FDA, CMS Parallel Review Aims to Speed Access to Innovative Technologies

A strategy of simultaneous assessment by the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) should help streamline the approval process for certain medical devices. The agencies announced the initiative in the October 11, 2011, issue of the Federal Register.

For now, parallel review is strictly a pilot program and requests for this type of review will be accepted for 2 years beginning November 10, 2011. However, no more than 3 to 5 candidates will be accepted per year and there will be no public disclosure of participation. If all goes well, the agencies intend to use their experience with the medical devices pilot program to develop a broader parallel review program for drugs and biological products.

David E. Kandzari, MD, of the Piedmont Heart Institute (Atlanta, GA), told TCTMD in a telephone interview that the parallel review program is an important step for the FDA in deflecting recent criticism from both the medical community and the public over increasing delays in device and drug approvals in the United States.

A shining example of this criticism is the Sapien transcatheter heart valve (Edwards Lifesciences, Irvine, CA), which was approved by European regulatory authorities in 2007, but remains unapproved in the United States despite good evidence that it is a feasible alternative to surgery for the many patients with symptomatic, severe aortic stenosis whose age or illness makes them poor surgical candidates. Given the years of successful use of transcatheter aortic valve replacement (TAVR) in Europe, and publication of the PARTNER trial, Dr. Kandzari said there is no doubt that it has been a great impetus for change in the regulatory arena.

Combining Two Steps

According to the FDA, the program is the result of the agency understanding that “innovators have generally focused solely on obtaining FDA approval, only to later realize that Medicare payment may not automatically be forthcoming.”

The new parallel program is intended to reduce the time between FDA marketing approval or clearance decisions and Medicare National Coverage Determination (NCD). Among the expected benefits are:

• Quicker access for patients to innovative medical technologies
• Timely insight into the information needs of CMS with respect to pursuing a positive NCD, as well as a potentially shortened time to payment due to a streamlined multi-review process for sponsors
• Enhanced channels of communication between FDA and CMS
• Early involvement of CMS to focus attention on health outcomes of importance to Medicare, and provide early awareness of any remaining evidence gaps

Additionally, if FDA approval or clearance is conditioned on a post-approval study request, CMS could decide to cover the device within the parameters of the post-approval study under the Coverage with Evidence Development program.

Focus on Innovative Technologies

According to the FDA, the pilot phase of this program is expected to “focus on truly innovative technologies that are most likely to benefit from the efficiencies of parallel review.” They add that appropriate candidates for parallel review are medical devices that use new technologies:

• For which the sponsor/requester has had sufficient pre-investigational device exemption (IDE) interaction with FDA or approved IDE application
• For which an original or supplemental application for premarket approval (PMA) or petition for de novo review would be required
• That fall within the scope of a Part A or Part B Medicare benefit category and are not subject to an NCD

With so few devices being accepted for parallel review each year, competition is likely to be fierce.

“I think this will be interesting to watch because many companies are going to think their product fulfills an unmet need and will be applying for one of these spots,” Dr. Kandzari said.

Hazard or Help?

Although at first glance it seems to be an ideal compromise between FDA and CMS, he added, the devil lies in the execution. “Overall this is a welcome program but there are some potential downsides for the device industry,” Dr. Kandzari said.

Among these are issues surrounding confidentiality agreements, because FDA is held to regulatory statutes about confidentiality while CMS is not. “This could be of particular issue for companies for whom the technology is very exclusive,” Dr. Kandzari said.

Another issue is that there may be concern that through greater agency collaboration and interaction, somehow CMS could influence device approval, labeling or indications.

“One example of that in reverse is carotid stenting where the FDA has approved it for both high risk asymptomatic and symptomatic patients and yet CMS only reimburses for high risk symptomatic patients outside of clinical trials,” Dr. Kandzari said.

“It also comes down to issues of unpredictable change to the system of approval that may hinder more than help in terms of the time to approval. It adds one more layer to the process,” he asserted. “The FDA approves based on a reasonable assurance of efficacy but CMS reimburses based on reasonable appropriateness and need of the procedure, and those are two very different things.”

Finally, Dr. Kandzari said there are legitimate concerns that joint review could slow down the process even further and make things worse than they are already.

“That’s probably unlikely, but it’s still a possibility,” he said.

Source:

Centers for Medicare and Medicaid Services and Food and Drug Administration. Pilot program for parallel review of medical products. www.gpo.gov/fdsys/pkg/FR-2011-10-11/html/2011-25907.htm. Published October 11, 2011. Accessed October 14, 2011.

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