6.4 Input of the sponsor into the PBAC consideration
The government aims to ensure that the processes for considering public subsidy of medicines and vaccines are transparent to all stakeholders.
Sponsors with submissions being considered by the PBAC are able to respond to evaluations of the submissions and other technical documents provided to the PBAC.
Responses are opportunities to clarify, explain and reanalyse information in the submission. Additional clinical trial information or substantially amended models are not acceptable for inclusion in responses, because there is usually no opportunity to evaluate new data or models (both economic and financial). If new data are provided, the PBAC can decide whether it will consider this at the meeting or defer its consideration pending evaluation of the information.
For major submissions, sponsors have two opportunities to provide written input, the pre-subcommittee response and the pre-PBAC response, and one opportunity to present comments to the PBAC in the form of a hearing.
For minor submissions, sponsors have one opportunity to provide written input for the PBAC. This input is called the pre-PBAC response.
6.4.1 Pre-subcommittee response
Sponsors receive the commentary on a major submission 14 calendar days before the meetings of ESC and DUSC. Sponsors have seven calendar days to prepare and provide a response to the department for inclusion in ESC’s and DUSC’s agenda papers. The response must be provided by midday on Wednesday of week 11 of the PBAC cycle. Refer to the calendar of dates published on the PBS website for dates applicable to each meeting.
Responses to evaluations of major submissions are limited to four pages of text, and two pages of graphs and tables. Where the evaluation is for an integrated codependent major submission, the sponsor is allowed ten pages for text, and four pages of graphs and tables. This response is considered by both the PBAC and MSAC.
6.4.2 Pre-PBAC response
In addition to the commentary, each sponsor with a major submission under consideration by PBAC will receive an ESC Advice and a DUSC Advice (if applicable), plus any additional technical documents that will be provided to the PBAC.
Sponsors with special products – for example, vaccines – may receive additional information. Further information on advice prepared for the PBAC about submissions for vaccines, nutritional products, contributions through consumer comments and additional information provided to PBAC is provided in the following sections (eg vaccines is in Section 6.5).
For minor submissions, sponsors receive a document called an overview. This is usually prepared by the department for the PBAC. DUSC can also be asked to consider issues in minor submissions and, if this is the case, the DUSC Advice is also given to sponsors.
Sponsors have seven calendar days to prepare and provide a pre-PBAC response to the department to include in the agenda papers of the PBAC. The response must be provided by midday on the Wednesday of week 16 of the PBAC cycle.
Responses for all agenda items considered by the PBAC should be no longer than three pages. For integrated codependent submissions, sponsors may provide six pages. Top of page
6.4.3 PBAC hearings
A sponsor submitting a major submission can make an oral presentation to the PBAC during the PBAC meeting. The content of these presentations is limited to matters raised in their submission, during the evaluation, or as part of the advice prepared by the subcommittees. No new evidence is to be presented.
6.4.4 Procedures to request a hearing
A sponsor requesting a hearing should contact the department (see Appendix A) at least 12 calendar days before the PBAC meeting. Sponsors should provide the names of personnel attending, and whether an electronic presentation will be used for the hearing. Where the attendees are not employees of the sponsor who prepared the submission, the names and affiliations of each person should be supplied at least seven days before the PBAC meeting. Each invited non-employee of the sponsor will need to provide a conflict of interest statement.
6.4.5 Preparation for hearing
Each hearing lasts up to 10 minutes. An accompanying electronic presentation is acceptable. Microsoft PowerPoint 2010 is supported by the department. The presentation needs to be provided to the PBAC Secretariat on the Friday before the PBAC meeting. The sponsor should ensure that the non-employees attending the hearing are conversant with the contents of the submission and the issues arising during the evaluation process.
The PBAC can ask those attending questions about the content of the submission, clinical practice and quality use of medicine or vaccine issues associated with listing the medicine or vaccine.