8 Procedures for a positive recommendation to list
Following a positive PBAC recommendation to the Australian Government Minister for Health to list a medicine on the PBS schedule, there are several activities the sponsor needs to complete and documents that must be submitted before the medicine can be recommended to the minister for listing. Each step must be completed in time for preparing and signing the legislative instruments and publication of the schedule on the PBS website.
Unless otherwise stated, items that are available on the PBS are also available on the RPBS, and references to the PBS in this section should be taken to include the RPBS.
The activities and documents that need to be completed by the sponsor are:
- Negotiation of a price and completion of a ‘Request for approved ex-manufacturer price’ form (pb11a) that reflects the price agreed in principle by the department. Refer to Section 8.1.
- Agreement on the expected utilisation and financial (budget) cost to the Australian Government. Refer to Section 8.2.
- Agreement of the restriction wording to be published on the PBS and RPBS schedule and in the listing instrument. Refer to Section 8.3.
- Establish a deed of agreement or other documentation related to a MAP, RSA and special pricing arrangement (SPA) if required. Refer to Section 8.4.
- Letter of application. Refer to Section 8.5.1.
- Assurance that the product will be available for supply on the date of listing. Refer to Section 8.5.2.
- Declaration of Responsible Person. Refer to Section 8.5.3.
- Application to list a medicine as a pharmaceutical benefit (pb11). This is provided in submission documentation. Refer to Section 5.