PHP339 - Risk Sharing Agreements (RSA): Exploratory Analysis of the Current Situation in Developed and Emerging Markets

Abstract

To understand what risk sharing agreements (RSA) are, the types of RSA, the expectation of HTA agencies / payers and examples of implementation in developed and emerging markets. The constant growth in prescription drug spending over the last years pushed countries to think in alternative ways to incorporate new technologies. Although risk sharing agreements may be on these alternatives it is not widely known. Thus, we searched public databases (i.e. Pubmed, ISPOR Scientifc presentations database) and government websites (i.e. Brazilian Ministry of Health, AIFA, NICE) and presentations in Health Technology Assessment (HTA) congresses / meetings (i.e. ISPOR Brazil), to identify publications that could support this study. From 11 studies found, 8 were selected for our analysis. Three were excluded because were not related to healthcare. RSA can be defined as agreements between a payer and a manufacturer where the price level and/or revenue received is related to the future performance of the product in either a research or a real-world environment (Towse and Garrinson 2010). RSA can be split into two big types: i) financial schemes and ii) outcomes-based schemes. Outcomes-based schemes are used only in exceptional cases because are complex and costly (Puig-Peiró, 2011). 90% of HTA agencies prefer simple discounts (Bruinsma et al, 2012). In England 5 RSA apply: dose capping, simple discount, response scheme, free stock, rebate (Gallo et al 2010). In Italy 3 RSA apply: cost sharing, pay by results, reimbursement for non-responders (Gallo et al 2010). In Spain there is a guidance in place for RSA (Gilabert-Perramon et al, 2014). In China, financial‐based RSA were more often implemented than outcomes‐based schemes: 14 vs. 1 (Chen et al, 2013). Risk sharing schemes seen as beneficial for selected diseases. Payers prefer simple schemes.