Abstract
BackgroundIn Australia, the Pharmaceutical Benefits Scheme (PBS) has developed a set of arrangements to control access to high-cost medicines to ensure their use is cost-effective. These medicines include the tumour necrosis factor-alpha inhibitors (TNFIs) for the treatment of rheumatoid arthritis. The aim of this first phase of a qualitative study was to explore basic views on the restricted access to TNFIs in order to confirm where further investigation should take place in the next phase.MethodsSemi-structured interviews were conducted in 2004 with a member of the four relevant stakeholder groups. Participants were asked their opinions about features of the establishment, process and effects of the system of restricted access to TNFIs. Views on the collaboration between stakeholder groups in the decision-making process were also collected.ResultsThe principle of 'controlled access' to TNFIs was supported in general. There were concerns regarding some of the specific eligibility criteria. Wider and more transparent stakeholder consultation was judged desirable. Some flexibility around prescribing of TNFIs by physicians, and regular review of the arrangements were proposed. These themes will inform the next phase of the study.ConclusionThis first phase highlighted a range of issues associated with the PBS arrangements restricting access to TNFIs. Timely review and report of issues and concerns associated with such policy developments that arose in practice are essential. There is a need for a more comprehensive exploration across a wide range of stakeholders with different perspectives that will in turn be helpful in guiding policy and practice around national arrangements to manage access to high-cost medicines.
Highlights
In Australia, the Pharmaceutical Benefits Scheme (PBS) has developed a set of arrangements to control access to high-cost medicines to ensure their use is cost-effective
We considered that careful examination of the recent developments in targeting access to high-cost medicines, using tumour necrosis factor-alpha inhibitors (TNFIs) as an example, would be instructive in informing the debate concerning the principles and processes that might underpin appropriate and ethical access to expensive pharmaceuticals under the PBS or similar access systems
This initial phase identified a range of concerns, as held by individuals from different stakeholder groups, that arose in practice associated with the recent developments to control access to a group of high-cost medicines in Australia
Summary
Semi-structured interviews were conducted in Sydney in 2004 with four individuals to explore four different perspectives about access to TNFIs under the PBS. Interviewees were asked their opinions about features of the establishment, process and effects of the arrangements for targeting access to TNFIs. Views on the decision-making process and collaboration between stakeholder groups were collected. Purposeful sampling was used to select participants on the basis of their primary membership of different stakeholder groups with respect to the controlled access to TNFIs: a rheumatologist, a health advisor to the government, an employee of a pharmaceutical company, and a patient (who had used a TNFI). The study was approved by the Human Research Ethics Committees of St Vincent's Hospital Sydney, and the University of New South Wales, Australia
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