OBJECTIVES: The European Union (EU) is introducing a mandatory Joint Clinical Assessment (JCA) that will produce a single non-binding outcome for oncology drugs and advanced therapeutic medicinal products (2025), and orphan drugs (2027). JCAs aim to standardise Health Technology Assessment (HTA) processes to improve EU-wide access and reduce national HTA workload. Currently, there is inter-country heterogeneity in drug appraisals, which must be addressed for the project to succeed. This research aims to understand barriers to adopting conclusions from cross-national JCAs by comparing HTA outcomes between France and Germany.

METHODS: HTA outcomes were extracted for orphan and oncology drugs published by Haute Autorité de Santé (HAS) and Gemeinsamer Bundesausschuss (G-BA) in 2020-2021. HTA ratings were standardised on a single scale to allow comparison. Ratings for individual drugs were compared and classified as ‘equivalent’ (same rating), ‘minor difference’ (one rating apart) or ‘major difference’ (two+ ratings apart), with the reasons for differences identified.

RESULTS: Of the 37 identified drugs, 22 (59%) outcomes were deemed equivalent between HAS/G-BA. Where differences occurred, G-BA outcomes tended to be more favourable. Twelve (32%) outcomes had minor differences, half of which resulted from the guaranteed benefit for orphan drugs in Germany. Three drugs (gilteritinib, cannabidiol and fenfluramine) showed major differences, caused by conflicting views on factors including comparative data, safety, and long-term outcomes.

CONCLUSIONS: Differences in how drugs are appraised between France and Germany led to discrepancies in almost half of HTA outcomes for oncology and orphan drugs. With the two largest European markets entrenched in their methodologies, significant work will be required to ensure sufficient alignment to allow EU countries to benefit from this system. If these differences are not resolved, JCA outcomes are unlikely to be followed by countries. If consensus is reached, manufacturers will need clear instructions on how submissions will be reviewed to ensure evidence meets expectations.