OBJECTIVES: To estimate the cost-effectiveness of febuxostat compared with allopurinol in the treatment of hyperuricaemia in patients with chronic gout when urate deposition has already occurred. METHODS: A Markov model was developed to estimate costs, clinical outcomes, and QALYs for patients with hyperuricaemia and chronic gout. Febuxostat 80 mg/120 mg as first line therapy (with or without allopurinol as second line therapy) and as second line therapy (after first line allopurinol) was compared to current standard therapy, i.e. allopurinol 300 mg daily with no second line treatment. A dichotomous sUA response/no response outcome after the first 3 months of each active treatment was used to decide when patients switched to a second line treatment. The definition of sUA response was applied using a target sUA level of < 6.0 mg/dL which was based on the latest EULAR guidelines.  Efficacy data (sUA levels) were derived from febuxostat Phase III trials (APEX, FACT). Unit costs were derived from official tariffs (€2009). 3% discount rate and 5-year time horizon was applied in the primary analysis. Sensitivity analyses were performed to assess the impact of variations on all model inputs and subgroup analyses (patients intolerant to allopurinol, or patients having mild-moderate renal impairment). Analyse was carried out from the National Health System perspective. RESULTS: The addition of febuxostat in any therapeutic strategy (both as first-line or second line treatment) is an efficient option, with incremental cost-effectiveness ratios (ICER) compared with standard allopurinol 300 mg ranging from 3,800 € to 6,600 €. The cost-effectiveness results show that the two-step two-drug treatment strategies provide additional QALY benefit over the single-step single-drug treatment strategies. CONCLUSIONS: Results suggest that febuxostat is a cost-effective treatment in Spain for the management of hyperuricemia in patients with gout, showing ICERs far below the commonly cited efficiency threshold in Spain (30,000€/QALY).