Patient Access Delays for Subsequent High-Value Indications of Multi-Indication Treatments: An Assessment of Health Technology Assessment Decision Making
Author(s)
Jorge Mestre-Ferrandiz, BSc, MSc, PhD1, Coby Martin, MS, BS2, Rachel Gamburg, BS2, Divya Tamminina, MPharm, MBA3, Matthew Hodgson, MSc4, Keiko Higuchi, MPH5, Hugo Dubucq, MPH, BSc6, Gaelle Bego Le Bagousse, Sr., MSc7, Zhixiao Wang, PhD8, Donia Bahloul, PharmD, MSc7.
1Profesor Asociado, Economics Dept, Universidad Carlos III, Madrid, Spain, 2Axtria Inc., Berkeley Heights, NJ, USA, 3Axtria India Pvt. Ltd., Gurugram, India, 4Sanofi, Reading, United Kingdom, 5Sanofi, Morristown, NJ, USA, 6Sanofi, Barcelona, Spain, 7Sanofi, Gentilly, France, 8Regeneron Pharmaceuticals, Inc., Sleepy Hollow, NY, USA.
1Profesor Asociado, Economics Dept, Universidad Carlos III, Madrid, Spain, 2Axtria Inc., Berkeley Heights, NJ, USA, 3Axtria India Pvt. Ltd., Gurugram, India, 4Sanofi, Reading, United Kingdom, 5Sanofi, Morristown, NJ, USA, 6Sanofi, Barcelona, Spain, 7Sanofi, Gentilly, France, 8Regeneron Pharmaceuticals, Inc., Sleepy Hollow, NY, USA.
OBJECTIVES: Multiple indication (MI) therapies may be affected by delays in reimbursement approval for subsequent indications due to complex reimbursement negotiations with health technology assessment (HTA) bodies, delaying patient access to these high-value treatments. We aimed to quantify the time from marketing authorisation to reimbursement decision for subsequent indications of MI therapeutics, focusing on assessment duration.
METHODS: Six innovative MI therapeutics—adalimumab, mepolizumab, dupilumab, upadacitinib, risankizumab-rzaa, and pembrolizumab—were selected based on their global presence. HTA bodies chosen to ensure variability in value frameworks, and included bodies from Canada, England, France, Germany, Italy, and South Korea. The time intervals (days) from market authorisation to a reimbursement decision for the first three new indications were analysed across six HTA bodies, using dates from the European Commission for European HTA bodies.
RESULTS: In total, we reviewed 503 assessments from these HTA bodies between 2004 and 2024. Analysis revealed delays in subsequent reimbursement decision, with HTA bodies in majority of the countries requiring longer evaluation periods for the 3rd indication than the 1st indication (median [mean], in days): Canada, 245 (180) vs. 160.5 (134.33); England, 462 (518.67) vs. 334 (339.67); France, 137 (164.67) vs. 265.5 (253.33); Germany, 188 (191.8) vs. 210 (212.2); Italy, 421 (393) vs. 419 (517.17); South Korea, 1011 (1034.33) vs. 526.5 (835.67). A consistent pattern of greater delays was observed from 2nd to 1st and from 3rd to 2nd indications.
CONCLUSIONS: This analysis demonstrated consistent delays in reimbursement decisions of subsequent new indications by various HTA bodies. The delay unnecessarily hinders the efforts to provide important medications to patients who need them most.
METHODS: Six innovative MI therapeutics—adalimumab, mepolizumab, dupilumab, upadacitinib, risankizumab-rzaa, and pembrolizumab—were selected based on their global presence. HTA bodies chosen to ensure variability in value frameworks, and included bodies from Canada, England, France, Germany, Italy, and South Korea. The time intervals (days) from market authorisation to a reimbursement decision for the first three new indications were analysed across six HTA bodies, using dates from the European Commission for European HTA bodies.
RESULTS: In total, we reviewed 503 assessments from these HTA bodies between 2004 and 2024. Analysis revealed delays in subsequent reimbursement decision, with HTA bodies in majority of the countries requiring longer evaluation periods for the 3rd indication than the 1st indication (median [mean], in days): Canada, 245 (180) vs. 160.5 (134.33); England, 462 (518.67) vs. 334 (339.67); France, 137 (164.67) vs. 265.5 (253.33); Germany, 188 (191.8) vs. 210 (212.2); Italy, 421 (393) vs. 419 (517.17); South Korea, 1011 (1034.33) vs. 526.5 (835.67). A consistent pattern of greater delays was observed from 2nd to 1st and from 3rd to 2nd indications.
CONCLUSIONS: This analysis demonstrated consistent delays in reimbursement decisions of subsequent new indications by various HTA bodies. The delay unnecessarily hinders the efforts to provide important medications to patients who need them most.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA264
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas