OBJECTIVES: EU HTA Regulation 2021/2282 mandates JCA for oncology products and ATMPs from January 2025. EUnetHTA21 is developing guidelines covering methodology, JCA/CA, JSC, and transversal activities. We aim to assess challenges and opportunities from various stakeholders' perspectives (i.e., HTA bodies [HTAb], manufacturers, and others) in France, Italy, and Poland.

METHODS: EU HTA Regulation deliverables from March 2022 to June 2023 by EUnetHTA were downloaded and reviewed. HTA processes for France, Italy, and Poland were reviewed to identify potential impact of JCA on timeline and methodology.

RESULTS: In total, 14 final deliverables were found and reviewed, and three main areas of challenge were identified. First, introduction of JCA could reduce time to access for medical products, but other forms of local early funding might be impacted. Specifically for France, Early Access Programmes could be influenced since requiring submission of clinical evidence before marketing authorization and this could overlap with evidence submitted for JCA. Second, adaptation of evidence required in local dossiers will be necessary since any evidence submitted for JCA cannot be submitted locally. Time for manufacturers to prepare local dossiers should decrease, but e.g., in Italy, updates of AIFA guidelines will be needed to specify what kind of evidence should be included or excluded and how JCA Dossier and Report will be included. Lastly, appointed JCA assessors and co-assessors may be required to assess the evidence twice (during JCA and at local level) using different methodologies. This could be relevant for Poland which applies local AOTMiT HTA methodological guidelines from 2016.

CONCLUSIONS: The EU HTA Regulation aims to reduce access time, prevent duplication of work for HTAb, and enhance pharmaceutical product accessibility for EU patients. Local HTAb and manufacturers must proactively prepare and adapt local regulations on reimbursement procedures to facilitate EU-level work and to avoid delays in local processes.