OBJECTIVES: Identify potential criteria that could influence P&R approval of ODs in Spain.

METHODS: ODs approved by the European Commission between 2012-2018 were classified according to their P&R status in Spain: approved, undergoing decision and rejected. P&R approval timelines in Spain were analysed. Hypotheses on likelihood of ODs reimbursement approval were formulated based on formal and informal criteria used in the Spanish P&R process: existence of alternative therapies, the availability of hard clinical trial outcomes, a superior comparative efficacy profile, a positive safety profile that raised less uncertainty among evaluators, a positive Therapeutic Positioning Report (TPR) opinion and the existence of conditional approval status granted by the European Agency of Medicines (EMA). Economic variables were not assessed due to a lack of information. A logistic regression model was used to predict the impact of studied variables on reimbursement in Spain.

RESULTS: 72 ODs were identified, from which 28 (38.9%) were reimbursed, 26 (36.1%) were undergoing decision and 18 (25%) were rejected. The mean time from P&R request to P&R approval in Spain was 14.6 ± 9 months. Two variables showed to have a relationship with P&R approval: a positive TPR opinion, meaning that ODs recommended to a group of patients or considered as a therapeutic equivalent to an approved alternative in Spain would be more likely to be reimbursed, and a conditional approval status, meaning that ODs without conditional approval status granted by the EMA would be more likely to be reimbursed in Spain.

CONCLUSIONS: P&R approval for ODs in Spain could be positively affected by a positive TPR opinion and the absence of conditional approval status.