FDA sharing device information to insurers more quickly
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Senior Manager, Health Research Institute, PwC USSeptember 14, 2018
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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.