Outcomes of Pharmaceutical Benefits Advisory Committee meetings

Background information on outcomes of PBAC meetings, and links to PBAC meeting outcomes

In this section:

PBAC Outcomes by Meeting

PBAC Outcomes by meeting.

Background information on outcomes of PBAC meetings

Useful things to know in relation to Pharmaceutical Benefits Advisory Committee outcomes

The Pharmaceutical Benefits Scheme (PBS) ensures that the all Australian residents have access to necessary and lifesaving medicines at an affordable price.

The Pharmaceutical Benefits Advisory Committee (PBAC) assesses applications for listing of medicines on the PBS. The PBAC meets four times a year.

New or revised submissions can be lodged with the PBAC following any previous consideration.

After the PBAC makes a recommendation to list a new medicine on the PBS, there are a number of other processes that need to be completed before the recommendation can be implemented. When listed, the medicine appears in the Schedule of Pharmaceutical Benefits.

Technical terms are used in many of the outcomes of PBAC meeting summaries. Some of the more common technical terms are included in the Glossary to Accompany the Guidelines for the Pharmaceutical Industry on the Preparation of Submissions to the PBAC: Glossary of Full Terms.

You can search for all outcomes of PBAC meetings from June 2003 and for recommendations to list or to change the conditions of a previously listed medicine on the PBS made by the PBAC from December 2000 to March 2003.

Processes that need to be completed before the medicine can be listed on the PBS

Once a medicine has been recommended by the Pharmaceutical Benefits Advisory Committee (PBAC), a number of processes need to be completed before the medicine can be listed on the Pharmaceutical Benefits Scheme (PBS). These include:

Consideration by the Pharmaceutical Benefits Pricing Authority (PBPA).

Pricing negotiations by the manufacturer and the Department of Health and Ageing.

Finalisation of the details for listing the medicine on the PBS.

Quality and availability checks.

Consideration by Government..
(All PBAC recommendations are considered by Government. If a drug is expected to cost more than $5 million a year, it is considered by the Commonwealth Department of Finance and Administration. If a drug is expected to cost more than $10 million a year, it is considered by Cabinet).

Once the PBAC makes a recommendation to list a medicine on the PBS, these processes are progressed as quickly as reasonably possible.

But often it is not possible to say when these processes might be completed, as negotiations regarding listing details and PBS costs can be complex. Currently, the usual minimum time for these processes to be completed is around five months.

What the Pharmaceutical Benefits Advisory Committee takes into account when considering submissions

When considering a submission for listing a medicine on the PBS, the PBAC takes into account a number of factors. These include:

The conditions for which the drug has been approved for use in Australia by the Therapeutic Goods Administration. The PBAC only recommends the listing of a medicine for use in a condition which is in accordance with the Australian Register of Therapeutic Goods.

The conditions in which use has been demonstrated to be effective and safe compared to other therapies.

The costs involved. The PBAC is required to ensure that the money that the community spends in subsidising the PBS represents cost-effective expenditure of taxpayers' funds.

A range of other factors and health benefits. These factors may include, for example, costs of hospitalisation or other alternative medical treatments that may be required, as well as less tangible factors such as patients' quality of life.

In making its recommendations, the PBAC may also recommend maximum quantities, number of repeats and restrictions that may apply for the medicine to be prescribed under the PBS.

Once the PBAC recommends to list a medicine on the PBS a number of processes need to be completed before the medicine appears in the Schedule of Pharmaceutical Benefits.