This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number of patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents, for both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However, concerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in patient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar policies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which may provide a basis for future risk-management activities including vigorous pharmacovigilance data collection.

Center of Healthcare Quality Assessment and Control Ministry of Health of the Russian Federation Moscow Russia

Department of Drug Management Faculty of Health Sciences Jagiellonian University Medical College Krakow Poland

Department of Health Policy and Health Economics Eötvös Loránd University Budapest Hungary

Department of Organisation and Management in Pharmacy Faculty of Pharmacy Comenius University Bratislava Slovakia

Department of Pharmaceutics and Central Clinical Pharmacy University of Pécs Pécs Hungary

Department of Social and Clinical Pharmacy Faculty of Pharmacy Charles University Prague Hradec Králové Czech Republic

Egis Pharmaceuticals Budapest Hungary

Faculty of Pharmacy Medical University Sofia Sofia Bulgaria

Faculty of Technical and Human Sciences Sapientia University Tirgu Mures Romania

Kazakh Agency for Health Technology Assessment Astana Kazakhstan

Management Center Innsbruck Innsbruck Austria

Syreon Research Institute Budapest Hungary

Syreon Research Romania Tirgu Mures Romania

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