OBJECTIVES: In 2025, Joint Clinical Assessment (JCA) will start for oncology drugs and advanced therapy medicinal products (ATMPs) according to the European Health Technology Assessment (HTA) regulation. This law standardizes the clinical evidence review across European (EU) member states, eliminating the need for multiple submissions of the same evidence. To explore the potential impact on health authorities and health technology developers (HTDs), as well as possible variability in JCA adoption across Europe, interviews with relevant stakeholders were conducted.

METHODS: Current and former national payers, representatives from HTA agencies or health ministries in France, Germany, Italy, and Poland were interviewed. The focus was on assessing the impact of JCA on health authorities and HTDs, necessary national adjustments, as well as commonalities or differences between countries’ views on JCA and potential divergent conclusions by individual member states.

RESULTS: Interviewees agreed that JCA's unified approach could enhance patients’ access to new treatments and enable earlier launch (Italy, Poland). However, country-specific evaluations may still lead to varied decisions. Stakeholders highlighted that JCA could be particularly beneficial in countries lacking robust evaluation systems. However, successful implementation depends on: 1) PICOs (Population, Intervention, Comparator, Outcomes) are manageable and amendable to national rules, 2) Raising awareness of JCA among HTDs, especially outside Europe, 3) Adaptation of processes within agencies including resourcing, and 4) Addressing HTD’s concerns regarding disadvantages and absence of a formal arbitration process.

CONCLUSIONS: JCA represents a significant step towards harmonizing and expediting access to new treatments across EU Member States. Despite positive perceptions of a single clinical assessment, integrating JCA within national frameworks induces challenges and uncertainties. Some countries expect significant adjustments at the national level, and HTDs need to master the new process. All stakeholders expect refinements to the JCA process to allow better alignment but also discrepant outcomes on added value between member states.