OBJECTIVES: Healthcare systems across the globe are currently challenged to ensure better budgetary control and access to high-cost innovative therapies introduced into cancer treatment. Risk-sharing agreement (RSA) is a management tool that links patient access and payment to the manufacturer according to a drug’s clinical benefit. This study makes a systematic review of research on RSA and cancer drugs.

METHODS: A systematic review was conducted in the Web of Science database up to December 2018. Articles were selected by following the strategy of searching titles, abstracts and keywords for 1="risk-sharing" and oncology; 2="risk-sharing" and "cancer drug"; #1 OR #2. The search resulted in a total of 23 articles after evaluation of the inclusion criteria of the study. All the papers were classified based on their main theme.

RESULTS: The 23 selected works were taken from 18 different journals, 12 works were published from 2016 and most of the studies were conducted in Europe (17 works). RSA application differs across countries and over time. There is not yet a gold standard methodology in relation to the type of RSA to be practiced. Between 2010 and 2015, most articles evaluated RSA models (5 works), many based on real-world data (3 works). Between 2016 and 2018, articles on RSA models (7 works) were also predominant, but with the use of clinical trial data (3 works).

CONCLUSIONS: In the literature, there has been interest in the potential for RSA, but little information is publicly available, mainly with real-world data. Examples to date have shown that RSA application is problematic for a variety of reasons, including difficulties in outcome definition, monitoring and control of patient register, logistical setup, integration and the interoperability of the health information technology infrastructure. RSA may be helpful, but has not always been successful due to its inability to deal with dynamics in the market.