Payer Workshops on Clinical Endpoints and P&R for Novel Biologic

ClientEuropean based bio-pharmaceutical company /Pricing Scope – EU5 & US
Company Objectives

Client needed constructive payer input into clinical development program that would also gauge P&R implications for and innovative therapy in a high-need area.

Expose payers to a new and unique product profile to understand their ability to judge the unique value proposition.

Gather input on the optimal Phase III trial design from the payer perspective on multiple levels.

Project DescriptionCollaboratively designed, meticulously planned EU and US payer workshops including development of all materials and content.

MME moderated the 1.5 day workshops, gaining responses and general consensus to a target product profile around the following key parameters:

  • P&R needs/expectations
  • Label, including primary and secondary clinical endpoint evaluations
  • Outcomes data requirements.
Client gained first-hand feedback from the payer community. MME analyzed, summarized, and interpreted the key findings and recommendations.
Project OutcomeNew higher price level was deemed achievable once payer input was properly gathered.

MME's recommendations are being built into the PII/PIII study design. Client is proceeding with the confidence of knowing that the P&R strategy is realistic and obtainable.