Post-market Review of Opiate Dependence Treatment Program (ODTP) Medicines

Page last updated: 28 May 2021


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. 

In line with the established and publicly available framework for the conduct of a PMR, a public consultation process for the draft Terms of Reference (ToR) for the PBS ODTP review will be open from Friday, 28 May and will close on Wednesday, 30 June 2021.

Interested organisations, state and territory governments and individuals are invited to provide comments on the draft ToR. To provide comments please visit the Draft ToR consultation page.

Draft Terms of Reference

  1. Describe and compare essential elements of models of service delivery for opioid dependence treatment (ODT) in Australia (and internationally) including best practice guidelines and current models that support access to ODT medicines through both pharmacy and non-pharmacy settings.
  2. Examine the consumer experience, focusing on equity of access and affordability of ODT medicines across the different models of delivery. This will include consideration of access to ODT for at risk population groups including people living in rural and remote areas and Aboriginal and Torres Strait Islander peoples.
  3. Explore the utilisation of PBS subsidised ODT medicines in Australia, including funding and costs incurred in the supply and dispensing of Opiate Dependence Treatment Program (ODTP) medicines in pharmacy and non-pharmacy settings. This will include examination of current PBS restriction criteria and the impact of the listing of modified release buprenorphine injections on the PBS ODTP.
  4. Propose alternative service delivery arrangements for access to ODT medicines, with an aim of identifying an accessible, cost-effective and efficient ODTP for both consumers and the Australian Government.

Summary of State and Territory Opioid Dependence Treatment Programs

A summary of information provided by state and territory representatives regarding their opioid dependence treatment programs is available in the link below.

Summary of State and Territory ODT Programs - April 2021 (PDF 664KB) - (Word 35KB)