Impact of National Criteria and Healthcare System Characteristics on Access to Biologic Dmards in Rheumatoid Arthritis in Europe

Biologic disease modifying antirheumatic drugs (bDMARDs) for the treatment of rheumatoid arthritis (RA) are not always accessible to all patients as outlined in international guidelines, partly due to their high direct costs against a background of restricted healthcare budgets. This study considers the current (2014) number of RA patients with access to bDMARDs across 37 European countries, Russia and Turkey according to their national reimbursement criteria compared to treatment eligibility defined by European League Against Rheumatism (EULAR) recommendations. Eligibility for bDMARD treatment was estimated in a population model using RA epidemiological data and clinical criteria defined by 2013 EULAR recommendations along with national reimbursement criteria and system characteristics defined in a survey of the 39 countries in November 2015 and validated during interviews with experts in key countries. To contextualise the hypothetical estimates, real world bDMARD uptake was estimated from actual sales data. Thirty-two percent (32%) of the total RA population in the European region is eligible for bDMARD treatment according to EULAR recommendations. However, only an average 63% of this EULAR eligible population remains eligible after applying national reimbursement criteria (range: 97% in countries defined as ‘high access’ - 10% in countries defined as ‘low access’). Real world evidence generally showed that even less patients are treated with bDMARDs than would be predicted based on national reimbursement criteria. Access to reimbursed bDMARDs remains unequal in the European region due to national reimbursement criteria as well as less tangible system characteristics. However, as biosimilars of bDMARDs are introduced, changes in reimbursement criteria are expected to increase access to bDMARDs and potentially to reduce inequities across the region. Further research is recommended to understand the implicit barriers that may further inhibit access to bDMARDs, such as those related to local funding protocols and limitations on who can prescribe.