Medicare will pay the costs of brain imaging that uses a Eli Lilly and Co. drug to help diagnose Alzheimer’s disease only for patients participating in approved clinical studies, regulators proposed.
There isn’t enough evidence to show the scan will benefit all people with dementia, though in some cases it may help diagnose whether a patient has Alzheimer’s, the most common form of dementia, the Centers for Medicare & Medicaid Services said last week in its proposed coverage decision.
The decision had been eagerly anticipated [1] by the industry. Lilly says the drug should help reduce misdiagnosis [2] of the disease.
Medicare, the U.S. health plan for the elderly and disabled, will reimburse patients for a scan if they are part of an approved clinical trial for the prevention, treatment or better diagnosis of Alzheimer’s, the agency said.
The $3,000 test, approved last year by the U.S. Food and Drug Administration, uses Lilly’s Amyvid imaging agent to trace a brain protein linked to Alzheimer’s. The disease affects 5 million Americans, a number that patient advocates say may double by 2050. In younger patients or those where the diagnosis is unclear, the benefit of the scan may be greatest, scientists have said.
In its proposed decision, the agency set out criteria for clinical studies that would allow Medicare recipients to be covered for the costs of the brain scans, including whether using the test would spare unnecessary treatments or improve the patients’ quality of life.
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