Study: Cologuard Less Effective And More Costly Than Alternatives

Exact Sciences’ Cologuard test is less effective at saving lives and more costly than other CMSreimbursed colorectal cancer screening tests, according to a study published September 4 in PLOS One, a peer-reviewed scientific journal published by the Public Library of Science.

The study was requested by CMS and conducted by investigators at the Cancer Intervention and Surveillance Modeling Network. Lead authors were Steffie Naber, PhD, from the Department of Health Care Innovation & Evaluation at University Medical Center Utrecht in the Netherlands, and Amy Knudsen, PhD, from the Institute for Technology Assessment at Massachusetts General Hospital. No conflicts of interest were reported.

The researchers used three different models to simulate a cohort of previously unscreened 65-yearold Americans who are screened with Cologuard every three years, or one of six other CMS-reimbursed screening strategies.

Life Years Gained
Compared to no screening, triennial Cologuard testing resulted in an average of 82 life years gained (LYG) per every 1,000 simulated individuals. This was more than for sigmoidoscopy (80 LYG) at a five-year interval, but less than every other simulated strategy. The most effective strategy by far was a 10-yearly colonoscopy (104 LYG).

The reduction in lifetime risk of death from colorectal cancer was lowest for Cologuard (66%reduced risk) and highest for 10-yearly colonoscopy (84%).

Cost Effectiveness
The study found that at its 2017 reimbursement rate of $512, Cologuard was the most expensive strategy. Two of the models showed that reimbursement for triennial Cologuard testing would need to be drastically lower, in the range of $6–18 per test, for it to be cost-effective. In the third
simulation model, there was no level of reimbursement at which Cologuard would be cost effective (unless priced below zero).

The most cost-effective strategies were 10-yearly colonoscopy and an annual fecal occult blood test (either guaiac-based or FIT).

What can CMS do?
The Medicare Part B program spent $170 million on Cologuard testing in 2018 and analysts’ projections suggest Part B spending on the test will rise by 78% to about $300 million this year. But there isn’t a clear-cut way for CMS to change its reimbursement rate for Cologuard under PAMA regulations. However, private insurance companies are likely to jump on the study’s findings as rationale to cut their rates. Over the long term, this should lead to significantly lower Medicare rates for Cologuard.