HTA for Obesity and T2DM Indications: A Review and Recommendations for Future Appraisals
Author(s)
Tiago M. de Carvalho, PhD, Heather Eames, BSc, MSc, PharmD, Emer Fogarty, PhD, Patrick Kearns, BSc, MPH, Joy Leahy, PhD, Orla Maguire, MSc, Roisin Adams, PhD, Laura Mccullagh, BSc, PhD.
National Centre for Pharmacoeconomics, Dublin, Ireland.
National Centre for Pharmacoeconomics, Dublin, Ireland.
OBJECTIVES: Several HTAs of Glucagon-Like Peptide-1 (GLP-1) class drugs for obesity and/or T2DM (type 2 diabetes mellitus) indications have been submitted to national HTA bodies (HTAb) in the last five years. These drugs are characterized by a high budget impact and their assessments contain a high degree of modelling complexity due the need to account for multiple clinical events. With potentially, multiple GLP-1s being subject to appraisal in the near future, we describe the most common issues in obesity and T2DM modelling for HTA.
METHODS: We reviewed publicly available assessment reports from NICE (UK), CADTH (Canada), NOma (Norway), PBAC (Australia) and NCPE (Ireland). We categorized the most common concerns identified by HTAb into different themes with focus on modelling issues and describe potential common solutions and uncertainties.
RESULTS: We retrieved 16 publicly available HTA reports published since 2020, in June 2025, from NICE, CADTH, NOma, PBAC and NCPE for liraglutide, semaglutide and tirzepatide for obesity and/or T2DM indications. We classified all queries by HTAb into six categories: modelling strategy, comparative effectiveness, baseline characteristics, risk equations, HRQoL utilities and post-treatment assumptions. Key recommendations include: to provide sufficient information for input validation and implementation of scenario analyses, when using non-standard software or programming languages for modelling; to adequately justify choice of baseline characteristics and risk equations and for utility gains during treatment to be consistent with potential utility losses post-treatment, as patient outcomes are likely to revert to baseline; Selection of HRQoL utilities is often justified based on its usage in previous submissions and this may result in a trade-off between suitability of modelling approach and consistency between HTA appraisals.
CONCLUSIONS: In this review we highlight several issues concerning HTAs in medicines for obesity and T2DM. Our recommendations will be informative for HTAb and health technology developers of drugs for obesity and T2DM indications.
METHODS: We reviewed publicly available assessment reports from NICE (UK), CADTH (Canada), NOma (Norway), PBAC (Australia) and NCPE (Ireland). We categorized the most common concerns identified by HTAb into different themes with focus on modelling issues and describe potential common solutions and uncertainties.
RESULTS: We retrieved 16 publicly available HTA reports published since 2020, in June 2025, from NICE, CADTH, NOma, PBAC and NCPE for liraglutide, semaglutide and tirzepatide for obesity and/or T2DM indications. We classified all queries by HTAb into six categories: modelling strategy, comparative effectiveness, baseline characteristics, risk equations, HRQoL utilities and post-treatment assumptions. Key recommendations include: to provide sufficient information for input validation and implementation of scenario analyses, when using non-standard software or programming languages for modelling; to adequately justify choice of baseline characteristics and risk equations and for utility gains during treatment to be consistent with potential utility losses post-treatment, as patient outcomes are likely to revert to baseline; Selection of HRQoL utilities is often justified based on its usage in previous submissions and this may result in a trade-off between suitability of modelling approach and consistency between HTA appraisals.
CONCLUSIONS: In this review we highlight several issues concerning HTAs in medicines for obesity and T2DM. Our recommendations will be informative for HTAb and health technology developers of drugs for obesity and T2DM indications.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA185
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity)