Contributing Writer

While the FDA and Centers for Medicare & Medicaid Services (CMS) have yet to issue final decisions on either of the two products accepted into the parallel review pilot program, everyone involved said they are very pleased with the program thus far.

The pilot program was launched in 2011 to both excitement and skepticism from industry. On one hand, a concurrent FDA/CMS review could eliminate the potential six to nine month delay between the time FDA completes its review of an application and CMS opens a national coverage decision (NCD). On the other hand, a concurrent review could prove more burdensome as it relates to designing clinical trials that satisfy the requirements of both agencies.

Because of this uncertainty, combined with the narrow criteria for participation, the agencies said they anticipated limited interest in the program. Ten companies applied and were accepted to participate in the pilot, but only two of those companies ultimately advanced to the point of having their products concurrently reviewed.

"FDA anticipated a small number of participants a year and the candidates for the pilot are limited to candidates for an NCD, typically a small subset of devices approved in a year," an FDA spokesperson told Medical Device Daily. "Under the terms of the parallel review pilot, FDA and CMS will not reveal participation of a sponsor/requester in parallel review before CMS's posting of [an NCD] tracking sheet, a milestone that has not yet occurred for any participant."

However, Medtronic (Minneapolis) and Exact Sciences (Madison, Wisconsin) have made public their participation in the program, and the former believes the experience has been very positive and productive.

"We see parallel review as a novel way to accelerate patient access to new and potentially beneficial technologies and therapies," said Mitchell Sugarman, VP of health economics, policy and payment at Medtronic. "The meetings we had with both CMS (coverage and analysis group) and FDA were very productive in gaining an understanding of each agency's perspective while simultaneously enabling both agencies to provide input into the direction of our research activities. While the program is still a work in progress, our experience taught us the value in early communication with both agencies and doing so in a very transparent and candid way."

Sugarman also is not concerned that the agencies have yet to approve or issue an NCD for its Symplicity renal denervation device, adding that one of the benefits in parallel review is that "CMS could be completely up-to-speed and ready to pull the trigger on an NCD almost immediately at the time of PMA approval."

"Also, it's possible that because CMS would have been fully informed of clinical data prior to PMA approval, they might not even need an NCD but rather 'signal' to Medicare payers (Medicare administrative contractors) that they felt the data were sufficient for coverage without an NCD," he said. "In other words, not all new technologies go through the NCD process – in fact, most don't, especially if they will fit already into an appropriate [Medicare severity diagnosis related group]."

While it is too soon to tell exactly how much time or money the companies or the agencies saved overall with concurrent review, Sugarman said the real long-term payoff will be in the relationships Medtronic has formed with regulators.

"While traditionally we have interacted early with FDA (pre-IDE meetings, etc.), our interactions with leaders and teams at [CMS' coverage and analysis group] helped us build a much better relationship with the group, one which I'm sure will continue to help us whether in formal parallel review or not," said Sugarman. "We see even informal early communication with CMS about clinical trial design, outcomes, durability, etc. as being crucial to reducing the time between regulatory approval and coverage by CMS."

For its parts, the agencies described their working relationship as "very collegial" and pilot participants as "very responsive."

"The agencies work independently to arrive at conclusions to satisfy each agency's regulatory needs for the product(s) under consideration," an FDA spokesperson said. "Also, the companies who stood up for the pilot have been good about providing information needed for adequate review."

When asked if either agency has seen any major saving in terms of time or money from conducting concurrent reviews, the FDA spokesperson told Medical Device Daily that overlapping timeframes in agencies review processes create the potential for small but important efficiencies.

"Greater efficiencies may be realized by earlier coordination among FDA, CMS, and product sponsors on trial design, the spokesperson said. "Additional data about the value of coordination is necessary to assess the extent these potential efficiencies can be realized."

Once the agencies have reached a decision on these products, the agencies plan to assess the program to determine if the program should be permanent or expanded to include additional types of products.

CMS and Exact Sciences did not return phone calls for comment in time for publication.

Published: July 21, 2014