Presentation (CTI)

OBJECTIVES: To develop an auditable actuarial risk-sharing framework that mitigates fiscal uncertainty in innovative chronic therapies characterized by surrogate outcomes, fragmented hospital data, and strict public procurement constraints.
METHODS: A decision-analytic framework was modeled combining BaxHTN trial parameters with European public health cost data, evaluated against standard volume-based rebates. Two target populations were segmented: males with documented spironolactone-induced hormonal intolerance (gynecomastia OR: 8.39; real-world discontinuation: 3-5%; surgical cost: EUR 2,500-EUR 3,700/patient) and patients with early target-organ damage. The 9.8 mmHg systolic surrogate reduction was translated into probabilistic MACE avoidance coefficients using validated cardiovascular risk equations. Trial safety signals -- 7.9% hyperkalemia incidence and 15.6% eGFR reduction exceeding 30% -- were modeled as structured cost provisions with predefined outpatient monitoring thresholds, shifting risk-contingent budgeting from acute inpatient events toward longitudinal laboratory surveillance. Operational governance utilizes a 10-hospital sentinel network monitored by an independent external data clearinghouse, ensuring compliance with EU Public Procurement Directive 2014/24/EU by substituting direct hospital financial co-liability with audit-contingent institutional budget adjustments.
RESULTS: Restricting eligibility to the hormonally intolerant cohort -- estimated 24,000-84,000 patients in Spain currently without effective fourth-line therapy -- shifts the economic baseline from generic benchmarks (EUR 5/month) to cumulative untreated disease costs, improving ICER defensibility without head-to-head efficacy data. Actuarial framework simulation demonstrated a 24% reduction in unprovisioned budget volatility versus traditional volume rebates. The independent clearinghouse architecture restricted non-compliant prescription overspill to less than 3% of total cohort volume.
CONCLUSIONS: Conventional rebates fail to manage surrogate endpoint uncertainty and data fragmentation simultaneously. This actuarial framework provides a legally viable, fully auditable mechanism linking public healthcare expenditure directly to verified real-world performance -- a scalable blueprint for innovative therapies entering European public payer systems under evidentiary uncertainty.