Medicare lifts limit on brain scans for Alzheimer's patients
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Medicare administrators have finalized plans to broaden coverage of PET scans for Alzheimer's patients — a move that potentially boosts the fortunes of promising new antibody treatments like Eisai and Biogen's Leqembi.
What happened: The Centers for Medicare and Medicaid Services on Friday lifted a single-test cap on scans for the protein beta-amyloid that's believed to contribute to the condition.
- That could allow providers to make more diagnoses and determine whether treatment with the new drugs is appropriate.
- Leqembi was found to slow progression of the disease and reduce the buildup of sticky beta-amyloid plaques in the brains of patients.
Yes, but: CMS will leave it to Medicare contractors to make the actual coverage decisions, which could cause confusion and may force the agency to revisit its decision, Cowen analyst Eric Assaraf wrote in a note.
What they're saying: "Broader access to amyloid PET scans will enable earlier and more accurate diagnosis, and better care management," said Maria Carrillo, chief science officer of the Alzheimer's Association. "Their use can lead to better health outcomes for people living with Alzheimer's or another dementia."
Catch up quick: The FDA in July gave full approval to Leqembi after it was found to have modest success slowing Alzheimer's progression in clinical trials.
- CMS agreed to pay for the drug for Medicare beneficiaries if health providers agree to collect and share data about the drug's performance. The agency had previously restricted coverage to those patients enrolled in clinical trials.
- The FDA is expected to make a decision by year's end on another Alzheimer's drug, Eli Lilly's donanemab, which was shown to be 35% effective at slowing the rate of the disease, and 60% effective in early-stage patients.
Don't forget: The Institute for Clinical and Economic Review said in April that, with its $26,500 annual price tag, Leqembi would cause "rapid growth in health care insurance costs that would threaten sustainable access to high-value care for all patients."
- The nonprofit organization, which assesses the value of drugs, suggested that Leqembi should cost between $8,900 and $21,500.
- More than 6 million people are living with Alzheimer's in the U.S., and the number is expected to more than double by 2050, per the Alzheimer's Association.
