An Overview of Pricing and Reimbursement Frameworks for Medicinal Products in Central and Eastern European (CEE) Countries: Mechanisms, Rules, And Managed Entry Agreements (MEAs)

OBJECTIVES: According to a 2024 Waiting to Access Innovative Therapies (WAIT) study, Central and Eastern European (CEE) countries account for 78% of the lowest quartile of medicine availability rates across Europe, despite many having large populations. With the exception of Czechia and Bulgaria, all CEE countries fall below the EU average in availability rates, and all but Czechia experience longer-than-average times from central approval to availability. This highlights a clear need to improve both the availability and timeliness of medicines in CEE countries. This study aimed to clarify pricing and reimbursement frameworks in the CEE region by reviewing and analysing country-level processes.
METHODS: Desk-based research was conducted from 1^st December to 24^th December 2024, using targeted searches on HTA body websites and PubMed. Screening was performed by an independent reviewer and sense-checked by a team of experienced market access professionals.
RESULTS: Medicinal product pricing across CEE countries varies significantly. Seven countries, including Austria and Czechia, employ external reference pricing, benchmarking prices against other countries. A minority, including Poland and Lithuania, use internal reference pricing, based on domestic market factors. Three countries—Bulgaria, Croatia, and Hungary—set prices through wholesalers or manufacturers, while others combine the lowest manufacturer price from reference countries with therapeutic value assessments. Policies on managed entry agreements (MEAs) also differ, with some countries requiring mandatory agreements and others adopting flexible approaches like financial risk-sharing for uncertain clinical outcomes.
CONCLUSIONS: Pricing and reimbursement policies in CEE countries are highly diverse. MEAs and other strategies aim to balance access to innovative treatments with cost containment. The introduction of the Joint Clinical Assessment (JCA) is expected to standardise clinical evidence assessments, further influencing MEAs and pricing processes. Manufacturers must ensure they understand these variations to navigate the evolving landscape effectively.