OBJECTIVES: The EU HTA Regulation will come into force in 2025, aiming to expedite patient access by reducing duplication of efforts across HTAs in the region. The research aim is to understand if the EU HTA joint clinical assessment (JCA) supports these objectives and how its content will impact EU Member States’ (MS) ability to determine added value.

METHODS: Four MS were selected for the analysis based on payer archetype (budget impact, cost-effectiveness, clinical differentiation). Clinical dossier templates, HTA assessments and other publicly available materials were utilized to assess the alignment of MS clinical assessments with the JCA.

RESULTS: The analysis, conducted for Denmark, Netherlands, Poland, and Sweden to cover different payer archetypes, identified that Sweden (TLV) and the Netherlands (ZIN) currently have no clinical effectiveness submission template. The sections of the JCA dossier template covered the information requested by MS for clinical effectiveness assessments for all four MS. It also provides additional information not requested by MS (percentage of additional sections: Netherlands 40%, Poland 55%, Denmark 37%, and Sweden 82%), namely current use of the technology and comparator clinical effectiveness (trial information and results). However, further analysis of the specific requirements of each section revealed that country-specific data, including epidemiology, clinical guidelines and definitions, preferred treatment decision-making tools and healthcare system readiness, are likely to be missing from the JCA.

CONCLUSIONS: Assuming PICOs are aligned, the JCA dossier includes all the information MS require for clinical assessment. However, manufacturers’ need to ensure the content is applicable across countries means country-specific context and bespoke communication of value will be lacking. This may reduce the efficiency with which MS are able to determine added value. Initial resource savings from JCA may be redundant due to the supplemental activities required by both parties to adequately support value perception and health economic evaluation.