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 applicant 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 applicant are:

  • Completion of the Notice of Intent for Pricing Form (Part A of Application for Pricing Services). Refer to Section 8.2
  • Lodge 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.
  • 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.

There are several points at which a decision will be needed to progress to the next step, require re-work, be paused, or ceased. If each step/requirement is complete and aligned with the PBAC recommendation then this will assist the application to move quickly through the interactive two way process.

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. 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.

previous | next