The Centers for Medicare & Medicaid Services (CMS) could remove PET scan restrictions to better determine whether patients qualify for new drugs and to shine light on whether a drug is slowing cognitive decline in people with Alzheimer’s disease symptoms.
The memo, released July 18, suggests removing the national coverage determination (NCD) that is currently applied to beta amyloid imaging.
“We believe removal of [the NCD] will allow appropriate coverage of amyloid PET scans and will greatly reduce provider and patient burden from the existing requirements and test limitation,” according to the memo. “Stakeholders and patients have particularly emphasized the constraints on choice of treatments and appropriate management of proven antiamyloid treatments due to the once-in-a-lifetime limitation.”
PET scans, one of the most used methods for patient selection in clinical trials, help confirm whether brain amyloid exists and can guide future treatment. Medicare first started covering singular PET scans for clinical trials in 2013.
Now, CMS believes more than one PET scan may be beneficial for clinical studies, as it proposes to remove the rule limiting just one brain scan per trial. Medicare determinations will be made by Medicare Administrative Contractors and could allow for scans outside of clinical trials.
“Isolated PET research separate from treatment trials through this CED NCD is no longer needed and no longer being requested by stakeholders,” according to the memo. “Moreover, stakeholders and patients have specifically noted that the once in a lifetime limit on amyloid PET is outdated and not clinically appropriate due to the development of antiamyloid treatments and the need to confirm the presence of amyloid to start these treatments and to possibly discontinue treatments when brain amyloid has been completely removed to avoid unnecessary treatment harms.”
Other innovative treatment, like inhibitor drugs and nanotechnologies, did not exist when prior coverage and limitations were established but also “need confirmation of the presence of brain amyloid.”
Scientists disagree as to which monoclonal antibodies are most effective versus Alzheimer’s. Lecanemab, also referred to as Leqembi, recently secured full FDA approval and more expansive coverage from Medicare.
Beta amyloid presence is regarded as a hallmark of Alzheimer’s, even after an investigation found flaws in previous Alzheimer’s studies, but it’s unclear whether it is a cause or simply a sign of the disease, the memo states.