How Health Policy Influences HTA Outcomes: Comparative Insights From Ukraine, Moldova, and Bulgaria
Author(s)
Malwina Holownia-Voloskova, MSc, PharmD1, Elena Chitan, MPH, PharmD2, Oresta Piniazhko, PhD3, Antoan Rangelov, MPharm, PhD4, Grzegorz Obrzut, MSc1, Jacek Walczak, MD1.
1Certara, Krakow, Poland, 2Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, Republic of, 3State Expert Center of the Ministry of Health of Ukraine, Kyiv, Ukraine, 4National Council on Prices and Reimbursement of Medicinal Products, Sofia, Bulgaria.
1Certara, Krakow, Poland, 2Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, Republic of, 3State Expert Center of the Ministry of Health of Ukraine, Kyiv, Ukraine, 4National Council on Prices and Reimbursement of Medicinal Products, Sofia, Bulgaria.
OBJECTIVES: This study examines the influence of national health policy frameworks on health technology assessment (HTA) outcomes in three Central and Eastern European countries—Ukraine, Moldova, and Bulgaria. It aims to explore how political, regulatory, and institutional contexts shape HTA effectiveness and reimbursement decisions.
METHODS: A comparative, descriptive analysis was conducted using legislative documents, HTA guidelines, and peer-reviewed literature from each country. Stakeholder interviews (where available) and institutional reports were reviewed to assess how policy priorities, regulatory maturity, and system constraints affect HTA implementation and decision-making.
RESULTS: In Ukraine, HTA has evolved since the adoption of national legislation in 2016 and continues to align with international practices. Since 2022, conflict-related disruptions have strained the healthcare system, highlighting the need for technical capacity and agile, responsive HTA processes. In Moldova, HTA elements have been applied to outpatient medicine reimbursement since 2015, with price negotiations and device coverage added in 2021. However, the absence of a formal, institutionalized framework limits systematic application. Bulgaria operates a structured HTA process, but implementation is often influenced by shifting policy priorities and cost-containment goals within the National Health Insurance Fund. Across all three countries, strategic priorities, budget constraints, and institutional coordination significantly influence HTA outcomes and access timelines.
CONCLUSIONS: Health policy plays a central role in shaping HTA processes across the region. While Bulgaria benefits from greater policy stability, Ukraine and Moldova face institutional and contextual barriers. In Ukraine, the ongoing crisis resulting from the conflict has strained institutional capacity and created a need for more flexible and responsive HTA processes. Strengthening policy-HTA alignment and regional collaboration could support more transparent and equitable access to innovative therapies.
METHODS: A comparative, descriptive analysis was conducted using legislative documents, HTA guidelines, and peer-reviewed literature from each country. Stakeholder interviews (where available) and institutional reports were reviewed to assess how policy priorities, regulatory maturity, and system constraints affect HTA implementation and decision-making.
RESULTS: In Ukraine, HTA has evolved since the adoption of national legislation in 2016 and continues to align with international practices. Since 2022, conflict-related disruptions have strained the healthcare system, highlighting the need for technical capacity and agile, responsive HTA processes. In Moldova, HTA elements have been applied to outpatient medicine reimbursement since 2015, with price negotiations and device coverage added in 2021. However, the absence of a formal, institutionalized framework limits systematic application. Bulgaria operates a structured HTA process, but implementation is often influenced by shifting policy priorities and cost-containment goals within the National Health Insurance Fund. Across all three countries, strategic priorities, budget constraints, and institutional coordination significantly influence HTA outcomes and access timelines.
CONCLUSIONS: Health policy plays a central role in shaping HTA processes across the region. While Bulgaria benefits from greater policy stability, Ukraine and Moldova face institutional and contextual barriers. In Ukraine, the ongoing crisis resulting from the conflict has strained institutional capacity and created a need for more flexible and responsive HTA processes. Strengthening policy-HTA alignment and regional collaboration could support more transparent and equitable access to innovative therapies.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR114
Topic
Epidemiology & Public Health, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas