The Centers for Medicare & Medicaid Services ruled against new reimbursement coverage for beta-amyloid imaging agents in use with positron emission tomography scans with exceptions for certain indications.
The CMS ruling denied coverage for most PET Aβ scans, saying that there was "insufficient evidence" that such imaging is "reasonable and necessary" for the indications examined. The healthcare regulators granted 2 exceptions:
- to exclude Alzheimer’s disease (AD) in narrowly defined and clinically difficult differential diagnoses, such as AD versus frontotemporal dementia (FTD); and
- to enrich clinical trials seeking better treatments or prevention strategies for AD, by allowing for selection of patients on the basis of biological as well as clinical and epidemiological factors.
CMS agreed to cover 1 PET Aβ scan per patient in clinical studies that meet the agency’s criteria. The rules for reimbursement, deemed "coverage with evidence development," include requirements that any potential studies receive approval from CMS, fit in CMS time-frames and that use of PET Aβ in such studies appears to improve health outcomes.
The ruling was widely criticized by healthcare giant Eli Lilly (NYSE:LLY), which expressed "disappointment" in the agency’s decision, saying that "coverage with evidence development" creates new hurdles for healthcare providers looking for new options for their patients.
"This final decision is not only contrary to expert opinion and published Appropriate Use Criteria previously recommended by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging, but contradicts the statutory authority CMS has over coverage determinations for diagnostics," according to a company statement. "CMS participated in creating this plan aimed at developing new and innovative ways to diagnose, support and treat patients suffering from Alzheimer’s Disease – yet the same agency is challenging the value of the only technology approved by the Food and Drug Administration for estimating beta-amyloid neuritic plaque density in the living brain, which can aid in helping doctors make a more informed diagnosis."
Eli Lilly, which manufactures the Amyvid amyloid imaging agent, had in July 2012 asked CMS to reconsider its non-coverage decision for PET scans, hoping to win coverage for scanning to "estimate amyloid neuritic plaque density in adult patients with documented cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment," according to the CMS decision memo.
CMS has not previously covered PET Aβ, but does provide national coverage for PET with fluoro-D-glucose F18. Amyvid is the only FDA-approved radiopharmaceutical for estimating "Aβ neuritic plaque density in adult patients with cognitive impairment who are being evaluated for AD and other causes of cognitive decline."
