WASHINGTON — Medicare advisers on Tuesday recommended that the program alter its requirements for drugs, diagnostics, and medical devices that face coverage restrictions to make the process more transparent and better incorporate diversity data.
The niche regulatory tool, called a Coverage with Evidence Development, has gotten outsized attention recently because it has been applied to a new class of Alzheimer’s drugs that target amyloid plaques in the brain. The tool allows some Medicare beneficiaries to access the product, but also forces drugmakers to continue to study their efficacy.
Medicare developed a coverage policy for a class of Alzheimer’s treatments based on data from a controversial drug, Aduhelm, that had questionable clinical benefit for patients, roiled expert advisers, and has been an unmitigated commercial failure. That policy has become even more controversial after the FDA approved an Eisai drug called Leqembi that had more promising data results. Unless Medicare acts, the same historically restrictive coverage policy applies.
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