The Global Impact of EU HTA: Insights From 13 Non-EU Countries
Author(s)
Garcia MJ1, Monteiro I2, Kommandantvold SA3, Buckfelder T4, Julian E5, Ruof J5, Schaub V6
1F. Hoffmann-La Roche Ltd, Basel, BS, Switzerland, 2Roche Farmacêutica e Química, Lda, Lisbon, Portugal, 3Roche Norge AS, Oslo, Norway, 4Roche Diagnostics, Pleasanton, CA, USA, 5Secretariat of the European Access Academy, r-connect Ltd, Basel, Switzerland, 6F. Hoffmann-La Roche Ltd, Basel, Switzerland
Presentation Documents
OBJECTIVES: The European Union (EU) health technology assessment regulation (HTAR) applies from January 2025 and covers voluntary cooperation, joint clinical assessments and scientific consultations, and identifying emerging health technologies. Our study aimed to assess awareness of the HTAR, understand the willingness and challenges to use EU HTA reports beyond the EU, and explore overall interest in cross-country/region HTA collaborations.
METHODS: A double-blinded survey with 18 questions was conducted. Participants were selected based on geographic scope and professional background, resulting in 14 countries represented across 5 continents with mature or nascent HTA systems. Results were synthesized in aggregate figures, split by HTA systems and per country. Different analysis methods were used for continuous and categorical data.
RESULTS: With a 93% response rate, respondents represented diverse geographies and participating countries were well balanced concerning HTA maturity. Most respondents are familiar with the HTAR and believe it would positively impact patient access in the EU. However, regarding its potential positive impact on patient access in their own countries they are less certain, particularly among mature HTA systems. Efficiency, timeliness and access to knowledge are seen as important benefits of EU HTA, while reliability and scientific rigor are key factors for using EU HTA outputs. Political resistance, differences among healthcare systems and inadequate resources are highlighted as key challenges for such collaboration models to be established outside the EU. Identifying emerging technologies and advancing HTA science are the most common areas of interest for a joint HTA collaboration.
CONCLUSIONS: Non-EU countries are aware of and willing to utilize EU HTA reports for their own decision-making. The benefits of using EU HTA reports for their systems, outweigh the potential challenges, particularly for nascent HTA systems. Interest exists in exploring similar initiatives for horizon scanning, HTA methods development and work sharing within and across regions.
Conference/Value in Health Info
Value in Health, Volume 27, Issue 12, S2 (December 2024)
Code
HPR133
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas