12:00 AM
Feb 04, 2013
 |  BioCentury  |  Regulation

Amyloid ambivalence

National Medicare coverage of Lilly's Amyvid in dementia may be two years away

Conclusions reached by a Centers for Medicare & Medicaid Services advisory committee suggest that national coverage of beta amyloid PET imaging agents will have to wait at least two years for data demonstrating a benefit on health outcomes in patients with early symptoms of cognitive dysfunction.

CMS's Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) met Jan. 30 to discuss a National Coverage Assessment (NCA) for beta amyloid PET imaging for diagnosing and managing dementia and neurodegenerative disease.

Because no data have been published showing that PET imaging of beta amyloid in the brain changes health outcomes in patients who display early symptoms of cognitive dysfunction, eight of 12 committee members voted 1 or 2 on a 5-point scale, where 1 is low confidence, 3 is intermediate confidence and 5 is high confidence.

They said they wanted to see data showing how scan results change patient management and the longitudinal effects of management decisions on patients. Some also wanted data on how disease progression varies with beta amyloid status.

The remaining four panel members voted 3 or 4. Two of them said case studies presented at the meeting showed PET imaging affected clinicians' management decisions in ways that benefited patients.

According to Eli Lilly and Co. and General Electric Co.'s GE Healthcare unit, ongoing and/or planned studies of their imaging agents could generate data needed to fill the evidence gaps in about two years.

In the meantime, these imaging products will be reimbursed case-by-case at the discretion of local and regional Medicare carriers.

Certain comfort

The proposition for beta amyloid PET imaging agents is that an increased certainty of diagnosis would lead to better treatment decisions and thus better outcomes.

Current diagnostic methods for Alzheimer's disease have a false positive rate of 16%, which means tens of thousands of people are treated for AD when they actually have some other condition, such as depression or vascular dementia....

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