NEW YORK (360Dx) – The US Food and Drug Administration today added CareFirst BlueCross BlueShield and United Health Group to its list of private payors participating with the agency to provide presubmission feedback on investigational devices.
The Private Payor Program, similar to the FDA and Centers for Medicare & Medicaid Services' Parallel Review Program, allows device manufacturers to receive feedback from the FDA and non-governmental health technology assessors on what evidence they need to generate to fulfil regulatory and coverage requirements for an investigational product.
In 2016, the FDA issued an open request to private coverage entities to gauge their willingness to provide feedback to device makers in pre-submission meetings, and eventually launched the Private Payor Program. In addition to the two payors who joined the program recently, six other payors and health technology assessment organizations are participating, including BlueCross BlueShield Association, Duke Evidence Synthesis Group, ECRI Institute, Humana, Kaiser Permanente, and the National Institute for Health and Care Excellence.
"By facilitating communications between device makers and payors, the FDA hopes to shorten the time between FDA approval and coverage decisions," FDA Commissioner Scott Gottlieb wrote in a blog post today. Gottlieb acknowledged that the process for a device to go through FDA premarket review and then garner payor coverage can be a lengthy one that's often costly and unsustainable for smaller device companies. This in turn can hinder patient access to devices critical for diagnosing and treating serious diseases.
"[The Private Payor Program] can be particularly beneficial for manufacturers creating new and innovative devices who also need to secure coverage of their devices by payors," Gottlieb wrote.
Since the launch of the program, there have been 10 engagements — including presubmission meetings — between device manufacturers and private payors or health tech assessment entities. According to Gottlieb, the program is gaining momentum and is receiving new inquiries weekly.
The program aims to benefit all stakeholders involved — the FDA, private payors, health tech groups, and device makers — through improved coordination. Payors gain insight on new technologies slated for the market, device makers get a head start on collecting the evidence necessary for coverage and reimbursement, and the FDA can ensure that patients have speedier access to safe, effective, and innovative products. "To that end, we continue to support and encourage the collection of clinical evidence that’ll not only support regulatory decisions but also inform coverage decisions — ultimately providing an opportunity for more timely patient access to new technologies," Gottlieb wrote.
Meanwhile, the FDA/CMS Parallel Review Program, which was launched as a pilot in 2011 and made permanent in 2016, is also growing. Foundation Medicine is the latest graduate of the program, having successfully garnered FDA approval and a national coverage determination from CMS for its next-generation sequencing cancer panel, FoundationOne CDx.
According to Gottlieb, the FDA has received more than 75 inquiries about the program and 36 formal applications to engage in parallel review for a product. The FDA keeps participants' information confidential, though manufacturers may decide to make their participation public.