Presentation (CTI)

OBJECTIVES: The EU Regulation on Health Technology Assessment (HTA) introduced Joint Clinical Assessment (JCA), whose purpose is a decontextualized, judgement-free assessment of comparative clinical evidence to support national HTA bodies. In the US, decision-makers rely on distinct evidence interfaces: the Academy of Managed Care Pharmacy (AMCP) dossier serves as a standardized platform for payers to download decision-ready evidence, while the Institute for Clinical and Economic Review (ICER) produces a full HTA dossier and independent value assessment integrating clinical and economic evidence. This research maps evidence expectations across EU JCA, AMCP, and ICER to identify alignment/divergence and proposes a modular approach to streamline dossier preparation.
METHODS: We conducted a structured crosswalk of EU JCA templates and guidance, AMCP requirements, and ICER methods. Evidence was coded into domains (population/comparator scope, outcomes, evidence synthesis, risk-of-bias/certainty assessment, safety, indirect comparisons, economic/budget evidence, transparency/reproducibility) to identify gaps and overlaps. Findings were synthesized into a modular architecture with a shared core and decision-maker-specific add-ons.
RESULTS: All three processes prioritize valid comparative clinical evidence and transparency but differ in purpose, scoping, evidentiary emphasis, and downstream use. EU JCA applies centrally defined PICOs, systematic reviews, risk-of-bias/certainty approaches, safety standards, and documentation of indirect comparisons. AMCP emphasizes concise, payer-ready clinical and economic narratives. ICER integrates structured evidence reviews with cost-effectiveness modeling, scenario analyses, budget impact, and reproducible methods. Substantial overlap exists in core clinical evidence, enabling reuse via a modular approach.
CONCLUSIONS: Given their fundamentally different purposes— decontextualized clinical assessment (JCA), payer decision support (AMCP), and independent value appraisal (ICER)—synergies are challenging. Early global HTA integration and a modular evidence strategy, with a shared core plus EU- and US-specific add-ons, can reduce rework, lower costs, minimize launch delays, and accelerate reimbursement.