The Listing Steps
The Listing Steps
A step-by-step guide to listing on the PBS
- Step 1: Seek advice from the PEB (Optional but recommended)
- Step 2: Making an application
- Step 3: Communication
- Step 4: Send response
- Step 5: Communication of PBAC outcomes
- Step 6: Sending pricing details and other documentation
- Step 7: Entering agreements to share risk
- Step 8: Confirming the agreed price
- Step 9: Agreement on usage estimates
- Step 10: Formal advice of listing
Please note that the steps listed here apply to all submissions that are considered by the PBAC. Details of the different submission categories can be found below.
How does the listing system work
The PBS specifies which medicines and for which indication, are subsidised by the Australian Government. This information is contained in the PBS Schedule, which is updated monthly.
An application to have an item listed on the PBS can be made for any medicine for any use for which it is registered on the Australian Register of Therapeutic Goods at the time of listing.
The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent statutory committee that meets three times a year to assess applications for listing on the PBS based on the clinical benefit and cost-effectiveness compared with other treatments or products for the same condition or use. It is assisted by the PBAC secretariat and teams of expert drug evaluators.
The PBAC may reject an application or make recommendations regarding a medicine’s uses and any conditions or restrictions on those uses and the Minister of Health can only approve the subsidy of a medicine in line with that independent recommendation.
The Pharmaceutical Benefits Pricing Authority (PBPA) is a non-statutory committee that meets three times a year following PBAC meetings. It may recommend either a ceiling price or price range for an item that has been approved by the PBAC following negotiation.
The decision to subsidise an item is considered by Cabinet if the net cost to the PBS is greater than $20 million per year, and then determined by the Minister for Health. The Government also exercises a number of controls to manage the overall cost of the scheme.
|Major Submissions||Tier 1||Applications for the listing of new drugs where the claim is one of cost minimisation (or ‘at least no worse than’ according to the PBAC guidelines), where pricing is based on a nominated dosage relativity, and where the prices to pharmacist proposed are in accord with the PBPA methods of price calculations.|
|Tier 2||Submissions for new drug listing where the claim is one of acceptable incremental cost effectiveness (or new drug listings where the claim is one of cost minimisation but where pricing is not in accord with the PBPA criteria) and applications for changes to listings, both cost minimisation and cost effectiveness, and where the estimated net cost to the PBS is less than $20 million per annum in any of the first four years of listing.|
|Tier 3||Any submission where the estimated net cost to the PBS is estimated to be $20 million or more in any of the first four years of listing.|
|Minor Submissions||Secretariat||These are minor changes to existing items and can be listed within two months of PBAC meetings. In these cases, there is no need for PBAC to consider efficacy, price is not affected and there is no substantive financial impact on the PBS.|
|Other||These are minor changes to existing items that do not have significant financial implications but do require consideration by PBAC because of their potential impact on the PBS. These are listed no earlier than two months after PBAC meetings.|
Changes to the prices of medicines on the PBS may only occur at the beginning of April, August or December. Therefore, any new listing or change to an existing listing that directly or indirectly results in a price change can only occur at these times.
A new brand of a drug that is already listed on the PBS is not considered by PBAC or PBPA. Application to list a new brand that does not lead to a price change can be made at any time and listing occurs approximately ten weeks after the relevant deadline.
You can find contact details for the PBAC and PBPA on the PBS Contacts page