8  Procedures for a positive recommendation to list

Following a positive PBAC recommendation to list a medicine on the PBS schedule, there are several additional processes that must be completed before the medicine can be recommended to the Minister for Health for listing.

This includes:

• Completion of the Notice of Intent for Pricing Form (Part A of Application for Pricing Services). Refer to Section 8.2
• Lodgement of all documents required in the Pricing Offer Package. Refer to Section 8.3.
• 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 8.3.
• Agreement on the expected utilisation and financial (budget) cost to the Australian Government. Refer to Section 8.5.
• Agreement of the restriction wording to be published on the PBS and RPBS schedule and in the listing instrument. Refer to Section 8.6.
• Establish a deed of agreement or other documentation related to a MAP, RSA and special pricing arrangement (SPA) if required. Refer to Section 8.7.
• Provision of a letter of application. Refer to Section 8.8.1.
• Assurance that the product will be available for supply on the date of listing. Refer to Section 8.8.2.
• Declaration of Responsible Person. Refer to Section 8.8.3.
• Application to list a medicine as a pharmaceutical benefit (PB11). This is provided in submission documentation. Refer to Section 5.
• Payment of all invoices issued as part of the listing process (from pre-submission fees to pricing fees) to enable a listing to occur.

Table 8.1         PBS listing steps responsibilities and timeframes

Week	Event	Responsible	Next step
17	PBAC – Wednesday to Friday of 1st week of month 1.	PBAC
18	Notification of PBAC outcome.	Department
19
20	Ratified PBAC Minutes to applicant for positive PBAC recommendations.	Department
	Notice of Intent for Pricing form lodged through Part A of Application Form for Pricing Services – mandatory step to advice whether the applicant is proceeding to pricing services, returning to the PBAC for reconsideration or withdrawing from the process.	Applicant	Go / No Go
	Pricing offer package lodged through Part B of the Application Form for Pricing Services. The applicant must: (1) make a price offer (PB11a form); (2) provide pricing calculations or information to support price proposed in PB11a; (3) provide SPA request (if any); (4) agree in principle to the PBAC recommended deed; (5) confirm PBAC recommended restriction wording;  (6) provide TGA approval letter; (7) update Utilisation and cost model; and (8) provide signed Responsible Person form.	Applicant
	Check for complete pricing offer package and utilisation and cost model format per website.	Department	Go /No Go
	In principle price agreement*	Department	Go / No Go
	Utilisation and cost model agreed; Deed terms agreed in-principle; and Restriction agreed in-principle.	Department/Applicant	Go / No Go
	Government processes begin: Deed signed by both parties; Restrictions finalised; No outstanding cost-recovery fees; and Listing 1st of each month. (up to 26 weeks in total for this step)	Department Department/Applicant Department/Applicant Applicant Department

* A positive PBAC recommendation for which no acceptable price offer package was received within 6 months from when the applicant is issued the ratified PBAC Minutes, is deemed to be inactive for the purpose of seeking a PBS listing and will be recorded as inactive on the Medicine Status Website.

* In addition, if after 6 months from the date an applicant lodges their pricing offer package, there is no active negotiation between the applicant and the department, the department may cease to provide pricing services. If pricing services are ceased by the department, an applicant would be required to lodge a new Notice of Intent for Pricing form and pricing offer package to recommence negotiations with the department – refer to the Cost Recovery Administrative Guidelines for further information on this process.

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.

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.

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