HTA Life-Cycle Concepts: The Need for HTA Bodies to Grow Beyond Their Traditional Scope
Author(s)
Jelle Stoelinga, PharmD, MSc1, Carla Hollak, PhD2, Lonneke Timmers, PhD3, Wim Goettsch, MSc, PhD3, Christine Leopold, PhD1.
1Utrecht University, Utrecht, Netherlands, 2Amsterdam Medical Center, Amsterdam, Netherlands, 3Zorginstituut Nederland, Diemen, Netherlands.
1Utrecht University, Utrecht, Netherlands, 2Amsterdam Medical Center, Amsterdam, Netherlands, 3Zorginstituut Nederland, Diemen, Netherlands.
OBJECTIVES: In 2015, the new definition of Health Technology Assessment (HTA) first included the words “at different points throughout its lifecycle” for determining the value of health technologies. Since then, a plethora of HTA lifecycle concepts emerged, reflecting the doubt about which approach to prioritize for implementation and what the responsibilities are of each stakeholder. We aim to provide a comprehensive overview of HTA lifecycle concepts.
METHODS: We developed a scoping review protocol based on the PRISMA-ScR guideline for reporting, identifying scientific articles in PubMed and Embase that focused on an HTA lifecycle concept of medicines as their primary topic. We excluded articles that focused on environmental lifecycle assessments, hospital HTA, and individual Health Technology (re)Assessments. We categorized the lifecycle concepts based on the terminology used and performed a thematic analysis to identify trends in activities employed, needs addressed, and stakeholders involved in each lifecycle concept.
RESULTS: After screening, we included 65 out of 663 articles. Based on preliminary results, we identified five HTA lifecycle concepts, including Lifecycle HTA, Living HTA, Health Technology Management, Health Technology Reassessment, and Learning Healthcare Systems. While their scope and methodology may differ, all of these concepts address the need to minimize the large clinical and non-clinical uncertainties present at initial marketing authorization. Furthermore, many lifecycle concepts extend the role of HTA bodies beyond technology assessment at initial marketing authorisation. For example, HTA lifecycle concepts that propose the use of Real World Data (RWD) spark debate about who is responsible for ensuring good quality RWD generation and setting up disease registries.
CONCLUSIONS: The emergence of lifecycle concepts shows the growing role of HTA. HTA bodies can embrace this increasing role by either taking more responsibility themselves or fostering new collaborative relationships with stakeholders. Future research could support cross-country learning by investigating the HTA lifecycle concepts outlined in national policies.
METHODS: We developed a scoping review protocol based on the PRISMA-ScR guideline for reporting, identifying scientific articles in PubMed and Embase that focused on an HTA lifecycle concept of medicines as their primary topic. We excluded articles that focused on environmental lifecycle assessments, hospital HTA, and individual Health Technology (re)Assessments. We categorized the lifecycle concepts based on the terminology used and performed a thematic analysis to identify trends in activities employed, needs addressed, and stakeholders involved in each lifecycle concept.
RESULTS: After screening, we included 65 out of 663 articles. Based on preliminary results, we identified five HTA lifecycle concepts, including Lifecycle HTA, Living HTA, Health Technology Management, Health Technology Reassessment, and Learning Healthcare Systems. While their scope and methodology may differ, all of these concepts address the need to minimize the large clinical and non-clinical uncertainties present at initial marketing authorization. Furthermore, many lifecycle concepts extend the role of HTA bodies beyond technology assessment at initial marketing authorisation. For example, HTA lifecycle concepts that propose the use of Real World Data (RWD) spark debate about who is responsible for ensuring good quality RWD generation and setting up disease registries.
CONCLUSIONS: The emergence of lifecycle concepts shows the growing role of HTA. HTA bodies can embrace this increasing role by either taking more responsibility themselves or fostering new collaborative relationships with stakeholders. Future research could support cross-country learning by investigating the HTA lifecycle concepts outlined in national policies.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA187
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas