Submission executive summary
Page last updated: September 2016
Information Requests
- Provide an executive summary of no more than 12 pages
- Address each key aspect indicated in Checklist 1
The executive summary will be included in the agenda papers for the PBAC meeting and is the sponsor’s primary method for communicating with each PBAC member; therefore, it is important to lay out clearly the key aspects and issues presented in the submission. The summary also provides the basis for subsequent summary documents relating to the submission, up to and including the public summary document. Checklist 1 lists what needs to be included in the executive summary of a submission.
|
Component |
Included? |
|---|---|
|
The Australian approved name, brand name and marketing status of the proposed medicine |
[Yes/No] |
|
The principal pharmacological action of the proposed medicine |
[Yes/No] |
|
The form(s), strength(s), pack size(s), maximum quantity(ies), number(s) of repeats and dispensed price(s) requested for PBS listing |
[Yes/No] |
|
The proposed patient indication(s) and any requested restriction(s) for PBS listing, with a brief rationale |
[Yes/No] |
|
The inclusion of a diagnostic requirement in a requested restriction, if relevant |
[Yes/No] |
|
The recommended course of treatment |
[Yes/No] |
|
The main comparator(s) and the main expected changes in the clinical management algorithm |
[Yes/No] |
|
Whether the key clinical evidence in the submission comes from direct randomised trials, from an indirect comparison of randomised trials involving a common reference (eg placebo or other active therapy) or from nonrandomised studies |
[Yes/No] |
|
The main results of the clinical evaluation in terms of comparative effectiveness and comparative toxicity |
[Yes/No] |
|
The therapeutic conclusion that best describes the proposed medicine and therefore the type(s) of economic evaluation presented |
[Yes/No] |
|
The reasons for, and results of, any transformation studies to generate variables for incorporation into a modelled economic evaluation |
[Yes/No] |
|
The cost per patient per course (for acute therapy) or the cost per patient per year (for chronic therapy) |
[Yes/No] |
|
The other types of health care resources affected by the listing of the proposed medicine and the net present value of the overall incremental costs in the base case of the economic evaluation |
[Yes/No] |
|
The net present value of the overall incremental effectiveness in the base case of the economic evaluation |
[Yes/No] |
|
The base-case results of the economic evaluation, together with the results of the stepped approach outlined in Section 3, if applicable |
[Yes/No] |
|
The main sources of uncertainty in the structure and variables in the economic evaluation, and the results of associated sensitivity analyses |
[Yes/No] |
|
The numbers of patients treated, the numbers of packs dispensed and the net costs to the PBS/RPBS of the proposed medicine in each year over six years |
[Yes/No] |