OBJECTIVES: EU HTA regulations (HTAR) come into force in Jan 2025, aligning clinical assessments for new technologies across all member states. GSK is preparing for EU HTAR by simulating likely evidence requirements for an asset, assessing their organisational resilience, and developing new models for ways of working that deliver high-quality EU HTA dossiers on time. These preparations have highlighted unresolved challenges with the Joint Clinical Assessment (JCA) process that will hinder the European Commission (EC) goal of accelerating and harmonizing access in Europe unless they are addressed. This research outlines those challenges and provides recommendations for improvement to the multi-stakeholder community responsible for EU HTA implementation.

METHODS: GSK conducted a PICO (population, intervention, comparator, outcome) simulation for an oncology drug, anticipating what evidence will be requested relative to current clinical standards of care, accounting for local differences. Cross-functional internal activities were mapped to ensure ways of working are adapted to successfully respond to EU HTA.

RESULTS: As of June 2024, applying official JCA regulations, implementation acts and guidelines resulted in over 30 unique likely PICOS requiring over 3000 individual analyses. Proposals to rationalize this number include prioritizing only comparators that align with up-to-date international clinical guidelines, and deprioritizing outcomes not considered patient-centered, potentially eliminating ~50% of PICOs that do not align with clinical best-practice whilst reducing Health Technology Developer (HTD) and JCA assessor burden. Without guidance for reducing PICO volume, misalignment between Member States and HTD on JCA expectations is considered likely, resulting in ‘poor’ JCA outcomes and risking delays in patient access.

CONCLUSIONS: This project demonstrated that achieving timely patient access as an outcome of JCA will require extensive early planning by manufacturers, to avoid delays and mismatches in expectations; to translate this early planning to an efficient JCA process, changes to rationalize the scoping process are urgently needed.