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. 2017 Dec;35(12):1271-1285.
doi: 10.1007/s40273-017-0559-4.

The Implementation of Managed Entry Agreements in Central and Eastern Europe: Findings and Implications

Alessandra Ferrario  1 , Diāna Arāja  2 , Tomasz Bochenek  3 , Tarik Čatić  4 , Dávid Dankó  5 , Maria Dimitrova  6 , Jurij Fürst  7 , Ieva Greičiūtė-Kuprijanov  8 , Iris Hoxha  9 , Arianit Jakupi  10 , Erki Laidmäe  11 , Olga Löblová  12 , Ileana Mardare  13 , Vanda Markovic-Pekovic  14   15 , Dmitry Meshkov  16 , Tanja Novakovic  17 , Guenka Petrova  18 , Maciej Pomorski  19 , Dominik Tomek  20 , Luka Voncina  21 , Alan Haycox  22 , Panos Kanavos  1 , Patricia Vella Bonanno  23 , Brian Godman  24   25   26
Affiliations

The Implementation of Managed Entry Agreements in Central and Eastern Europe: Findings and Implications

Alessandra Ferrario et al. Pharmacoeconomics. 2017 Dec.

Abstract

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 and 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 Anatomical Therapeutic Chemical (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%).

Conclusions: 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 publicly funded health systems, confidential discounts can still be tolerated, particularly when it is not clear which country and party they are really benefiting. Furthermore, 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.

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Conflict of interest statement

Data availability statement

Data on which this study was based are available in Figs. 1, 2, 3 and Table 3.

Funding

No sources of funding were used for this study.

Conflict of interest

The authors declare they have no conflicts of interest. However, Diāna Arāja, Maria Dimitrova, Jurij Fürst, Ieva Greičiūtė-Kuprijanov, Iris Hoxha, Arianit Jakupi, Erki Laidmäe, Vanda Markovic-Pekovic, Dmitry Meshkov, Guenka Petrova, Maciej Pomorski and Patricia Vella Bonanno work directly for national health authorities or are advisers to them. Alessandra Ferrario, Tomasz Bochenek, Ileana Mardare, Dominik Tomek, Luka Voncina, Alan Haycox, Panos Kanavos, Olga Löblová, and Brian Godman are academics and independent researchers also working with national and regional health authorities and others to improve the quality and efficiency of prescribing, and Tarik Catic, Dávid Dankó,and Tanja Novakovic are involved with pharmaceutical, pharmacoeconomics and outcomes research groups in their countries. Olga Löblová has also carried out remunerated consultancy activities for A&R Partners, Baxter AG and Instytut Arcana and Ileana Mardare has signed a consulting contract with Ewopharma A.G. Romania. The content of the paper and the conclusions are those of each author and may not necessarily reflect those of any organisation that employs them.

Figures

Fig. 1
Fig. 1
Implementation of MEAs in Central and Eastern Europe as of February 2017. Countries coloured in blue implement MEAs. The years refer to the year the first MEA was introduced in a particular country. In some countries, for example Serbia, the legislation was introduced well before (2014) the first MEA was signed (2016). Countries coloured in orange did not implement MEAs as of February 2017, and countries coloured in grey were either not part of the study or we did not have any information on them. AL Albania, BG Bulgaria, BH Bosnia and Herzegovina, CZ Czech Republic, EE Estonia, LT Lithuania, LV Latvia, HR Croatia, HU Hungary, KV Kosovo, PL Poland, RO Romania, RS Serbia, SL Slovenia, SK Slovakia, MEAs managed entry agreements
Fig. 2
Fig. 2
Total number of different MEA instruments implemented in Slovenia, Hungary, Latvia, Estonia and Romania in 2016. a Overall. One trade name may be associated with one or more MEA instruments, e.g. discount and payback, and these were counted separately. b By country. If a trade name was associated with more than one MEA instrument, e.g. discount and payback, these were counted separately. Data for Hungary include the retail sector only. MEA managed entry agreement
Fig. 3
Fig. 3
Number of trade names with one or more MEAs, by therapeutic groups in Bulgaria, Hungary, Lithuania, Latvia, Serbia, Estonia and Romania in 2015/16. The number of MEAs reported is by total number of trade names with one or more MEAs, while Fig. 2a, b present the total number of different MEA instruments implemented. The 230 discount agreements in the outpatient sector in Estonia were not included in Fig. 2 due to lack of data on the ATC group. The remaining agreements (n=6) with available ATC information in Estonia were included. MEA managed entry agreement, ATC Anatomical Therapeutic Chemical, ATC-A alimentary tract and metabolism, ATC-B blood and blood-forming organs, ATC-C cardiovascular system, ATC-G genitourinary system and sex hormones, ATC-H systemic hormonal preparations, excluding sex hormones and insulin, ATC-J anti-infectives for systemic use, ATC-L antineoplastic and immunomodulating agents, ATC-M musculoskeletal system, ATC-N nervous system, ATC-P antiparasitic products, insecticides and repellents, ATC-R respiratory system, ATC-S sensory organs, ATC-V various. There are approximately 40 MEAs in the hospital sector in Hungary, approximately 25 of which were for oncology treatments (ATC-L01/02) and 15 were contracts for other therapeutic areas. Data for Hungary, Latvia, Serbia, Estonia and Romania refer to 2016, while data for Bulgaria and Lithuania refer to 2015
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References

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