8.4 Negotiation and agreement
Where the applicant and department work together regarding the terms of the listing within the parameters of the PBAC’s recommendation.
This step commences once the department has confirmed the submitted pricing offer package is complete and ends when there is agreement to the terms of the listing. The negotiation and agreement step includes the following:
- Negotiation of a price;
- Negotiation of the expected utilisation and financial (budget) costs. Refer 8.5 Finalisation of budget impact for more information;
- Negotiation of a deed of agreement or other documentation relation to a Managed Access Program, risk share arrangement and special pricing arrangement (if required); and
- Finalisation of proposed restriction wording. Refer 8.6 Restriction Wording for more information.
Once negotiations have been agreed in‑principle between the applicant and the department, the applicant is required to update the PB11a form as necessary and provide a signed copy to the department by email or post (refer to contact details in Appendix A).
Once this step has occurred, government processes can commence whilst the department and the applicant finalise the following in preparation for listing:
- Deed of Agreement (if applicable) to be signed by both parties;
- Restriction wording finalised; and
- All outstanding cost recovery fees are paid.
Where an applicant has not actively pursued a price negotiation for 6 months, the proposed listing will be considered inactive for reporting and data collection purposes. This status is administrative only and does not impact on the PBAC’s processes for reconsidering or rescinding positive recommendations which are not yet implemented.