HOW AVAILABLE IS INFORMATION ON HTAR-RELATED PROCESS ADAPTATION AMONG THE 34 AUTHORITIES AND BODIES IN THE JCA SUBGROUP?
Author(s)
Penelope Cervelo Bouzo, MRes, Tina Wang, PhD, Belen sola, PhD, Neil McAuslane, BSc, MSc, PhD.
CIRS, London, United Kingdom.
CIRS, London, United Kingdom.
OBJECTIVES: With the implementation of the EU HTA Regulation (HTAR), understanding the national HTA process remains critical for pricing and reimbursement decisions. This study establishes a baseline across European HTA authorities and bodies (HTAb), examining how processes are adapting to HTAR, including which HTAb have introduced and documented changes to support Joint Clinical Assessment (JCA) integration.
METHODS: The 34 HTAb included in this study are members of the subgroup for JCA, medicinal products configuration. A data collection framework was developed to collect whether national submission templates reference HTAR/JCA, whether national procedures have been updated for HTAR and whether national processes can begin before JCA report publication. Data were collected through structured review of publicly available information from official sources up to April 2026, HTAb were contacted to validate the data.
RESULTS: Of the 34 HTAb, 16 (47%) showed evidence of changes to their HTA or reimbursement processes to adapt to HTAR. Submission templates were identified for 11/34 (32%) HTAb, of which 10 (91%) explicitly referenced HTAR or JCA. For the remainder, it was unclear whether the templates were unavailable publicly or simply do not exist, or the HTAb does not assess medicinal products. Information on whether national processes can begin prior to JCA publication was available for only 5/34 (15%) HTAb: 3 confirmed that the process can begin beforehand (G-BA, INAMI/RIZIV and AIFA), 2 confirmed it cannot.
CONCLUSIONS: Fewer than half of the HTAb have publicly documented HTAR-related procedural changes and information on templates and timing of submission relative to JCA remains scarce. This creates uncertainty for companies planning national submissions and for patients seeking to understand how JCA affects their national access to medicines. Mapping how national processes are evolving provides a foundation for measuring how efficiently and effectively JCA is being implemented and used at national level.
METHODS: The 34 HTAb included in this study are members of the subgroup for JCA, medicinal products configuration. A data collection framework was developed to collect whether national submission templates reference HTAR/JCA, whether national procedures have been updated for HTAR and whether national processes can begin before JCA report publication. Data were collected through structured review of publicly available information from official sources up to April 2026, HTAb were contacted to validate the data.
RESULTS: Of the 34 HTAb, 16 (47%) showed evidence of changes to their HTA or reimbursement processes to adapt to HTAR. Submission templates were identified for 11/34 (32%) HTAb, of which 10 (91%) explicitly referenced HTAR or JCA. For the remainder, it was unclear whether the templates were unavailable publicly or simply do not exist, or the HTAb does not assess medicinal products. Information on whether national processes can begin prior to JCA publication was available for only 5/34 (15%) HTAb: 3 confirmed that the process can begin beforehand (G-BA, INAMI/RIZIV and AIFA), 2 confirmed it cannot.
CONCLUSIONS: Fewer than half of the HTAb have publicly documented HTAR-related procedural changes and information on templates and timing of submission relative to JCA remains scarce. This creates uncertainty for companies planning national submissions and for patients seeking to understand how JCA affects their national access to medicines. Mapping how national processes are evolving provides a foundation for measuring how efficiently and effectively JCA is being implemented and used at national level.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA151
Topic
Epidemiology & Public Health, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas