Zaric GS, Zhang H, Mahjoub R. Modeling risk-sharing agreements and patient access systems. In: Zaric G, editor. Research on operations and health policy. International series in Operations Research und Management Science, 190. New York: Springer; 2013. pp. 295-310. Park SY, Han E, Kim J, Lee EK. Factors that influence the difference between the quantities of drugs planned and the actual quantities of sale under the price/volume agreement concluded in South Korea. Health policy. 2016;120 (8):678-774.
Price-volume agreements are the most common type and performance-based ones are emerging and are expected to become more frequent in the future, probably in the context of the development of personalized medicine. The administrative complexity associated with these agreements and the need to change the legislative and regulatory framework are seen as the main obstacles to their wider application. Over the past two decades, public health systems have put in place several management tools to cope with increasing pressure from pharmaceutical companies to introduce new products, usually at high prices, amid uncertainty and budget cuts. These instruments have been repeatedly referred to as money-back guarantee schemes, managed entry agreements, coverage with proof agreements, performance payments, results-based payments or price-volume agreements. In this paper, we use the notion of risk-sharing agreements to refer to both price/volume agreements (mainly to alleviate the financial burden) and performance agreements (linking drug payments to clinical outcomes). They aim to facilitate access to new health technologies in the event of uncertainties about clinical outcomes (e.g. .B. medium-term effectiveness of treatments and potential targets) and budget implications (e.g. B duration of treatment). It is in this sense that there is a lot of concern right now when there are uncertainties about how efficacy can be generalized to actual medical practice, as has been demonstrated in clinical trials.
Through the implementation of these contracts, both the health administration and pharmaceutical companies share uncertainty about the financial and clinical implications and benefit from faster access to new products. Depending on the nature of these agreements, pharmaceutical companies may apply either discounts on sales volume (price-volume agreements) or depreciable in whole or in part, if the treatments are not as effective and safe as initially planned (pay-per-performance agreements). Therefore, pricing and public funding are linked to financial and clinical outcomes [1,2,3,4,5,6]. The financial sustainability of health care systems is a major issue, given the increase in health costs due to new technologies and the increase in demand for health care, mainly due to the aging of the population of Western societies. Since health authorities and pharmaceutical companies are risk-averse, risk-sharing contracts can be seen as a way to minimize the financial and clinical risks inherent in implementing a new treatment. Given that these characteristics are likely to be present in the coming decades, it is likely that these contracts will spread in the future and are likely to be extended to other technologies [7,8,9]. Cook JP, Vernon YES, Manning R. Pharmaceutical Risk-Sharing-Vereinbarungen. . .