Published online Sep 14, 2017. doi: 10.3748/wjg.v23.i34.6294
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
Processing time: 118 Days and 13.4 Hours
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.
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.
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).
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.