5 September 2018 - The case for not doing so is now very weak.

The availability of the Public Summary Documents (PSDs) is the result of initiatives coming out of the 2005 Australian-United States Free Trade Agreement. The purpose of a PSD is to provide to the public, information pertaining to PBAC recommendations, so that stakeholders are aware of the rationale for specific PBAC recommendations, and gain an improved understanding of the overall PBS listing process. Insofar as PBAC recommendations are driven by the results of cost-effectiveness analyses, the inclusion of information on the economic evaluation in a submission to the PBAC and its assessment of that evaluation in a PSD is a  key element of gain a greater understanding of the PBS listing process and in particular, PBAC decision-making.

The PSDs are prepared by the Department of Health (DoH). For many years, information on cost-effectiveness analyses has been presented by the DoH in the PSDs by way of ICER bands (i.e. ICER <$15,000/QALY gained, $15,000-$45,000/QALY gained, >$45,000/QALY gained). The PSDs often cite the ICER band for the base-case proposed by the applicant/sponsor in the submission. Insofar as the PBAC regularly has an issue with the target patient population and/or the company's economic evaluation (e.g. model structure/inputs/time horizon, etc.) the PBAC's base-case ICER is invariably different to that of the applicant/sponsor. The PSDs frequently do not cite whether the PBAC's final base-case ICER is in the same band as that of the applicant/sponsor.

The DoH's failure (or reluctance) of the non-disclosure of the PBAC's final base-case ICER (be it a band or a point estimate) in a PSD is not consistent with the current practices of health technology assessment agencies around the world, such as NICE in England, CADTH in Canada, the Transparency Commission in France and ICER in the US. Some examples to demonstrate the DoH's tardiness will be provided in tomorrow's issue of MAESTrO Daily.