Public Consultation for the Post-market Review of Opiate Dependence Treatment Program Medicines

Closed 1 Oct 2021

Opened 17 Aug 2021

Published responses

View submitted responses where consent has been given to publish the response.


There are currently three medicines available for the treatment of opioid dependence under the Pharmaceutical Benefits Scheme (PBS) Opiate Dependence Treatment Program (ODTP). These medicines are buprenorphine (tablets and modified release injections), buprenorphine with naloxone (films) and methadone (oral liquid).

Under the ODTP, the Australian Government pays the full cost of the medicines made available under state and territory government opioid dependence treatment programs in both pharmacy and non-pharmacy settings.

On 24 March 2021 the Department of Health announced it would conduct a Post-market Review of the medicines available under the PBS ODTP (the ODTP PMR).

The ODTP PMR is being carried out under the Australian Government’s post-market monitoring program, which aims to ensure the continued safe, cost-effective and quality use of medicines listed on the PBS.

During the ODTP PMR, the Australian Government will continue to support state and territory governments to deliver opioid dependence treatment programs by continuing to fund the full cost of medicines for the treatment of opioid dependence. 

Public consultation addressing the ODTP PMR and Terms of Reference (ToR) closed on Friday, 1 October 2021.

Why your views matter

This consultation seeks your comments addressing the Post-market Review of the Opiate Dependence Program medicines and final Terms of Reference.

The ODTP PMR is an opportunity to review the current program arrangements to ensure that Australians who have an opioid dependency continue to have access to medicines to help treat their opioid dependence.

The ODTP PMR examines important issues such as barriers to access and the future delivery of opioid dependence treatment.

This ODTP PMR will follow the Post-market Review Framework, which includes the opportunity to provide submissions to the review and is the purpose of this consultation. An opportunity to comment on the draft review report will occur at a later stage

Submissions received during the public consultation will be considered by the review Reference Group and made available to the Pharmaceutical Benefits Advisory Committee (PBAC) for consideration with the review report. 

Late submissions or requests for extension will not be accepted.

What happens next

This review will follow the Post-market Review Framework.  This includes an opportunity for key stakeholders and the public to comment on the draft Review Report. The draft Review Report will be published on the PBS Website at a later stage.  

For PBS news updates and the latest information on post-market reviews, including public consultation processes and publication of review reports, please subscribe to the PBS email list. For any queries, please contact the ODTP PMR secretariat.


  • Anyone from any background


  • Pharmaceutical benefits