Comparative Analysis of Early Scientific Advice Mechanisms: EU JSC vs. National HTA Bodies (HAS, G-BA, NICE)
Author(s)
Kamilia Ben Abdallah, Biological Engineer1, Farah Moalla, Biological Engineer1, Imen Soussi, Biological Engineer1, Aleksandra Caban, Head of PRMA department2, Mondher Toumi, Sr., MSc, PhD, MD3.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Cracow, Poland, 3University Aix-Marseille /Creativ-Ceutical, Paris, France.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Cracow, Poland, 3University Aix-Marseille /Creativ-Ceutical, Paris, France.
OBJECTIVES: With the EU Health Technology Assessment Regulation coming into effect in 2025, the Joint Scientific Consultation (JSC) process is anticipated to become a key tool to harmonize evidence generation across member states. This study compares early scientific advice mechanisms at the EU level through JSC and nationally via HAS (France), G-BA (Germany), and NICE (UK).
METHODS: A review of early advice processes in the UK, France, Germany and JSC was performed. Six core dimensions were examined: selection criteria, scope of advice, impact on downstream HTA decisions, timelines, fees, and stakeholder involvement.
RESULTS: The EU JSC focuses on centrally authorized products, prioritizing oncology, rare diseases, and advanced therapies, with a strong emphasis on aligning evidence to future joint clinical assessments. HAS focuses on innovative medicines that are likely to bring added therapeutic value in areas where there’s an unmet medical need with the advice mainly covering clinical development plans (including trial design, choice of comparators, endpoints, patient populations) and strategies for generating evidence. The G-BA puts particular emphasis on methodological alignment, especially regarding comparator and endpoint selection. Meanwhile, NICE offers comprehensive guidance that combines clinical and economic perspectives, which is crucial for cost-effectiveness assessments. Timelines for these advice processes typically range from three to six months. Fees vary widely: in France and Germany advice is usually free, while in the UK fees can be substantial. At national level, stakeholder involvement is most structured during NICE consultations, whereas EU JSCs involve a broader range of expert stakeholders—including patient organizations, healthcare professional organizations, and clinical societies—engaged via a coordinated stakeholder network.
CONCLUSIONS: Early advice mechanisms differ a lot in terms of accessibility, scope, and strategic value. Using both EU-level Joint Scientific Consultations and national early advice can create a solid foundation for aligning regulatory and market access strategies—provided practical considerations are addressed.
METHODS: A review of early advice processes in the UK, France, Germany and JSC was performed. Six core dimensions were examined: selection criteria, scope of advice, impact on downstream HTA decisions, timelines, fees, and stakeholder involvement.
RESULTS: The EU JSC focuses on centrally authorized products, prioritizing oncology, rare diseases, and advanced therapies, with a strong emphasis on aligning evidence to future joint clinical assessments. HAS focuses on innovative medicines that are likely to bring added therapeutic value in areas where there’s an unmet medical need with the advice mainly covering clinical development plans (including trial design, choice of comparators, endpoints, patient populations) and strategies for generating evidence. The G-BA puts particular emphasis on methodological alignment, especially regarding comparator and endpoint selection. Meanwhile, NICE offers comprehensive guidance that combines clinical and economic perspectives, which is crucial for cost-effectiveness assessments. Timelines for these advice processes typically range from three to six months. Fees vary widely: in France and Germany advice is usually free, while in the UK fees can be substantial. At national level, stakeholder involvement is most structured during NICE consultations, whereas EU JSCs involve a broader range of expert stakeholders—including patient organizations, healthcare professional organizations, and clinical societies—engaged via a coordinated stakeholder network.
CONCLUSIONS: Early advice mechanisms differ a lot in terms of accessibility, scope, and strategic value. Using both EU-level Joint Scientific Consultations and national early advice can create a solid foundation for aligning regulatory and market access strategies—provided practical considerations are addressed.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PT24
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas