CMS panel finds lack of evidence to support beta-amyloid PET

Panelists voted “low to intermediate confidence” during a Jan. 30 hearing in response to whether there is adequate evidence available to determine whether or not PET imaging of beta-amyloid changes health outcomes in patients with early symptoms or signs of cognitive dysfunction.

The Centers for Medicare & Medicaid Services (CMS) convened a Medicare Evidence Development & Coverage Advisory Committee (MedCAC) meeting to hear evidence regarding the clinical utility of beta-amyloid imaging agents, such as Florbetapir F-18 (Amyvid, Eli Lilly).

The panel voted on two questions, giving a score from one to five—one being low confidence, five being high confidence. The questions focused on whether there is adequate evidence to determine if PET imaging of brain beta-amyloid changes health outcomes in patients who display early symptoms or signs of cognitive dysfunction, and if the evidence can be generalized to the Medicare beneficiary population.

In addition to the low to intermediate vote on the scan’s impact on health outcomes, the panel voted “high confidence” that these conclusions are generalizable to the Medicare beneficiary population.

The vote may impact future Medicare coverage decision for beta-amyloid agents, Indianapolis-based Lilly said in a press release.

"When making a final coverage decision, we encourage the CMS to heavily consider the real-world medical experience presented today, and the appropriate use criteria recently released by the Society of Nuclear Medicine and Molecular Imaging and the Alzheimer's Association supporting the use of these imaging agents," Wei-Li Shao, senior director of the Alzheimer's division at Eli Lilly, said in the release.

The Alzheimer's Association expressed its strong support for early and accurate diagnosis of Alzheimer's disease, and belief that it leads to better outcomes and higher quality of life for people with Alzheimer's and their families. It does this by: enabling earlier access to appropriate treatments, allowing the family to build a care team and seek out education and support services, enabling enrollment in Alzheimer's/dementia clinical trials and providing an opportunity for the development of advance directives and financial planning, the association said in a release.

The Alzheimer’s Association has recommended the use of brain amyloid imaging and associated insurance coverage primarily to clarify an unclear diagnosis in people who are already experiencing memory and thinking symptoms.

For more about amyloid imaging, please read "Florbetapir: What It Means for Dementia Evaluation."