Department requests earlier Notices of Intent for PBAC submissions
18 Sep 2025
Key information
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March 2026 PBAC meeting: NOIs were requested by 17 September 2025. Sponsors unable to meet this date should email pbac@health.gov.au and submit their NOI as soon as possible. The Department may request further information to assist with planning.
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July 2026 PBAC meeting: NOIs will be requested by 14 January 2026, 8 weeks before the submission due date. This applies to all submissions, including integrated co-dependent submissions.
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Regulatory framework: Under the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022, NOIs can continue to be submitted up to 20 business days before the submission due date. The Department plans to seek approval to amend the regulations so that NOIs are due 8 weeks before submissions, with consultation with sponsors/industry.
Purpose of submission
Sponsors should prepare the purpose section of the NOI form carefully before submission. Once saved, it cannot be changed. The purpose is used to prepare the published agenda. Include:
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Population details: Line of therapy, clinical criteria (e.g., genetic testing), age, gender, etc.
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Level of restriction: e.g., Restricted Benefit, Authority Required (Written/Online/Telephone), Streamlined.
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Schedule type: e.g., PBS General Schedule, s100, National Immunisation Program.
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Forms and strengths: e.g., 100mg tablet.
Example purpose:
Purpose: [Resubmission, if applicable] To request listing of [DRUG] [for use in combination with DRUG/S, if applicable] for the [treatment/prophylaxis] of [population, e.g., adults, children] with [indication, line of therapy, clinical criteria such as biomarkers].
Level of restriction: [Authority Required OR Restricted Benefit OR Unrestricted]
Schedule: [PBS General Schedule, PBS s100, NIP]
Forms and strengths: [e.g., 100mg tablet]
If the 2,500-character limit is insufficient, provide the purpose via HPP correspondence after submitting the NOI.
Additional information requested
After submitting the NOI, sponsors should provide additional details via HPP correspondence using the category ‘Additional information’. This information helps the Department plan internal and external resources for evaluating submissions. Include:
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Comparator(s): Brief description
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Clinical data: Single or multiple RCTs, ITC, or other
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Economic model type: Partitioned survival analysis, Markov, Microsimulation, or other
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Software used: Excel (with/without macros), TreeAge, or other
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TGA pathway and submission number: Standard, Priority, Provisional, or other
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TGA Delegate overview: Date received / due date
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Orphan drug status: Yes / No
How to submit additional information:
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After submitting your NOI, go to the correspondence page in HPP and click ‘New correspondence’.
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Search for the relevant NOI and click ‘Start’.
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Select ‘Additional information’ as the correspondence category and follow prompts.
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Click Submit to send directly to the Department.
This process ensures the Department can plan efficiently for evaluating submissions and preparing PBAC meeting agendas.
Source: Department of Health, PBAC Notice of Intent guidance, September 2025
