PMS138 - Assessment of Risk Sharing Agreements (Rsas) in Select Global Markets with Specific Focus on Activities Surrounding Immunomodulators

Abstract

To understand current Risk Sharing Agreements (RSAs) for immunomodulators for rheumatoid arthritis, psoriasis, and psoriatic arthritis in 11 markets aimed to optimize specific RSA strategies/ payer partnerships. Review of publicly available health authority websites and peer-reviewed journals. Interviews with payers and stakeholders who influence RSA decisions and ex-pharma executives for validation and gap filling. USA manufacturers negotiate RSAs with private health insurers and states. Payers in USA integrate financial risks with manufacturers using outcome based agreements (OBAs). Canada established RSAs with Provinces and use financial based agreements (FBAs) but some are OBAs. France requires volume based FBAs for new high-priced therapies to limit budget impact. Germany uses FBAs at the sickness fund level rather than the Gemeinsamer Bundesausschuss (G-BA) level because sickness funds manage their own budgets. Some OBAs exist with clearly defined outcomes. Italy negotiates RSAs at the national level for new therapies entering the market ranging from FBAs to OBAs depending on the specific therapy and target patient population. Italy may also require manufacturers to incorporate drug monitoring registries in the RSA. In Spain performance based OBAs are used for new therapies with nominal additional benefit at the regional level with clearly established outcomes. Netherlands and Sweden use evidence development (CED) agreements for high priced products to generate cost effectiveness data. In Switzerland, RSAs are new and mostly FBAs and mainly for orphan disease therapies and off-label indications with price capping. In the UK,FBAs with few OBAs are used affecting product price but are not rebate based. Australian RSAs are mostly FBAs and are referred to as “Deeds of Agreement.” With high-cost immunomodulators, authorities are shifting towards integrating RSAs in price negotiations to optimize budget expectations prior to launch. Europe prefers FBAs to OBAs which often require clearly defined outcomes.