Wednesday, November 9, 2016

Brief Blog: Growing Outreach and Collaboration between FDA and Payers

For several years, the FDA has floated a few initiatives to increase collaboration with payers.  This week, there is a joint op ed in JAMA from Robert Califf, head of FDA, and Andrew Slavitt, acting head of CMS.

  • The JAMA article, "Knowing When and How to Use Medical Products: Shared Responsibility for FDA and CMS," is online here.   
  • A concurrent article at Healthcare Dive notes that BCBS Association will also join the FDA Payer Communication Task Force (PCTF), here.
    • Note: This Healthcare Dive article works, but it links to a dead BCBS website, on November 29.  To see the BCBS press release, here.
  • For a commercially-sponsored December 14 "Summit" on CDRH and Payers, featuring Dr Shuren and other CDRH staff, here.
This Is a Continuing Trend

This is on ongoing policymaker attention to a trend we forecast.

  • See our earlier blog, February 2016, "FDA Invites Payers to the Party," here.

UK Has Similar Ideas

In the U.K., there is also a plan to coordinate regulatory decisions with payer  decisions (NHS/NICE) to speed market access to important new medical products (here).  However, for an article on how accelerated approval wreaks havoc with NICE procedures (no data for cost/QALY), Pink Sheet, November 21 (subscription), here.


For a November 29, 2016 article in Crain's Business on the FDA/Payer topic, see here.

For a November 21 article at Pink Sheet (subscription), here. and February 23 at MedTechInsight (subscription), here.  February 23 open access article at RAPS, here.

For FDA Payer Communication Task Force homepage, here.  For FDA/CRDH 18 page deck, here.