Step 4: Send response

You will receive advice of the considerations from the Drug Utilisation Sub Committee (DUSC) and the Economics Sub Committee (ESC) and may respond to their advice to the Pharmaceutical Benefits Advisory Committee (PBAC) in writing prior to the cut off date.

You may choose to request a hearing before the PBAC and should prepare a presentation of no more than 10 minutes. You may also be required to work with the Restrictions Working Group (RWG) to develop restrictions and the restrictions’ wording.

Applications for listing tier 1 drugs must also contain all final documentation. This is required to support the speedy listing of these drugs onto the Schedule. You must provide:

• Copy of letter confirming registration on the Australian Register of Therapeutic Goods ;
• Copy of current Certificate of Registration or Certificate of Listing issued by the Therapeutic Goods Administration (TGA);
• Current approved Product Information where applicable;
• Copy of primary pack label;
• Written assurance that stock of the product will be available from the date of listing.

This is the last step before consideration of the submissions by PBAC.

At its meeting the PBAC considers:

• your submission
• the PBAC secretariat overview and sub-committee secretariat commentaries
• the RWG advice
• DUSC and ESC advice
• your responses to the commentaries and advice, and
• relevant product information such as TGA documents.
• your 10-minute presentation

Two members of the PBAC, nominated because of their particular expertise introduce, discuss in detail, and make recommendations about individual applications.

The PBAC either:

• recommends the medicine for listing, OR
• defers its decision and seeks further information, OR
• does not recommend the medicine for listing.

Handy hint: If your application is deferred or the requested listing is not recommended, you may put in a ‘resubmission’, except when an independent review is under way.

If your listing is not recommended you may formally request an independent review of the decision.

Whether it is based entirely on new data, or only slightly modifies the previous submission, a resubmission is regarded as a new submission. This is because the information in the resubmission will subject to the same level of scrutiny as any other submission.

You can find contact details for the PBAC, ESC, DUSC and RWG on the PBS Contacts page