Pharmaceutical Benefits Advisory Committee

Interim Document to accompany the 1995 Guidelines for the Pharmaceutical Industry on Preparation of Submissions to the PBAC

The Interim Document contains revisions of Sections 2.1, 2.2 and 3, a new Section 2.2A and new appendices A1 and K1. It was first released in April 2000.

• revised Sections 2.1 and 2.2
• a new Section 2.2A
• a revised Section 3
• a new Appendix A1
• a new Appendix K1

Status of this Interim Document

This Interim Document relates to the Guidelines for the Pharmaceutical Industry on Preparation of Submissions to the Pharmaceutical Benefits Advisory Committee: including major submissions involving economic analyses released in November 1995. The Pharmaceutical Evaluation Section will follow this Interim Document when preparing commentaries on major submissions lodged after 1 June 2000. It will be superseded with the next edition of the PBAC Guidelines following the completion of the current revision process. It represents substantial agreement among the pharmaceutical industry, the PBAC and the PBAC's advisers. The PBAC endorsed the approach taken in this Interim Document in 1999.

Sponsors of drugs proposed for listing on the Pharmaceutical Benefits Schedule are therefore encouraged to follow this Interim Document in place of the relevant sections in the November 1995 PBAC Guidelines when preparing a major submission. This involves consideration of:

• a re-arrangement of Sections 2.1 and 2.2;
• a new Section (labelled 2.2A to minimise confusion in the counting of Sections);
• an extensive revision of Section 3; and
• a new Appendix (labelled K1 to minimise confusion in the counting of Appendices).

Major submissions following this Interim Document should follow this labelling format.

The changes reflected in this Interim Document compared to the November 1995 PBAC Guidelines relate to:

• the selection of randomised trial evidence from the results of the literature and other searches; and
• the presentation of modelled economic evaluations.

As with all aspects of the PBAC Guidelines and related documents, feedback on this Interim Document is welcome, and should be forwarded to:

The Director
Pharmaceutical Evaluation Section
Department of Health and Aged Care
GPO Box 9848
Canberra ACT 2601
AUSTRALIA