Very Brief Blog: AHRQ Undertaking Review of Liquid Biopsy in the Medicare Population

I'm not sure of the backstory on this, but AHRQ is in the process of doing a report for CMS on the value of liquid biopsy in the Medicare population.

UPDATE:  When I wrote this June blog, I failed to link it to the February 28, 2020 CMS announcement that it was undertaking a review of liquid biopsy tests for colorectal cancer screening.  The CMS NCD review and the AHRQ liquid biopsy review are likely related.   The NCD tracking page is here.  CMS opened this agenda item on February 28, 2020, and will issue a proposed decision memo on August 28, 2020.

Here, you'll see they are showing an in-progress report with a link that ties to an 8 page outline and key questions document.  I've also put the 8 page outline in the cloud here.  It's dated May 2020.  

My first guess is that CMS may consider undertaking an NCD in the liquid biopsy space once this review is completed (which probably will take 6-12 months).   

On the other hand, CMS may find the space too complex, diverse, and fast-moving for an NCD.  CMS might state in an NCD that FDA-approved tests in this space would be Medicare-covered, while LDT tests would be up to local MACs.

In the structured questions, they're prepared for most any use of liquid biopsy - for example, from colon cancer screening to rule in/rule out suspected cancer (e.g. nodule on imaging) to the more familiar testing of tumor oncogenes like ALK via liquid biopsy.

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Update: The AHRQ comment period ran May 27-June 12.

Update: For a July 2020 consensus review in Nat Rev Clin Oncol on LBx in colorectal cancer, 14pp, Dasari et al., here.

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.
• UPDATE: See AHRQ review on this topic, June 2020, 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.