With FDA and CMS evaluation both being critical to new medical technology, two initiatives have attempted to bridge the gap between those two processes: Parallel review and coverage with evidence development (CED).
While there have been successes in the programs, there have been fewer than anticipated, raising concern about the programs’ ability to reach their potential and provide timely processes for bringing new medical devices to market, notes a recent Health Affairs policy brief.
The two separate evidentiary hurdles “can lead to substantial delays or limitations in patient access or can even block market entry,” says author Liz Richardson, research associate for the Engelberg Center for Health Care Reform at the Brookings Institution.
While the FDA determines whether new devices are “safe and effective,” CMS evaluates whether they are “reasonable and necessary” and will be covered under Medicare, which sets the tone for coverage by the commercial health insurance industry.
CMS funding and staff cuts are among the issues impacting CMS’ ability to more fully implement their parallel review or CED programs, Richardson says, along with challenges such as narrow eligibility standards.
The future of both programs is in question, given that the parallel review pilot program is set to expire in December, and the agency with the authority to invoke CED is actually the Agency for Healthcare Research and Quality (AHRQ), which the House Appropriations Committee has moved to eliminate in its draft budget.
With or without those initiatives, the FDA and CMS will have to continue forward in some form that would, ideally for new medical device manufacturers, ease the time and expense involved in undergoing both reviews.
There is no escaping the need for both measurements, but there is also the need for them to be done expeditiously, says David Friend, MD, MBA, managing director and chief transformation officer at the BDO Center for Healthcare Excellence and Innovation.
“The process of undergoing both reviews is bureaucratic, and it is daunting if you’re a device manufacturer or anybody else,” Friend tells Healthcare Dive. “It’s a twin challenge, but that is the future of healthcare.”
He adds he sees the concept of parallel review as valuable, even if the current program itself expires or requires change.
“In an ideal world you would do things in parallel because it should be faster,” he says. “In other parts of the world of commerce, you price and look at the product at the same time – you have to. So, I think it’s incumbent upon government to protect us from bad devices and drugs, but they should try to do it faster.”
Friend adds if we as a society want the best drugs and devices, we should make the process simpler and less expensive for companies to create them.
However, not everyone may want to see a change in the status quo, Friend points out. Existing companies that have successful products entrenched in the healthcare industry might see the bureaucratic barrier to entry as a good thing, as it slows down their competitors. “It cuts both ways if you’re a maker of these devices or an investor,” Friend says.
One champion of the parallel review process is Kevin Conroy, Chairman and CEO of Exact Sciences—one of only two companies to participate in the program, and the only one to complete it. He calls it a critical factor in the company’s ability to bring Cologuard, a colorectal cancer screening test, to the millions of patients who need it.
“Without the parallel review process we would have had to conduct two separate clinical trials; one for FDA and the other for CMS,” Conroy tells Healthcare Dive. “That would have added one to three years to the process and tens of millions in additional cost.”
Conroy says he was impressed with both agencies when he underwent the experimental process and that he sees it as supportive of medical innovation.
“I would highly recommend this program for those manufacturers who are open to working in a collaborative manner with the two agencies,” he says. “That collaborative spirit was important to ensure the parallel review process was positive for all of us involved.”
As for the CED program, one of the issues Richardson notes in the policy brief is ambiguity regarding the evidentiary threshold for triggering CED, as well as for determining that the "reasonable and necessary" bar has been met.
This, combined with high expectations for technologies to prove they offer a meaningful improvement and/or are significantly more cost-effective, could deter some entrepreneurs from attempting the process.
“Setting the bar too high may discourage companies from ever trying in the first place,” warns Nimesh Shah, partner at Domain Associates, a dedicated medical device venture capital investor.
“This can be helped by transparency from the agencies in what they seek, a recognition of what is reasonable (and a mindfulness of perfection is the Enemy of Good Enough), and the ability to gather that data in a post-approval environment.”