Access to high-cost medicines such as to the tumour necrosis factor inhibitors (TNFIs) for the treatment of rheumatoid arthritis is tightly regulated under Australia's Pharmaceutical Benefits Scheme (PBS) to ensure their cost-effective use. OBJECTIVES: To explore stakeholders' perceptions and experiences associated with the restricted access to TNFIs and the process of collaboration between key stakeholders who formulated the access criteria. METHODS: Thirty-three, in-depth semi-structured interviews were conducted between 2004 and 2005. Participants included rheumatologists, patients treated with TNFIs, consumer representatives, government health advisors, public servants, and representatives from pharmaceutical companies involved in formulating and implementing the access restrictions. Participants were asked to comment on the access restrictions that have applied since August 2003, and their views on the collaboration between stakeholders were collected. Interviews were recorded, transcribed verbatim, and thematically analysed. RESULTS: The principle of “controlled access” to TNFIs was in general accepted by all, despite the different perspectives each person represented. However, there were concerns regarding some of the specific PBS criteria. Overall, the collaborative approach that was taken to formulate the criteria for access to TNFIs was perceived by key stakeholders as a valuable advance and has set a new paradigm for subsequent PBS subsidy decisions. However, a wider and more transparent decision-making process, and a more structured and continuing communication between stakeholders were judged desirable. Some degree of flexibility with respect to physician prescribing, and a need to increase education to healthcare professionals and the community were proposed. CONCLUSION: Targeting access to high-cost medicines through a national subsidy system was agreed to be practical and equitable. Increased transparency, communication and education were identified as the main elements needed to secure support of the final access criteria by all involved. In order to confirm these primary themes, further interviews are being undertaken until data saturation is achieved.