Sunday, March 1, 2020

CMS Opens NCD on First FDA-Approved Blood-Based Screening Test for Colorectal Cancer

CMS covers a range of services for screening for colorectal cancer - colonoscopy, fecal occult blood testing by immunoassay, and most recently, the Cologuard FDA-approved oncogene detection test which is stool-based.

2018 payments for Cologuard (CPT 85128) were $170M, about 15% of all Medicare genomic payments [excluding virology; this blog, here.]  However, Cologuard has recently been faulted in terms of cost-effectiveness (here).

On Friday, January 28, 2020, CMS announced it was opening a review of another FDA-approved colon cancer screening test, the Epi proColon test.
  • See the CMS tracking sheet here.  CMS will take public comment on the proposal to review Epi proColon from 2/28/2020 to 3/29/2020.
  • CMS expected to release a draft NCD by August 28, 2020 and a final NCD by November 26, 2020.
    • Epigenomics, the parent company, requested the NCD in April 2019 (here).  
    • This means the duration from from request to final NCD will be about 16 months.
    • BUT: I think it's clear from Epigenomics quarterly investor calls that discussions with CMS began much earlier, closer to its FDA approval in June 2016 and thus through CY2017 and CY2018.
  • See Genomeweb open access summary here.
A substantial proportion of US beneficiaries get no colorectal cancer screening by any method.  A blood test could provide access to screening for those who are not performing the stool tests nor undergoing outpatient colonoscopy.

Other companies are putting blood-based CRC screening tests into large clinical trials, e.g. Guardant Health (here).   Typically, the screening studies survey circa 10,000 patients to have a 1% hit rate (100 patients) with actual colorectal cancer, to allow good statistics around that subpopulation of n=100 who are true positives.

A recent publication, supported in part by Epigenomics, found that while colonoscopy has very high theoretical health impact, at real-world reported adherence rates, other tests such as Epi proColon (methylated Sept9) may have equal or better health impacts.  See D'Andrea et al. 2019 here.