Analysis of the Implementation of Additive PICOs in a European Joint Health Technology Assessment Implications of EUHTA for Pharma: A Qualitative Exploration
Author(s)
Anne V. Schröder, MSc1, Yvonne-Beatrice Böhler, MBA, MD2.
1Institute of Business Administration at the Department of Chemistry and Pharmacy, University of Munster, Muenster, Germany, 2TH Koeln - University of Applied Sciences, Leverkusen, Germany.
1Institute of Business Administration at the Department of Chemistry and Pharmacy, University of Munster, Muenster, Germany, 2TH Koeln - University of Applied Sciences, Leverkusen, Germany.
OBJECTIVES: Industry stakeholder responses to the EU HTAR indicate significant uncertainty among pharmaceutical companies about its operational implications. Given the expected impact of the new EU-HTA legislation on a wide range of stakeholders, we aimed to understand how the regulatory shift could affect pharmaceutical companies by means of stakeholder interviews.
METHODS: We conducted eight semi-structured expert interviews with professionals from consultancy agencies/scientific associations with direct involvement/advisory roles on the EU-HTA process. Interviews were analyzed by qualitative content analysis, applying a mixed deductive-inductive coding approach based on predefined thematic categories and emerging data. The interviews took place until December 2024.
RESULTS: The analysis revealed challenges in terms of strategic planning, operational challenges, and resource allocation, which were grouped into six key topics: methodological challenges, resource burden, strategic uncertainty, company-specific adaptability, financial implications, and long-term benefits. Experts emphasized critical issues such as process complexity, tight timelines, data gaps, and unpredictable PICO requirements. Larger companies were generally better equipped to manage these challenges due to their established infrastructure, whereas smaller companies faced constraints related to resources and prior experience—yet often benefited from greater organizational flexibility. Methodological concerns included the feasibility of indirect comparisons and the high volume of required analyses. Financial concerns focused on the necessity for early investment and the risk of resource waste due to non-utilized PICO anticipations.
CONCLUSIONS: EU-HTA introduces significant burdens related to tight timelines and uncertain PICO requirements. As required PICOs increase, indirect comparisons and high analysis volumes add complexity. Early anticipation of requirements, aligned with strategic planning and resource allocation, is essential but may impede the capabilities of smaller or less experienced companies. A learning process across stakeholders and close collaboration between industry and HTA bodies will be crucial to addressing methodological challenges, reducing inefficiencies, and realizing the benefits of a harmonized European HTA system.
METHODS: We conducted eight semi-structured expert interviews with professionals from consultancy agencies/scientific associations with direct involvement/advisory roles on the EU-HTA process. Interviews were analyzed by qualitative content analysis, applying a mixed deductive-inductive coding approach based on predefined thematic categories and emerging data. The interviews took place until December 2024.
RESULTS: The analysis revealed challenges in terms of strategic planning, operational challenges, and resource allocation, which were grouped into six key topics: methodological challenges, resource burden, strategic uncertainty, company-specific adaptability, financial implications, and long-term benefits. Experts emphasized critical issues such as process complexity, tight timelines, data gaps, and unpredictable PICO requirements. Larger companies were generally better equipped to manage these challenges due to their established infrastructure, whereas smaller companies faced constraints related to resources and prior experience—yet often benefited from greater organizational flexibility. Methodological concerns included the feasibility of indirect comparisons and the high volume of required analyses. Financial concerns focused on the necessity for early investment and the risk of resource waste due to non-utilized PICO anticipations.
CONCLUSIONS: EU-HTA introduces significant burdens related to tight timelines and uncertain PICO requirements. As required PICOs increase, indirect comparisons and high analysis volumes add complexity. Early anticipation of requirements, aligned with strategic planning and resource allocation, is essential but may impede the capabilities of smaller or less experienced companies. A learning process across stakeholders and close collaboration between industry and HTA bodies will be crucial to addressing methodological challenges, reducing inefficiencies, and realizing the benefits of a harmonized European HTA system.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA33
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas