Abstract
Access to "high cost medicines" through Australia's Pharmaceutical Benefits Scheme (PBS) is tightly regulated. It is inherently difficult to apply any criteria-based system of control in a way that provides a fair balance between efficient use of limited resources for community needs and equitable individual access to care. We suggest, in relation to very high cost medicines, that the present arrangements be re-considered in order to overcome potential inequities. The biological agents for the treatment of rheumatoid arthritis are used as an example by which to discuss the ethical issues associated with the current scheme. Consideration of ethical aspects of the PBS and similar programs is important in order to achieve the fairest outcomes for individual patients, as well as for the community.
Highlights
The goal of health care, stated in the Australia's National Medicines Policy, is to achieve optimal health and economic outcomes for society as a whole as well as for the individual patient [1]
While High cost medicines" (HCMs) have not been explicitly defined within the Pharmaceutical Benefits Scheme (PBS) it is important to note that if the total use of a drug is expected to cost more than AUD$10 million a year, its subsidy needs approval by the Commonwealth Department of Finance and Administration, or by the Cabinet [5]
We examine, from an ethical perspective, recent approaches used in Australia to govern access to HCMs, using the example of the biological medicines ("biologicals") for the treatment of rheumatoid arthritis
Summary
The goal of health care, stated in the Australia's National Medicines Policy, is to achieve optimal health and economic outcomes for society as a whole as well as for the individual patient [1]. The anti-rheumatic biologicals are expensive (high cost per patient per year), they exhibit high cost-effectiveness ratios, their cumulative expenditure is likely to be high because rheumatoid arthritis is a relatively prevalent chronic condition, and there are uncertainties regarding their longer-term safety (such as risks of lymphoma and rare, serious infections). For these reasons, they provide a representative illustration of ethical issues associated with the current scheme
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