Drug maker Eli Lilly & Co. today announced it would continue with a brain-imaging agent to detect Alzheimer's in PET scans despite a government ruling that Medicare would not pay for patients who undergo the test.
The chemical, called Amyvid, is considered a breakthrough in that it's the first of its kind to scan for characteristic beta amyloid protein plaques that are a biomarker for Alzheimer's Disease. At present, most people are diagnosed with "probable Alzheimer's Disease" based on physical and mental symptoms and scores on memory and cognition tests.
The FDA approved the drug in 2011 and in January the European Union approved its use. In the United States, a Centers for Medicaid & Medicare Services board said more tests were needed to demonstrate the drug's effectiveness and would not provide Medicare coverage for general use at this time. It will, however, pay for those already involved in clinical trials using the chemical.
The decision released today is subect to change before a final decision in October, especially if the drug company can account for current evidentiary gaps.
"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 chief executive of Lilly's Avid Radiopharmaceuticals Inc., in a prepared statement.