GLOBAL AVAILABILITY AND ACCESS TO EVIDENCE-BASED ANTI-OBESITY PHARMACOTHERAPIES: A SYSTEMATIC ASSESSMENT OF REGULATORY AND REIMBURSEMENT LANDSCAPES
Author(s)
Stefan Walzer, MA, PhD1, Julie Frappier, BS, MSc2, Bjoern Schwander, BSc, MA, RN, PhD3, Sally Lewis, MSc4, Casandra Poitras, MSc5;
1MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 2TOWWERS Institute (Data 4 Actions), Montreal, QC, Canada, 3AHEAD GmbH, Bietigheim-Bissingen, Germany, 4kintsugi international, Davenport, United Kingdom, 5Conseils Zèbre Politique, Montreal, QC, Canada
1MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 2TOWWERS Institute (Data 4 Actions), Montreal, QC, Canada, 3AHEAD GmbH, Bietigheim-Bissingen, Germany, 4kintsugi international, Davenport, United Kingdom, 5Conseils Zèbre Politique, Montreal, QC, Canada
OBJECTIVES: To systematically assess the global availability, regulatory approval status, and reimbursement of modern anti-obesity pharmacotherapies, and to evaluate the alignment between therapeutic access and global disease burden. Despite substantial clinical advances—from GLP-1 receptor agonists to dual incretin therapies—access remains highly inconsistent across regions. This study quantifies these disparities.
METHODS: A structured review (2016-2024) was conducted using regulatory databases (FDA, EMA, MHRA, Health Canada, TGA, PMDA), national reimbursement lists, HTA documentation, and payer policy statements. Key agents assessed included orlistat, bupropion/naltrexone, phentermine/topiramate, liraglutide 3.0 mg, semaglutide 2.4 mg, and tirzepatide. Extracted variables included regulatory approval status, market availability, public and private reimbursement conditions, prescriber restrictions, and patient eligibility criteria. Countries were grouped by income level to examine global disparities.
RESULTS: Regulatory and reimbursement landscapes show substantial regional variation.Regulatory Approval: Semaglutide 2.4 mg is approved in the USA, Canada, EU, UK, Australia, and selected Latin American and Middle Eastern countries, but approvals remain limited in Asia and Africa. Tirzepatide has received approval for obesity in USA, UK, and Canada, with submissions under review in several other regions. Older agents remain more widely available but demonstrate significantly lower efficacy.Reimbursement: Public reimbursement is extremely limited worldwide.
• USA: Coverage fragmented; Medicare excludes obesity drugs.
• Canada: Minimal provincial reimbursement; coverage largely private and inconsistent.
• Europe: Very limited reimbursement; some regional access in Denmark and Germany.
• Middle-income regions: Approvals rarely translate into funded access; out-of-pocket payment dominates.
Across all settings, an estimated <10% of eligible patients have reimbursed access to evidence-based pharmacotherapy.
CONCLUSIONS: Global access to effective anti-obesity pharmacotherapies is profoundly misaligned with epidemiological need. While regulatory approvals are increasing, reimbursement remains the major barrier, resulting in significant inequities in treatment availability. These findings highlight the need for coordinated international policy development and innovative contracting approaches, including prospective data collection, to enable sustainable and equitable access.
METHODS: A structured review (2016-2024) was conducted using regulatory databases (FDA, EMA, MHRA, Health Canada, TGA, PMDA), national reimbursement lists, HTA documentation, and payer policy statements. Key agents assessed included orlistat, bupropion/naltrexone, phentermine/topiramate, liraglutide 3.0 mg, semaglutide 2.4 mg, and tirzepatide. Extracted variables included regulatory approval status, market availability, public and private reimbursement conditions, prescriber restrictions, and patient eligibility criteria. Countries were grouped by income level to examine global disparities.
RESULTS: Regulatory and reimbursement landscapes show substantial regional variation.Regulatory Approval: Semaglutide 2.4 mg is approved in the USA, Canada, EU, UK, Australia, and selected Latin American and Middle Eastern countries, but approvals remain limited in Asia and Africa. Tirzepatide has received approval for obesity in USA, UK, and Canada, with submissions under review in several other regions. Older agents remain more widely available but demonstrate significantly lower efficacy.Reimbursement: Public reimbursement is extremely limited worldwide.
• USA: Coverage fragmented; Medicare excludes obesity drugs.
• Canada: Minimal provincial reimbursement; coverage largely private and inconsistent.
• Europe: Very limited reimbursement; some regional access in Denmark and Germany.
• Middle-income regions: Approvals rarely translate into funded access; out-of-pocket payment dominates.
Across all settings, an estimated <10% of eligible patients have reimbursed access to evidence-based pharmacotherapy.
CONCLUSIONS: Global access to effective anti-obesity pharmacotherapies is profoundly misaligned with epidemiological need. While regulatory approvals are increasing, reimbursement remains the major barrier, resulting in significant inequities in treatment availability. These findings highlight the need for coordinated international policy development and innovative contracting approaches, including prospective data collection, to enable sustainable and equitable access.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR75
Topic
Health Policy & Regulatory
Topic Subcategory
Health Disparities & Equity
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)