step description

1. Application received for dd/mm/yyyy PBAC Meeting

The submission (also known as an application) seeking assessment by PBAC of a medicine for listing on the PBS. The date displayed is the PBAC Meeting date the submission will be considered at.

2. Opportunity for consumer comment

Open dd/mm/yyyy and closed dd/mm/yyyy

Consumers have an opportunity to provide input to the PBAC regarding medicines submitted for assessment. The date displayed is the date that consumer input opens and closes. To provide input or to find out more information, please the visit PBAC Meeting Agenda and Consumer Comments  page.

3. PBAC meeting

Held on dd/mm/yyyy

This is the date of the PBAC meeting that the medicine was considered at. PBAC meeting cycles are three days in duration and occur three times a year (usually March, July and November). The meeting date recorded is the first day of the three-day meeting cycle.

4. PBAC outcome

Recommended / Not Recommended / Deferred

This is the outcome determined by the PBAC based on its consideration of the PBAC submission/application. The Outcomes of the PBAC  meeting will be available six (6) weeks after each PBAC meeting. If the submission receives a positive PBAC outcome and requires pricing activities, the applicant must lodge a Notice of Intent for Pricing form and a pricing offer package.

4a. Notice of intent for pricing received

dd/mm/yyyy

The Notice of Intent for Pricing form is used to initiate the pricing activities required to complete the listing process for submissions that receive a positive PBAC recommendation. The form provides the department with formal notice of the applicant’s intention to: proceed to negotiations, resubmit to the PBAC or withdraw from the listing process. This form is required to enable cost recovery for government services provided during the Negotiations between applicant and the department step.

5. Applicant’s pricing offer package received

dd/mm/yyyy

The pricing offer package is a set of documents that the applicant is required to submit to the department to commence the negotiation process. An incomplete pricing offer package will not progress further until any missing information is provided by the applicant. Once the department receives the pricing offer package they must check all of the required documents have been submitted before accepting it as complete and moving to negotiations.

5a. Complete pricing offer package

Accepted / Not accepted

The department must check each of the required documents have been provided before accepting the package is complete. If the pricing offer package is incomplete the department will provide feedback to the applicant to request the missing information. Once all of the required documents have been received, the department must accept the pricing offer package as complete before negotiations commence.

6. Negotiations between applicant and the department

Commenced on: date??

Negotiations continuing / Negotiations finalised

The negotiations between applicant and the department step is when the applicant and department work together on the proposed terms of the listing within the requirements outlined by the PBAC. This step commences once the department has accepted the pricing offer package submitted by the applicant as complete and ends when the terms of listing are ready for government processes. The terms of listing are determined at the PBAC meeting and are detailed in a separate document provided to the applicant called the ratified PBAC Minutes.

To agree on the terms of the listing, the applicant and the department must:

• Negotiate the price of the medicine to enable listing on the PBS.
• Negotiate the expected financial and budget cost impacts based on the estimated patient utilisation of the medicine.
• Negotiate a deed of agreement which is a commercial agreement between the Australian Government and pharmaceutical company. This agreement helps to maintain the appropriateness and cost-effectiveness of the listing.
• Finalise the restriction wording which details the circumstances for prescribing that should apply for the medicine to be available at the government-subsidised price.

The terms of listing negotiated with the department are subject to agreement by the Minister for Health (or an approved delegate), and other relevant Government entities, through the government processes step.

7. Government processes

Commenced on dd/mm/yyyy

Once negotiations between applicant and the department step is complete, government processes can commence. This step can take up to 26 weeks and includes approval to the terms of the listing by other Government agencies, such as agreement of the financial and budget cost impacts and the requirements of the restrictions for use of the medicine.

When a medicine is expected to cost the Australian Government more than $20 million over four years, the decision to approve this medicine is made by the Cabinet. Cabinet processes occur within the 26 weeks. 

There is a set of listing documents (e.g. assurance of supply) which must be provided by the applicant to complete the listing and enable to medicine to be available to consumers via the PBS. The listing cannot progress until these documents have been provided by the applicant and processed by the department. 

Once government processes are complete, the decision to list a medicine on the PBS is made via a legislative instrument which is signed by the Minister for Health (or an approved delegate) and registered on the Federal Register of Legislation.

8. Medicine listed on the PBS

dd/mm/yyyy

Once the government processes step is complete, the medicine is published on the PBS schedule list and will be available for medical professionals to prescribe and pharmacies to dispense to patients at the Government-subsidised price. The PBS schedule is updated on the first of every month and is available on the PBS website