With the introduction of Section 114 of the Food and Drug Administration Modernization Act (FDAMA) in 1997, a pathway for communication of health care economic information (HCEI) between manufacturers and formulary and treatment decision-makers was established. However, the lack of specific guidance from the FDA has caused confusion among payers and providers, creating potential impact on their decision-making.


We know that healthcare stakeholders rely on different types of data and evidence to inform their decision-making. But what kinds of evidence do they really want and need?


A new white paper from Xcenda and the National Pharmaceutical Council (NPC) highlights survey findings from payers and providers on what types of evidence are most important to them when it comes to making population coverage decisions for formularies and care pathways. Recognizing the importance of these decisions on patients’ lives, it’s not surprising that payers and providers use multiple sources of information that offer a more complete picture about a treatment and its outcomes and impact on cost and quality, rather than just a snapshot.

Key insights from the survey include:

  • Payers and providers desire for more information: Both payers and providers value having several types of information available when making decisions; however, few of these types of information are typically available on a product's FDA-approved label.
  • Decision-making is limited by the available information: Both payers and providers felt limited in the resources available to them to make decisions.
  • Weighing potential benefits and harms of more information: Payers and providers agreed that benefits appear to outweigh potential harms when it comes to more information.

For further details on payer and provider perspectives regarding what kinds of evidence they really want and need, download the full report below.

Information Wanted: Finding the Balance in Pharmaceutical Evidence Exchange With Payers and Providers

Download White Paper