Parallel Review Progress: FDA Approves, CMS Assesses Cologuard Cancer Test

CMS opened a national coverage determination for Exact Sciences Cologuard, the first stool-based colorectal cancer screening test on the same day FDA approved the test. This is the first simultaneous approval/coverage determination under FDA and CMS’ joint parallel review program.

FDA’s approval of Exact Sciences Corp.’s PMA for the Cologuard stool-based colorectal screening teston Aug. 11, the same day CMS proposed national coverage for the unique non-invasive cancer test, marks an important milestone for the agencies’ parallel review program.

Cologuard is the first product to complete parallel FDA-CMS review under the pilot parallel review program, a voluntarily pilot open to certain medical device applications within the scope of Medicare Part A or Part B. It is intended to bring new technology to patients faster than the traditional process of waiting for FDA approval to begin the coverage determination process (Also see "FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says" - Medtech Insight, 1 Apr, 2013.).

“The parallel review process was instrumental to making Cologuard available to patients broadly,” Exact Sciences Chairman and CEO Kevin Conroy said an in interview. “For a screening test, we needed a national coverage decision and typically that would follow a year or more behind FDA approval, and potentially even longer if CMS wanted to see a second study with a different patient population. Instead, FDA and CMS collaborated in what we think is a really favorable way for our industry.”

FDA says that ten companies have applied to participate in the parallel review program, but only Exact Sciences and Medtronic have been publicly disclosed as participants.

Exact Sciences approached FDA and CMS about participating in the parallel pilot in 2010 and has praised the program for cutting two or three years off of the time it would otherwise take to earn Medicare coverage for the test. Also, by conducting a single study to support both FDA approval and Medicare coverage, Exact Sciences saved the cost of having to conduct separate studies for FDA and CMS, which can cost up to $30 million, Conroy said. Without parallel review, “it could have been almost impossible to bring Cologuard to patients if the agencies hadn’t shown so much foresight,” he said.

The company emphasizes that Cologuard is simple to use, highly accurate, and widely accessible. Using stool samples, Cologuard detects hemoglobin and mutations associated with colorectal cancer in the DNA of cells shed from advanced adenomas. Patients with positive test results are referred for diagnostic colonoscopy. The approval was based largely on the results of the 90-site, 10,000-patient DeeP–C Study, which showed that Cologuard’s multitarget stool DNA testing detected significantly more cancers than fecal immunochemical tests, although it produced more false positive results.

FDA’s Molecular and Clinical Genetics Advisory Panel voted unanimously to support FDA approval of Cologuard in March (Also see "Exact Sciences’ Cologuard Gets Panel Nod As Colorectal Cancer Screen" - Medtech Insight, 27 Mar, 2014.). The company is also supporting a five-year post-approval study.

In the draft coverage decision memo posted Aug. 11, CMS proposes to require national Medicare coverage of Cologuard once every three years for beneficiaries age 50 to 85 who are asymptomatic for colorectal disease including and are at average risk of developing colorectal cancer based on family history and their own history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease.

CMS is seeking comments on the proposed decision until September 10 and expects to post a final decision on November 11.

Although Cologuard is the first device to get this far under parallel review, the agencies have considered other devices for this accelerated process. FDA and CMS agreed to review Medtronic PLC’s Symplicity renal denervation hypertension treatment in parallel, but that process came to a halt when the firm’s SYMPLICITY HTN-3 trial failed to meet its primary efficacy endpoint (Also see "Renal Denervation Downer: Medtronic’s Pivotal Trial Misses Efficacy Endpoint" - Medtech Insight, 10 Jan, 2014.)). The future of Symplicity and all renal denervation ablation catheters to treat hypertension is currently uncertain (Also see "Hypertension Experts Push For New Trial Of Renal Denervation To Show Efficacy" - Medtech Insight, 24 Jul, 2014.).

FDA says that 10 companies have applied to participate in the program, but under the terms of the parallel review pilot, the agencies cannot reveal the identity of those companies until CMS posts a National Coverage Decision tracking sheet or the company choses to make its participation public.

Also, prior to the initiation of the formal parallel review pilot program, the agencies collaborated under a 2010 memorandum of understanding, which allowed CMS to open a national coverage analysis for transcatheter aortic valve replacements procedures in 2011, even before FDA had approved any TAVR devices. CMS ultimately issued a national coverage decision for TAVR about six months after FDA approved Edwards Lifesciences Corp.Sapien TAVR system (Also see "CMS Policy Sets Boundaries On Transcatheter Valve Procedure" - Medtech Insight, 7 May, 2012.).

[Editor’s note: Each week, “The Pink Sheet” DAILY features a story contributed by “The Gray Sheet,” highlighting a current topic in the medical device or diagnostics sectors.]