Copyright
©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
Access to biologicals in Crohn’s disease in ten European countries
Márta Péntek, Peter L Lakatos, Talitha Oorsprong, László Gulácsi, Milena Pavlova, Wim Groot, Fanni Rencz, Valentin Brodszky, Petra Baji, Crohn’s Disease Research Group
Márta Péntek, László Gulácsi, Fanni Rencz, Valentin Brodszky, Petra Baji, Department of Health Economics, Corvinus University of Budapest, H-1093 Budapest, Hungary
Peter L Lakatos, McGill University, MUHC, Montreal General Hospital, H3G 1A4 Montreal, Canada
Peter L Lakatos, 1st Department of Internal Medicine, Semmelweis University, H-1083 Budapest, Hungary
Talitha Oorsprong, Milena Pavlova, Wim Groot, Department of Health Services Research, CAPHRI, Maastricht University Medical Centre, Faculty of Health, Medicine and Life Sciences, Maastricht University, 6229 GT Maastricht, The Netherlands
Wim Groot, Top Institute Evidence Based Education Research (TIER), Teachers Academy, Maastricht University, 6211 KH Maastricht, The Netherlands
Author contributions: Péntek M, Lakatos PL, Gulácsi L, Pavlova M, Groot W and Baji P contributed to study conception and design; Oorsprong T, Rencz F, Brodszky V and Baji P contributed to data acquisition, data analysis; all authors contributed to the interpretation of data; Péntek M, Lakatos PL, Oorsprong T, Gulácsi L and Baji P contributed to the writing of the article; Pavlova M, Groot W, Rencz F and Brodszky V contributed to editing, reviewing of the manuscript and all authors gave their final approval of the manuscript; Crohn’s Disease Research Group filled in the survey questionnaire and provided data.
Supported by ÚNKP-16-4/BCE-0025 New National Excellence Program of the Ministry of Human Capacities (Hungary).
Institutional review board statement: No patients were included in the study, and no patient-related data were collected. Country-level data on access were collected from experts. Thus, no ethical approval was needed to carry out the study.
Informed consent statement: No patients were included in the study, thus informed consent of patients was not needed. All experts agreed to participate in the survey and provided their consent via e-mail. Experts are listed as contributors of this paper.
Conflict-of-interest statement: Petra Baji has received research funding from the ÚNKP-16-4/BCE-0025 New National Excellence Program of the Ministry of Human Capacities (Hungary) for this study. The rest of the authors declare no conflicting interest related to the work submitted for consideration of publication.
Data sharing statement: There is no additional data available in this study. Data collection was not sponsored, data was exclusively used for the purpose of this study and not used for commercial use.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: László Gulácsi, Professor, Department of Health Economics, Corvinus University of Budapest Fővám tér 8. H-1093 Budapest, Hungary. laszlo.gulacsi@uni-corvinus.hu
Telephone: +36-1-4825147 Fax: +36-1-4825164
Received: May 19, 2017
Peer-review started: May 19, 2017
First decision: June 22, 2017
Revised: July 5, 2017
Accepted: August 8, 2017
Article in press: August 8, 2017
Published online: September 14, 2017
AIM
To analyze access (availability, affordability and acceptability) to biologicals for Crohn’s disease (CD) in ten European countries and to explore the associations between these dimensions, the uptake of biologicals and economic development.
METHODS
A questionnaire-based survey combined with desk research was carried out in May 2016. Gastroenterologists from the Czech Republic, France, Germany, Hungary, Latvia, Poland, Romania, Slovakia, Spain and Sweden were invited to participate and provide data on the availability of biologicals/biosimilars, reimbursement criteria, clinical practice and prices, and use of biologicals. An availability score was developed to evaluate the restrictiveness of eligibility and administrative criteria applied in the countries. Affordability was defined as the annual cost of treatment as a share of gross domestic product (GDP) per capita. Correlations with the uptake of biologicals, dimensions of access and GDP per capita were calculated.
RESULTS
At the time of the survey, infliximab and adalimumab were reimbursed in all ten countries, and vedolizumab was reimbursed in five countries (France, Germany, Latvia, Slovakia, Sweden). Reimbursement criteria were the least strict in Sweden and Germany, and the strictest in Hungary, Poland and Slovakia. Between countries, the annual cost of different biological treatments differed 1.6-3.3-fold. Treatments were the most affordable in Sweden (13%-37% of the GDP per capita) and the least affordable in the Central and Eastern European countries, especially in Hungary (87%-124%) and Romania (141%-277%). Biosimilars made treatments more affordable by driving down the annual costs. The number of patients with CD on biologicals per 100000 population was strongly correlated with GDP per capita (0.91), although substantial differences were found in the uptake among countries with similar economic development. Correlation between the number of patients with CD on biologicals per 100000 population and the availability and affordability was also strong (-0.75, -0.69 respectively).
CONCLUSION
Substantial inequalities in access to biologicals were largely associated with GDP. To explain differences in access among countries with similar development needs further research on acceptance.
Core tip: We carried out a questionnaire survey with gastroenterologists combined with desk research to analyze access to biologicals for Crohn’s disease in ten European countries. Regarding availability, reimbursement criteria were the least restrictive in Sweden and Germany, and the most restrictive in Hungary, Poland and Slovakia. Between countries, the annual cost of biological treatments differed 1.6-3.3-fold. Treatments were the most affordable in Sweden and the least affordable in Hungary and Romania. The number of patients on biologicals per 100000 population was strongly correlated with gross domestic product, although substantial differences were found in the uptake among countries with similar economic development.
