WHY DO SIMILAR CLINICAL DATA RESULT IN DIFFERENT HTA CONCLUSIONS AND REIMBURSEMENT DECISIONS? THE CASE OF SEMAGLUTIDE AND TIRZEPATIDE IN OBESITY
Author(s)
Malwina Holownia-Voloskova, MPharm, PhD1, Katarzyna Lasota, MSc1, Sanja Stanisic, MPharm, MSc2, Jacek Walczak, MD1, Roman Casciano, MSc3.
1Certara, Inc., Kraków, Poland, 2Certara, Inc, Milan, Italy, 3Certara USA Inc., Mamaroneck, NY, USA.
1Certara, Inc., Kraków, Poland, 2Certara, Inc, Milan, Italy, 3Certara USA Inc., Mamaroneck, NY, USA.
OBJECTIVES: Obesity is increasingly recognized as a chronic disease associated with substantial clinical and economic burden. The introduction of semaglutide and tirzepatide has challenged HTA agencies to balance clinical value against affordability. This study evaluated how European HTA agencies interpreted the same clinical evidence and whether differences in HTA conclusions translated into divergent reimbursement decisions.
METHODS: We conducted a review of publicly available HTA reports and reimbursement decisions (January 2025-June 2026) for semaglutide and tirzepatide for obesity management across 30 European jurisdictions (27 EU Member States, the UK, Norway, and Switzerland). Data extracted included interpretation of clinical evidence, accepted endpoints, economic evaluations, price and reimbursement conditions and underlying HTA and payer rationale.
RESULTS: Ten HTA assessments of semaglutide and/or tirzepatide were published during 2025-2026 (Austria, Denmark, France, Greece, Ireland, Poland, Spain, Sweden, Switzerland and the UK), and two (Germany and Italy) before 2025. In the remaining countries, HTA assessments were ongoing (10) or no reports were identified (8). Across the 12 completed assessments, substantial heterogeneity was observed despite largely comparable clinical evidence. Agencies differed in their interpretation of the available evidence on cardiovascular outcomes, durability of treatment effects, and the certainty surrounding long-term clinical benefits. While several HTA bodies recognized clinically relevant benefits, they valued differently the magnitude of additional benefits of these therapies. Positive reimbursement recommendations were frequently accompanied by restrictions, including eligibility limited to patients with obesity-related comorbidities, mandatory demonstration of defined weight loss after approximately six months of treatment, and confidential pricing agreements or other measures to improve cost-effectiveness and manage budget impact.
CONCLUSIONS: Differences in patient access are not explained solely by budget impact or pricing negotiations. Variation arises during HTA through different interpretations of the same clinical evidence, while national reimbursement policies and financing models further influence patient access to anti-obesity medicines across Europe.
METHODS: We conducted a review of publicly available HTA reports and reimbursement decisions (January 2025-June 2026) for semaglutide and tirzepatide for obesity management across 30 European jurisdictions (27 EU Member States, the UK, Norway, and Switzerland). Data extracted included interpretation of clinical evidence, accepted endpoints, economic evaluations, price and reimbursement conditions and underlying HTA and payer rationale.
RESULTS: Ten HTA assessments of semaglutide and/or tirzepatide were published during 2025-2026 (Austria, Denmark, France, Greece, Ireland, Poland, Spain, Sweden, Switzerland and the UK), and two (Germany and Italy) before 2025. In the remaining countries, HTA assessments were ongoing (10) or no reports were identified (8). Across the 12 completed assessments, substantial heterogeneity was observed despite largely comparable clinical evidence. Agencies differed in their interpretation of the available evidence on cardiovascular outcomes, durability of treatment effects, and the certainty surrounding long-term clinical benefits. While several HTA bodies recognized clinically relevant benefits, they valued differently the magnitude of additional benefits of these therapies. Positive reimbursement recommendations were frequently accompanied by restrictions, including eligibility limited to patients with obesity-related comorbidities, mandatory demonstration of defined weight loss after approximately six months of treatment, and confidential pricing agreements or other measures to improve cost-effectiveness and manage budget impact.
CONCLUSIONS: Differences in patient access are not explained solely by budget impact or pricing negotiations. Variation arises during HTA through different interpretations of the same clinical evidence, while national reimbursement policies and financing models further influence patient access to anti-obesity medicines across Europe.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA328
Topic
Epidemiology & Public Health, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Diabetes/Endocrine/Metabolic Disorders (including obesity)