INDIRECT TREATMENT COMPARISONS IN DUTCH HEALTH TECHNOLOGY ASSESSMENT: EVOLVING METHODOLOGICAL EXPECTATIONS FROM 2017 TO 2025
Author(s)
Marnix Gert Uyterlinde, MSc1, Esra Çakar, MSc2, Fredrik O L Nilsson, MSc, PhD3, Laura Anna van der Linde, MSc4, Sophia van Beekhuizen, MSc4, Ha Anh Pham, MSc4.
1Cytel, Leiderdorp, Netherlands, 2Pfizer, Capelle aan den Ijssel, Netherlands, 3Pfizer, Solna, Sweden, 4Cytel, Rotterdam, Netherlands.
1Cytel, Leiderdorp, Netherlands, 2Pfizer, Capelle aan den Ijssel, Netherlands, 3Pfizer, Solna, Sweden, 4Cytel, Rotterdam, Netherlands.
OBJECTIVES: Indirect treatment comparisons (ITCs) are increasingly used to support reimbursement submissions when direct comparative evidence is unavailable. This is particularly relevant in oncology, where rapidly evolving treatment landscapes and single-arm studies are more common. Understanding how health technology assessment (HTA) bodies evaluate ITCs help contextualize future evidence requirements under the evolving European HTA framework. This study aimed to evaluate the use of ITCs in Dutch submissions and assess how ITC appraisals by the Dutch National Health Care Institute (ZIN) have evolved over time.
METHODS: A review was conducted of ZIN assessments published between 2017 and 2026. Data extracted included disease setting, pivotal trial design, inclusion of pharmacoeconomic evaluation, use of an ITC, data availability, and methodological comments provided by ZIN. Trends over time and recurring themes in the appraisal of ITCs were explored descriptively.
RESULTS: A total of 153 reimbursement assessments were included, of which 61 included at least one ITC. The use of ITCs increased over time with a peak in 2025 (n=15 ZIN submission publications included an ITC). ITCs were most common in oncology submissions (59%). Approximately half of the submissions including an ITC were based on a single-arm pivotal trial. Uncertainty inherent to unanchored ITC method was flagged in all resubmissions (n=4), yet all received a positive recommendation. More than half of the ITC submissions were based on equal therapeutic value claims. In the oncology submissions that included an ITC, only about a third of the added value submissions received an initial positive reimbursement recommendation. ZIN demonstrated higher expectations regarding transparency and robustness of comparative analyses, especially in added clinical value claim submissions.
CONCLUSIONS: The use of ITCs in Dutch reimbursement submissions has increased substantially over the last decade. These findings provide insight into current Dutch HTA indirect evidence requirements and acceptance under the evolving European HTA framework.
METHODS: A review was conducted of ZIN assessments published between 2017 and 2026. Data extracted included disease setting, pivotal trial design, inclusion of pharmacoeconomic evaluation, use of an ITC, data availability, and methodological comments provided by ZIN. Trends over time and recurring themes in the appraisal of ITCs were explored descriptively.
RESULTS: A total of 153 reimbursement assessments were included, of which 61 included at least one ITC. The use of ITCs increased over time with a peak in 2025 (n=15 ZIN submission publications included an ITC). ITCs were most common in oncology submissions (59%). Approximately half of the submissions including an ITC were based on a single-arm pivotal trial. Uncertainty inherent to unanchored ITC method was flagged in all resubmissions (n=4), yet all received a positive recommendation. More than half of the ITC submissions were based on equal therapeutic value claims. In the oncology submissions that included an ITC, only about a third of the added value submissions received an initial positive reimbursement recommendation. ZIN demonstrated higher expectations regarding transparency and robustness of comparative analyses, especially in added clinical value claim submissions.
CONCLUSIONS: The use of ITCs in Dutch reimbursement submissions has increased substantially over the last decade. These findings provide insight into current Dutch HTA indirect evidence requirements and acceptance under the evolving European HTA framework.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA230
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas