OBJECTIVES: Assess current access situation for ODs in Spain comparing results with EU4 countries (France, Germany, Italy and UK).

METHODS: ODs approved by the European Commission (EC) between 2012-2016 and with a request for authorisation in Spain were included in the study and classified into three P&R categories: approval, undergoing decision and rejected. P&R approval timelines in Spain were analysed. Results were compared to ODs’ reimbursement status in EU4 countries. ODs’ prices were searched in EU5 countries using the following sources: AMELI database (France), LauerTaxe (Germany), Codifa webpage (Italy), Botplus (Spain) and MIMS database (UK).

RESULTS: CONCLUSIONS: Access to ODs is inequitable within Europe, as availability of ODs to patients varies across countries. EU5 countries might have different value drivers to reimburse ODs, as no common criteria for reimbursement appear to exist. There is a lack of transparency when trying to understand and make comparisons of ODs’ prices, as real prices can vary between 10%-50% from the list price in certain countries.