CMS creates blood-based CRC test approval guideline, but denies 1st-FDA-approved test

CMS issued a proposal which declined to cover the first FDA-approved blood-based colorectal cancer screening test, but created a guideline for still-in-development tests to earn approval, according to an Oct. 16 memo.

The proposal can be revised until January 2021, when it's believed CMS will issue a final guideline. CMS believes there is enough evidence to allow for a blood-based biomarker test to treat certain Medicare beneficiaries once every three years or at an FDA-designated screening interval. 

CMS will approve the test for patients that are: 

  • Between 50-85 years old
  • Asymptomatic
  • At average risk for developing CRC

To earn CMS' approval, the test must: 

  • Have FDA-market authorization with an indication for CRC screening
  • Have proven test performance with sensitivity greater than or equal to 74 percent and specificity greater than or equal to 90 percent — which are the rates of leading colonoscopy alternatives
  • Be included as a recommended CRC screening test in a professional society guideline or by the U.S. Preventive Services Task Force

CMS commenced the review and created the guidance at the request of pharmaceutical company Epigenomics. The company was seeking CMS approval for its FDA-approved blood-based screening test Epi proColon. CMS ultimately determined that the test did not meet the proposed criteria. 

In a statement, CMS said: "Overall, the Epi proColon test is not a suitable screening test for CRC. There is no direct evidence that shows screening for colorectal cancer with Epi proColon is more effective than [fecal immunochemical testing]. ... As compared to the FIT test, the specificity for Epi proColon was lower. Therefore, compared to FIT, there is no indirect evidence that using the blood-based Epi proColon test is appropriate for prevention or early detection of colorectal cancer among Medicare beneficiaries."

CMS noted its findings were consistent with the U.S. Multi-Society Task Force, the American Cancer Society and the National Comprehensive Cancer Network, who do not recommend the test.  

A 'staggering' precedent 

Epigenomics CEO Greg Hamilton took issue with several of the methods CMS used in its review, he said to Becker's. While the company agrees CMS should cover a test that is equal to or better than tests available to the public, Mr. Hamilton took particular issue with a decision CMS made to cite but not include a study in its analysis that showed epi ProColon was more clinically effective than multitarget stool DNA test Cologuard — which CMS used as its specificity marker.  

Another study, which CMS did include, showed the test was more effective in detecting cancers at every stage than FIT. The test also detected precancerous adenomas almost as effectively as FIT, although neither detected them with any prominence. 

"We are beside ourselves on how CMS could ignore this data," Mr. Hamilton said. "To make matters worse, CMS randomly cherry-picked different point estimates from different tests. They took the sensitivity of FIT, the specificity of Cologuard and the interval of Cologuard and said this is going to be the standard, and we're going to infer that it will reduce mortality with zero evidence." 

Mr. Hamilton cited data, provided to Becker's, from Harvard University's Predict Microsimulation Model that showed CMS' would-be-approved blood test would avert fewer deaths than either epi Pro Colon, FIT or Cologuard.

"The precedent they're setting here is staggering," Mr. Hamilton said. "CMS has never put test performance criteria into a decision. The reason is specificity and sensitivity has always been an FDA determination. … CMS has gone and basically set a new precedent that we know and can prove is highly, highly dangerous." 

The company plans to challenge CMS' decision if the proposal moves forward unaltered. 

Want to share your thoughts? Email eoliver@beckershealthcare.com

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