Eli Lilly and its subsidiary Avid Radiopharmaceuticals are expressing disappointment in the July 3 draft decision by the U.S. Centers for Medicare and Medicaid Services (CMS) that stopped short of fully endorsing PET beta-amyloid imaging for dementia or neurodegenerative disease.
The agency ruled there is "insufficient" evidence to conclude that PET beta-amyloid imaging improves health outcomes for patients with dementia or neurodegenerative disease. However, the agency did agree to cover one PET beta-amyloid scan per patient under certain circumstances.
Lilly is marketing the radiopharmaceutical Amyvid (florbetapir F-18) in the U.S. and Europe for PET beta-amyloid scans in adults being assessed for Alzheimer's disease or other causes of cognitive issues.
"CMS appears to be challenging the value of an adjunctive tool that can assist physicians in making a more informed diagnosis for patients with cognitive impairment," said Dr. Daniel Skovronsky, PhD, president and CEO of Avid Radiopharmaceuticals, in a prepared statement.
"Restricting coverage could hinder a timely and accurate diagnosis," which conflicts with the advice of Alzheimer's disease experts and with the Obama administration's National Alzheimer's Project Act, he added.
CMS has initiated a 30-day comment period for interested parties to give feedback regarding the decision.
