ACCESS TO MODERN THERAPIES FOR PROSTATE CANCER PATIENTS IN CENTRAL AND EASTERN EUROPE (CEE): A CROSS-COUNTRY ASSESSMENT OF HTA AND REIMBURSEMENT PATHWAYS
Author(s)
Elzbieta Soltysiak, MSc, PhD1, Malwina Holownia-Voloskova, MSc, PharmD1, David Suchanek, PharmD2, Patricia Monica Amarie, MD3, Judit Károly-Rózsa, MSc4, Adam Csizmadia, MSc4, Paula Siinmaa, MSc5.
1Certara Evidence and Access, Krakow, Poland, 2OAKS Consulting, s.r.o., Prague, Czech Republic, 3Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, 4MediConcept Tanacsado Kft, Budapest, Hungary, 5CentralPharma Communications OÜ, Tallinn, Estonia.
1Certara Evidence and Access, Krakow, Poland, 2OAKS Consulting, s.r.o., Prague, Czech Republic, 3Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, 4MediConcept Tanacsado Kft, Budapest, Hungary, 5CentralPharma Communications OÜ, Tallinn, Estonia.
OBJECTIVES: Prostate cancer (PC) is the most diagnosed cancer among men in 118 countries, with over 86,200 cases and 26,700 deaths annually in Central and Eastern Europe (CEE). Modern therapies for PC include nonsteroidal second-generation androgen receptor inhibitors (ARPI), targeted therapies such as poly (ADP-ribose) polymerase (PARP) inhibitors or radioligand therapies, and combined products. This research assesses the availability and market access conditions of these modern PC therapies in selected CEE countries.
METHODS: We conducted a targeted review of reimbursement and access conditions of modern PC therapies in Poland, Czechia, Hungary, Lithuania, and Romania, based on data available as of February 2026. We also reviewed country-specific pricing and reimbursement frameworks for oncology drugs.
RESULTS: Poland and Lithuania offer the widest range of reimbursed modern therapies (ARPI, PARP inhibitors, radioligands) and are progressing through advanced price negotiations for 177Lu vipivotide tetraxetan. In contrast, Hungary remains in a transitional phase with several key drugs awaiting decisions. All analyzed countries use a 100% reimbursement model via specialized drug programs, positive lists or confidential managed entry agreements (MEAs). Across the region, market access is governed by mandatory Health Technology Assessment (HTA) reports and the strategic use of risk-sharing agreements to manage high innovation costs. Significant discrepancies between statutory timelines and real-world implementation exist; the Czech Republic and Poland offer the most efficient paths (~10-12 months), while processes in Romania and Lithuania can reach 24 months due to prolonged post-decision price negotiations.
CONCLUSIONS: Access to modern PC therapies varies across CEE in therapeutic breadth and administrative efficiency. While leading markets provide comprehensive portfolios, others face delays driven by financial constraints and complex risk-sharing negotiations. Consistent with literature showing a vast reimbursement gap (64% in Czechia vs. 19% in Slovakia), systemic resource limits and administrative reality gaps result in persistent regional inequalities regarding the timely availability of patient access.
METHODS: We conducted a targeted review of reimbursement and access conditions of modern PC therapies in Poland, Czechia, Hungary, Lithuania, and Romania, based on data available as of February 2026. We also reviewed country-specific pricing and reimbursement frameworks for oncology drugs.
RESULTS: Poland and Lithuania offer the widest range of reimbursed modern therapies (ARPI, PARP inhibitors, radioligands) and are progressing through advanced price negotiations for 177Lu vipivotide tetraxetan. In contrast, Hungary remains in a transitional phase with several key drugs awaiting decisions. All analyzed countries use a 100% reimbursement model via specialized drug programs, positive lists or confidential managed entry agreements (MEAs). Across the region, market access is governed by mandatory Health Technology Assessment (HTA) reports and the strategic use of risk-sharing agreements to manage high innovation costs. Significant discrepancies between statutory timelines and real-world implementation exist; the Czech Republic and Poland offer the most efficient paths (~10-12 months), while processes in Romania and Lithuania can reach 24 months due to prolonged post-decision price negotiations.
CONCLUSIONS: Access to modern PC therapies varies across CEE in therapeutic breadth and administrative efficiency. While leading markets provide comprehensive portfolios, others face delays driven by financial constraints and complex risk-sharing negotiations. Consistent with literature showing a vast reimbursement gap (64% in Czechia vs. 19% in Slovakia), systemic resource limits and administrative reality gaps result in persistent regional inequalities regarding the timely availability of patient access.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA20
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology