Strategic Roadmap for Successful Market Penetration in the Dynamic Central and Eastern Europe: Prospect for US/Global Companies?

OBJECTIVES: This study aims to optimize market access strategies for Central and Eastern Europe (CEE), which is boasting a diverse population of 340 million and emerges as a pivotal market for pharmaceutical products, outstripping Western Europe by 145 million. A surging awareness of healthcare needs and an escalating demand for advanced medical solutions in CEE underscore a significant expansion in clinical trials, constituting 26.3% of all EU-wide trials. The region's commitment to bolstering healthcare infrastructure is reflected in a continuous upswing in healthcare expenditures.

METHODS: To reach our goal we had dissected specific dossier requirements across fourteen countries through policy and literature reviews. Available HTA variations for the different CEE markets were reviewed and summarized.

RESULTS: Divergent dossier requisites emerge across CEE nations. A comprehensive Health Technology Assessment (HTA) dossier encompassing clinical assessment with meta-analysis, cost-effectiveness model, and budget impact model is imperative for market access in Poland, Hungary, Bulgaria, Russia, and Lithuania. Conversely, a streamlined dossier focusing on clinical assessment and budget impact model suffices for Ukraine, Slovakia, Czechia, Romania, Greece, Croatia, and Slovenia. Estonia and Latvia necessitate an overview assessment, encapsulating clinical trials with proposed prices and target estimated populations.

CONCLUSIONS: Given Poland's stringent HTA guidelines and its sizable population of 38 million, an effective market access strategy involves initiating the process by submitting a comprehensive dossier to Poland, followed by tailored adaptations for other CEE countries. This approach aligns with the region's evolving healthcare needs and diverse regulatory landscapes, providing pharmaceutical companies with a strategic roadmap for successful market entry and expansion in the dynamic CEE region.