OBJECTIVES: As cell and gene therapies (C&GTs) encompasses some of the world’s most innovative and expensive interventions, equitable access is critical. While regional marketing authorization in the European Union (EU) may be granted, access across member states may vary, leading to health inequities. This study aims to analyze the access landscape for C&GTs across a range of EU member states and identify if inequities in access exist, and what access strategies could be considered.

METHODS: 14 C&GTs were identified between 2015-2024. National health technology assessment (HTA) reports for these therapies were reviewed in Italy, France, Germany, Greece, Ireland, Poland, and Sweden. Therapeutic positioning reports (IPTs) were reviewed in Spain. HTA reports from the English HTA agency were included despite England not currently being an EU member state.

RESULTS: Among the 14 approved C&GTs, reimbursement rates >75% were observed in France (12/14) and Germany (12/14), with IPT favorable recommendation rates >75% in Spain (11/14), showing a higher tendency for positive assessment outcomes when only clinical-effectiveness was evaluated. Reimbursement rates were 64% in Greece (9/14), 50% in Italy (7/14), 43% in England (6/14), 36% in Sweden and 29% in both Ireland and Poland (4/14), showing reduced reimbursement and subsequent country inequities where economic discussions are also considered in the HTAs.

CONCLUSIONS: Access to C&GTs is highly variable, especially across mid-sized cost-effectiveness countries. This is likely due to smaller target populations and the high price of C&GTs reducing affordability and pushing the incremental cost-effectiveness ratios above accepted thresholds. Although economic discussions have been shown to be a tool for resource rationalization and efficiency, their impact on equity may need to be re-considered. Managed entry agreements and innovative pricing strategies such as joint procurement cooperations, demonstrated recently by the successful BeNeLuxA negotiations for Libmeldy, may support price discounts and achievement of cost-effectiveness, thus reducing health inequities across Europe.