In 2014 managed entry agreements (MEA) between Swedish health care payers (regions), the reimbursement authority (the Dental and Pharmaceutical Benefits Agency (TLV)) and pharmaceutical companies were introduced to facilitate early and equal access to treatments. MEAs complement the value-based pricing system for out-patient drugs and enables stakeholders to negotiate risk-sharing agreements to manage uncertainties at launch.
In this study, the use of risk-sharing agreements so far was reviewed to determine what types of uncertainties were identified and what mechanisms were put in place to deal with these uncertainties. This was based on a review of negotiated contracts.
Three types of uncertainties were identified: the size of the treated population, the duration of treatment and the effectiveness. Mechanisms to deal with uncertainties were limited to maximum costs per patient, stepped and flat rebates. Over time, the trend has been towards simpler agreements.
Health Policy, 2020, 124(4): 404-410