Presentation (CTI)

OBJECTIVES: We propose a conceptual framework for integrating pricing strategy into early market access planning and describe mechanisms by which earlier alignment may support access and health system sustainability. We focus on the feasible list-to-net price corridor and its determinants (e.g., willingness-to-pay, budget impact, and international reference pricing).
METHODS: A critical review was conducted of publicly available HTA/payer method guidance, appraisal documents, and reimbursement policy sources (2020-2025) from the US, UK, and Germany. Sources spanned a broad cross-section of therapeutic areas, reflecting varied disease burden and evidence constraints. The review identified statements describing how evidence generation choices influence cost-effectiveness conclusions, affordability assessments, and access conditions (e.g., population restrictions, managed entry agreements [MEAs]). Concepts were extracted and synthesized into a conceptual framework from Phase I up to launch.
RESULTS: Four major themes were identified: (1) pricing and evidence strategy iteratively inform selection of comparators and endpoints that drive payer perceptions of value; (2) cross-functional stress-testing of cost effectiveness and affordability reduces evidence gaps and idealistic internal expectations; (3) scenario planning around asset and emerging competitor trial readouts enables proactive pricing risk mitigation; and (4) early feasibility assessment of innovative contracting models clarifies which MEAs are most appropriate and what evidence is needed to implement them effectively and credibly. The importance of these mechanisms was emphasized for orphan and other high-cost therapies, where evidence constraints and affordability concerns are greatest
CONCLUSIONS: Early integration of pricing strategy into market access planning can strengthen the credibility and reliability of evidence packages and support reimbursement outcomes, helping translate HEOR insights into timely access decisions. Empirical validation of the framework is required to quantify impact on HTA outcomes, MEA uptake, and time to access.