Data from a study presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology, EULAR Congress 2012, demonstrates the vast inequalities in access to biologicals for the treatments of rheumatoid arthritis across 46 European countries [1, 2].
The study, carried out by researchers from Portugal and The Netherlands, showed that 10 countries (22%) did not reimburse a biological for rheumatoid arthritis at all.
The study was carried out by means of a questionnaire, which was sent to one representative rheumatologist in 48 countries of the European region. Data on the number of reimbursed drugs; prices of biologicals and the cultural acceptability of biologicals were collected. Rheumatologists were also asked whether either reimbursement or clinical recommendations or both were mainly regulating prescription in clinical practice. Further information was collected on minimal disease duration required, number of previous disease modifying anti-rheumatic drugs (DMARDs) which must have failed and requirements for disease activity or severity, mandatory before the start of a biological. A total of 46 countries (response rate 96%) provided data.
In the 36 countries with access to reimbursed biologicals, only Luxembourg did not regulate access. In 13 (36%) countries reimbursement criteria were the major source of eligibility, while in 7 (19%) clinical recommendations predominated and in 15 (42%) both reimbursement criteria and clinical recommendations were used.
Five or more biologicals were reimbursed in 26 countries, with the number of reimbursed drugs showing a moderate to very strong correlation with economic welfare and an inverse correlation with rheumatoid arthritis health status. After adjusting for purchasing power parity, prices for biologicals ranged from US$14,446 to US$61,552 which had a strong inverse correlation with economic welfare and a positive correlation with rheumatoid arthritis health. This demonstrates that European countries with lower socio-economic status seem to have less access to biologicals in terms of lower availability, affordability and acceptability (more barriers), while the health of rheumatoid arthritis patients in these countries is worse.
Among those with at least one biological reimbursed, 20 countries (56%) had no requirement for disease duration in order to initiate a biological, and for the remaining countries duration of three to 12 months was mandatory. The majority of the countries (47%) required a failure of two synthetic DMARDs to qualify for therapy with biologicals. Thirty out of 36 countries (83%) specified a minimum level of disease activity that had to be fulfilled before treatment with biologicals, with 19 of these countries (53%) having a stricter requirement than DAS28 ≥ 3.2. Countries from Eastern Europe and the former Soviet Union were more likely to have more stringent requirements for eligibility.
In the treatment of patients with rheumatoid arthritis, EULAR recommends the initiation of biological DMARDs when synthetic DMARDs fail. However, biologicals are costly and, as this study clearly shows, this can influence whether patients gain access to these life-changing drugs or not. The authors conclude that there is inequality to access to biological therapies for rheumatoid arthritis across the countries studied and that these findings should alert stakeholders to further strive for optimal standards of rheumatologic care and implement them across all European countries.
Conflict of interest
Authors of the study declared that they had no conflicts of interest to report.
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References
1. Putrik P, et al. Inequalities in access to biologic DMARDs for patients with rheumatoid arthritis across 46 European countries. EULAR 2012, Berlin, Germany; 6-9 June 2012.
2. Putrik P, et al. Inequalities across 46 European countries in clinical eligibility criteria for the start of a first (reimbursed) biologic DMARDs in patients with rheumatoid arthritis. EULAR 2012, Berlin, Germany; 6-9 June 2012.
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