Abstract

To describe the use of risk sharing agreements (RSA) in Catalonia compared with other European Union (EU) countries. The local RSA implemented in Catalonia between January 2011 and May 2018 were identified (excluding the Spanish nationwide RSA) and classified according to type of RSA: based on economic outcomes (RSA economic) and health outcomes (RSA health); and type of therapeutic area (oncology, haematology, rare, autoimmune and infectious disease and “others”). The Catalan experience was also compared with 3 EU countries (Spain, Italy and UK) through a desk research including public sources and grey literature. The information was reviewed and analysed using the same approach described for Catalonia. Catalonia implemented 20 local RSA between January 2011 and May 2018 (14% RSA economic and 86% RSA health). Spain implemented 29 nationwide RSA (97% RSA economic and 3% RSA health), Italy 48 RSA (36% economic and 64% RSA health) and UK 149 RSA (92% economic and 8% RSA heath). The most representative therapeutic area in Catalonia, Italy and UK was oncology (71%, 54% and 36%, respectively) and in Spain was infectious disease (41%). The main type of RSA implemented in Catalonia was based on health outcomes mainly linked to uncertainties on efficacy of oncology drugs. When compared with other EU countries, Italy showed the same trend while in Spain and UK the most frequently implemented RSA were based on economic outcomes, dealing with challenges of incremental pharmaceutical expenditure associated with high list prices.

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