Thursday, February 23, 2023

Very Brief Blog: CMS Turns Down Alzheimer Association Request on Drug NCD

In December 2022, the Alzheimer Associated submitted a detailed formal request to CMS, asking for reconsideration of a current, extremely limiting coverage of FDA-approved Alzheimer drugs.  See my blog with links here.

On February 22, 2023, CMS issued a press release that the request would not be accepted; the status quo remains.   Here.

CMS writes in the press release, 

At this time, CMS is not reconsidering the national coverage determination (NCD) for Food and Drug Administration (FDA)-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable.  After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration.

CMS also refers to "CMS's letter to the Alzheimer's Association," suggesting that there's a letter circulating behind this press release.

Alzheimer's Association released its own press release and therein, linked to the 3-page CMS response letter in PDF.

See Reuters here.  See Fierce Pharma here.  See "New Drug is Game Changer" at Nature here.  A pivotal study for lecanemab appeared last month in NEJM here.

CMS in its response said it was waiting for FDA  confirmation of "clinical improvement" but the FDA accelerated approval, and NEJM publication, including significant impact on clinical memory scales, which to my ear, IS clinical improvement (in a disease which is a cognitive disorder).   

See a trade journal article on Alzheimer measurement scales by Annalee Armstrong who is a senior editor at Fierce Biotech - here.