REIMBURSEMENT UNDER UNCERTAINTY: HOW EUROPEAN HTA ORGANISATIONS MANAGE EVIDENCE GAPS IN ONCOLOGY — A CASE STUDY OF PARP INHIBITORS
Author(s)
Josephien Bakker, MSc1, Lonneke Timmers, PharmD, PhD2, Wim Goettsch, MSc, PhD2, Christine Leopold, PhD1.
1Utrecht University, Utrecht, Netherlands, 2Zorginstituut Nederland, Diemen, Netherlands.
1Utrecht University, Utrecht, Netherlands, 2Zorginstituut Nederland, Diemen, Netherlands.
OBJECTIVES: To examine uncertainties identified in PARP inhibitor Health Technology Assessments (HTAs) across Europe and how HTA organisations addressed these through reimbursement strategies and Health Technology Reassessment (HTR).
METHODS: Six PARP inhibitor indications subject to a Dutch HTR published in June 2025 served as the starting point. A total of 47 HTA reports from six European countries (the Netherlands, Germany, France, England, Ireland and Denmark) published between 3 June 2015 and 12 February 2026 were included: 30 initial assessments and 17 reassessments covering 15 cases, of which two were reassessed twice. Each case represents one indication assessed by one HTA organisation (e.g. olaparib in recurrent ovarian cancer assessed by HAS). Where no initial assessment report was publicly available (four cases), the reimbursement recommendation was inferred from reassessment documentation. Uncertainties were extracted using a PICOTS-based framework and reimbursement recommendations classified as full, conditional, restricted, or negative.
RESULTS: Of 36 possible organisation-indication combinations, 30 initial assessments were available. Overall survival (OS) immaturity was the most frequently reported uncertainty, identified in 21 of 30 assessments. Reimbursement recommendations varied between and within organisations: full reimbursement was granted in 18 cases (including four inferred), conditional in 10, restricted in four and negative in two. England and Germany were the only organisations to explicitly link conditional reimbursement to pre-specified reassessment requirements. Five of six organisations conducted HTRs covering 15 cases, resulting in confirmation in 10, narrowing in two and withdrawal in three. All HTRs focused on mature OS data from pivotal trials.
CONCLUSIONS: Approaches to managing OS uncertainty varied considerably across organisations. Despite OS data maturing over a product's lifecycle, formal reassessment remains not systematically applied. Where HTRs were conducted, mature OS data were consistently the primary focus, yet reassessment mechanisms are rarely triggered, pointing to a structural gap in post-reimbursement evaluation across European HTA systems.
METHODS: Six PARP inhibitor indications subject to a Dutch HTR published in June 2025 served as the starting point. A total of 47 HTA reports from six European countries (the Netherlands, Germany, France, England, Ireland and Denmark) published between 3 June 2015 and 12 February 2026 were included: 30 initial assessments and 17 reassessments covering 15 cases, of which two were reassessed twice. Each case represents one indication assessed by one HTA organisation (e.g. olaparib in recurrent ovarian cancer assessed by HAS). Where no initial assessment report was publicly available (four cases), the reimbursement recommendation was inferred from reassessment documentation. Uncertainties were extracted using a PICOTS-based framework and reimbursement recommendations classified as full, conditional, restricted, or negative.
RESULTS: Of 36 possible organisation-indication combinations, 30 initial assessments were available. Overall survival (OS) immaturity was the most frequently reported uncertainty, identified in 21 of 30 assessments. Reimbursement recommendations varied between and within organisations: full reimbursement was granted in 18 cases (including four inferred), conditional in 10, restricted in four and negative in two. England and Germany were the only organisations to explicitly link conditional reimbursement to pre-specified reassessment requirements. Five of six organisations conducted HTRs covering 15 cases, resulting in confirmation in 10, narrowing in two and withdrawal in three. All HTRs focused on mature OS data from pivotal trials.
CONCLUSIONS: Approaches to managing OS uncertainty varied considerably across organisations. Despite OS data maturing over a product's lifecycle, formal reassessment remains not systematically applied. Where HTRs were conducted, mature OS data were consistently the primary focus, yet reassessment mechanisms are rarely triggered, pointing to a structural gap in post-reimbursement evaluation across European HTA systems.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA267
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology