Section 3B Cost minimisation
Page last updated: September 2016
This section provides information requests for preparing Section 3 using a cost-minimisation approach (see Section 3, Introduction).
The assumption of noninferiority (or superiority), with respect to both effectiveness and safety, needs to be well justified for the cost-minimisation approach to be accepted. Irrespective of the therapeutic claim, if the adverse effect profiles of a proposed medicine and its main comparator are significantly different in nature, it is unlikely that the cost-minimisation approach will suffice. The implications of these differences, for both health outcomes (ideally, utility) and resource use, should be explored in a full economic evaluation.
The cost-minimisation approach has an abbreviated Section 3, but provide sufficient detail to establish equi-effective doses. Also identify any differences between the proposed medicine and the comparator that are likely to result in a difference in health resource use. This includes identifying differences in:
- the costs of prescribing or administering the medicines
- the costs of monitoring or managing adverse events associated with the medicines
- anything else that may impact health resource use.
Flowchart 3B.1 Overview of information requests for Section 3B of a submission to the PBAC based on a cost-minimisation approach