7 September 2018 - Important content is either not reported or not reported in a consistent manner.

The availability of PBAC Public Summary Documents (PSDs) is the result of the Australian-United States Free Trade Agreement of 2005.

The purpose of PSDs 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.

The structure of the PSDs is the result of collaboration between the Australian Government and the pharmaceutical industry, and is aimed at providing consistent information across PBAC recommendations.

As an analyst of the PBAC submissions and their related outcomes and thus a regular reader of the PSDs, MAESTrO Database has noted that the following submission/outcome attributes are either not reported or not reported in a consistent manner:

• Comparators - for submissions with multiple comparators, it is difficult at times to determine what was the main comparator and what was a secondary comparator
  
• Patient-reported outcomes - the PSDs often state that health-related quality of life was measured in the relevant clinical trials, but often do not note which instrument/s were used.
  
• Incremental health/QALY gain (empirical and/or modelled)
  
• Final base-case ICER - the PSDs frequently do not cite the PBAC's final base-case ICER expressed as a band (i.e. $45,000 - $75,000/QALY gained) or as a point estimate.
  
• Estimated patient population - the PSDs often cite a number/range estimated by the sponsor/applicant but of the PBAC.  The PSDs often state that the PBAC was of the view that the company's estimate was an over/under estimate but nothing else. 
  
• Budget impact estimate - the PSDs often cite a number/range estimated by the sponsor/applicant but of the PBAC. The PSDs often state that the PBAC was of the view that the company's estimate was an over/under estimate but nothing else. Furthermore, the PSDs report estimates for different time periods.
  

MAESTrO Database recognises that some of these data may be commercially sensitive and are redacted by a given sponsor company from a PSD prior to its publication. Nonetheless, there is scope for considerable improvement. The publications of other health technology assessment agencies regularly publish this information.