In Australia, the Pharmaceutical Benefits Advisory Committee (PBAC) makes recommendations to the Minister for Health on which pharmaceuticals should be subsidised. Given the implications of PBAC recommendations for government finances and population health, PBAC is required to provide advice primarily on the basis of value for money.The aim of this article is twofold: to describe some major limitations of the current PBAC decision-making process in relation to its implicit aim of maximising value for money; and to suggest what might be done toward overcoming these limitations. This should also offer lessons for the many decision-making bodies around the world which are similar to PBAC.The current PBAC decision-making process is limited in two important respects. First, it features the use of an implicit incremental cost-effectiveness ratio (ICER) threshold that may not reflect the opportunity cost of funding a new technology, with unknown and possibly negative consequences for population health. Second, the process does not feature a means of systematically assessing how a technology may be of greater or lesser value in light of factors that are not captured by standard measures of cost effectiveness, but which are nonetheless important, particularly to the Australian community. Overcoming these limitations would mean that PBAC could be more confident of maximising value for money when making funding decisions. Key Points for Decision Makers: The current decision-making process of Australia's Pharmaceutical Benefits Advisory Committee (PBAC) is limited in relation to its implicit aim of maximising value for money.2  The decision-making process features the use of an implicit incremental costeffectiveness ratio threshold that may not reflect the opportunity cost of funding a new technology; moreover, it does not feature a means of systematically assessing how the value of a technology may differ in light of important factors not captured by standard measures of cost effectiveness.  Some attempts have been made outside of Australia to overcome such limitations, and if similar attempts were undertaken in Australia, PBAC could be more confident of maximising value for money when making funding decisions. Submissions for government subsidy serve to provide PBAC with evidence about the proposed pharmaceutical. Ideally, this evidence speaks to the criteria that PBAC members use to determine whether government subsidy is warranted. But for PBAC members to meaningfully apply criteria, they require standards. The evidence can then be used to determine whether a technology meets the standards. In other words, the evidence submitted may indicate how 'good' a proposed pharmaceutical is, but a decision maker needs some notion of when a technology is 'good enough' [4]. There is simply no other way to make a decision. Compliance with Ethical StandardsThe aim of this article is twofold: to describe some major limitations of the current PBAC decision-making process in relation to its implicit aim of maximising value fo...

while the cost for hospitalization and clinic visit were captured from Hong Kong Gazette. FTE hour was determined by literature review and converted to monetary value by an hourly rate at mid-point of nurse and pharmacist post. All costs were expressed in Hong Kong Dollar (1 USD= 7.8 HKD). Costs were not discounted due to short time horizon. One-way deterministic sensitivity analysis was performed to see the effect of changes of drug acquisition, changes in the FTE based on confidence interval and changes in body weight (±20%) on cost differences. RESULTS: Based on literature evaluation, 0.18 FTE nursing time and 0.14 FTE pharmacist time could be saved weekly if SC formulation was employed. After an 18-cycle of treatment with SC trastuzumab, the drug acquisition cost and the cost for health care professionals were lowered by HKD 73,720.0 and HKD 4,416.0 respectively, equivalent to an annual saving of HKD 52,316,614. The current model was most sensitive to body weight and drug acquisition cost but not changes in nursing and pharmacist time. CONCLUSIONS: This study demonstrated that SC formulation of trastuzumab would be a cost-saving therapy for HER2+ breast cancer patients in Hong Kong. Drug acquisition cost was identified as the most sensitive parameter to the total cost of treatment.

IntroductionAustralia has a two-tier public funding system, and many genetic tests are funded by different states and territories prior to being considered for public funding by the Federal government. In this context, health technology assessments (HTAs) of genetic tests for heritable conditions are problematic. We aimed to discuss the possible impacts on HTA methodology of a shift from regional to federal funding for genetic testing for heritable conditions.MethodsSeveral HTA reports and economic models on genetic tests considered by the Medical Services Advisory Committee (MSAC) were reviewed and compared to ‘real world’ clinical practice.ResultsEvery HTA of germline testing performed for the MSAC have so far compared genetic testing versus no genetic testing. However, testing for BRCA1/2 for patients with breast cancer currently occurs in Familial Cancer Centres, and testing for germline mutations for familial hypercholesterolaemia currently occurs through specialist lipid clinics. In both settings, the index patient and family members are given multidisciplinary support, including genetic counselling. The HTA comparison therefore did not reflect what the true clinical and cost-effectiveness impact of federal funding would be. Federal funding means that tests may be ordered by a broader range of specialists or general practitioners. The evidence identified was predominantly sourced from specialised centres, where knowledge regarding how to interpret the tests is high. The clinical utility of these tests largely depended on how clinicians understood and conveyed the results.ConclusionsThe benefit of testing may have been overestimated due to the comparator and setting used (i.e. specialised and centralized care, associated with high clinical utility). Any HTA of genetic testing for heritable conditions, which could result in a shift in the delivery of testing or care for the patient, should consider the applicability of the evidence identified. Further, it should assess the subsequent impact this may have on the effectiveness and cost-effectiveness of the test and the quality of care provided for patients and their family.