Recommended outcome for a PBAC Submission

A ‘recommended’ outcome is often referred to as a ‘positive PBAC recommendation’. The Government cannot list a medicine or modify a listing on the PBS without a PBAC recommendation to do so.

The PBAC determines the circumstances for a positive recommendation. The PBAC may outline the maximum quantities, number of repeats and restrictions that need to apply for the medicine to be prescribed under the PBS. These ‘parameters’ may differ to those requested by the applicant.

The circumstances for the positive recommendation are outlined in the PBAC Minutes provided to applicants three (3) weeks after the PBAC meeting. The PBAC Minutes are not publicly available however, the key information is summarised in the Public Summary Document. These are available on the PBS website  approximately four (4) months after the meeting.

Once the applicant understands the circumstances for the positive recommendation, they must determine whether they wish to:

• Proceed with the listing;
• Withdraw from the process; or
• Lodge a new submission for PBAC consideration.

 

If the applicant chooses to proceed, several activities are required before the medicine can be available through the PBS. These activities include:

• Submission of required documentation;
• Agreement and finalisation of the listing arrangements;
• Quality and availability checks on the medicine; and
• Government processes and approval of the PBS listing.

 

See the MSW glossary to read more about the steps and activities involved following a positive recommendation.