Comparing HTA Outcomes and Rationale for Decision Making Between Countries With Mature vs. Newly Founded HTA Systems: Evidence From England, France, and Greece
Author(s)
Panagiotis Therianos, MSc1, ILIAS-IOANNIS KYRIOPOULOS, PhD2, Panos Kanavos, BSc, MSc, PhD1.
1Medical Technology Research Group, London School of Economics and Political Science, London, United Kingdom, 2London School of Economics and Political Science, London, United Kingdom.
1Medical Technology Research Group, London School of Economics and Political Science, London, United Kingdom, 2London School of Economics and Political Science, London, United Kingdom.
OBJECTIVES: To review and compare HTA outcomes, reimbursement decisions and suggested clinical restrictions on a set of originator drugs reimbursed in Greece and assessed in England and France, in order to analyze country differences in the rationale for decision-making.
METHODS: Our sample consists of all drug-indication pairs, which were assessed and ultimately approved for reimbursement in Greece between 2019 and 2023. These were matched with assessments of the same drug-indication pairs in France (HAS), and England (NICE). HTA outcomes (L=List; LWCR=List-with-Clinical-Restrictions; R=Rejected, NA=Not Assessed) and the rationale for decision-making were extracted from publicly available English and French HTA reports and reimbursement approvals in Greece.
RESULTS: Of the 169 drug-indication pairs, the following HTA outcomes were recorded: Greece (L=70%, LWCR=30%), France (L=56%, LWCR=33%, R=11%), and England (L=38%, LWCR=45%, R=6%, NA=11%). Significant differences were observed in the clinical restrictions recommended between Greece vs France and England. The majority of restrictions recommended in France and England limited use to strictly defined sub-populations based on diagnostic and/or clinical criteria, or to specific circumstances (e.g., failure of prior therapy, unsuitability of alternatives) within the relevant indication. In Greece, the indication perimeter was less frequently regulated, with restrictions often providing more flexibility or relating to aspects such as treatment duration or delivery setting. The same drug-indication pairs were also observed to receive different clinical restrictions between Greece and the comparator settings.
CONCLUSIONS: Differences in HTA outcomes and the rationale for decision-making between mature (England, France) and newly-founded (Greece) HTA systems, indicate a number of inconsistencies in the latter vis-à-vis the former: willingness to accept based on the approved indication and reduced ability or willingness to restrict use to patient sub-groups that are likely to benefit most. Lack of ability or willingness to implement population restrictions carries significant resource implications for newly-founded systems and their ability to reimburse new technologies.
METHODS: Our sample consists of all drug-indication pairs, which were assessed and ultimately approved for reimbursement in Greece between 2019 and 2023. These were matched with assessments of the same drug-indication pairs in France (HAS), and England (NICE). HTA outcomes (L=List; LWCR=List-with-Clinical-Restrictions; R=Rejected, NA=Not Assessed) and the rationale for decision-making were extracted from publicly available English and French HTA reports and reimbursement approvals in Greece.
RESULTS: Of the 169 drug-indication pairs, the following HTA outcomes were recorded: Greece (L=70%, LWCR=30%), France (L=56%, LWCR=33%, R=11%), and England (L=38%, LWCR=45%, R=6%, NA=11%). Significant differences were observed in the clinical restrictions recommended between Greece vs France and England. The majority of restrictions recommended in France and England limited use to strictly defined sub-populations based on diagnostic and/or clinical criteria, or to specific circumstances (e.g., failure of prior therapy, unsuitability of alternatives) within the relevant indication. In Greece, the indication perimeter was less frequently regulated, with restrictions often providing more flexibility or relating to aspects such as treatment duration or delivery setting. The same drug-indication pairs were also observed to receive different clinical restrictions between Greece and the comparator settings.
CONCLUSIONS: Differences in HTA outcomes and the rationale for decision-making between mature (England, France) and newly-founded (Greece) HTA systems, indicate a number of inconsistencies in the latter vis-à-vis the former: willingness to accept based on the approved indication and reduced ability or willingness to restrict use to patient sub-groups that are likely to benefit most. Lack of ability or willingness to implement population restrictions carries significant resource implications for newly-founded systems and their ability to reimburse new technologies.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA82
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas