8.3 Pricing offer package
A complete pricing offer package will ensure a medicine’s listing can progress expeditiously from the point of offer. Applicants submit their pricing offer package by completing Part B of the Application Form for Pricing Services.
Applicants are able to submit their pricing offer package within a minimum of seven days and a maximum of 42 days after lodgement of the Notice of Intent for Pricing form. If the pricing offer package is not received within 42 days, applicants will be required to lodge a new Notice of Intent for Pricing form. The earliest opportunity for applicants to submit a pricing offer package would be in week 5, which would generally facilitate a reduction in the overall time to listing.
The pricing offer package must include:
- a complete PB11a form (‘Request for approved ex-manufacturer price’)
- pricing calculations or information to support price proposed in the PB11a;
- a special pricing agreement request (if any, refer PBS website for further details);
- agreement in principle to any PBAC advice on deed arrangements;
- confirmation of PBAC recommended restriction wording;
- TGA approval letter;
- updated utilisation and cost model (refer PBAC website for further information); and
- completed and signed Responsible Person form (refer Section 8.8.3), which includes the authorised representative(s).
Where an applicant is requesting a waiver or exemption, the PB11b form could be included to support this request. Guidance on how to submit a waiver application is included in the Cost Recovery Administration Guidelines.
An incomplete pricing offer package will not progress further until the missing information is provided by the applicant. If the department rejects the applicant’s pricing offer (pb11a form), the department will provide information as to why the offer was rejected. The level of detail included in the rationale will be based on the quality of information in the pricing offer package.
Once the department has confirmed the pricing offer package is complete and includes all of the required components (within 3-5 working days), the department and applicant will commence negotiation of the terms of listing (refer Section 8.4).
8.3.1 Cost of goods (PB11b)
A completed and signed ‘Cost of goods information’ (PB11b) form for the medicinal product proposed for listing is required at the time of submission to the PBAC (refer to Section 5).