8.2 Notice of Intent for Pricing
The Notice of Intent for Pricing form (Part A of the Application Form for Pricing Services) is mandatory for all submissions that receive a positive PBAC recommendation and pricing activities are required to complete the listing process. A pricing offer package or request for price negotiations will not proceed if the Notice of Intent for Pricing form has not been submitted. The only exception is if the department decides that progressing the application is necessary to address an urgent public health need.
The earliest opportunity for an applicant to submit their Notice of Intent for Pricing form is week 4 following a positive PBAC recommendation. The form is to be submitted to PBS Pricing (refer contact details in Appendix A). The department will reply within one business day to confirm receipt of the form.
The completed Notice of Intent for Pricing form will advise the department that:
- the applicant intends to submit a pricing offer package and, if so, the expected timing of this offer (within the required 7-42 day timeframe) and, ideally, confirmation of a date for which supply of the medicine will be available in Australia; or
- the applicant intends to return their submission to the PBAC for reconsideration as a resubmission; or
- the applicant does not intend to submit a pricing offer package (which would be recorded as withdrawing from the listing process); and
- for submissions with PBAC advice to support the Pricing Pathway A option, whether the applicant accepts the recommendation of Pricing Pathway A.
If an applicant does not lodge a Notice of Intent for Pricing form within 60 calendar days of being issued the ratified PBAC Minutes the submission will be deemed ‘inactive’ for data collection and reporting 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.