What is PIE? In the context of bio-pharmaceuticals, it is Preapproval Information Exchange (PIE). This is designed to allow the flow of information in the US from marketers to payers in order to improve patient access to new medicines and devices when they are approved for launch. PIE allows manufacturers to proactively share certain scientific and health care economic information about products prior to FDA approval.
Providing this information prior to product approval helps payers plan ahead for new products and allows manufacturers to start the conversation earlier in preparation for product launch.
The legislation in 2018 established the PIE deck concept and rules for content and use. The stated purpose of the legislation was to “improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers”.1 The key areas suggested for inclusion in a PIE deck are2.
Product information (e.g., drug class, device description, and features)
Information about the indication(s) sought, such as information from the clinical study protocol(s) about endpoint(s) being studied and the patient population under investigation (e.g., number of subjects enrolled, subject enrollment criteria, subject demographics)
Anticipated timeline for possible FDA approval/clearance/licensure of the product or of the new use
Product pricing information
Patient utilization projections (e.g., epidemiological data projection on incidence and prevalence)
Product-related programs or services (e.g., patient support programs)
Factual presentations of results from studies, including clinical studies of drugs or devices or bench tests that describe device performance (i.e., no characterizations or conclusions should be made regarding the safety or effectiveness of the unapproved product or the unapproved use)
According to AMCP survey published March 2022, only 39% of healthcare payers report consistently receiving PIE even in response to an unsolicited request, and 26% report that they rarely or never receive a response.3 Some attribute this hesitancy by some manufacturers to utilize PIE for payer communications given the lack of clarity if it can be provided proactively to health payers or must be provided only in response to unsolicited requests for information. This led to new legislation introduced in March 2022 to further clarify the scope of PIE permitted. This legislation has now passed the house as of June 8, 2022, and pending action in the Senate.
Key areas to focus on during development of PIE decks are:
The need for, and timing of, a PIE deck
Content to include based on payers needs
Developing and refining messages, slides, and research needed to support areas such as disease and unmet needs
Ensure submissions conform to the standards issued for both content and referencing
We will continue to monitor future developments regarding PIE deck legislation and use as well as payer needs. As well as assessing the needs and impact on decision-making that PIE decks have for payers through market research with our proprietary payer panel. We are planning to share these results once they become available.
In the meantime, we encourage you to please contact us to discuss how we can assist in your planning for, and development of, PIE decks. We are here and ready to help ensure our clients get their slice.
3.AMCP report: Pre-approval Information Exchange Act (H.R. 7008) Frequently Asked Questions