The MSW includes information on submissions considered by the PBAC from July 2019 onwards. The MSW does not include information on listing processes for vaccines or generic medicines. Please email the Department of Health, Disability and Ageing (pbs@health.gov.au) or call 1800 020 613 for information on medicines considered before July 2019.
The information on the MSW is updated periodically and is not real-time. Publishing timelines are outlined in the MSW Factsheet. The ‘Page last updated’ field at the bottom of each web page shows the date of the last update.
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What is the PBAC?
The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent expert body appointed by the Australian Government. Members include doctors, health professionals, health economists and consumer representatives.
The PBAC’s primary role is to consider medicines for listing on the Pharmaceutical Benefits Scheme (PBS) and vaccines for inclusion on the National Immunisation Program (NIP). The Government cannot list a medicine or modify a listing on the PBS without a PBAC recommendation to do so. The PBAC holds three scheduled meetings each year, usually in March, July and November.
When considering a medicine for listing, the PBAC takes into account:
- The medical condition(s) for which the medicine was registered for use in Australia; and
- The clinical effectiveness, safety and cost-effectiveness (‘value for money’) compared with other treatments, including non-medical treatments.
The PBAC may also recommend maximum quantities, number of repeats and restrictions that may apply for the medicine to be prescribed under the PBS.
For more information, visit the PBS website.
What does the PBS listing process look like?
The below diagram provides an overview of the PBS listing process. Check the PBS Process Step Descriptions to learn more.
How can consumers contribute to PBAC decision-making?
Patients are central to the quality use of medicines and vaccines. The PBAC is committed to understanding consumer perspectives, and integrating them into its consideration of medicines and vaccines. Consumer information helps the committee understand what consumers consider the main benefits and harms of the proposed medicine or vaccine.
Consumers are able to provide their views about medicines or vaccines on each PBAC agenda. The PBAC agenda is available on the PBS website fourteen (14) weeks before the PBAC meeting. The PBAC agenda is updated nine (9) weeks before the PBAC meeting to reflect lodgement of Early Re-entry or Early Resolution Pathway resubmissions. Consumers have eight (8) weeks to submit their comments directly to the department for most submissions, and three (3) weeks for Early Re-entry or Early Resolution Pathway resubmissions. The MSW includes the opening and closing dates for consumer comments for each medicine.
Any individual or organisation are able to submit their comments via the form available on the PBS website.
What happens after a PBAC meeting?
Submissions considered by the PBAC result in one of the following outcomes:
- ‘Recommended’;
- ‘Deferred’; or
- ‘Not recommended’.
A ‘recommended’ outcome is often referred to as a ‘positive recommendation’. While a positive recommendation allows the submission to proceed, it is up to the applicant to initiate the next step towards listing their product on the PBS. If the applicant chooses to proceed, several activities are necessary before the medicine is available on the PBS. The department and the applicant work together to complete these processes as quickly as possible. However, there is varying time needed based on the complexity of the listing arrangements.
The Government has a commitment for 80% of new medicines recommended for listing by the PBAC to be listed on the PBS and therefore available to consumers within six (6) months of agreement of budget impact and price. Annual performance against this commitment is available in the Department of Health, Disability and Ageing’s Annual Reports. In 2018-19, the department achieved this commitment for 100% of new medicine listings.
Click on the links below to learn more about the post meeting processes for each PBAC outcome.
Recommended outcome for a PBAC Submission
After the PBAC makes a recommendation to list a new medicine on the PBS, several processes must be completed before the medicine is available to consumers on the PBS.
Deferred outcome for a PBAC Submission
The PBAC may defer making a decision until further information or analysis is provided to the Committee.
Not Recommended outcome for a PBAC Submission
When the PBAC outcome is ‘not recommended’, the applicant may decide to lodge a resubmission for PBAC consideration at a future meeting.
Find out more
- Visit the glossary page for definitions and descriptions.
- Learn more about the MSW publishing timeframes.
- To submit feedback on the functionality of the MSW, please email us at medstatusfeedback@health.gov.au.
- Learn more about the Pharmaceutical Benefits Scheme.
- Look at the agendas for Pharmaceutical Benefits Advisory Committee (PBAC) meetings.
- Make a consumer comment on an upcoming application to the PBAC.
- See the PBAC Outcomes to see recommendations coming from PBAC meetings.