Ferrario A, Kanavos P. Management of uncertainty and high prices for new drugs: a comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden. Soc Sci Med. 2015;124:39-47. The level of implementation of risk-sharing agreements in Spain has been high, with 90% of respondents saying that they currently have such a contract with a pharmaceutical company and that they want to renew it or sign new ones. Respondents noted that the most frequent risk-sharing agreements take the form of price volume. Oncology, neurology, dermatology and infectious diseases were the main medical specialties that used these agreements. Morel T, Arickx F, Befrits G, Siviero P, van der Meijden C, Xoxi E, et al. Compatibility of cost and outcome insecurity with the need for access to orphan medicines: a comparative study on entry agreements managed in seven European countries. Orphanet J Rare Dis. 2013;8:198. For hospitals that have only entered into price volume agreements, the number of drug units per year, the high budgetary impact of treatment, the size of the target population, the unit cost per dose and the duration of treatment were the most influential variables in the definition of such agreements.
However, for hospitals with paid agreements, the influential variables were the effectiveness of treatments, uncertainty about treatment effectiveness, adverse effects and toxicity, and relative safety compared to existing treatment, as perceived by about 90% of responders. Toumi M. ZardJ, Duvillard R, Jonmi C. Innovative drugs and market access agreements. Pharmaceutical records. 2013;71(5):302–25. Regarding the formality of the agreements, 28% of participants said they only used a written document, while 4% said they had only been agreed orally; A combination of the two forms was used by 68% of the responders. Garattini L, Casadei G. Risk-sharing agreements: what are the lessons of Italy? Int J Technol Review of Health Care. 2011;27 (2):169-72. Kanavos P, Ferrario A, Tafuri G, Siviero P.
Manage risks and uncertainty in the introduction of health technology: the role of managed entry agreements. The Glob Directive. 2017;8( S2:84-92. Neumann PJ. Where are we in risk-sharing agreements? Health value. 2013;16:701-2. Jaroslavski S, Toumi M. Agreement on Access to the European Medicines Market: Diversity of approaches and approaches. BMC Health Serv Res.
2011;11:259. Makady A, van Veelen A, de Boer A, Hillege H, Klungel OH, Goettsch W. Implementation of Managed Entry Agreements in practice: the Dutch reality check. Health policy. 2019;123(3):267–74. Although there was initial interest in testing some possible associations between the variables, no statistical findings were recommended due to the small sample size.