Budget Impact Minimization Approaches Used Across Europe, Brazil, and Japan in the Reimbursement of Obesity Medications
Author(s)
Grace Miller, MRes, Vishal Chanda, MSc, Graham Foxon, MBA, DPhil.
Remap Consulting UK Ltd, Macclesfield, United Kingdom.
Remap Consulting UK Ltd, Macclesfield, United Kingdom.
OBJECTIVES: The market entry of effective obesity medications offers promise to patients with obesity and obesity-related comorbidities. However, the high prevalence of the disease plus the cost of such medications raises affordability concerns amongst payers. This analysis evaluates approaches used by HTA bodies across select markets to mitigate the budget impact (BI) of obesity medications.
METHODS: A review of grey literature and HTA reports was conducted to analyse whether BI was cited as a consideration for reimbursement decision-making in Brazil, Denmark, Italy, Japan, Spain, and UK for key obesity medications: liraglutide, semaglutide, and tirzepatide. Further research explored how identified BI concerns were addressed in specific markets.
RESULTS: Overall, BI was reported as a consideration for obesity medication reimbursement in 4/6 markets (Brazil, Denmark, Italy, Japan, Spain, and UK). It was explicitly cited as a concern in 2/9 HTA reports (Brazil, UK). formal cost-containment measures to mitigate the BI risk have been employed in 2/6 markets (Denmark, UK). Tirzepatide was forecast to exceed the UK BI threshold of £20 million, prompting a 12-year staggered rollout period at launch to partly mitigate the anticipated BI. In Denmark, risk-sharing mechanisms were trialled to manage the BI risk for semaglutide. Japan has no specific BI mechanism for semaglutide, beyond established cost containment measures. Decision makers in Italy and Brazil have cited BI and health-system costs as concerns but have not yet enforced formal mitigation measures. Spanish payers have not commented on the BI of obesity medications.
CONCLUSIONS: Across markets, the BI of obesity medications are frequently cited as a concern. However, the limited formalisation of these concerns in HTA reports may hinder the implementation of formal cost-containment measures. Such measures, if successful, could be used in the future to enable wider access to obesity medications, particularly in markets where BI poses a barrier to reimbursement.
METHODS: A review of grey literature and HTA reports was conducted to analyse whether BI was cited as a consideration for reimbursement decision-making in Brazil, Denmark, Italy, Japan, Spain, and UK for key obesity medications: liraglutide, semaglutide, and tirzepatide. Further research explored how identified BI concerns were addressed in specific markets.
RESULTS: Overall, BI was reported as a consideration for obesity medication reimbursement in 4/6 markets (Brazil, Denmark, Italy, Japan, Spain, and UK). It was explicitly cited as a concern in 2/9 HTA reports (Brazil, UK). formal cost-containment measures to mitigate the BI risk have been employed in 2/6 markets (Denmark, UK). Tirzepatide was forecast to exceed the UK BI threshold of £20 million, prompting a 12-year staggered rollout period at launch to partly mitigate the anticipated BI. In Denmark, risk-sharing mechanisms were trialled to manage the BI risk for semaglutide. Japan has no specific BI mechanism for semaglutide, beyond established cost containment measures. Decision makers in Italy and Brazil have cited BI and health-system costs as concerns but have not yet enforced formal mitigation measures. Spanish payers have not commented on the BI of obesity medications.
CONCLUSIONS: Across markets, the BI of obesity medications are frequently cited as a concern. However, the limited formalisation of these concerns in HTA reports may hinder the implementation of formal cost-containment measures. Such measures, if successful, could be used in the future to enable wider access to obesity medications, particularly in markets where BI poses a barrier to reimbursement.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA60
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity)