What pharma companies need to know about the new PBS Notice of Intent requirements

The Department of Health, Disability and Ageing has announced changes to their PBS Notice of Intent (NOI) process that will impact your market access timeline and preparation strategy for submissions from 2026 onwards.

The bottom line for your business

Earlier deadlines require adjusted project management

As per the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2022, the Department will continue to accept NOIs submitted up to 20 business days before the submission due date. For the March 2026 PBAC meeting, the Department has requested NOIs by 17 September 2025 (7 weeks prior); if you missed this deadline, urgently notify pbac@health.gov.au for late submission. Starting from July 2026 (NOIs due 14 January 2026, the Department plans to seek approval to amend these Regulations for a standard 8-week NOI deadline, with industry consultation. This shift from 4 to 7 weeks (75% increase) for March 2026 and 8 weeks (100% increase) thereafter represents a notable change that will compress your preparation window and require more upfront strategic planning.

More granular disclosure requirements means submission planning just got more complex

The Department is requesting substantially more detail at the NOI stage, essentially moving elements of your submission strategy disclosure forward by several months. The new requirements demand that you’ve crystallised key strategic decisions much earlier in your submission journey.

• Comparator strategy: You’ll need to commit to your positioning approach before you’ve completed all clinical analyses
• Economic modelling approach: Your health economics methodology must be locked in at NOI stage
• Clinical evidence package: The scope and nature of your evidence base needs early definition

The expanded NOI requirements essentially create a public preview of your submission strategy. Your comparator choices, clinical evidence approach, and economic modelling methodology will be visible to competitors, payers, and clinicians once the Consumer Comments Portal opens on the same day the PBAC Meeting agenda is published (3 weeks post-submission deadline).

What your teams need to do differently

Accelerate strategic decision-making

The luxury of refining your approach during the traditional submission preparation period is diminishing. Clinical, regulatory, and market access teams will need to align on core strategies much earlier in the development process.

Lodging the NOI earlier is expected to lead to earlier invoicing for PBS Cost Recovery Fees (evaluation fee is usually invoiced 14 days post NOI lodgement) with payment required within 28 days. This means you will need to pay the evaluation fee (210 – 270K for Category 1 – 2 submissions) 3 weeks prior to submitting the dossier.  Refund requests are possible however requiring a lot of administrative burden and usually have lengthy processing delays.

Enhanced cross-functional coordination

The detailed NOI requirements span clinical evidence (RCT specifications), health economics (model type and software), regulatory affairs (TGA pathway details), and commercial strategy (population positioning). This requires tighter integration across functions.

Earlier health economics investment

With economic model specification required at NOI stage, your health economics development timeline needs to move forward. You’ll need preliminary model structures and software decisions (eg. Excel with/without macros, TreeAge).

The regulatory context

This change reflects the Department’s broader push toward more predictable PBAC meeting preparation and enhanced stakeholder communication. The expanded “Purpose” descriptor requirements for web agendas suggest increased focus on internal planning within the Department and allocation to evaluation groups, plus public transparency around submission intent and scope.

For companies with integrated co-dependent submissions, the NOI timing remains unchanged.

Next steps for your organisation

1. Review your 2026 PBAC submission pipeline against the new NOI deadlines
2. Assess current cross-functional collaboration processes for earlier strategic alignment
3. Evaluate health economics development timelines for acceleration feasibility. Consider outsourcing the work if more complex modelling (eg. CUA) is required for your submission
4. Consider competitive implications of earlier strategic disclosure

Pulse Economics helps pharmaceutical companies navigate complex policy environments and optimise market access strategies. For support with PBAC submission planning under the new requirements, contact our team.