WHAT SHOULD 2028 FIX FIRST? A PRIORITISED AGENDA FOR THE EU HTA ARTICLE 31 REVIEW
Author(s)
Hend Jedidi, DMD1, Chiraz Hicheri, BioEng1, Lylia Chachoua, PharmD, PhD2, Mondher Toumi, MSc, PhD, MD3.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Paris, France, 3Aix-Marseille University, Marseille, France.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Paris, France, 3Aix-Marseille University, Marseille, France.
OBJECTIVES: The EU HTA Regulation's first review (Article 31, due 2028) is a one-off chance to course-correct, yet the Regulation offers no agreed priorities or success measures. This study built a transparent, prioritised agenda to help the European Parliament and Commission decide what to address first — and with which instrument.
METHODS: A modified Delphi-inspired structured expert consensus was conducted with five senior experts spanning HTA, epidemiology, public health, policy evaluation, market access, and implementation science. Thirty-nine implementation issues were consolidated into thirteen priorities, each scored on two lenses: a prioritisation score (seven criteria, 0-35) and estimated cross-stakeholder support (six groups, 0-30). Each priority was then mapped to the least intrusive reform instrument — guidance, implementing act, delegated act, evaluation methodology, or legislation.
RESULTS: Thirteen priorities clustered into three tiers and three roadmaps: better patient access; a more attractive Europe for innovation; and better governance and continuous improvement. The highest-scored were proportionality of evidence requirements and administrative burden/competitiveness (both 34/35), then the KPI framework (33/35) and innovation and access (32/35). A deliverable first tier — where high priority met broad support — comprised stakeholder participation and trust, innovation and access, the KPI framework, rare diseases and advanced therapies, and burden measurement. Two findings stood out. Most priorities can be advanced through HTACG guidance or by designing the evaluation well, without amending the Regulation. And the single biggest risk is reaching 2028 with no agreed way to measure success, because signals such as trust, burden, and predictability must be captured prospectively rather than reconstructed later.
CONCLUSIONS: The first review should be treated as a portfolio, not a verdict: advance guidance-ready priorities now, build measurement into the evaluation's design, reserve legislation for the few issues that need it, and approach 2028 as the start of continuous improvement rather than the end of the first cycle.
METHODS: A modified Delphi-inspired structured expert consensus was conducted with five senior experts spanning HTA, epidemiology, public health, policy evaluation, market access, and implementation science. Thirty-nine implementation issues were consolidated into thirteen priorities, each scored on two lenses: a prioritisation score (seven criteria, 0-35) and estimated cross-stakeholder support (six groups, 0-30). Each priority was then mapped to the least intrusive reform instrument — guidance, implementing act, delegated act, evaluation methodology, or legislation.
RESULTS: Thirteen priorities clustered into three tiers and three roadmaps: better patient access; a more attractive Europe for innovation; and better governance and continuous improvement. The highest-scored were proportionality of evidence requirements and administrative burden/competitiveness (both 34/35), then the KPI framework (33/35) and innovation and access (32/35). A deliverable first tier — where high priority met broad support — comprised stakeholder participation and trust, innovation and access, the KPI framework, rare diseases and advanced therapies, and burden measurement. Two findings stood out. Most priorities can be advanced through HTACG guidance or by designing the evaluation well, without amending the Regulation. And the single biggest risk is reaching 2028 with no agreed way to measure success, because signals such as trust, burden, and predictability must be captured prospectively rather than reconstructed later.
CONCLUSIONS: The first review should be treated as a portfolio, not a verdict: advance guidance-ready priorities now, build measurement into the evaluation's design, reserve legislation for the few issues that need it, and approach 2028 as the start of continuous improvement rather than the end of the first cycle.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
SA61
Topic
Study Approaches
Topic Subcategory
Surveys & Expert Panels
Disease
No Additional Disease & Conditions/Specialized Treatment Areas