Release of the Draft FDA Guidance on Communications with Payors provided additional clarity on the topic of promotional HCEI communications to payers regarding approved products and opened an opportunity to proactively communicate with payers about investigational products. Cross-functionally aligned operationalization of the Draft FDA Guidance has emerged as a critical success factor for effective and compliant communications with payers to enable informed formulary decision-making and planning, leading to improved patient access.
- Plan and conduct a series of semi-structured cross-functional workshops to review, interpret and articulate company’s position on the topics of payer communications regarding approved and investigational products.
- Create an Internal Guidance document operationalizing the provisions of the Draft FDA Guidance in the context of the company’s organizational structure, including definitions of key terms and authorized communicators, process for development, approval and retirement of payer communication materials.
- Roll out the Internal Guidance document and train developers, reviewers, approvers and communicators of payer communication materials.
Result / Impact
Standardized and compliant processes have been put in place to enable consistent approach for development, approval, and training of promotional HCEI materials for approved products and proactive communications for investigational products to payers.