In its July 3 proposed decision memo, the agency ruled there is "insufficient" evidence to conclude that the use of PET beta-amyloid imaging improves health outcomes for patients with dementia or neurodegenerative disease. However, the agency did agree to cover one PET beta-amyloid scan per patient under certain circumstances.
PET advocates were hoping that CMS would give the go-ahead for broader use of the modality to detect the accumulation of beta amyloid in the brain, which has been cited as an early indicator of risk for conditions such as Alzheimer's disease.
The CMS decision is of particular interest to Eli Lilly and its subsidiary Avid Radiopharmaceuticals, which launched its radiopharmaceutical Amyvid (florbetapir F-18) in the U.S. in June 2012. Amyvid also has marketing clearance from the European Commission.
Amyvid has been approved for injection as a diagnostic radiopharmaceutical for PET imaging of beta-amyloid plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive impairment.
In its July 3 proposal, CMS conceded that PET beta-amyloid imaging could be "promising" when used to exclude Alzheimer's disease among "narrowly defined and clinically difficult differential diagnoses," as well as in clinical trials to develop treatment or prevention strategies for Alzheimer's by enrolling patients based on certain biological, clinical, and epidemiological factors.
The agency agreed to cover one PET scan to exclude Alzheimer's disease under a coverage with evidence development (CED) program as part of a clinical study, with stipulations including the following:
- The clinical study must be approved by CMS; include subjects from appropriate populations; be comparative, prospective, and longitudinal; and use randomization and postmortem diagnosis as the end point where appropriate.
- Radiopharmaceuticals used in the PET beta-amyloid scans must be cleared by the U.S. Food and Drug Administration (FDA).
- The studies must address who may be at risk for developing Alzheimer's disease, and whether the results lead to improved health outcomes.
The July 3 decision may have been foreshadowed by a CMS advisory committee meeting in January, which gave PET imaging of beta amyloid a less-than-enthusiastic review. The modality scored only 2.2 -- with 5 meaning high confidence -- regarding there being adequate evidence to determine whether brain beta-amyloid PET imaging changes health outcomes of patients who display early symptoms.
CMS said it is accepting public comment on the decision memo. To comment and to review the memo in its entirety, click here.
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