Variations in criteria regulating treatment with reimbursed biologic DMARDs across European countries. Are differences related to country's wealth?
OBJECTIVE
To explore criteria regulating treatment with reimbursed biologic disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) across Europe and to relate criteria to indicators of national socioeconomic welfare.


METHODS
A cross-sectional study among 46 European countries. One expert from each country completed a questionnaire on criteria regulating the start, maintenance/stop and switch of reimbursed bDMARDs. A composite score was developed to evaluate the level of restrictions in prescription of a first bDMARD (0=highly restricted, 5=most liberal). The level of restrictiveness was correlated with national socioeconomic welfare indicators.


RESULTS
In 10 countries (22%), no bDMARD was reimbursed. Among 36 countries with at least one biologic reimbursed, 23(64%) had no requirement for disease duration to initiate a biologic. Half of the countries required a failure of two synthetic DMARDs to qualify for therapy. 31 countries specified a minimum level of disease activity to be fulfilled and in 20 (56%) countries cut-off for disease activity score with 28-joint assessment was higher than 3.2. Four countries (11%) had the maximum composite score (most liberal) and 20 (56%) scored between 0 and 2 (more restrictive). Criteria for initiation of a bDMARD were negatively associated with countries' socioeconomic welfare (-0.34 to -0.64), and a moderate positive correlation was found between the composite score and welfare indicators (0.59-0.72). Only some countries had regulations for stopping (n=14(39%)) or switching (n=19(53%)).


CONCLUSIONS
Clinical criteria regulating prescription of bDMARDs in RA differ significantly across Europe. Countries with lower socioeconomic welfare tend to have stricter eligibility criteria, pointing to inequities in access to treatment.
Department of Health Promotion and Education, Maastricht University, School for Public Health and Primary Care (CAPHRI), Maastricht, The Netherlands.
Polina
P
Putrik
Department of Clinical Immunology & Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands Department of Rheumatology, Hospital Garcia de Orta, Almada, Portugal.
Sofia
S
Ramiro
Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Tore K
TK
Kvien
Department of Medicine, Jyväskylä Central Hospital, Jyvaskyla, Finland.
Tuulikki
T
Sokka
Department of Rheumatology, National Research Center for Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Till
T
Uhlig
Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and School for Public Health & Primary Care (CAPHRI), University Maastricht, Maastricht, The Netherlands.
Annelies
A
Boonen
D018501:Antirheumatic Agents / Q000191:economics / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000191:economics; D001688:Biological Products / Q000191:economics / Q000627:therapeutic use*; D003430:Cross-Sectional Studies; D011307:Drug Prescriptions / Q000191:economics / Q000706:statistics & numerical data; D004363:Drug Utilization / Q000191:economics / Q000706:statistics & numerical data; D005060:Europe; D015276:Health Care Rationing / Q000191:economics / Q000706:statistics & numerical data; D054625:Healthcare Disparities / Q000191:economics / Q000706:statistics & numerical data; D006801:Humans; D018579:Patient Selection; D010818:Practice Patterns, Physicians' / Q000191:economics* / Q000706:statistics & numerical data; D012051:Reimbursement Mechanisms; D012720:Severity of Illness Index; D012959:Socioeconomic Factors
D018501:Antirheumatic Agents; D001688:Biological Products
DMARDs (biologic); Health services research; Rheumatoid Arthritis; Treatment