Presentation (CTI)

OBJECTIVES: Although WHO and the European Association for the Study of Obesity classify obesity as a chronic disease at BMI ≥30 kg/m², European HTA bodies frame it inconsistently. The lifestyle-versus-disease divide is well described; less understood is how that framing is operationalised into access restrictions. We examined how framing translates into reimbursement conditions for anti-obesity medicines (AOMs).
METHODS: We reviewed (June 2026) HTA assessments published 2017-2025 for liraglutide, semaglutide, tirzepatide and naltrexone/bupropion across eight bodies (HAS, G-BA/IQWiG, NICE, SMC, AIFA, AEMPS, ZIN, TLV). We extracted framing statements, BMI thresholds, comorbidity and prior-treatment criteria, comparators and ICERs, and analysed EMA §4.1/§5.1 handling of comorbidity indications.
RESULTS: Across 19 assessment decisions (six issuing bodies; G-BA excludes AOMs by statute, TLV none), framing did not predict access. HAS recognised obesity as a disease yet restricted tirzepatide to BMI ≥35 kg/m², age ≤65 and prior failure; ZIN applied a hybrid framing (disease, risk factor and lifestyle) with mixed outcomes — refusing semaglutide, restricting liraglutide to BMI ≥35, yet recommending naltrexone/bupropion at its full label. Half of approved decisions reimbursed only at BMI ≥35 despite disease defined at ≥30, requiring prior deterioration. UK ICERs were largely £9,000-17,000/QALY (some £21,000-30,000), yet most decisions were restricted or denied — gating that was often budget- rather than value-driven. Comorbidity expansion offered limited relief: EMA absorbed weight-mediated benefits (sleep apnoea, cardiovascular, heart failure) into §5.1 without a discrete indication, while only condition-specific endpoints (renal, hepatic) earned recognition, routed outside the obesity brand.
CONCLUSIONS: EU HTA bodies rarely dispute obesity's disease status; instead, they operationalise budget control through BMI, comorbidity and prior-failure thresholds, restricting cost-effective therapies irrespective of framing. The decisive levers for manufacturers and clinical societies are therefore weight-independent hard-outcome evidence, distinct regulatory/brand strategies, and advocacy to align reimbursement thresholds with the clinical definition of obesity, not the disease-versus-lifestyle debate itself.