Case study

Operationalizing FDA Payer Guidance Internal Operationalization Roadmap

Internal and external opportunities with FDA payer guidance


FDA Payer Guidance was released and it was seized as an opportunity to improve the company’s operationalization of payer communications.



AESARA assessed the company’s current process, interviewed key stakeholders and reviewed health care economic information (HCEI) materials intended for payer audience.


Conducted cross-functional stakeholder workshop to increase understanding of the opportunities and areas for alignment on the interpretation of the FDA Payer Guidance.


Developed an internal guidance with appropriate guard-rails for development, review and approval of compliant HCEI materials for the field

Management Consulting

  • Process improvement
  • Region
  • Client
    HEOR Team


  • Clear understanding of the communication requirements and guardrails led to timely deployment of HCEI materials for the field
  • Aligned interpretation the FDA Payer Guidance at the review committee level led to quicker approval of HCEI materials
  • Payers received impactful HCEI communications to inform access decisions

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