The ups and downs of the first two keynotes at the 2016 Mayo Transform Conference were mirrored in the session The Challenges of Change which highlighted the story of Cologuard. Cologuard is a joint venture between Mayo Clinic and Exact Sciences whose sole goal for the venture was to create a less invasive way for early detection of colon cancer. They succeeded in this goal and were also the first product to receive FDA clearance and CMS reimbursement on the first day. Cologuard launched to much fanfare on national news.
Did they knock it out of the park? Yes. Are they wildly successful today? No. Why? Keep reading and I’ll tell you.
First let’s start with the problem. Colonoscopies, while effective, are not favored by most people. The preparation is extremely uncomfortable, they require general or partial anesthesia, and people need to take time off work. In addition, in some remote communities, it is difficult to get access to care from specialists. As a result, people put off or skip getting colonoscopies and by the time cancer is detected it is often too late. A clinical challenge with colonoscopies is that they are good at detecting left-side tumors but not right side tumors, the incidence of which has been increasing since the 1980s.
Cologuard solves all of these problems. The test is designed to be used at home and is basically a nicely-packaged stool collection kit combined with specialized testing at Cologuard’s lab. No time, and no procedure required for an individual. As well, Cologuard is more effective than colonoscopy at detecting right side tumors, and comparably effective at left-side tumors. Since it’s a home collection, and all tests are processed at Cologuard, access to care is not an issue either and it’s widely used in the Alaska Native Tribal Health Consortium, which was presented as a success story.
Sounds great, yes? Everyone (aka people who at some point will need a colonoscopy or have already had one) I talked to about it thought so. So what’s the problem? As usual, what’s preventing this innovation is an issue of reimbursement. Colonoscopies are a profit center for healthcare organizations, and they are effective, so this isn’t necessarily a case of a better technology losing. It’s the case of a more patient-friendly technology losing, except in Alaska where there really isn’t a viable option for delivering colonoscopies. As well in violation of CMS, some payers are refusing to cover Cologuard.
Cologuard CEO Kevin Conroy was evasive when asked about pricing, which is more expensive than other screenings but pales in comparison to the costs of a procedure that requires booking an operating room and an anesthesiologist.
Let’s hope that a shift to value-based care changes this. From a patient’s perspective it can’t come soon enough.
PS Apparently a lot of single Cologuard kits are being ordered by cardiologists and other specialists. Conroy thinks they’ve recognized the value and are using the kits on themselves. Harrumph.