OBJECTIVES: Real world evidence (RWE) and risk sharing agreements (RSA) have experienced an increased focus in the latest years. An example of their importance has been reflected in the publication of ISPOR Good Practices Guidelines for both Real World Data studies and Performance-Based RSA. The aim of this work was to analyse and compare the objectives, methods and applications of RWE and RSA.

METHODS: A narrative literature review was carried out to identify the definition, objectives, requirements, applications and limitations of both RWE and RSA. A comparative analysis was then performed to discuss their aims and commonalities, as well as how they provide with different elements and contribute to (better) healthcare decision making.

RESULTS: Whilst RSA have a very precise objective and application (to accelerate patient access and manage uncertainty of payers in the context of pricing and reimbursement decisions of new health interventions), the objectives of RWE are broader (‘generation of new clinical evidence from real practice data’; ’moving from efficacy to effectiveness’) and their applications less concrete (‘improve healthcare decisions’). Even RWE and RSA share some essential requirements, e.g. to ensure data quality, focus in disease-specific data, etc., the implementation methods are usually different: systematic data collection, big data and sophisticated data analysis techniques are used to implement RWE studies; ad-hoc data collection and simple patient registries are the common procedures followed by RSA.

CONCLUSIONS: The use of RWE and RSA to support the healthcare decision making process should be complementary, but clarifying specific objectives may help their proper application in the definition, implementation and evaluation of health policies.