With the nation's largest commercial payer on board, the maker of the at-home DNA colon cancer screening test will put more focus on physician education and consumer awareness, with the hope of increasing screening rates for a test that patients find uncomfortable and inconvenient.
Starting July 1, 2017, UnitedHealthcare will begin covering Cologuard, a stool DNA screening test for colorectal cancer that will be available to 86% of covered lives, a share that will reach 95% by 2018, according to several projections.
Cologuard, approved in August 2014 through a joint FDA-CMS parallel review program, took flight last summer after the US Preventive Services Task Force clarified its recommendations; it changed language to reflect that the DNA test was an A-rated preventive service under the Affordable Care Act (ACA). UnitedHealthcare’s decision follows Aetna’s March ruling to cover the DNA test once every 3 years. It is also covered by Humana, Cigna, and Tricare.
Colorectal cancer (CRC) is the third most common cancer in the United States. About 65% survive 5 years, but the disease is costly to Medicare—and, thus, the ACA has encouraged screening as a covered preventive service starting at age 50. However, many adults—especially those who are still working—find the test burdensome, since it requires patients to fast and take medications to clear out their bowels. Most must miss a day of work and get someone to drive them to and from the test site.
Colonoscopy remains the recommended test for those with a family history of the disease, or for those whose previous screenings have uncovered lesions or polyps. But for those with average risk who would otherwise skip a screening, the DNA test offers an option, said Kevin Conroy, CEO of Exact Sciences, which makes the test. As commercial coverage has expanded, Exact Sciences has seen an uptick in use by working age adults.
“We expected that would occur over time,” Conroy said. The discomfort and burden of colonoscopy—from the prep time, the lost time from work, the embarrassment—all limit the number of people who will complete the procedure, he said. “The key thing is giving patients a choice—having a conversation between the patient and the doctor, and shared decision-making.”
Colon cancer screening rates were 65% of the recommended population in 2013, and the US Healthy People 2020 guidelines call for raising this rate to 70% by the end of the decade. Of note, 76% of those who had never been screened had insurance, which suggests there are other barriers to testing.
Cologuard is not the first at-home colorectal screening, but has been found to be more sensitive than the fecal immunochemical test (FIT). According to an advisory published by Mayo Clinic, sensitivity of Cologuard for CRC was 92.3% overall and 94% for the earliest and most curable cancer stages, which the advisory called “on par with colonoscopy.” FIT was 73.8% overall and 70% for the most curable cancers.
For polyps with high-grade dysplasia, detection rates were 69.2% with Cologuard, compared with 46.2% with FIT, while rates for serrated sessile polyps measuring 1 centimeter or more were 42.4% for Cologuard and 5.1% for FIT.
Taking a Cologuard test starts with a patient’s registration on Exact Sciences’ website, and forms are sent to the physician who forwards the prescription to the company. A kit arrives at the patient’s home, with plastic containers for the stool samples that take about 10 minutes to collect and reseal within the same box. No fasting or prep is required. Conroy said about two-thirds of the patients return the kits with little or no follow-up, but the company keeps after the rest.
For commercial payers, the rapid uptake could be due to cost: Cologuard costs $599 (Medicare pays $502), while colonoscopy costs considerably more. The test could change the math from what was projected just a few years ago in studies in The American Journal of Managed Care®.
Studies published in 2015, but submitted just as Cologuard was reaching the market, estimated that increasing the uptake of screening from 50% to 100% would boost costs for a commercial payer by $3 per member per month, while decreasing cancer treatment costs by $1 per member per month in the 50 to 64 age group. Kathryn Fitch, RN, MEd, and her co-authors estimated that the cost of screenings per life saved at $12,000, comparable to lung cancer screening and lower than cervical or breast cancer screening.
But Jennifer K. Maratt, MD, and Sameer D. Saini, MD, MS, writing in that same issue of AJMC®, pointed out the rub of colon cancer screening for commercial payers—assuming at that time that most would get a colonoscopy. The procedure’s cost—which can vary from $1200 to more than $2500 depending on where a patient lives—meant that commercial payers might pay for the screening, but the downstream savings would largely accrue to Medicare.
Payers, providers, and health systems will soon have additional incentives to encourage the use of an at-home test if it means they will get more people screened: the prospect of penalties under the Medicare Access and CHIP Reauthorization Act (MACRA). As alternative payment models take hold, doctors and accountable care organizations could face penalties if they have inadequate screening rates, and Conroy said Exact Sciences is educating doctors about Cologuard’s convenience and its extensive follow-up with patients—from reminder mailers to phone calls if patients don’t send back their kit right away.
With payer coverage largely resolved, Conroy said Exact Sciences will put more focus on physician education and consumer awareness. “In the last couple of quarter, we have seen 700 to 800 new ordering physicians every week,” he said. Once a physician tries the test for 1 or 2 patient, he or she typically starts ordering more tests.
Not having to chase down patients to return the tests has huge appeal for doctors, Conroy said. “They love the fact that we are making the effort on our dime to work on patient engagement.”