PNS45 Pricing and Reimbursement of Innovative Medicines: Challenges and Lessons from South-Eastern Europe

Abstract

While Western European states sustain comparatively generous pharmaceutical benefit packages, less affluent South-eastern European countries (SEE) face substantial challenges in keeping pace with financing innovative (usually expensive) medicines. Pricing and reimbursement (P&R) processes present one of those challenges. The purpose of the study is twofold. First, it aims to provide a concise yet in-depth comparative overview of the procedures and rules governing the P&R of innovative medicines in the SEE region. Second, it seeks to contribute to the discussion on improving the outcomes of P&R by comparing and studying the successes and failures of contemporary national P&R processes and therefore contribute to reducing hurdles to equal, generous and timely access to new innovative medicines for all citizens. Data were collected from non-systematic literature review (including policy-related sources) and interviews with national experts from ten SEE countries. P&R systems are compared and evaluated through a research framework that focuses on: 1) public financing of innovative medicines, 2) definition of benefit packages, 3) requirements for the submission of reimbursement dossiers, 4) assessment and appraisal processes, 5) reimbursement decision making, 6) processes that occur post reimbursement and 7) pricing. All stages of P&R processes in SEE countries would benefit from relying on clearly defined rules, procedures and processes. Due to the lack of financial resources, low institutional capacities and few experts in the Health Economics field, it seems unwise to suggest that SEE P&R systems should be strengthened by developing extensive and sophisticated Health Technology Assessment (HTA) processes. Simple yet robust and systematic decision-making frameworks (including guidelines, scorecards, checklists, consensus building methodologies, etc.) which rely on international HTA procedures and are based on the pursuit of transparency seems as a more cost-effective approach to strengthening P&R systems in South-east Europe.