FDA sharing device information to insurers more quickly

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Alexander Gaffney Senior Manager, Health Research Institute, PwC US September 14, 2018

FDA moving faster sharing device info
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Insurance companies are working with the FDA under a pilot program aimed at accelerating patients’ access to medical devices. Under the program, insurance companies can tap into information needed to make coverage determinations more quickly after a device receives approval or clearance. The aim would be to help manufacturers understand which evidence would be useful to insurers when they’re making coverage determinations. The FDA’s Private Payor Program encourages interaction among regulators, manufacturers and insurers during clinical trials’ planning phases.

CareFirst BlueCross BlueShield and United Health Group will participate in the new program, the agency said in a statement. The two insurers cover more than 46 million Americans.

HRI impact analysis

The program could help device-makers by reducing the number of trials they must conduct to satisfy FDA and insurer requirements, and by reducing time-to-market delays. Thirty-four percent of value-based contracts are formulated before a drug obtains regulatory approval, according to pharmaceutical executives surveyed by PwC, indicating that additional companies may be willing to participate in the program. The program is similar to the FDA’s Parallel Review Program with CMS, started in 2011, in which the FDA shares information with CMS to allow faster coverage determinations.

More of this week's stories:

  • FDA: 60-day reviews for some devices
  • FDA sharing device information to insurers more quickly
  • Montana insurer wins cost-sharing reduction case
  • Hospitals refile lawsuit against HHS to maintain 340B drug discount program
  • Medicare Advantage payers win overpayment rule lawsuit

Contact us

Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Alexander Gaffney

Senior Manager, Health Research Institute, PwC US

Tel: +1 (202) 836 1604

Jason Ranville

Senior Manager, Health Research Institute, PwC US

Noah Marwil

Research Analyst—Health Research Institute, PwC US

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