Thursday, June 16, 2022

Very Brief Blog: CMS Starts NCD Process on Beta-Amyloid PET Scans

CMS reopens discussion on a ten-year-old NCD that allows beta-amyloid PET scans to be covered only in clinical trials.


Famously, over the past year CMS announced then finalized a decision not to cover the Alzheimer drug Aduhelm (except in new RCTs).  Here.   In the background was the last time they considered a NCD on an Alzheimer product - when they reviewed the Lilly amyloid tracer Amyvid in 2013 (negative outcome here.)   Since then, for nearly a decade, CMS has covered PET scans with Amyvid (or similar tracers) in a few studies, notably one called IDEAS.   From time to time there have been complaints (e.g. a 2021 letter to CMS on the poor Amyvid coverage, here. Authors included the American Academy of Neurology.) 

With the uptick in interest in Alzheimer's disease drugs, and more coming through the FDA pipeline, it's been asserted that this should be a golden age for Alzheimer diagnostics - for example, a 2021 article in Forbes, here.  The FDA approved the first-ever CSF test for Alzheimer's disease, a Fujirebio amyloid protein test, in May 2022, here.  And with the current boom in the horizons of sensitive proteomics, blood-based Alzheimer tests for tau and amyloid may not be far off.  See a 2022 open access review on PubMed, here.

On June 16, 2022, CMS opened a new NCD process, seeking public comment on whether (and how) to reconsider its non-coverage of Amyloid PET scans.  See the CMS webpage for this topic here.   

CMS writes, 

CMS internally generated the opening of this NCD analysis based on stakeholder feedback, including public comments received during the finalization of the NCD for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease because clinical study protocols may involve more than one PET Aß scan per patient.

The timeline proposed is the typically slow one for NCDs.  CMS opens public comment on the "idea," now, til July 15, and then will issue a proposed decision by December 16.   While CMS could issue a proposed decision faster, it almost always issues a proposed decision after the full six month delay the law allows.