As FDA and CMS officials develop steps for parallel medical product reviews, a key question is when CMS should be brought into the pre-market process.

“When do we bring in CMS? Do we engage CMS initially when we have a device where the manufacturer has indicated an interest in parallel review and [if] we think it is an appropriate candidate? Also, when does CMS begin its analysis for a preliminary national coverage determination recommendation?” asked Nancy Stade, deputy director for policy at FDA’s Center for Devices & Radiological Health.

“Those are two of the big questions we still have that we are going to need to sort through.”

Stade and two CMS regulators talked about their ongoing work to develop a parallel review process during a Dec. 10 session at the Elsevier-sponsored FDA/CMS Summit for Biopharma Executives in Washington, D.C.

In FDA's view, a major benefit of FDA-CMS pre-market collaboration would be to speed the path to market for innovative products.

Louis Jacques, director of the Coverage and Analysis Group at CMS’ Office of Clinical Standards and Quality, and Tamara Jensen, deputy director of the Coverage and Analysis Group, also participated in the discussion.

FDA and CMS signed a memorandum of understanding June 23 to promote the sharing of information and to explore the possibility of starting, at a manufacturer’s request, a Medicare national coverage analysis while a device is still under FDA pre-market review. Right now, FDA review typically happens first. (See “ Also see "FDA And CMS Agree To Share Data Routinely In Step Toward Parallel Reviews" - Medtech Insight, 28 June, 2010. ” – “The Gray Sheet,” June 28, 2010.)

A pilot program will eventually launch the formal effort. Public comments on the pilot were due in mid-December. (See “ Also see "FDA And CMS Parallel Reviews Will Begin With Device Pilot Program" - Medtech Insight, 20 September, 2010. ” – “The Gray Sheet” Sept. 20, 2010.)

Jacques indicated that CMS engagement at the clinical trial stage would be helpful.

"One of the things that is extraordinarily frustrating for us is sometimes manufacturers get through FDA and they come to us, and it turns out that even they have to admit that the evidence ... is entirely off the map for CMS. And we kind of sit there and go, 'If only we had talked two or three years ago,'" Jacques said.

A Catalyst For Innovation?

Some device firms have expressed wariness about participating in parallel reviews. And the device trade association AdvaMed has warned that both agencies may have too many other pressing changes in the works right now to thoroughly pursue the idea. (Also see "Device Firms Weigh Pros And Cons Of FDA-CMS Parallel Review" - Medtech Insight, 22 November, 2010. – “The Gray Sheet” Nov. 22, 2010.)

But many investors have been clamoring for the process, said FDA’s Stade.

“We do hear from venture capitalists that parallel review – collapsing the time frames for review and the timeframe between when a product is approved by FDA and when it would be covered – is one of the things the agencies can do to really encourage investments,” she said.

In FDA's view, one of the major benefits of FDA-CMS collaboration would be to speed the path to market for innovative products, Stade added.

"The second benefit is anything that encourages product sponsors to think about the populations their device will be used in, and to think about developing data that will demonstrate use in the Medicare population if that is where it is going to be used, is to the benefit of public health," said Stade.

Jensen, of CMS, agreed, commenting that if both CMS and FDA are at the table in the pre-clinical stage, "it won't be a secret as to what we are looking for."

“You can develop whatever trial that needs to be developed that will not only answer FDA’s questions but will also likely answer Medicare’s questions,” Jensen said.

As a general rule, CMS wants to see evidence that the technology in question improves health outcomes in the 65-and-older Medicare population, whereas FDA focuses on the somewhat different questions of whether the device is safe and does what it claims to do.

More Benefit To Small Innovators?

Jacques cautioned that he sees some tension in the device industry over the issue of parallel reviews.

Smaller, venture-backed companies, he said, may be eager for parallel reviews because they are concerned about their cash burn rate, and lack “a vast pantheon” of products to support development costs.

“They need answers and in some cases they want an answer, whether it is a yes or no. The issue is they need [coverage] sooner rather than later,” Jacques said.

“Whereas for a larger company it might be to their advantage to keep the question unanswered, and keep the ball in play for a period of time, hoping for different political winds or something else.”

Stade agreed. “Smaller companies that are reliant on venture capital markets are probably more interested in any incentive that would collapse the time from when they get a favorable FDA decision to when they get a favorable coverage decision from CMS,” she said.

Stade added that she wants to hear from companies about the types of products for which parallel review “is most appealing.”

A Modest Beginning For Parallel Review

When parallel review begins, all said they expect the process to be relatively modest. And they stressed that it will be a voluntary program that codifies something that in fact already occurs unofficially on a case-by-case basis.

An overflowing workload at both agencies also makes it unlikely that parallel reviews will become commonplace anytime soon.

“On a practical basis, where [in the process] I want to be involved is probably less important than where we have enough resources to be involved,” Jacques said.

“We want to engage CMS when we feel pretty confident that this is a product that is going to get out there with an approval” – FDA’s Nancy Stade.

The process will probably be most appropriate for PMA products, said FDA’s Stade.

“The pool of products that are candidates for parallel review is fairly small,” she noted, adding that only 15-20 devices a year are considered for national coverage determinations.

“I couldn’t imagine it having a major impact on 510(k) products,” she said.

Stade said the pilot will begin with a product that appears to have a fairly sure shot at regulatory success.

“We don’t want any huge debacle in the first trial run for parallel review,” she said. “We want to engage CMS when we feel pretty confident that this is a product that is going to get out there with an approval.”

By Mark Hollmer

A Question For Parallel Review Planners: When CMS Should Get Involved

More from Archive

More from Medtech Insight