Access to Alzheimer’s drug bogged down by Medicare policy

by Admin
Access to Alzheimer’s drug bogged down by Medicare policy

Alzheimer’s is a progressive, fatal disease that boggled scientists for a century. In the past 30 years, $42 billion has been invested in research and development of drugs that could treat it. More than 150 trials ended in failure. Now, at last, we have two treatments with significant clinical benefit — one, lecanemab, approved by the Food and Drug Administration and another, donanemab, recently endorsed by its advisory panel — and a scientific pathway that could one day point the way toward a cure.

Unfortunately, it’s not clear how quickly patients and their families will be able to benefit. It could be months before the FDA approves donanemab. These drugs work best at early stages of this progressive disease. Patients who could see results from treatment today may not be eligible tomorrow. Our agencies must refocus their efforts on ensuring safe, appropriate access for people who may benefit from the first new treatments for Alzheimer’s in three decades. 

Eisai’s Leqembi (lecanemab) received FDA approval more than a year ago after demonstrating a 27% decline in early disease progression; donanemab achieved 35%. But rather than cover the drug for seniors who need it, the Centers for Medicare and Medicaid Services (CMS), which administers Medicare, restricted access, citing the very safety concerns the FDA scrutinized before granting approval.

The newly FDA approved Alzheimer’s treatment Leqembi is prepared at Abington Neurological Associates in Abington, Pennsylvania, on Nov. 7, 2023 (Hannah Yoon/for The Washington Post)

The result? After more than a year on the market, the drug has reached only 5,000 patients

Though the FDA reviewed the data and determined lecanemab’s benefit outweighed the risks, CMS continues to press for more data on its clinical benefit and safety. The agency isn’t supposed to consider cost in a coverage decision, but that certainly seems to be a factor. It effectuated one of the largest premium increases in the history of the Medicare program to manage the projected budget impact of a similar Alzehimer’s drug, Aduhelm — then restricted access to it and rebalanced premiums

The tool used to nullify these drugs is “coverage with evidence development,” or CED. This program was designed to speed new technologies to market, protect patients and spur innovation. But CMS has warped its purpose, using CED to impede access not only to Alzheimer’s treatments but to diagnostic too. 

PET scans are the gold standard for diagnosing Alzheimer’s by confirming the presence of amyloid plaque in the brain. A second test is used after treatment to confirm that plaques have been removed. After tying up these tests in CED for more than a decade, CMS finally concluded last October what we’ve known for years: that the preponderance of data supports using PET scans to diagnose Alzheimer’s disease. Now we must ensure equitable access to these tools in practice. The new drugs deliver the most benefit when administered early in the progression of disease, so getting a timely, accurate diagnosis is crucial. 

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