Public Summary Documents Explained - In Depth Structural Information

The following sections are included in PSDs:

1. Purpose of the application

Provides a brief explanation of the sponsor’s request. For example to list a new medicine on the PBS or change the current circumstances through which a medicine is already listed on the PBS.

2. Background

Provides a summary of whether the application has been previously considered by the PBAC and the relevant PBAC outcome/s.

3. Registration status

States the uses for which the medicine is approved to be supplied in Australia, as registered by the Therapeutic Goods Administration.

4. Listing requested and PBAC’s view

States the requested circumstances for PBS subsidy including the wording of any restriction to apply to the prescribing of the medicine through the PBS.

5. Clinical place for the proposed therapy

States the usefulness of the medicine within the context of currently available therapeutic alternatives.

6. Comparator

States the treatment nominated by the sponsor that the medicine is likely to replace in clinical practice.

7. Clinical trials

Provides a list of clinical trials of the medicine included in the sponsor’s submission.

8. Results of trials

Provides the results of key trials included in the submission, used to justify PBS listing.

9. Clinical claim

Provides the sponsors claim/s of the clinical advantages of the medicine requested for PBS listing.

10. Economic analysis

Provides the method of economic analysis for the requested listing as presented in the submission, for example cost-effectiveness analysis or cost-minimisation analysis.

11. Estimated PBS usage and financial implications

Provides an estimation of expected usage through the PBS and the resulting net cost to government, as presented in the submission. The PBAC’s views of these estimates are also provided.

12. Recommendations and reasons

Provides the considerations taken into account by the PBAC forming the rationale for the PBAC recommendation. Also provides the actual recommendation, for example to agree to listing, reject or defer the application for future consideration pending the provision of further information.

13. Context for decision

Provides an explanation of the context of PBAC recommendations with respect to the opportunity for sponsor’s to resubmit to PBAC and/or seek an independent review of the recommendation.

14. Sponsors comments

Provides opportunity for the sponsor to comment which may include its future intention/s with respect to the application.