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.
