The implementation of managed entry agreements in Central and Eastern Europe: findings and implications

Background: Managed entry agreements (MEAs) are a set of instruments to facilitate access to new medicines. This study surveyed the implementation of MEAs in Central and Eastern Europe (CEE) where limited comparative information is currently available. Method: We conducted a survey on the implementation of MEAs in CEE between January-March 2017. Results: Sixteen countries participated in this study. Across five countries with available data on the number of different MEA instruments implemented, the most common MEAs implemented were confidential discounts (n=495, 73%), followed by paybacks (n=92, 14%), price-volume agreements (n=37, 5%), free doses (n=25, 4%), bundle and other agreements (n=19, 3%), and payment by result (n=10, >1%). Across seven countries with data on MEAs by therapeutic group, the highest number of brand names associated with one or more MEA instruments belonged to the ATC-L group, antineoplastic and immunomodulating agents (n=201, 31%). The second most frequent therapeutic group for MEA implementation was ATC-A, alimentary tract and metabolism (n=87, 13%), followed by medicines for neurological conditions (n=83, 13%). Conclusion: Experience in implementing MEAs varied substantially across the region and there is considerable scope for greater transparency, sharing experiences and mutual learning. European citizens, authorities and industry should ask themselves whether within public health systems confidential discounts can still be tolerated, particularly when it is not clear which country and party they are really benefiting. Further, if MEAs are to improve access, countries should establish clear objectives for their implementation and a monitoring framework to measure their performance as well as the burden of implementation.