The Centers for Medicare and Medicaid Services sees little benefit in using PET scans to detect beta-amyloid buildups in dementia patients, and the agency has declined to cover the procedure as a diagnostic, a blow to companies like GE Healthcare ($GE), Eli Lilly ($LLY) and Navidea ($NAVB).
In its rejection memo, CMS said there's no sufficient evidence that scanning for beta-amyloid would help diagnose or treat patients with dementia or neurodegenerative diseases. However, CMS agreed to cover the procedure in two cases: to rule out Alzheimer's disease "in narrowly defined and clinically difficult differential diagnoses," and to select patients for clinical trials.
Lilly said in a statement that the ruling not only contradicts the opinions of experts but flies in the face of CMS' stated commitment to encourage the development of life-saving diagnostics.
CMS' narrow coverage plan "does not provide patients appropriate access to these amyloid imaging brain scans," Lilly Alzheimer's chief Eric Dozier said in a statement. "Instead, it creates additional complexity for the broader community in determining the best path forward for patients."
The agency made its ruling based on Lilly's Amyvid, a PET agent FDA-approved to detect beta-amyloid deposits, similar to investigational agents like GE's flutemetamol and Navidea's NAV4694. Neither GE nor Navidea responded to requests for comment.
All three companies are chasing an indication to diagnose Alzheimer's, betting that spotting the beta-amyloid biomarker early on can lead to more effective treatment. In 2011, the FDA rejected Lilly's effort to get Amyvid approved as a diagnostic for the disease, but the company has since retooled its approach, in April buying two Alzheimer's-related PET agents from Siemens Healthcare ($SI). GE and Navidea are both in the midst of Phase III studies for their agents.
- read the CMS memo
- check out Lilly's statement