Variations in criteria regulating treatment with reimbursed biologic DMARDs across European countries. Are differences related to country's wealth?

Polina Putrik*, Sofia Ramiro, Tore K. Kvien, Tuulikki Sokka, Till Uhlig, Annelies Boonen, Ledio Collaku, Ruzanna Harutyunyan, Helga Radner, Nikolay Soroka, Herman Mielants, Sekib Sokolovic, Lyubomir Sapundzhiev, Miroslav Mayer, Paraskevi Charalambous, Jiri Vencovsky, Merete Lund Hetland, Tõnu Peets, Bruno Fautrel, Khatuna LetsveridzeUlf Müller-Ladner, Prodromos Sidiropoulos, Márta Péntek, Gerður María Gröndal, Fiona McGrehan, Seriolo Bruno, Togizbayev Galymzhan, Daina Andersone, Irena Butrimiene, Marco Hirsch, Snezana Misevska-Percinkova, Karen Cassar, Elena Deseatnicova, Dusan Mustur, Filip Raciborski, Viviana Tavares, Florian Berghea, Ivan Shirinsky, Miodrag Veljkovic, Maria Kovarova, Matija Tomsic, Francisca Sivera, Ingemar Petersson, Axel Finckh, Shaydullo Sharipov, Nevsun Inanc, Tatyana Dumenko, Suzanne Verstappen, Hojimurad Khudoberdiev

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

80 Citations (Scopus)


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.

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%)).

Objectives: 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.

Original languageEnglish
Pages (from-to)2010-2021
Number of pages12
JournalAnnals of the Rheumatic Diseases
Issue number11
Publication statusPublished - 1 Nov 2014


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