From JCA to Local PR: Evaluating Impact Across Europe
Author(s)
Nebibe Varol, PhD1, Laetitia Gelbert, PharmD2, Caroline Delaitre-Bonnin, PharmD3, Paulina Rolska-Wójcik, PhD4.
1Senior Director, GHEOR European Markets, Bristol Myers Squibb, Uxbridge, United Kingdom, 2Bristol Myers Squibb, Brussels, Belgium, 3Thermo Fisher Scientific, Ivry-sur-Seine, France, 4Evidera, PPD, ThermoFisher, Warsaw, Poland.
1Senior Director, GHEOR European Markets, Bristol Myers Squibb, Uxbridge, United Kingdom, 2Bristol Myers Squibb, Brussels, Belgium, 3Thermo Fisher Scientific, Ivry-sur-Seine, France, 4Evidera, PPD, ThermoFisher, Warsaw, Poland.
OBJECTIVES: This study aimed to characterize the expected impact of Joint Clinical Assessments (JCA) on local health technology assessment (HTA) and pricing and reimbursement (P&R) processes and methods across various European countries. These countries were selected based on HTA archetypes to ensure a diverse representation. Monitoring expected local impact is essential to understand the implications of JCA on patient access to innovative therapies.
METHODS: The study monitors local implementation changes resulting from JCA in 14 European countries. Data were collected from various sources, including government and HTA websites, national health ministries, specific HTA bodies' websites, and local trade associations’ websites. Additionally, information was gathered directly through collaboration with local BMS teams. The study collected information on key market characteristics, ongoing local changes driven by JCA including aspects related to HTA and legal framework and their impact on patient access, HTA methods, and HTA or P&R processes.
RESULTS: Member States are undergoing or have undergone changes in their P&R processes and HTA guidelines to adapt to the JCA process. JCA significantly influences local reimbursement processes, with legal changes introduced in some markets. Potential delays in local processes may be incurred in countries that will wait for the final JCA report to start national assessment. Conversely, several countries will maintain national timelines by allowing submissions before publication of the JCA report. Local scoping meetings will provide opportunities to engage early with some national HTA bodies. Concerns about capacity issues have been expressed by several HTA bodies, including EU funding and workforce expansion.
CONCLUSIONS: This study highlights significant variation in the impact of JCA on local P&R processes and the varying level of readiness of national HTA bodies to adapt to these changes. It also underscores the continued need to monitor the evolution of integration at the local level.
METHODS: The study monitors local implementation changes resulting from JCA in 14 European countries. Data were collected from various sources, including government and HTA websites, national health ministries, specific HTA bodies' websites, and local trade associations’ websites. Additionally, information was gathered directly through collaboration with local BMS teams. The study collected information on key market characteristics, ongoing local changes driven by JCA including aspects related to HTA and legal framework and their impact on patient access, HTA methods, and HTA or P&R processes.
RESULTS: Member States are undergoing or have undergone changes in their P&R processes and HTA guidelines to adapt to the JCA process. JCA significantly influences local reimbursement processes, with legal changes introduced in some markets. Potential delays in local processes may be incurred in countries that will wait for the final JCA report to start national assessment. Conversely, several countries will maintain national timelines by allowing submissions before publication of the JCA report. Local scoping meetings will provide opportunities to engage early with some national HTA bodies. Concerns about capacity issues have been expressed by several HTA bodies, including EU funding and workforce expansion.
CONCLUSIONS: This study highlights significant variation in the impact of JCA on local P&R processes and the varying level of readiness of national HTA bodies to adapt to these changes. It also underscores the continued need to monitor the evolution of integration at the local level.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA154
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas