Sponsor Information Session

Page last updated: 27 November 2025

The Department held a webinar on Tuesday 11 November 2025 to present some upcoming changes to its processes and timelines to support PBAC decision-making, and have a discussion on how to improve the usefulness of PBAC sponsor hearings. 

The key information provided at that meeting is described below:

1. Pilot of joint DUSC – ESC discussions

• A pilot was conducted during the July 2025 PBAC cycle, where four submission items were discussed jointly by DUSC and ESC members, and one set of advice was provided for sponsors and the PBAC. The pilot aimed to enhance support for decision-making, streamline processes, and identify any unintended consequences from holding joint discussion. Positive feedback was received from both sponsors and committee members, but some challenges were identified.
• Based on this feedback, a decision has been made to conduct an expanded pilot during the March 2026 PBAC cycle where all items allocated for both DUSC and ESC discussion will be considered jointly. The ESC meeting dates have been moved forward by one week to overlap with DUSC meetings but processes and timelines for sponsors will not change. Sponsors will be notified individually if their submissions have been allocated for joint discussion.
• For those items selected for joint DUSC-ESC discussion, DUSC and ESC advice will be presented in a single document rather than separately.
• DUSC will continue with its non-submission work, in meeting outside of the joint discussion.
• While ESC meeting dates have been advanced for the whole of next year, a decision about continuing joint DUSC-ESC discussions will be reconsidered after the expanded pilot, taking into account feedback from sponsors and committee members.

2. Changes to the internal PBAC cycle timeline

While the 17-week PBAC cycle will remain, the Department is making changes to timelines starting in the March 2026 PBAC cycle and already reflected in the online PBS calendar:

• To support planning of resources, sponsors are requested to submit their Notice of Intent (NOI) at the earlier acceptance date.
• Sponsors were thanked for the earlier submission of their NOIs and provision of additional information by email for the March 2026 PBAC cycle. Earlier NOIs helped the Department for planning resources.
• Work is being done to revise the Health Products Portal (HPP) to permit direct entry of the additional information.
• 1-week advancement of publication of the PBAC Web Agenda
• 1-week advancement of both the opening and closing of the public consultation period
• 1-week advancement of ESC meeting (to facilitate the joint DUSC ESC meeting)
• Combined release date for all PSDs to week 35 to reduce internal workload and improve efficiency

3. The PBAC Sponsor Hearings: PBAC and Industry perspectives

Key points from the PBAC representative

• As outlined in the free trade agreement between the Australian and USA governments in 2004, sponsor hearings are intended to provide focused input on key issues, close to the time of the PBAC deliberation process.
• Hearings have evolved from in-person to virtual formats, with both pre-recorded and real-time options now available.
• While hearings will rarely change the PBAC decision, they can provide valuable contextual information around the decision.
• Real-time feedback immediately after live sponsor hearings and after discussion of pre-recorded sponsor hearings is being requested from PBAC members.
• There is currently a wide variation in the value of sponsor hearings from the PBAC members’ perspectives, but this can be due to submission itself rather than due to the quality of the hearing.
• The feedback has highlighted that it is important for sponsors to make clear their reasons for requesting a hearing, choose the appropriate hearing type, and ensure participants are well-briefed and speak to relevant issues.
• The feedback also highlighted the importance of who should attend the hearing. The PBAC often hears from clinicians who may not always be the most appropriate speaker, such as when the key issues are related to the economic model, for example.
• Sponsors are advised to focus on presenting new or more in-depth information, avoid repeating content from the submission, and ensure participants are well-prepared to answer anticipated questions.
• The two types of hearings have different benefits. Pre-recorded hearings can be considered before the PBAC meeting and provide an opportunity for the PBAC discussant to ask the sponsor for clarifications before the meeting. Real-time virtual hearings provide the opportunity for immediate questions and dialogue.

Key points from the representative of Medicines Australia

• Medicines Australia is updating its 2010 code of practice on hearings to reflect current processes and expectations.
• The revised guidance will cover the purpose, types, and procedures for hearings, and will be developed in consultation with the department, PBAC leadership, and sponsors.

4. Q & A session.

Departmental Directors on the Q&A Panel were introduced, and questions and comments were invited from all participants with the importance of sponsor feedback being emphasised. The availability of the PBAC inbox for ongoing sponsor feedback and queries was also highlighted, noting that it is monitored daily.

Q. Given the move to publish PSDs on the same date, is there a possibility the Department could consider that all PBAC minutes be provided to sponsors on the same date (ideally early), to facilitate preparation for post-PBAC meetings.

A. The process for writing the PBAC minutes requires review and ratification, making an earlier release date very challenging. While it is acknowledged that the timeline between sponsors receiving PBAC minutes and the post-PBAC meetings is tight for all involved, this timeline is hard to move.

Q. Noting that all PSDs will now be published after the cut off, there are situations where there's been a recommendation made at a previous PBAC meeting that is important for informing a submission. It is useful to have the PSD before the cutoff rather than having to rely on the published outcome. Could all PSDs be published in Week 33 rather than Week 35?

A.  Publication of all PSDs in week 33 would be very challenging. Timeframes for resolving internal review requests (which may be received as late as 7 business days prior to the week 33 publication date and need to be resolved in that timeframe) are already tight. Moving to a single publication deadline in week 35 will allow more time for the Department to consider and resolve the redaction requests from companies. It will also allow the Department to finalise PSDs more efficiently. The Department would be interested to know the extent to which companies have revised submissions based on information in a PSD published the Friday prior to the submission deadline of Wednesday. We would be happy to receive this feedback via email, and will use it to improve how we can support companies making submissions.

Q. Will the collated feedback and insights from PBAC members regarding sponsor hearings be shared in a report with redactions, where necessary?

A. There are no plans to develop a written report and most of the feedback and insights were already provided in the presentation today. However, the key insights will be reflected in the revised Code of Conduct. The Department is also working on enhancing instructions and guidance for sponsors when they book a sponsor hearing.

Q. It is a struggle for sponsors to prepare an informed, well briefed pre-recorded hearing on the main issues identified by ESC when the pre-PBAC response is due around the same time. Is there an opportunity to create some time and space to separate those deadlines and make those pre-recorded hearings more practical?

A. The Department and the PBAC are respectful of the time required to prepare a pre-recorded sponsor hearing and is conscious of the tight time frames within the 17-week cycle. Possibilities for tweaking the timeline within the 17-week cycle are being considered.

Q. Are there any examples where the PBAC would have wanted a hearing but the sponsor didn't request one? If so, what are the reasons?

A. Yes where there's been key issues that would have been able to be addressed in the hearing. For example, there are times when there was uncertainty about the clinical algorithm and how the drug would be used and it would have been nice to ask direct questions to a clinical expert about how clinical practise might change.

Q. When is it useful for sponsors to submit a written document or a letter as a hearing, rather than a pre-recorded or real-time hearing?

A. The free trade agreement was intended to be an interaction just before or at the PBAC and a letter is not really in the spirit of what was intended. There may be some letters that would be just as valuable being submitted through the public consultation process where it could be presented to the subcommittees and then to the PBAC. However, the public consultation period may be too early to be able to focus on the key issues.

5. Closing remarks

The Department thanked the speakers and participating sponsors and committed to sharing further details and outcomes from the various process changes in future webinars and PBAC news items. Sponsors were encouraged to send any feedback to the PBAC inbox.