Denise Sánchez Palomo and Sissi Pham

The Evolution of HCEI/PIE Opportunities- Are you up to Speed?

Denise Sánchez Palomo and Sissi Pham

Over the last 25 years, there has been an evolution in the statutory and regulatory framework for dissemination of healthcare economic information (HCEI) and, more recently, the creation of a pathway for pre-approval product information exchange (PIE) to payors and similar entities responsible for making formulary and coverage decisions on a population basis. The enactment of Section 114 of the Food and Drug Administration Modernization Act (FDAMA 114) in 1997 created much initial enthusiasm within industry. FDAMA 114 was the first legislative measure that created opportunities for companies to communicate HCEI to payors and similar entities. But aspects of the FDAMA 114 statutory language were ambiguous and subject to differing organizational interpretations. Further, the Food and Drug Administration (FDA) remained silent on specific HCEI guidance at that time. As a result, many organizations were unsure as to how to properly leverage the opportunities FDAMA 114 afforded and cited concerns about incurring potential enforcement action as a reason for not pursuing HCEI organizational efforts. 

Fast forward to 2023. We are now witness to the various legislative and regulatory agency efforts in the payor communications landscape that, through their spirit and intent, have moved the needle forward. These include, among other aspects, clarifications to the definition of HCEI as enacted in the 21st Century Cures Act (2016) issuance of final FDA Guidance on payor communications (2018 Guidance)-which includes recommendations for HCEI materials and also recommendations for the content and dissemination of PIE; and inclusion of devices in the definition of HCEI and statutory authorities explicitly authorizing PIE as enacted in the Food and Drug Omnibus Reform Act (2022) as part of the Consolidated Appropriation Act (2023).

The clarity provided in law and 2018 Guidance around the breadth of what constitutes HCEI has helped some organizations uncover the value of HCEI proactive communications and also propelled organizations to consider how best to position their health economics and outcomes research (HEOR) for eventual communication when designing their HEOR studies at the onset.

The PIE statutory provisions are intended to help expedite patient access to therapies and technologies as soon as possible upon FDA authorization. Congress and FDA worked together to have the enacted law reflect the PIE safeguards first introduced by FDA in the 2018 Guidance. The guidance had recommended a pathway for organizations to provide payors with truthful and non-misleading information about unapproved products and unapproved uses of approved products including information about indications sought, descriptions of clinical studies, anticipated timeline for possible FDA approval/clearance, product pricing, patient utilization projections, and product related programs or services. The enacted law explicitly confirms that where these communications are conducted by an organization in a truthful and non-misleading manner as outlined in the law, such communications about an investigational drug or device do not render the product misbranded.

To successfully harness the full potential of the HCEI and PIE provisions, organizations should strongly consider developing internal policy specific to their business and train robustly within their organizations on such policy. In our experience, policy that reflects cross-functional collaboration between HEOR, Regulatory, Legal, Commercial, and Medical stakeholders tends to be most successful for implementation. Here is a case study example of how we have helped to Operationalize FDA Payer Guidance Internal Roadmap. 

Through development of internal guidance or policy that applies the law and FDA Payer Guidance while considering business specific considerations, organizations can feel more confident in their abilities to leverage payor communications proactively and compliantly for both their FDA authorized products and investigational products in development.

Contact us if you would like our help to brainstorm and share pitfalls and best practices to developing internal ways of working to fully leverage the FDA Payer Guidance and the related law.


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