Further information about the Department’s request for earlier Notices of Intent for submissions to the PBAC

Page last updated: 18 September 2025

The Department held a webinar on Thursday 11 September about its requests for Notices of Intent (NOI) to be made earlier and for additional information to be provided to support meeting planning and publication of more informative agendas. Thank you to all sponsors who submitted NOIs by 17 September 2025.

The key information provided at that meeting is set out below:

KEY INFORMATION

• For the March 2026 meeting, the Department requested NOIs be lodged by 17 September 2025. If sponsors intend to make a submission for the March 2026 PBAC meeting but were not in a position to submit a NOI by 17 September, the Department requests email notification to pbac@health.gov.au and submission of the NOI as early as possible. The Department may reach out to see what information sponsors can share to help with planning.
• For the July 2026 PBAC meeting, the Department will be requesting NOIs by 14 January 2026, 8 weeks prior to the submission due date. This is the same deadline for integrated co-dependent submissions.
• As per the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022 (Regulations), the Department will continue to accept NOIs submitted up to 20 business days before the submission due day for the submission.
• The Department plans to seek approval to amend the Regulations so that the NOI due date will be 8 weeks prior to the submission due date.
• The Department will consult with sponsors/industry on any proposed amendments.

PURPOSE OF SUBMISSION

Sponsors are asked to include the following information in the purpose section of the NOI form in HPP:

• Requested population details (line of therapy, clinical criteria including genetic/other primary testing requirements, population criteria such as age, gender)
• Level of restriction (e.g. Restricted Benefit, Authority Required – written/online/telephone, Streamlined)
• Schedule type (e.g. General Schedule, s100, NIP)
• Forms and strengths

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 [indication, line of therapy, main clinical criteria such as genetic or other biomarkers or other clinical requirements].

Level of restriction: [Authority Required (Written OR Telephone/Online OR STREAMLINED) OR Restricted Benefit OR Unrestricted]

Schedule: [e.g. PBS General Schedule, PBS s100, National Immunisation Program]

Forms and strengths: [e.g. 100mg tablet]

Sponsors are asked to prepare the purpose of their submissions before creating the NOI form. Once saved, the purpose cannot be changed. In the event of an error or if the 2500 character limit for the purpose field is insufficient, sponsors are asked to provide the purpose via HPP correspondence after they have submitted their NOI.

The purpose will be used to prepare the published agenda for the upcoming meeting. 

ADDITIONAL INFORMATION REQUESTED WITH NOI

Sponsors are asked to provide the following information through HPP correspondence after they have submitted your NOI (not in any of the fields in the NOI online form). The correspondence category should be ‘Additional information’.

• 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

Sending correspondence: After you have submitted your NOI, from the correspondence page, click ‘New correspondence’ in the top right corner. This will display the Start new correspondence pop-up screen. In the search bar select the NOI lodgement the correspondence is related to and click ‘Start’. This will redirect you to the correspondence pop-up screen. See the HPP website for information on Managing Correspondence. The correspondence category should be ‘Additional information’. Follow the prompts to complete the relevant information, then click ‘Submit’. This will send your correspondence directly to the Department.

This information will be used for planning internal and external resourcing for evaluating submissions.