OBJECTIVES: Outcome-based agreements (OBAs) allow using real-world evidence to facilitate patient access to innovative therapies with high associated uncertainties. Whilst Spain (a decentralised healthcare system with similarities to Scandinavian regional payer systems) has introduced OBAs, Scandinavia is lagging behind. This study aimed to compare uncertainties highlighted by Scandinavian HTAs for therapies covered by OBAs in Spain, and to identify facilitators allowing OBA implementation in Spain potentially relevant for Scandinavian countries.

METHODS: OBAs implemented in Spain between Jan-2017 and Jun-2022 were retrieved from PubMed, BIFIMED/VALTERMED and ISPOR databases. A targeted-literature search (TLS) was performed in the same databases to identify publications analysing OBA implementation in Spain. Products covered by OBAs in Spain were screened in Denmark, Norway and Sweden to identify corresponding HTA reports, which were subsequently evaluated to collect reimbursement decision and uncertainties identified by payers. Lastly, a thematic analysis of the TLS publications was performed to identify key facilitators for OBAs implementation in Spain.

RESULTS: Overall, 19 OBAs were identified in Spain. Most of the indications covered by OBAs in Spain were also assessed through HTAs in Scandinavia. Reimbursement was granted in most cases in Norway and Sweden, but not in Denmark (Denmark=11/18, Norway=18/18 and Sweden=18/19). Scandinavian HTA reports expressed similar uncertainties regarding long-term efficacy and methodologies used to evaluate outcomes. Key facilitators identified from Spanish OBAs include a data-collection system that leverages existent infrastructure, systematic accountability for data-collection/processing and a scaling approach for OBA implementation championed by regional governments.

CONCLUSIONS: The Spanish model for OBAs provides an opportunity for increasing patient access in Denmark. Nonetheless, the potential benefits for Norway and Sweden are attractive mostly for payers, who can implement OBAs as a mechanism to share the uncertainty-related risks with manufacturers. Facilitators of OBAs in Spain could be replicated using existent infrastructure in Scandinavia.