8.1 Pricing pathways
There are five different pricing pathways to progress a positive PBAC recommendation.
Pricing pathways do not usually apply to generic medicines (refer section 5.8) or the post-PBAC processes for vaccines submissions to be listed on the NIP (refer section 8.10).
Pricing Pathway A requires the PBAC to recommend that it is appropriate for a submission to follow this pathway. All other pricing pathways are determined based on the listing arrangements required. Applicants nominate their pricing pathway via the Notice of Intent for Pricing form.
Pricing Pathway A - Facilitated
The PBAC will determine whether a submission is eligible for Pricing Pathway A as part of its recommendation. A high-level outcome of the PBAC's advice is provided to the applicant one week after the meeting via email (which will state the PBAC’s recommendation and if Pricing Pathway A applies). For applications that are recommended, details of the PBAC's advice will be included in the PBAC Minutes received by the applicant in the third week after the PBAC meeting.
Pricing Pathway A can apply for submissions where the PBAC considers that:
- the medicine is expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over any alternative therapies; and
- the medicine addresses a high and urgent unmet clinical need; and
- it would be in the public interest for the submission to be recommended to follow this pathway
In relation to the public interest component of the criteria, the PBAC will have regard to whether it is likely that the interests of the Australian public will be advanced by the recommendation being progressed via Pricing Pathway A, noting that the submission must also meet the first two criteria.
An applicant will either accept the PBAC’s Pricing Pathway A recommendation or nominate another pricing pathway via the Notice of Intent for Pricing form.
A Case Manager will be assigned where the applicant has accepted the PBAC’s recommendation for Pricing Pathway A. Refer to Section 8.1.1.
Pricing Pathway B – New deed
Pricing Pathway B applies for submissions which require negotiation and finalisation of a new deed of agreement where there are no similar arrangements in place. This could include an assessment of proposed risk-sharing, managed entry and/or special pricing arrangements.
Pricing Pathway C – Existing deed
Pricing Pathway C applies to submissions which require third-party responsible person notification of changes to an existing deed of agreement, and/or where an applicant has received a positive PBAC recommendation to list within the scope of existing arrangements, whether these relate to the new listing or to another existing listing. Where required, the deed’s original responsible person(s) will be notified of the provision of information to the new applicant. Refer to section 8.1.2 for additional guidance.
Pricing Pathway D – No deed
Pricing Pathway D applies to submissions which do not involve negotiation of a new or existing deed of agreement.
The secretariat pricing pathway applies to changes to listings of existing medicines which do not require a new price.
8.1.1 Case Manager
Where the applicant has accepted the PBAC recommendation for Pricing Pathway A via lodgement of the Notice of Intent for Pricing form, a Case Manager is assigned to facilitate communication and information sharing between the department and applicant (and other authorised agents as required) during the negotiation phase.
The role of the Case Manager is to ensure applicants are aware of the requirements and timeframes relating to their submission, and that applicants are provided with the necessary information for meeting these requirements in a timely manner. While Case Managers will support the overall administrative process, Case Managers will not facilitate, co-ordinate, or act as an intermediary in negotiation processes.
As decisions on the date of PBS listing remain a matter for Government, Case Managers will not be in a position to advise applicants about potential or actual listing dates.
8.1.2 Existing deed arrangement
When the applicant enters into the same therapeutic market as an already listed medicine (Pricing Pathway C) that is subject to a confidential deed of agreement, the applicant will be required to make confidentiality undertakings before any confidential details of the deed of agreement, for example a hidden price, are released to the applicant. This confidentiality process enables applicants to have access to information required to determine if they would like to submit a Notice of Intent for Pricing form. The applicant can choose to execute this step before they submit a Notice of Intent for Pricing form, or in parallel with the Notice of Intent for Pricing process.
The applicant initiates the Deed of Confidentiality process by contacting the department’s PBS Pricing and Managed Access Section (refer to contact details in Appendix A) to request the confidential effective price. This may be done any time after the ratified PBAC Minutes are provided to the applicant. If the PBAC recommendation is not yet public, the applicant will need to grant permission to the department, to allow the department to inform the responsible person of the comparator medicine about the new PBAC recommendation.
The department will then prepare a Deed of Confidentiality for the applicant requesting the confidential effective price.
The department will provide the Deed of Confidentiality within 3–5 business days after it receives the request. Once the Deed of Confidentiality is executed, the department can provide the applicant with the effective price and other relevant information.
This process enables applicants to have all available information to help them determine if they would like to proceed to pricing negotiations prior to lodging the Notice of Intent for Pricing form.