Eli Lilly ($LLY) has some allies for a brewing fight with Medicare. Alzheimer's groups are ready to back Amyvid, the company's imaging agent, in hopes that the Centers for Medicare and Medicaid Services will decide to pay for a diagnostic test after all.
In a draft coverage decision, CMS said it would only reimburse for an Amyvid diagnostic scan for patients taking part in clinical trials. The data supporting the test's utility is lacking, the agency said, at least for now. The proposal would give researchers an opportunity to clarify the case for Amyvid, while barring coverage for most Medicare beneficiaries.
As Bloomberg reports, the Alzheimer's Association will fight the proposal, and it expects patients and Alzheimer's researchers to do the same. Even before the CMS decision, the association had submitted an outline of the circumstances in which Amyvid scans would be useful. They could help rule out Alzheimer's disease and frontotemporal dementia, the group said, in a report co-authored by the Society of Nuclear Medicine and Molecular Imaging.
Other experts say CMS's draft decision is a good compromise. Amyvid is designed to highlight beta-amyloid, a substance that builds up in Alzheimer's patients' brains. But it's also found in people who don't have Alzheimer's, which means that Amyvid-enhanced imaging could flag patients who aren't suffering from that type of dementia--and might never develop it, one Alzheimer's expert told the news service. Paying for the test in trial participants helps researchers clarify how best to use Amyvid, while preventing unfounded fears, he said.
"I think CMS found a way to do something truly constructive while holding back what will undoubtedly be a tsunami of worried well who, if they had access to amyloid scans, would find that they have amyloid in their brains that is largely astymptomatic," said Dr. Sam Gandy, associate director of the Alzheimer's research center at Mount Sinai School of Medicine.
Lilly says Amyvid wasn't designed to predict Alzheimer's, but to rule it out in patients who've been difficult to diagnose. The company no doubt will join those protesting the CMS decision before the agency makes a final determination in October. Lilly needs Amyvid, one of its few new products, to help fill a yawning sales gap left by the loss of patent protection on some older blockbusters, including the antipsychotic Zyprexa. Analysts figure Amyvid could bring in as much as $500 million a year, provided reimbursement is widespread. If not, its prospects are more in the $100 million range.
- see the Alzheimer's Association statement
- read the Bloomberg story