Strategic Implications of EU HTAR (JCA and JSC) for Global Biopharma and Biotechs: Navigating Evolving Paradigms in Market Access
Author(s)
Clement Francois, MSc, PhD1, Shrividya Iyer, PhD2, Ulrike Kuchenbecker, PhD3, Malek Dimassi, MEng4, Anna Kuciara, MPH5, Cecile Remuzat, PharmD, MSc.6;
1Putnam, Partner, Paris, France, 2Putnam, New York, NY, USA, 3Putnam, Berlin, Germany, 4Putnam, Tunis, Tunisia, 5Putnam, Cracow, Poland, 6Putnam, Paris, France
1Putnam, Partner, Paris, France, 2Putnam, New York, NY, USA, 3Putnam, Berlin, Germany, 4Putnam, Tunis, Tunisia, 5Putnam, Cracow, Poland, 6Putnam, Paris, France
Presentation Documents
OBJECTIVES: The Health Technology Assessment Regulation (HTAR) in the European Union (EU), encompassing Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC), introduces a unified framework for evaluating the clinical value of drugs. A structured Population, Intervention, Comparator, Outcome (PICO) approach is central to the framework. The objective of our research was to define strategic approaches for Global Biopharma/Biotech to ensure compliance with HTAR requirements and enable timely patient access to innovative drugs in the EU.
METHODS: An in-depth review of current JCA/JSC requirements, guidelines coupled with relevant secondary desk research was conducted to assess the implications for internal biopharma processes and cross functional collaboration. The potential for leveraging real-world evidence (RWE) to shape future PICO criteria and optimize communication with key stakeholders was also explored.
RESULTS: Summary findings underscore the importance of early integration of PICO into Target Product Profile (TPP) and clinical development plans to optimize regulatory labeling and evidence-based value messaging. Predictive PICO models would help anticipate variations and customization of Evidence Generation Plans (EGPs). Indirect Treatment Comparisons (ITC) might help meet multiple national HTA requirements, ensuring readiness for both JCA submissions and local adaptations. To prepare effectively for JCA, global biopharma/biotech would need to harmonize regulatory, clinical development, RWE and market access strategies through JSC or national scientific advice, while adapting internal team structures, defining clear role responsibilities and aligning timelines. Finally clear understanding of local patient population, treatment patterns and related outcomes with RWE will allow for dynamic refinement of PICO elements ahead of JCA and meet evolving market needs.
CONCLUSIONS: Global biopharma/biotech would need to adopt a proactive approach to ensure HTAR compliance and develop a comprehensive integrated strategy that can facilitate harmonization across regulatory, clinical, RWE and market access functions and enable optimal patient access to innovative drugs in the EU.
METHODS: An in-depth review of current JCA/JSC requirements, guidelines coupled with relevant secondary desk research was conducted to assess the implications for internal biopharma processes and cross functional collaboration. The potential for leveraging real-world evidence (RWE) to shape future PICO criteria and optimize communication with key stakeholders was also explored.
RESULTS: Summary findings underscore the importance of early integration of PICO into Target Product Profile (TPP) and clinical development plans to optimize regulatory labeling and evidence-based value messaging. Predictive PICO models would help anticipate variations and customization of Evidence Generation Plans (EGPs). Indirect Treatment Comparisons (ITC) might help meet multiple national HTA requirements, ensuring readiness for both JCA submissions and local adaptations. To prepare effectively for JCA, global biopharma/biotech would need to harmonize regulatory, clinical development, RWE and market access strategies through JSC or national scientific advice, while adapting internal team structures, defining clear role responsibilities and aligning timelines. Finally clear understanding of local patient population, treatment patterns and related outcomes with RWE will allow for dynamic refinement of PICO elements ahead of JCA and meet evolving market needs.
CONCLUSIONS: Global biopharma/biotech would need to adopt a proactive approach to ensure HTAR compliance and develop a comprehensive integrated strategy that can facilitate harmonization across regulatory, clinical, RWE and market access functions and enable optimal patient access to innovative drugs in the EU.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HTA68
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas