INTERNATIONAL REFERENCE PRICING CAPS ARE HIGHLY DESIGN-SENSITIVE: CAP-SETTING COUNTRIES AND ACCESS SIGNALS FOR INCRETIN THERAPIES
Author(s)
Taraneh Mousavi, PharmD, Fadia T. Shaya, MPH, PhD;
School of Pharmacy, University of Maryland, Department of Practice, Sciences, and Health Outcomes Research (P-SHOR), Baltimore, MD, USA
School of Pharmacy, University of Maryland, Department of Practice, Sciences, and Health Outcomes Research (P-SHOR), Baltimore, MD, USA
OBJECTIVES: To quantify how international reference pricing (IRP) design choices alter implied price ceilings for incretin therapies (GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists), identify cap-anchoring reference markets, and contextualize findings using HTA restrictions and indication-specific launch lags (diabetes versus obesity), addressing limited evidence on IRP design sensitivity and cap-setting markets.
METHODS: Using NAVLIN, manufacturer prices (MNF, USD) were obtained in 2025 for liraglutide, semaglutide, tirzepatide, and dulaglutide in Canada, France, Germany, Italy, Japan, Switzerland, and the United Kingdom. Pack prices were standardized to monthly treatment costs using maintenance dosing and summarized at brand and molecule levels. IRP caps were simulated under different scenarios: base (median pack; median of basket), aggressive (minimum pack; minimum of basket), and conservative (maximum pack; maximum of basket). Each cap was applied to the U.S. median MNF to estimate the U.S./cap ratio and percent reduction. Country influence was assessed by recalculating caps after removing one country at a time. Launch lag by indication was compared using an unadjusted Wilcoxon rank-sum test. HTA recommendations and reimbursement restrictions were summarized descriptively by country, product, and indication.
RESULTS: In base design analysis, IRP caps were $58-$367/month versus U.S. medians of $464-$1,134/month, showing 68%-89% reductions. Across designs and pack choices, reductions ranged from 50% to 96%, with aggressive designs producing the largest cuts. Japan, Germany, and Switzerland were the most influential cap-setting countries. Across HTA records, 62% of final recommendations were conditional and 31% included explicit clinical or pricing restrictions. Launch delays were longer for obesity than diabetes (median 901 vs 495 days; p=0.040).
CONCLUSIONS: IRP is a sensitive, design-dependent benchmark. Estimated price reductions may reflect foreign pricing environments shaped by access restrictions and delayed launches, prioritizing lower prices over timely innovation. Future policy discussions should shift from externally determined benchmarks toward transparent IRP designs that explicitly center patient access and outcomes.
METHODS: Using NAVLIN, manufacturer prices (MNF, USD) were obtained in 2025 for liraglutide, semaglutide, tirzepatide, and dulaglutide in Canada, France, Germany, Italy, Japan, Switzerland, and the United Kingdom. Pack prices were standardized to monthly treatment costs using maintenance dosing and summarized at brand and molecule levels. IRP caps were simulated under different scenarios: base (median pack; median of basket), aggressive (minimum pack; minimum of basket), and conservative (maximum pack; maximum of basket). Each cap was applied to the U.S. median MNF to estimate the U.S./cap ratio and percent reduction. Country influence was assessed by recalculating caps after removing one country at a time. Launch lag by indication was compared using an unadjusted Wilcoxon rank-sum test. HTA recommendations and reimbursement restrictions were summarized descriptively by country, product, and indication.
RESULTS: In base design analysis, IRP caps were $58-$367/month versus U.S. medians of $464-$1,134/month, showing 68%-89% reductions. Across designs and pack choices, reductions ranged from 50% to 96%, with aggressive designs producing the largest cuts. Japan, Germany, and Switzerland were the most influential cap-setting countries. Across HTA records, 62% of final recommendations were conditional and 31% included explicit clinical or pricing restrictions. Launch delays were longer for obesity than diabetes (median 901 vs 495 days; p=0.040).
CONCLUSIONS: IRP is a sensitive, design-dependent benchmark. Estimated price reductions may reflect foreign pricing environments shaped by access restrictions and delayed launches, prioritizing lower prices over timely innovation. Future policy discussions should shift from externally determined benchmarks toward transparent IRP designs that explicitly center patient access and outcomes.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PT21
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)