The Centers for Medicare & Medicaid Services (CMS) has agreed to cover an expensive new brain scan test for Alzheimer’s disease, but only in specific circumstances, according to a proposed coverage decision announced last week.
The beta-amyloid imaging test uses a special brain imaging drug (Amyvid) in combination with a PET scan to measure the levels of beta-amyloid plaque, long viewed as a key symptom that differentiates Alzheimer’s disease from other forms of dementia. But a single test, including the pricey intravenous drug approved by the Food and Drug Administration in April, can cost between $3,000 and $10,000.
To qualify for coverage of the test under Medicare, beneficiaries must have a “clinically difficult” case that hasn’t been clearly diagnosed through other testing or must have a case that is considered a candidate to “enrich clinical trials seeking better treatments or prevention strategies,” CMS said in its decision.
Others worry that limiting the coverage of the test is counterintuitive to national goals of early intervention. "Restricting coverage could hinder a timely and accurate diagnosis, which is in conflict with the advice of Alzheimer's disease experts and with the administration's National Alzheimer's Project Act,” said Daniel Skovronsky, president and CEO of Avid Radiopharmaceuticals, the company that manufactures Amyvid, in a corporate statement. “In addition, it may stifle future innovation aimed at improving diagnosis."
But CMS argues that in most patients, a diagnosis can be made via other means, including detailed evaluations and MRI or CT scans. Other experts also warn that the test still requires interpretation, and that in some cases, the presence of beta-amyloid plaque does not always produce Alzheimer’s.