Section 3 Economic evaluation
Page last updated: September 2016
In Section 3, present an economic evaluation of substituting the proposed medicine for the main comparator in the context of the listing requested. Information requests cover a full and transparent description of the economic evaluation, with sensitivity analyses to characterise the uncertainty around the results.
The economic evaluation may be a full cost-effectiveness analysis (CEA) (Section 3A) or a cost minimisation (Section 3B).
A full CEA is appropriate where the clinical evaluation has concluded that the proposed medicine is:
- therapeutically superior to the main comparator, but likely to result in additional costs to the health system; or
- therapeutically inferior to the main comparator, but likely to result in lower costs to the health system.
This requires a full quantitative analysis of both the incremental health-related costs and health outcomes, associated with the proposed medicine. Ultimately, a full CEA estimates an incremental cost-effectiveness ratio.
A cost-minimisation approach is appropriate where there is a therapeutic claim of noninferiority (or superiority), the safety profile is equivalent or superior (in both nature and magnitude), and use of the proposed medicine is anticipated to result in equivalent or lesser costs to the health system.
For this approach, the difference between the proposed medicine and the main comparator is reduced to a cost comparison.
Go to the relevant version of Section 3 for the submission:
- Section 3A – guidance for preparing a full cost-utility or CEA
- Section 3B – guidance for presenting a cost-minimisation approach.