Neumann Discusses Cures Act and New FDA Draft Guidance on Communication
In his latest Health Affairs blog posting, PHE Scientific Advisor Peter Neumann and co-author Elle Pope examine Section 3037 of the Cures Act and new FDA draft guidance, which indicate that drug companies will have expanded flexibility to communicate proactively with payors and formulary committees about the real-world impacts of their products.
To read Dr. Neumann’s blog, please click here.
By: Jason Shafrin, PhD Sr. Director, Policy and Economics and Jacki Chou, MPL Senior Director, Policy and Economics The recent announcement that CVS Caremark will use value-based metrics to inform formulary design at first appears a step in the right direction. However, using value measurements from a single nongovernmental organization—the Institute for Clinical and Economic Review (ICER)—based on a limited picture of treatment value may be problematic. Using this single assessment of value in an effort solely to exclude drugs from a major insurance formulary is even more worrisome and fails to recognize the heterogeneity in patient clinical needs and preferences.