Drug makers will also have to gather and keep data in a registry showing how the drugs are working in the real world
By Physician’s Briefing Staff HealthDay Reporter
FRIDAY, June 2, 2023 (HealthDay News) — Medicare will soon cover a new class of drugs for Alzheimer disease if they receive full approval from the U.S. Food and Drug Administration, with some key limits.
Along with full approval, drug makers will also have to gather and keep data in a registry showing how the drugs are working in the real world, the U.S. Centers for Medicare & Medicaid Services announced Thursday.
“Alzheimer’s disease takes a toll on not just the people suffering from the disease but also on their loved ones and caregivers in a way that almost no other illness does. CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” CMS Administrator Chiquita Brooks-LaSure said in a statement announcing the change. “If the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered.”
The drugs in question — lecanemab (Leqembi) and aducanumab (Aduhelm) — have already been given accelerated approval to “fill an unmet medical need” while drug makers continue research on their effectiveness and safety. But neither drug has received full, traditional approval.
Not everyone was thrilled with the idea of collecting real-world data in a registry. In a statement, the Alzheimer’s Association called the registry requirement “an unnecessary barrier,” adding that the registry “should not be a requirement for coverage” of an FDA-approved treatment.
However, the CMS said there is a “strong precedent” for using registries.
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