An Actuarial Approach to Managed Access Agreements: Addressing Surrogate Endpoints, Data Silos, and Legal Procurement Constraints in Resistant Hypertension

Supplementary handout for poster HPR55 presented at ISPOR Europe 2026, Austria Center Vienna, November 8–11, 2026. Session: Poster Session 2, Monday November 9, 16:00–19:00. This document presents the AMEF (Actuarial Managed Entry Framework), a five-component methodology for designing Performance-Based Risk-Sharing Agreements (PBRSA) under surrogate endpoint uncertainty in European public payer systems. Applied to baxdrostat (aldosterone synthase inhibitor) in resistant hypertension within the Spanish NHS (SNS). Framework components: (1) REGICOR-based MACE asset valuation, (2) IBNR renal liability provisioning, (3) ex-ante stochastic budget modeling, (4) exogenous governance via independent clearinghouse, and (5) legal procurement reclassification via CPV 85149000-5 under Ley 9/2017 LCSP and EU Directive 2014/24/EU. Includes: extended NMA vs. PATHWAY-2, NHS economic return table (ROI €1.38/€1 per 10,000 patients over 10 years), PBRSA feasibility decision algorithm and structured discussion of methodological limitations and uncertainty.