Risk sharing in managed entry agreements-A review of the Swedish experience

Background: In 2014 managed entry agreements (MEA) between Swedish health care payers (county councils), 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 stake-holders to negotiate risk-sharing agreements. Aim: The aim of the study was to review existing agreements, describe the type of uncertainty dealt with, and to analyze incentives created using the literature on performance-based reimbursement schemes in Sweden. Method: A document review of all agreements made in the period January 2015 to August 2019 was conducted, classifying agreements by the type of uncertainty dealt with. Results: Agreements were made for 56 products during the studied time period (45 ongoing), mainly in the fields of hepatitis C (n = 10) and oncology (n = 14). Uncertainties addressed in ongoing agreements included size of treated population (10), treatment duration (13), and effectiveness (9). The mechanism for risk-sharing was limited to refunds based on patient numbers, duration or just flat-rate refunds. The estimated refund in 2018 was 50 % of total sales. Discussion: This review show that the main driver behind risk sharing in Sweden so far have seem to be affordability rather than managing uncertainty. (C) 2020 Elsevier B.V. All rights reserved.