As regular readers of MassDevice.com already know, the Sept. 17, 2010, Federal Register contained a request for comments on a proposal to initiate parallel review of medical products by the Food & Drug Administration and the Centers for Medicare and Medicaid Services (PDF). The Federal Register notice also unequivocally stated that the agencies will establish a pilot program for such parallel reviews as soon as comments are reviewed, referencing a recent memorandum of understanding between the FDA and CMS which details steps to be taken to implement the inter-agency information sharing — most particularly the commitment to and mechanisms for safeguarding company proprietary information — necessary for a meaningful parallel review process.
The principal express purpose of parallel review would be to improve consumer access to new, innovative, safe and effective medical products by shortening the time between regulatory clearance or approval and a Medicare National Coverage Determination. It also could, as stated in the published notice, “create incentives for venture capitalists and companies to increase their investment in innovative medical products by reducing the time to return on investment for those products eligible for parallel review.” Did you know that the FDA and CMS had, as part of their respective briefs, the duty to improve the medical technology investment climate? The agencies couldn’t be telling industry “you’ve got a friend” any more clearly if they’d paid James Taylor and Carole King to sing it at AdvaMed 2010 in Washington, D.C., next month.
There can, however, be no doubt that the two agencies are serious about a parallel review initiative. They’ve already invested too much effort, and committed themselves publicly, to write this off as simply a sop to industry upset at ongoing review of the 510(k) process and stepped-up FDA compliance enforcement efforts. Nor do I doubt the sincerity of the desire to get new, innovative, safe and effective products to consumers faster. For the FDA, this is just the latest in a number of procedural regulatory initiatives (e.g. fast-track designation for investigational drugs, least burdensome principles for device reviews, and adaptive clinical trials and Bayesian analyses) designed to smooth the path to widespread clinical use for clinically useful new products; for CMS, parallel review is consistent with such recent reforms to give beneficiaries earlier access to innovative technologies as coverage with evidence development, and coverage of IND and Category I device trials. There is, however, a legitimate question as to whether the substantive effect of a parallel review initiative will be meaningful. I have some thoughts about that.
- Only a small number of products will be accepted for parallel review. The developer, the FDA and CMS will all have to consent to a parallel review for any product. There will be defined regulatory standards for “qualification” for parallel review, such as a clinical need threshold, definition of the impacted population (CMS won’t invest scarce resources in parallel review of a pediatric product) and the degree of innovation. It is, for example, highly unlikely that any 510(k) devices will be accepted for parallel review — by definition, such devices cannot be sufficiently innovative, nor will they pose difficult coverage determination questions. There will also be limitations based upon availability of agency, specifically CMS, resources — FDA needs to process every new medical product, and is staffed to do so, but CMS can only manage and staff coverage analyses for products with a high probability of entering the clinic. It is certain that parallel review will be available only very selectively.
- Formal acceptance for parallel review will almost certainly come relatively late in a new product’s engagement with FDA. If CMS will need to be able to assess probability of successful market entry before allocating scarce resource to a parallel review, meaningful clinical data will be required. For drugs and biologics that probably means, at minimum, extremely robust phase 2 data, and may mean initial analyses of phase 3 data. For devices, data from a pivotal clinical trial will likely be required. Product developers seeking parallel review will need to do a lot of preparatory work with no guarantee of acceptance until pretty far along the regulatory pathway.
The availability of parallel review will encourage companies to do a series of things that they ought already to be doing anyway if they foresee Medicare coverage policy as an open issue: Meeting early with CMS to introduce their product and describe their clinical program and trial design, seeking CMS input regarding data requirements for a future coverage determination process, building reimbursement-driven data capture into their clinical trials and voluntarily authorizing FDA to share data with CMS. These four initiatives are all available today — and have been for years. Even with review by CMS conditioned upon prior FDA market clearance, they help to shorten the time to revenue and widespread clinical adoption. They will be essential to realizing the potential benefits of parallel review, and every company considering requesting parallel review ought to begin talking to CMS very early on.
Finally, it should be understood that a defined program for parallel review represents acknowledgment and formalization of a process for which there is rare but highly visible precedent. When human recombinant erythropoietin was approved for initial commercial distribution in 1989, the Medicare program had already determined both terms of coverage and a payment rate; something very similar was true for the initial introduction of drug-eluting stents. In both of these cases, the clinical record was unequivocally positive, there was great anticipation in the clinical community and well-funded product developers well-prepared and heavily invested in effective policy advocacy programs. Medicare responded constructively, and patients and providers had policy clarity from day one.
The current proposed parallel review program will establish clear rules and expectations for what was in the past very much an ad hoc response to a combination of real need and organized pressure. In doing so, it will clearly define standards and expectations, promote healthy transparency and level the playing field for newer and smaller companies by putting parallel review into the hands of product innovators regardless of their size, prior experience and advocacy financing capability. Those aren’t trivial effects.
Edward Berger is a senior healthcare executive with more than 25 years of experience in medical device reimbursement analysis, planning and advocacy. He’s the founder of Larchmont Strategic Advisors and the president of the Medical Development Group. Check him out at Larchmont Strategic Advisors.