The Centers for Medicare & Medicaid Services has handed down its final decision on Eli Lilly's Alzheimer's imaging agent Amyvid. The final answer, after appeals from Lilly and patient groups? No. Medicare won't pay for Amyvid-aided brain scans, not outside of clinical trials.
Naturally, Lilly ($LLY) isn't happy about CMS's choice. Amyvid is designed for use during positron emission tomography (PET) of the brain to highlight beta-amyloid plaque, a substance found in the brains of Alzheimer's patients. And the U.S. patients most likely to be undergoing PET scans for Alzheimer's diagnosis are older people covered by Medicare. Amyvid might have become a $500 million drug if reimbursement policies were favorable, analysts say. Without routine Medicare use, its prospects are capped at around $100 million.
And that's on the high side. So, Lilly says it's evaluating "all available options" to broaden reimbursement for the drug. What might those options include? In a statement, Lilly said CMS's decision "contradicts the statutory authority" the agency has over diagnostics coverage. Sounds like a hint of legal action to us.
The thing is, beta-amyloid is found not only in Alzheimer's patients, but in some people with normal cognition who may never go on to develop Alzheimer's. When the FDA approved Amyvid last year, the agency specified that the scans couldn't establish a definitive diagnosis of Alzheimer's. They could only help doctors make their own judgments. In fact, Amyvid's approval was delayed by concerns that the scans could lead to false-positive diagnoses.
The potential pitfalls apparently were too much for CMS, which says that the data for Amyvid's actual clinical utility are lacking. The CMS decision means that Medicare will pay for Amyvid in patients who are taking part in Alzheimer's research; that would allow researchers a chance to gather enough evidence to determine when and how the Amyvid-aided scans are most helpful.
But limiting coverage to research "does not provide patients appropriate access to these amyloid imaging brain scans," Eric Dozier, senior director of Lilly's Alzheimer's business, said in a statement. "Instead, it creates additional complexity for the broader community in determining the best path forward for patients." What's Lilly's path forward now? That's the question.
- read the Lilly statement
- here's FierceMedicalDevices' take
Special Report: Biopharma's Top R&D Spenders 2012 - Eli Lilly