OBJECTIVES: The selective T cell co-stimulation modulator abatacept was approved by EMEA in 2007 for the treatment of moderate to severe active RA patients with an insufficient response or intolerance to disease-modifying anti-rheumatic drugs (DMARDs), including at least one tumor necrosis factor-alpha antagonist (anti-TNF). The objective of this study was to assess the cost-effectiveness of abatacept in RA patients with an inadequate response to anti-TNFs in the Hungarian setting.METHODS: An individual state transition simulation cost-utility model based on disease progression expressed in Health Assessment Questionnaire (HAQ) disability index score change was developed to enrol patients corresponding to the patients of the ATTAIN clinical trial. This cost-utility analysis was conducted using a societal perspective, including all costs (direct and indirect) related to RA. We also present results from the perspective of Hungarian health insurance, where RA-related direct costs are the most relevant. In this cost-utility assessment, abatacept was compared to methotrexate(MTX), the most prescribed DMARDs. Current treatment patterns showing that patients with an insufficient response or intolerance to a first anti-TNF agent are switched to a subsequent anti-TNF agent, abatacept was also compared to cycled anti-TNFs based on data from the British Society of Rheumatology Biologics Registry. The model was populated with Hungarian cost, utility and epidemiological data. Costs and benefits were discounted at 5% per annum as per Hungarian guidelines.RESULTS: With reference to the ATTAIN trial, and assuming a treatment duration of 1 year and 10 years time horizon, abatacept was cost-effective compared to MTX, yielding 0.57 additional QALY at an additional cost of 2.03 million HUF with an incremental cost-effectiveness ratio of 3.6 million HUF/QALY based on a societal perspective. From the Hungarian health insurance perspective, the incremental cost-effectiveness ratio was 4.4 million HUF/QALY gained. Compared to cycled anti-TNFs, abatacept was dominant (more effective and overall less costly), with a QALY gain of 0.48 and estimated savings of 731 113 HUF. From the Hungarian health insurance perspective, the savings were 479 815 HUF. The results are robust to extensive sensitivity analyses.CONCLUSIONS: The results of this cost-utility assessment suggest that abatacept is cost-effective compared to MTX and to cycled anti-TNFs in Hungary for the approved indication, and within the usual acceptance cost-effectiveness ranges.