Patient Access Delays in Multi-Indication Medicines: A Review of Health Technology Assessment Timelines
Author(s)
Jorge Mestre-Ferrandiz, PhD, MSc, BSc1, Coby Martin, MS, BS2, Rachel Gamburg, BS2, Divya Tamminina, MPharm, MBA3, Matthew Hodgson, MSc4, Keiko Higuchi, MPH, BSc5, Hugo Dubucq, MPH, BSc6, Gaelle Bego Le Bagousse, 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: Multi-indication (MI) medicines face several patient-access-related challenges, including numerous health technology assessment (HTA) assessments and administration burden for payers, value assessment variation between reimbursement institutes, and managing budget uncertainty. The duration of HTA processes and reimbursement negotiations can lead to delayed patient access to innovative products. There is limited evidence comparing timelines of MI medicines to all medicines, so we aimed to address this gap.
METHODS: Six MI medicines were selected based on their global presence, and six HTA bodies were selected to provide variation in value frameworks, including National Institute for Health and Care Excellence (NICE), Haute Autorité de santé (HAS), Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)/Gemeinsamer Bundesausschuss (G-BA), Canada's Drug Agency (CDA), Agenzia Italiana del Farmaco (AIFA), and Health Insurance Review & Assessment (HIRA). We analyzed trends in reimbursement timelines by estimating the average time between marketing authorization and reimbursement decisions for all new indications, including first indications and age group expansions, and compared them with publicly available average timelines.
RESULTS: We reviewed 503 assessments from the selected HTA bodies between 2004 and 2024. Observed time to a reimbursement decision from market authorization was consistently greater for MI therapies compared to the industry average of all medicines: NICE: 409 vs. 347 days; HAS: 212 vs. 98 days; G-BA: 228 vs. 126 days; CDA: 257 vs. 144 days; HIRA: 723 vs. 620 days; AIFA: 541 vs. 424 days.
CONCLUSIONS: Delays in evaluating MI medicine were observed, which can lead to several negative consequences for patients. This longer evaluation time for MI medicines may indicate an opportunity for HTA bodies to improve their multiple indications evaluation process to optimally capture full value and facilitate access for physicians and patients. Healthcare systems and HTA processes adaptation to MI scientific innovation should be calibrated to appropriately value MI therapies across all indications.
METHODS: Six MI medicines were selected based on their global presence, and six HTA bodies were selected to provide variation in value frameworks, including National Institute for Health and Care Excellence (NICE), Haute Autorité de santé (HAS), Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)/Gemeinsamer Bundesausschuss (G-BA), Canada's Drug Agency (CDA), Agenzia Italiana del Farmaco (AIFA), and Health Insurance Review & Assessment (HIRA). We analyzed trends in reimbursement timelines by estimating the average time between marketing authorization and reimbursement decisions for all new indications, including first indications and age group expansions, and compared them with publicly available average timelines.
RESULTS: We reviewed 503 assessments from the selected HTA bodies between 2004 and 2024. Observed time to a reimbursement decision from market authorization was consistently greater for MI therapies compared to the industry average of all medicines: NICE: 409 vs. 347 days; HAS: 212 vs. 98 days; G-BA: 228 vs. 126 days; CDA: 257 vs. 144 days; HIRA: 723 vs. 620 days; AIFA: 541 vs. 424 days.
CONCLUSIONS: Delays in evaluating MI medicine were observed, which can lead to several negative consequences for patients. This longer evaluation time for MI medicines may indicate an opportunity for HTA bodies to improve their multiple indications evaluation process to optimally capture full value and facilitate access for physicians and patients. Healthcare systems and HTA processes adaptation to MI scientific innovation should be calibrated to appropriately value MI therapies across all indications.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA265
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas