Effective high-cost medicines, for example, tumour necrosis factor inhibitors (TNFIs), are subsidised in Australia under the Pharmaceutical Benefits Scheme (PBS), but access is restricted to ensure cost-effective use. An application for initial or continuing access to TNFIs requires detailed information on each patient, including laboratory markers and previous pharmacotherapies. OBJECTIVES: To examine the access to TNFIs in Australia for treating rheumatoid arthritis. METHODS: Both aggregated, and individual de-identified information were requested from the Health Insurance Commission (HIC) including the number of applications received and approved, patient demographics, use of other disease-modifying anti-rheumatic drugs, changes in clinical outcomes, the time interval between application and decision to approve, and geographical pattern of usage. Prescription and expenditure data (August 2003 – March 2005) for the TNFIs, etanercept, infliximab, and adalimumab, were examined. RESULTS: The detailed clinical information submitted with the applications was not captured by the HIC database. A total of 19,629 prescriptions was reimbursed: etanercept (15,675), infliximab (570), and adalimumab (3384), at a total cost of AUD$43.5 million. The uptake of these agents was considerably lower than expected. The number of patients using a TNFI under the PBS could only be approximated from these aggregated figures – more than 2,000 patients had been commenced on TNFIs. The proportion of patients that were approved to continue or switch between TNFIs was not available. CONCLUSION: The HIC is positioned to capture subsidised prescription-drug usage and clinical outcome data on a national basis. Unfortunately, it is impossible to access detailed data. Information on utilisation of TNFIs is far from adequate. Comprehensive drug usage and patient health outcome data need to be accessible in order to define the most appropriate use and access to these agents. Update of, and arrangements for access to the HIC database are encouraged.