Thursday, December 22, 2022

CMS Alzheimer News: PET Scan NCD Delayed; Alz Assoc Requests Drug Coverage Revisited

 A few pieces of year-end Alzheimer news on the CMS front.  An NCD about amyloid PET scans is delayed.  A new request for expansion is submitted, for the very narrow NCD on Alzheimer drug coverage.


Years ago, CMS reviewed the then-new amyloid PET scan biomarker AMYVID, and determined it would only be covered in endorsed clinical trials.  (One of these, IDEAS, was completed).   The NCD included a flat limit of one scan per patient. 

Now, there will potentially be Alzheimer drugs that require two or more serial amyloid PET scans.  In mid 2022, CMS announced it was revisiting its Amyloid/PET NCD, and posted an expected draft decision deadline of December 16, 2022.   Entry point here.

OK, the news:  That deadline has come and gone, and CMS posted a notice it was continuing to review recent data on the topic. Find update here, which states:

December 15, 2022 // CMS will not be issuing a proposed NCD on Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease today. A proposed decision is forthcoming after CMS has reviewed newly published evidence that is relevant to the proposed NCD.

That recent news, of course, is the lecanemab clinical trial, Van Dyck et al, November 29, 2022, NEJM here.


In 1H 2022, seems like a long time ago, CMS announced very limited clinical trial for the FDA-approved Alzheimer drug Aduhelm, with the result that the drug was essentially off the market. (Alz. Assoc comment here.)  

The NCD applies prospectively to future approvals of future amyloid drugs, something that riled some stakeholders and led Congr. Buchanan to introduce legislation - "MERIT" forbidding NCDs to have "class action" on all drugs in a class (here).  News item here, here.

What's new.  With a press release and an 11-page open letter to CMS, Alzheimer Associate asks CMS to substantially expand drug cover for this class of drugs.

NCD request letters are always worth reviewing to see how different stakeholders approach the problem.  It's an issue of providing thorough evidence, but not going on forever (10pp not 100pp).   It's an issue of convincingly stressing the positive, while not failing to mention or  deal with reader objections and counterarguments.   It's a tough balance and letters like this often go through a number of  re-writes.   


About the same time, ICER has released a pretty negative report on the health economics of  Alzheimer drugs.  Here.

For comparison, see a 14 page MolDx LCD request letter here.  For an extra type of comparison, see ACLA's short white papers and press releases on the validity and value of NIPS testing, here


For the CDC pages from HR 2617 and from Congr Record, here.