Managed Entry Agreements (Mea)

National payers across Europe are increasingly considering innovative approaches to reimbursement to compensate for the need for rapid access to potentially advantageous medicines with requirements, to create uncertainty limits, to obtain the best value for money or to ensure an affordable price. This has led to the increasing concept and implementation of so-called “managed entry” (MMA) agreements, which are defined as “cost-sharing agreements” and “risk-sharing agreements”. Health authorities and pharmaceutical companies have sought alternative funding formulas to share the risks and uncertainties arising from public coverage of new drugs whose clinical effectiveness and budgetary impact are still unknown. In Finland, one-fifth of all patented drugs administered in hospitals are consulted through managed entry agreements. It is difficult to know to what extent performance-based EREs have been successful to date. Few countries have formally assessed their experience. The confidentiality of agreements remains an obstacle to independent evaluation and little public evidence is availab evidence. However, information from expert interviews and previous studies shows that reports on the Evidence Development (EDC) agreements have so far had a poor record in reducing uncertainty about drug performance. Default payment agreements (PbRs) are still widespread, but they do not always provide evidence of product performance because the data used to trigger payments is not always aggregated and analyzed. The administrative burden of collecting and analyzing drug performance data can also make execution costly.

Our study shows that from 2016, financial agreements in the form of direct or indirect price reductions were the most common form of MEA used for oncology drugs in the countries included in this study. The same observation is reported by studies that examine AEMs in all areas of the disease (Vogler et al., 2012; Morel et al., 2013; Executive Insight Health Care Consultants, 2016). However, studies conducted before 2015 show that defined benefit agreements are often applied in Sweden and the Netherlands (Morel et al., 2013; Ferrario and Kanavos, 2015; van de Vooren et al., 2015).