Preapproval Information Exchange (PIE)

Where We Stand:

Background 
Preapproval Information Exchange (PIE) is a concept designed to improve patient access to emerging pharmaceuticals and devices. PIE allows manufacturers and health care decision-makers to proactively share certain health care economic and scientific information about products ahead of FDA approval. The need for proactive PIE communication is especially important as the health care system continues to evolve from a fee-for-service payment system to a value-based system rewarding quality, improved patient outcomes, and cost efficiency. PIE communication has proven particularly important during the COVID-19 public health emergency. 

Allowing access to this information in advance helps ensure that health care decision-makers can appropriately plan for, forecast, and budget for new pipeline  medications assigned a priority review, breakthrough therapy, accelerated approval or fast track designation employed by the FDA to make drugs available as rapidly as possible. Most importantly, it helps ensure that patients will have access to needed therapies in a timely manner.  

AMCP’s Position 
AMCP supports systems and processes that allow for clinical and economic information to be shared between manufacturers and health care decision-makers proactively and in a timely manner prior to FDA approval. A proactive PIE system would expedite coverage and utilization management policies for emerging therapies, including those granted breakthrough designation, providing earlier access for appropriate patients. 

PIE will allow health care decision-makers to better anticipate which patient populations would be eligible for coverage of a new drug or new therapy and properly assess clinical value and budget impact. AMCP also supports parameters that ensure that these communications remain limited in scope, allowing for the exchange of clinical and economic data only (not promotional, marketing, etc.). AMCP also supports limitations that ensure that these communications are exchanged between manufacturers and health care decision-makers. 

Call to Action 
AMCP supports potential legislation codifying current regulatory safe harbors that allow for PIE between manufacturers and health care decision-makers. A law providing such a safe harbor would allow for the sharing of truthful and accurate clinical and economic information about medications and devices in the pipeline, as well as new uses of approved products prior to FDA approval during the forecasting and rate-setting process.  

A legislative safe harbor for PIE will confirm that the proactive dissemination of certain information does not violate the prohibitions against preapproval promotion and is not in conflict with the labeling, constitutes misbranding, and violates intended use provisions of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. 

See also: 
AMCP Where We Stand series: https://www.amcp.org/policy-advocacy/policy-advocacy-focus-areas/where-we-stand-position-statements 

Approved by the AMCP Board of Directors, February 2021