Draft Terms of Reference for the Post-market Review of Opiate Dependence Treatment Program Medicines

Closed 30 Jun 2021

Opened 28 May 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 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.

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. 

The public consultation process for the draft Terms of Reference (ToR) for the ODTP PMR is now open and will close at 23:30 AEST on Wednesday,
30 June 2021. 

Why your views matter

This consultation seeks your comments specifically on the draft ToR for the ODTP PMR. The ToR will guide the focus of this review. 

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

Comments received as a result of this consultation will inform the finalisation of the ToR for endorsement by the Pharmaceutical Benefits Advisory Committee.

Once the ToR have been finalised there will be a public submission process where all interested parties will be invited to make a submission to the review.

The Framework sets out  a minimum two week period for stakeholders to provide written comments on the draft ToR. The consultation period for the ODTP PMR ToR is four weeks to allow interested organisations, state and territory governments and individuals to provide comments on the draft ToR. 

Late submissions or requests for extension will not be accepted. 

In Scope:

  • Comments and feedback on the draft ToR that will guide the focus of the review

Out of Scope:

  • A call for public submissions to address the final ToR will occur at a later date


Privacy Notification

The Department is bound by the Privacy Act 1988 and the Australian Privacy Principles (APPs).

The Department is collecting personal information about you in this consultation for the purposes of informing the ODTP PMR.

The collection of this information is required to inform a review of the medicines available under the PBS ODTP.

While the Department encourages respondents to self-identify in their submission, there is no requirement to do so. However, if for example, should you choose to make an anonymous submission, the Department will be unable to attribute views to you in the review report, or follow-up with you on any issues that you raise. The Department will seek your permission before attributing your views in the report.

The Department has an APP privacy policy which you can read at www.health.gov.au/internet/main/publishing.nsf/Content/privacy-policy

What happens next

Once the Terms of Reference have been finalised and published on the ODTP PMR webpage, there will be a public submission process where all interested parties will be invited to make a submission to the review.


  • Anyone from any background


  • Pharmaceutical benefits