Once again, drug developer Eli Lilly is expressing disappointment with a regulatory decision related to its Amyvid PET radiopharmaceutical for the detection of Alzheimer's disease.
The U.S. Centers for Medicare and Medicaid Services (CMS) on September 27 issued a final decision on reimbursement for beta-amyloid imaging agents such as Amyvid (florbetapir F-18). Instead of agreeing to pay for all PET scans for dementia or neurodegenerative disease, CMS said it would pay for one PET beta-amyloid scan to exclude Alzheimer's disease through the agency's coverage with evidence determination (CED) regulatory framework.
Eli Lilly said it believes the decision is "contrary to expert opinion" and clinical use guidelines, and that it contradicts the stated goals of the Obama administration's National Alzheimer's Project Act, which is designed to foster the development of new and innovative ways to diagnose and treat Alzheimer's disease.
The CED framework will not provide adequate patient access to beta-amyloid scans, said Eric Dozier, senior director of the Alzheimer's business division, in the statement. The firm "will be evaluating all available options to ensure patients and physicians can gain access" to the technology.
