OBJECTIVE: To generate estimates of the potential number of patients with rheumatoid arthritis (RA), who are considered candidates for etanercept in the Dutch health care setting in order to allow an assessment of the impact of etanercept on the annual drug budget. METHODS: A literature search on incidence and prevalence data for RA was performed on international and Dutch literature. A subsequent expert panel was used to 1) reach consensus on epidemiological data to be used for the budgetary impact analysis in The Netherlands, 2) validate the findings of the literature, 3) give estimates, where we did not find reliable data in the literature. This panel was a representative sample of Dutch rheumatologists. The budgetary impact analysis was performed from the perspective of the Ministry of Health. RESULTS: The total number of registered adult patients being treated by rheumatologists was based on a Diagnosis-Registration System (range: 30,000-60,000). The panel estimated that 98% of the patients will receive medication (range: 29,400-58,800) and that 7% of those patients are candidates for etanercept (range: 2,058-4,116). The total cost for etanercept is between NLG 64,084,000 (EURO 29,080,051) and NLG 128,169,000 (EURO 58,160,557), which is based on a twice weekly injection of NLG 299.42 (EURO 135.87). The expected costs are between NLG 49,265,000(EURO 22,355,482) and NLG 98,530,000 (EURO 44,710,965), when incorporating preliminary treatment termination and switching to a once weekly dosage. CONCLUSION: The use of literature and an expert panel allowed us to make a budgetary impact analysis for etanercept, which contributed to obtaining reimbursement.