ORGANIZING THE PHARMA COMPANY FOR JCA: OBSERVED INTERNAL OPERATING MODELS, ROLES AND CAPABILITIES IN THE FIRST YEAR OF IMPLEMENTATION
Author(s)
Aleksandra Caban, PhD1, Anna Kapusniak, MSc1, Aleksandra Matjaszek, MSc1, Malgorzata Wojtal, MSc1, Mondher Toumi, MSc, PhD, MD2.
1Clever Access, Cracow, Poland, 2Aix-Marseille University, Marseille, France.
1Clever Access, Cracow, Poland, 2Aix-Marseille University, Marseille, France.
OBJECTIVES: This conceptual paper reviews the principal pharma company organisational approaches adopted for JCA, discusses their strengths and limitations and provides recommendation on the optimal operating model.
METHODS: Conceptual paper
RESULTS: Pharmaceutical companies preparing for the European Union Joint Clinical Assessment (JCA) differ considerably in size, geographic footprint, portfolio complexity and internal capabilities. Large global organisations, medium-sized companies and highly specialised firms face different organisational constraints and opportunities. Likewise, EU-based and ex-EU-based companies vary in governance structures, decision-making processes and access to local market expertise. These differences have given rise to diverse approaches to organising EU-HTA activities.
Several operating models have emerged. Some companies centralise EU-HTA strategy and execution within corporate functions, while others rely on regional organisations or dedicated EU-HTA units. In some cases, JCA responsibilities are embedded within product teams or coordinated through cross-functional task forces. The role of affiliates and external partners also differs substantially, ranging from limited consultation to systematic integration into evidence planning and assessment preparation. Each model offers advantages but also presents challenges related to governance, accountability, agility and alignment with Member State expectations.
CONCLUSIONS: Although no single model is universally applicable, experience suggests that effective JCA preparation requires a balance between central coordination and product-level ownership. A hybrid model, led by the EU regional organisation with accountability anchored within the regional core product team, appears best suited to support timely evidence planning and cross-functional collaboration. Internal EU-HTA expertise should provide methodological guidance, capability building and knowledge sharing, while affiliate engagement ensures incorporation of national perspectives. External partners may complement internal capabilities, but strategic ownership should remain within the company.
METHODS: Conceptual paper
RESULTS: Pharmaceutical companies preparing for the European Union Joint Clinical Assessment (JCA) differ considerably in size, geographic footprint, portfolio complexity and internal capabilities. Large global organisations, medium-sized companies and highly specialised firms face different organisational constraints and opportunities. Likewise, EU-based and ex-EU-based companies vary in governance structures, decision-making processes and access to local market expertise. These differences have given rise to diverse approaches to organising EU-HTA activities.
Several operating models have emerged. Some companies centralise EU-HTA strategy and execution within corporate functions, while others rely on regional organisations or dedicated EU-HTA units. In some cases, JCA responsibilities are embedded within product teams or coordinated through cross-functional task forces. The role of affiliates and external partners also differs substantially, ranging from limited consultation to systematic integration into evidence planning and assessment preparation. Each model offers advantages but also presents challenges related to governance, accountability, agility and alignment with Member State expectations.
CONCLUSIONS: Although no single model is universally applicable, experience suggests that effective JCA preparation requires a balance between central coordination and product-level ownership. A hybrid model, led by the EU regional organisation with accountability anchored within the regional core product team, appears best suited to support timely evidence planning and cross-functional collaboration. Internal EU-HTA expertise should provide methodological guidance, capability building and knowledge sharing, while affiliate engagement ensures incorporation of national perspectives. External partners may complement internal capabilities, but strategic ownership should remain within the company.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA205
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas