DRUG PRICING AND HTA IN EUROPE: A COMPARATIVE ANALYSIS OF EU AND WESTERN BALKAN REGULATORY PATHWAYS
Author(s)
Athanassios Vozikis, Professor1, Platon Peristeris, Ph.D.2, Kristina Hristova, Sr., M.Sc.3, Zoran Sterjev, Ph.D.4, Aleksandra Kapedanovska Nestorovska, specialist in Clinical Pharmacy5, Luka Voncina, Ph.D.6, Tarik Catic, Ph.D.7, Arkadi Sharkov, Ph.D.8, Slaveyko Djambazov, Ph.D.9, Ivana Stevic, MSc10, Lidija Cizmovic, B.SC.Pharm11, Pia Vracko, MD, M.Sc.12.
1Economics Dept., Laboratory of Health Economics and Management (LabHEM), Unicersity of Piraeus, Piraeus, Greece, 2Economics Dept., Laboratory of Health Economics and Management (LabHEM), University of Piraeus, Piraeus, Greece, 3Health insurance fund, Skopje, North Macedonia, The Republic of, 4ISPOR Republic of Macedonia Chapter, Skopje, North Macedonia, The Republic of, 5ISPOR chapter Skopje, FAculty of Phramacy- Skopje, Skopje, North Macedonia, The Republic of, 6Faculty of Health Studies, University of Rijeka, Rijeka, Croatia, 7University SSST Sarajevo - Medical School, Sarajevo, Bosnia and Herzegovina, 8University of Sofia ‘St. Kliment Ohridski’, Sofia, Bulgaria, 9HTA Ltd., Sofia, Bulgaria, 10University in Belgrade, aculty of Pharmacy, Belgrade, Serbia, 11Institute for Medicines and Medical Devices of Montenegro, Podgorica, Montenegro, 12National Institut for Public Health of Slovenia, Ljubljana, Slovenia.
1Economics Dept., Laboratory of Health Economics and Management (LabHEM), Unicersity of Piraeus, Piraeus, Greece, 2Economics Dept., Laboratory of Health Economics and Management (LabHEM), University of Piraeus, Piraeus, Greece, 3Health insurance fund, Skopje, North Macedonia, The Republic of, 4ISPOR Republic of Macedonia Chapter, Skopje, North Macedonia, The Republic of, 5ISPOR chapter Skopje, FAculty of Phramacy- Skopje, Skopje, North Macedonia, The Republic of, 6Faculty of Health Studies, University of Rijeka, Rijeka, Croatia, 7University SSST Sarajevo - Medical School, Sarajevo, Bosnia and Herzegovina, 8University of Sofia ‘St. Kliment Ohridski’, Sofia, Bulgaria, 9HTA Ltd., Sofia, Bulgaria, 10University in Belgrade, aculty of Pharmacy, Belgrade, Serbia, 11Institute for Medicines and Medical Devices of Montenegro, Podgorica, Montenegro, 12National Institut for Public Health of Slovenia, Ljubljana, Slovenia.
OBJECTIVES: To examine regulatory pathways for drug pricing and health technology assessment (HTA) across eight EU and Western Balkan countries, focusing on the integration of pharmacoeconomic evidence in reimbursement decision-making.
METHODS: A cross-sectional comparative study was conducted across two regional blocks: 4 EU Member States (Croatia, Greece, Bulgaria, Slovenia) and 4 Western Balkan countries (North Macedonia, Montenegro, Serbia, Bosnia and Herzegovina). Data were collected through an ongoing structured survey targeting key stakeholders across pharmaceutical, academic, public-institutional, and health-policy sectors. Responses were analysed descriptively using frequency counts and comparative country-level mapping.
RESULTS: HTA maturity and pharmacoeconomic integration were heterogeneous. Mandatory HTA for new molecular entities exists only in 3/8 EU countries; two Western Balkan countries lack functional HTA systems, and three utilize HTA as auxiliary/advisory. Pharmacoeconomic evidence had moderate influence in 5/8 countries and minimal in 3/8. Budget Impact Analysis (BIA) was the dominant reimbursement criterion regionally (mean importance score: 3.62/4). Pricing transparency was full in 2/8 countries, partial/moderate in 4/8, minimal in 1/8, and absent in 1/8. Managed Entry Agreements are frequent in 5/8 countries, with rare/no use in the remainder. However, transitioning to performance-based outcomes is restricted by a lack of clinical registries in 6/8 countries. Main systemic barriers include delayed administrative procedures in 7/8 countries and HTA expertise shortages in 5/8 countries. Innovative medicine access was below the EU average in 4/8 countries, similar in 3/8, and better in 1/8. Reform priorities focused on strengthening HTA capacity and moving toward value-based frameworks.
CONCLUSIONS: Significant differences persist in HTA and pharmacoeconomic utilization between EU and Western Balkan systems. Strengthening HTA capacity and formalizing economic evaluation in the Western Balkans could enhance efficiency, transparency, and equitable access to medicines. Findings support regional cooperation to improve evidence-based decision-making.
METHODS: A cross-sectional comparative study was conducted across two regional blocks: 4 EU Member States (Croatia, Greece, Bulgaria, Slovenia) and 4 Western Balkan countries (North Macedonia, Montenegro, Serbia, Bosnia and Herzegovina). Data were collected through an ongoing structured survey targeting key stakeholders across pharmaceutical, academic, public-institutional, and health-policy sectors. Responses were analysed descriptively using frequency counts and comparative country-level mapping.
RESULTS: HTA maturity and pharmacoeconomic integration were heterogeneous. Mandatory HTA for new molecular entities exists only in 3/8 EU countries; two Western Balkan countries lack functional HTA systems, and three utilize HTA as auxiliary/advisory. Pharmacoeconomic evidence had moderate influence in 5/8 countries and minimal in 3/8. Budget Impact Analysis (BIA) was the dominant reimbursement criterion regionally (mean importance score: 3.62/4). Pricing transparency was full in 2/8 countries, partial/moderate in 4/8, minimal in 1/8, and absent in 1/8. Managed Entry Agreements are frequent in 5/8 countries, with rare/no use in the remainder. However, transitioning to performance-based outcomes is restricted by a lack of clinical registries in 6/8 countries. Main systemic barriers include delayed administrative procedures in 7/8 countries and HTA expertise shortages in 5/8 countries. Innovative medicine access was below the EU average in 4/8 countries, similar in 3/8, and better in 1/8. Reform priorities focused on strengthening HTA capacity and moving toward value-based frameworks.
CONCLUSIONS: Significant differences persist in HTA and pharmacoeconomic utilization between EU and Western Balkan systems. Strengthening HTA capacity and formalizing economic evaluation in the Western Balkans could enhance efficiency, transparency, and equitable access to medicines. Findings support regional cooperation to improve evidence-based decision-making.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA209
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas