Changes to the Notice of Intent process for submissions to the PBAC
Page last updated: 5 September 2025
To help the Department better plan for upcoming PBAC meetings, we’re making a few changes to the Notice of Intent (NOI) process for submissions to the PBAC.
Earlier NOI Submission Requested
Starting with the submissions for the March 2026 PBAC meeting, the Department is asking for NOIs to be submitted earlier than usual. This will support more effective preparation for the meeting and preparation of more helpful information for consumers, clinicians, and other stakeholders. If you have any concerns regarding the requested timing, please do not hesitate to contact us via pbac@health.gov.au.
For submissions to be considered at the March 2026 PBAC meeting, we request that sponsors submit their NOI by 17 September 2025.
The Department will seek approval to formalise this change in the regulations so that from 2026 onwards, the standard NOI deadline will move to eight weeks prior to the submission due date.
For integrated co-dependent submissions, the current NOI deadline of 10 September still applies.
Additional Information Requested with NOI
We are also requesting additional information with each NOI to support early planning. Please include the following in your HPP correspondence:
- Comparator(s): Brief description
- Clinical data: Single RCT / Multiple RCTs (please specify how many) / ITC / Other (please describe)
- Economic model type: Partitioned survival analysis / Markov / Microsimulation / Other (please describe)
- Software used: Excel (no macros) / Excel (with macros) / TreeAge / Other (please describe)
- TGA pathway and submission number: Standard / Priority / Provisional / Other (please describe)
- TGA Delegate overview: Date received / Due date
- Orphan drug status: Yes / No
If your submission involves more than one comparator, please provide the information for each.
Purpose of Submission – Web Agenda
We also ask sponsors to include a clear and informative ‘Purpose’ in the relevant HPP section. This will help inform consumers, clinicians, and other stakeholders via the PBAC web agenda.
Please include:
- Requested population details (e.g. line of therapy, genetic/other testing requirements)
- Level of restriction (e.g. Restricted Benefit, Authority Required – written/online/telephone, Streamlined)
- Schedule type (e.g. General Schedule, s100, NIP)
- Form and strengh
For example:
Purpose: [Where applicable: Resubmission] To request listing of [DRUG] [where applicable: for use in combination with DRUG/S] for the [treatment OR prophylaxis] of [where applicable: the population e.g. adults, children] with [listing requested by the sponsor].
Level of restriction: [Authority Required (Written OR Telephone/Online OR STREAMLINED) OR Restricted Benefit OR Unrestricted]
Schedule: [e.g. General Schedule, s100, NIP]
Form and strengths: [e.g. 100 mg tablet]
This will ensure consistency in the information sponsors provide, reduce the requirement for clarification with sponsors and assist preparation of more informative web agendas. Please note, web agendas will continue to be published after complete submissions have been lodged.
