA are in the best position to determine whether a drug is safe and effective,” UsAgainstAlzheimer’s Vice President Stephanie Monroe said. “Now that FDA has made their decision, it is not appropriate for CMS to second-guess that decision.”
The Alzheimer’s Association estimates that more than 6.7 million people in the United States who are age 65 or older have Alzheimer’s disease — or nearly 11% of the Medicare-eligible population. By 2050, the organization estimates that 12.7 million Americans could be living with the disease.
