3. How to use this Manual
This manual is to be used in conjunction with the PBAC Guidelines. It lists medical and other health‑related services that may be affected by therapy involving a medicine, and provides unit costs for services that are relevant to the economic evaluation of these therapies in the context of the PBS.
The manual comprises separate sections that relate to different categories of health care: medicines, medical services, hospital services and community-based services. Within each of these categories, individual resource items are identified and classified, and the units of measurement are defined. The associated unit costs are also presented to determine their value in an economic evaluation. Section 8 specifies the preferred method for determining variations to unit costs of PBS/Repatriation Pharmaceutical Benefits Scheme (RPBS) medicines when conducting financial analyses from the PBS/RPBS perspective rather than the societal perspective.
Sponsors are advised to familiarise themselves with each section of the manual to ensure that the data gathered during clinical trials for both the proposed medicine and its main comparator are compatible with these requirements.
Some economic evaluations may identify an item that is not included in this manual. In these cases, apply the general principles associated with establishing the unit cost in the resource category relevant to that item. Explain the nature of the resource item and the data sources used to determine its unit cost.
Unit costs in this manual were current at the time of its revision (2016). These unit costs will periodically be updated, and the manual will be revised as necessary. The vast majority of unit costs that are likely to be used in submissions are not contained in this manual – instead, cross‑references are made to other sources that include all the most frequently used unit costs (see hyperlinks throughout the manual, and Appendix 1).
The phrase ‘medicine or medicinal preparation’ within the manual should be interpreted as being the same as the phrase ‘drug or medicinal preparation’ under the National Health Act 1953.
As necessary, seek advice from the Pharmaceutical Evaluation Branch of the Australian Government Department of Health about how to determine a suitable unit cost (see contact details on page 1).