Characterization of the Pharmaceutical Risk-Sharing Arrangement Process in Catalonia.

Pharmaceutical risk-sharing arrangements have emerged as a reasonable tool to promote sustainable access to innovative medicines with uncertain clinical evidence and/or economic impact from the payer perspective. These funding mechanisms pose an alternative option to the traditional fixed-price methods and are intended to align the price of medication with the value delivered in treating patients, balancing clinical need with affordability in the face of increasing therapeutic innovation and ever-tight budgets. The Catalan Health Service (CatSalut) has set up a systematic, traceable, and transparent methodology for the design and implementation of risk-sharing arrangements and 15 of such access schemes have been successfully implemented until December 2019.