Availability and reimbursement of fixed-dose combination medicines for hypertension treatment in Central and Eastern Europe
20 affiliations
- 1Department of Nutrition and Drug Research, Institute of Public Health, Faculty of Health Science, Jagiellonian University Medical College
- 2Department of Pharmacy, Faculty of Medicine, University of Medicine
- 3Department “Organization and Economics of Pharmacy”, Faculty of Pharmacy, Medical University of Sofia
- 4National Council on Prices and Reimbursement of Medicinal Products
- 5Agency for Medicinal Products and Medical Devices of Croatia
- 6Faculty of Biotechnology and Drug Development, University of Rijeka
- 7EconHealth s.r.o.
- 8Institute of Family Medicine and Public Health, University of Tartu
- 9Center for Health Technology Assessment, Semmelweis University
- 10Syreon Research Institute
- 11Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Riga Stradins University
- 12Red Cross Medical College of Riga Stradins University
- 13Pharmacy and Pharmacology Center, Institute of Biomedical Sciences, Faculty of Medicine, Vilnius University
- 14Faculty of Pharmacy, Ss. Cyril and Methodius University in Skopje
- 15Department of Social Pharmacy, Nicolae Testemitanu State University of Medicine and Pharmacy
- 16Department of Pharmacology and Clinical Pharmacology, Faculty of Medicine, University of Montenegro
- 17Romanian Association of International Medicine Manufacturers (ARPIM)
- 18Department of Pharmacy, Faculty of Medicine, University of Niš
- 19Department of Organisation and Management in Pharmacy, Faculty of Pharmacy, Comenius University in Bratislava
- 20Medication Adherence Research Group, Center for Health Technology Assessment and Pharmacoeconomic Research, University of Pécs
Abstract
Introduction: Fixed-dose combinations (FDCs) represent an important strategy in modern pharmacotherapy and are particularly beneficial in the treatment of chronic conditions such as hypertension because they reduce pill burden and may improve patient adherence to therapy.
Objectives: The primary objective of this study was to compare reimbursement, pricing, and availability policies for FDC medicines used in the treatment of arterial hypertension across 15 CEE countries. Additionally, the study aimed to assess differences in HTA requirements and patient co-payments among the analyzed countries.
Methods: Data were collected from the reimbursement systems of 15 CEE countries using a questionnaire distributed to native experts in each country to ensure contextual accuracy. The list of potential active substance combinations was derived from established clinical guidelines. Associations were assessed using Spearman’s rank correlation coefficients and generalized linear mixed models (GLMMs).
Results: Substantial variation in reimbursement requirements was observed across CEE countries. The greatest variability concerned the inclusion of adherence and persistence outcomes in reimbursement decision-making processes. Seven countries considered these aspects in their reimbursement assessments, whereas the remaining countries did not. The four most frequently reimbursed two-component FDCs were combinations of ARBs with CCBs, ACEIs with CCBs, ACEIs with diuretics, and ARBs with diuretics. Public pharmaceutical expenditure related to hypertension treatment varied substantially across countries; with Estonia allocating the highest proportion of hypertension reimbursement expenditure to FDCs (68% in 2022). The time required for inclusion on reimbursement lists also differed markedly, ranging from less than 3 months in Latvia and Lithuania to more than 12 months in Albania and Romania. Spearman correlation analyses demonstrated that the total number of reimbursed FDCs in a given country was significantly associated with HTA requirements for FDCs containing previously reimbursed components (ρ = 0.641, p = 0.011) and with the time from reimbursement application to inclusion on the reimbursement list (ρ = −0.548, p = 0.041). Multivariable GLMM analysis confirmed that: i) countries with less stringent requirements for FDCs containing already reimbursed components (i.e., countries that either do not require an HTA assessment or make the HTA requirement contingent on the manufacturer’s proposed price) had a significantly higher number of reimbursed FDCs (p = 0.001); and ii) countries with less stringent HTA requirements for FDCs (i.e., those that do not require additional comparators beyond the individual FDC components) also tended to have a higher number of reimbursed FDCs (p = 0.010).
Conclusion: Across CEE countries, less burdensome HTA and reimbursement requirements for FDCs composed of already known and reimbursed active substances were associated with broader reimbursement of single-pill antihypertensive therapies. Streamlining assessment pathways for well-justified, guideline-supported combinations could improve patient access and better align reimbursement practice with current clinical guidelines, while preserving evidence-based decision-making. Common EU-level clinical assessment processes may further support consistency across national HTA systems, although pricing and reimbursement decisions remain within national competence.
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BibTeX
@article{nowak2026availability,
title = {{Availability and reimbursement of fixed-dose combination medicines for hypertension treatment in Central and Eastern Europe}},
author = {Rafał Nowak and Przemysław Holko and Iris Hoxha and Alexandra Savova and Pero Draganić and Jana Skoupa and Agnes Männik and Zoltán Kaló and Arturs Praskilevics and Kristina Garuoliene and Ljubica Shuturkova and Elena Chitan and Natasa Duborija-Kovacevic and Michał Owca and Ioana Bianchi-Manaila and Nikola Stefanovic and Tomas Tesar and Tamás Ágh and Paweł Kawalec},
journal = {Frontiers in Pharmacology},
year = {2026},
month = oct,
doi = {10.3389/fphar.2026.1889485},
url = {https://www.frontiersin.org/articles/10.3389/fphar.2026.1889485/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Availability and reimbursement of fixed-dose combination medicines for hypertension treatment in Central and Eastern Europe
AU - Rafał Nowak
AU - Przemysław Holko
AU - Iris Hoxha
AU - Alexandra Savova
AU - Pero Draganić
AU - Jana Skoupa
AU - Agnes Männik
AU - Zoltán Kaló
AU - Arturs Praskilevics
AU - Kristina Garuoliene
AU - Ljubica Shuturkova
AU - Elena Chitan
AU - Natasa Duborija-Kovacevic
AU - Michał Owca
AU - Ioana Bianchi-Manaila
AU - Nikola Stefanovic
AU - Tomas Tesar
AU - Tamás Ágh
AU - Paweł Kawalec
PY - 2026
DA - 2026/10/08
JO - Frontiers in Pharmacology
DO - 10.3389/fphar.2026.1889485
UR - https://www.frontiersin.org/articles/10.3389/fphar.2026.1889485/full
AB - Introduction: Fixed-dose combinations (FDCs) represent an important strategy in modern pharmacotherapy and are particularly beneficial in the treatment of chronic conditions such as hypertension because they reduce pill burden and may improve patient adherence to therapy. Objectives: The primary objective of this study was to compare reimbursement, pricing, and availability policies for FDC medicines used in the treatment of arterial hypertension across 15 CEE countries. Additionally, the study aimed to assess differences in HTA requirements and patient co-payments among the analyzed countries. Methods: Data were collected from the reimbursement systems of 15 CEE countries using a questionnaire distributed to native experts in each country to ensure contextual accuracy. The list of potential active substance combinations was derived from established clinical guidelines. Associations were assessed using Spearman’s rank correlation coefficients and generalized linear mixed models (GLMMs). Results: Substantial variation in reimbursement requirements was observed across CEE countries. The greatest variability concerned the inclusion of adherence and persistence outcomes in reimbursement decision-making processes. Seven countries considered these aspects in their reimbursement assessments, whereas the remaining countries did not. The four most frequently reimbursed two-component FDCs were combinations of ARBs with CCBs, ACEIs with CCBs, ACEIs with diuretics, and ARBs with diuretics. Public pharmaceutical expenditure related to hypertension treatment varied substantially across countries; with Estonia allocating the highest proportion of hypertension reimbursement expenditure to FDCs (68% in 2022). The time required for inclusion on reimbursement lists also differed markedly, ranging from less than 3 months in Latvia and Lithuania to more than 12 months in Albania and Romania. Spearman correlation analyses demonstrated that the total number of reimbursed FDCs in a given country was significantly associated with HTA requirements for FDCs containing previously reimbursed components (ρ = 0.641, p = 0.011) and with the time from reimbursement application to inclusion on the reimbursement list (ρ = −0.548, p = 0.041). Multivariable GLMM analysis confirmed that: i) countries with less stringent requirements for FDCs containing already reimbursed components (i.e., countries that either do not require an HTA assessment or make the HTA requirement contingent on the manufacturer’s proposed price) had a significantly higher number of reimbursed FDCs (p = 0.001); and ii) countries with less stringent HTA requirements for FDCs (i.e., those that do not require additional comparators beyond the individual FDC components) also tended to have a higher number of reimbursed FDCs (p = 0.010). Conclusion: Across CEE countries, less burdensome HTA and reimbursement requirements for FDCs composed of already known and reimbursed active substances were associated with broader reimbursement of single-pill antihypertensive therapies. Streamlining assessment pathways for well-justified, guideline-supported combinations could improve patient access and better align reimbursement practice with current clinical guidelines, while preserving evidence-based decision-making. Common EU-level clinical assessment processes may further support consistency across national HTA systems, although pricing and reimbursement decisions remain within national competence.
SN - 1663-9812
ER -