Sammendrag
OBJECTIVE: The objective of this study was firstly to examine which factors associate with managed entry agreements in Norway, Sweden, Finland and Denmark, and secondly, to identify and analyze the policy implications of managed entry agreements in the studied countries. METHOD: The method was two-fold. First, a systematic literature review following the PRISMA guidelines was conducted on the utilization of managed entry agreements in the studied countries. Second, a semi-structured interview study was performed with participants from both the public health authorities and payers and the pharmaceutical companies from all studied countries on the participants’ experiences and insights on managed entry agreements. RESULTS: The utilization of managed entry agreements is a rising trend in all the countries studied due to early access of new pharmaceuticals and the increasing amount of pharmaceuticals launched for small indication, which lead to a high uncertainty to determine the true value of a drug due incomplete data collection. MEAs are used to handle three main types of uncertainty; uncertainty on the clinical efficacy, the cost-effectiveness and/or the budget impact. A vast majority of MEAs implemented are financial agreements, performance based agreements being viewed as too complex and burdensome to use in practice. The policy implications of the MEAs can be divided into three: barriers of implementation, lack of transparency and its consequences and, the differences in the views of the health authorities and pharmaceutical companies and its consequences. The same issues apply to all countries studied, but there are country-specific challenges to be found as well in the implementation of MEAs due to e.g. unsuitable data infrastructure or challenges in legislation. CONCLUSION: This study presented the main factors associating with MEAs and the policy implications of MEAs in Norway, Sweden, Finland and Denmark. This work identified important concerns in the implementation of MEAs in the countries studied. The findings may help health authorities and pharmaceutical companies in developing policies and best practices for MEAs in the Nordic countries.