The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have jointly approved the first-ever product through a parallel review pilot program that seeks to accelerate the process by which device products obtain government reimbursement decisions.

Background

The pilot program, known as Parallel Review, was conceived in October 2011 as a way to allow companies to get their products from an investigational stage to reimbursement more quickly. At present, FDA's approval process and CMS' national coverage determination (NCD) process—the process by which it comes to a decision regarding whether it will pay for a product, generally through Medicare—are separate, and are handled by different staff and at different times of the development lifecycle.

"Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming," FDA explained in a statement at the time of the pilot program's launch. "Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare national coverage determinations."

The Parallel Review pilot program looks to change this by allowing concurrent review, hypothetically allowing companies to reduce the gap between obtaining FDA approval and a reimbursement decision. Because Medicare is one of the largest purchasers of medical device products in the US, a positive NCD can sometimes be a de facto approval for a product, as without the NCD a product might not have a market.

"The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes. Our goal is to reduce regulatory burden and improve patient outcomes," said Patrick Conway, CMS' chief medical officer, in 2011.

Stops and Starts

The Parallel Review pilot has seen more than a few setbacks since its inception.

While it was extended in December 2013, it had—up until today—never before approved a product (though some approvals have been similar in principle), and had seen little interest from members of industry.

And in January 2014, the program was dealt a potentially crushing setback through no fault of its own when Medtronic's Symplicity Renal Denervation Device failed a Phase III trial by missing its primary efficacy endpoint, thereby delaying its review under the program for several more years at best.

First Success

But despite the setbacks, the program has now witnessed its first success. On 11 August 2014, FDA announced that it had approved Exact Sciences' Cologuard, a non-invasive colorectal screening test that detects potentially cancerous growths through the use of DNA screening.

FDA explained: "Using a stool sample, Cologuard detects hemoglobin, a protein molecule that is a component of blood. Cologuard also detects certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Patients with positive test results are advised to undergo a diagnostic colonoscopy."

But what makes this approval notice different is that CMS simultaneously issued a proposed National Coverage Determination (NCD) for Cologuard based on its review of the device during FDA's approval process.

FDA officials noted that this was the first time that FDA had approved a device on the same day that CMS had proposed an NCD for that same device.

“This parallel review represents unprecedented collaboration between the two agencies and industry and most importantly will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer," said Patrick Conway, chief medical officer for CMS, in a statement.

FDA's Nancy Stade, deputy director for policy at the FDA's Center for Devices and Radiological Health (CDRH), said that the agency is already looking to apply lessons learned during the parallel review of Cologuard "to improve the efficiency of the medical device approval pathway for devices that address an important public health need."

What remains to be seen is whether the Cologuard approval is the first of many similar approvals, or a swan song for an otherwise beleaguered program.

FDA Statement