The Post-Authorisation Maze: Mapping of European Pharmaceutical Market Access Pathways in the Early JCA Era.

The Regulation (EU) 2021/2282 on health technology assessment (HTAR) harmonises clinical evidence assessment across Europe. However, national appraisal, pricing, and reimbursement processes remain divergent and could affect the efficiency of decision-making and patient access. Here we mapped the sequencing of national assessment, pricing, and reimbursement steps across 30 European countries. National pathways from marketing authorisation to reimbursed access were systematically identified and coded as categorical process sequences. Inpatient and outpatient pathways were analysed separately. Pathway dissimilarities were calculated using Optimal Matching and grouped by hierarchical clustering. We further explored whether clusters differed with regard to country-level indicators, including medicine availability, average time to access, gross domestic product, and healthcare expenditure. We found substantial procedural heterogeneity across countries in both inpatient and outpatient settings. Nevertheless, recurring pathway structures were identified. Across settings, the dominant distinction was between assessment-led pathways, in which evidence assessment precedes pricing and reimbursement steps, and pricing-led pathways, in which price formation occurs prior to assessment and reimbursement-related steps. Cluster membership was not associated with any country-level indicators. Our findings provide policymakers, agencies, and industry with a baseline for understanding national procedural heterogeneity and for evaluating how market access pathways evolve as the JCA is implemented.