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Post-market Review of Opioid Dependence Treatment Program Medicines

Page last updated: 17 May 2024

Background

Prior to 1 July 2023 there were three medicines available for the treatment of opioid dependence under the Pharmaceutical Benefits Scheme (PBS) Section 100 Opiate Dependence Treatment Program (ODTP). These medicines are buprenorphine (tablets and modified release injections), buprenorphine with naloxone (films) and methadone (oral liquid).

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

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

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

The ODTP PMR was 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 supported 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.

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)

On 26 October 2022, the Amendment to the National Health Amendment (General Co-payment) Bill 2022  passed through the Senate and introduced a change to Section 100 of the National Health Act 1953, requiring Section 100 programs on the PBS to be made via a legislative instrument from 1 July 2023.

The Minister for Health and Aged Care requested the Pharmaceutical Benefits Advisory Committee (PBAC) provide an early (interim) report to Government on the research and consultation undertaken for the ODTP PMR to ensure the Government could consider the advice and recommendations of the PBAC and effectively respond to the 1 July 2023 legislative timeframe.

In March 2023, the PBAC considered the interim report. The PBAC recommended the current listing of ODT medicines on the PBS Section 100 ODTP be amended and the listings moved to the Section 100 Highly Specialised Drugs (HSD) Program (Community Access) as Authority Required (STREAMLINED) listings. The PBAC noted that listing ODT medicines under the Section 100 HSD Program (Community Access) will benefit patients with access to the PBS co-payment and the PBS Safety-Net and it will also enable important supply to people in correctional facilities and GP clinics. Pharmacists would receive PBS dispensing fees set out under the Section 100 HSD Program.

In addition, the 2023-24 Budget commits $377.3 million over 4 years from 2023-24 (and $98.4 million ongoing) to reforming ODT access through community pharmacies.

Public Consultation on the draft Terms of Reference (Closed)

Public consultation on the draft Terms of Reference (ToR) for the ODTP PMR closed on 30 June 2021. To view feedback received on the draft ToR please go to the ODTP PMR Draft ToR page.

Final Terms of Reference

In August 2021, the Pharmaceutical Benefits Advisory Committee (PBAC) considered the draft ToR and comments from stakeholders.  The Minister for Health and Aged Care approved the final ToR for the ODTP PMR on 13 August 2021. 

  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 (including models developed in response to the COVID-19 pandemic) that support timely access to ODT medicines through both pharmacy and non-pharmacy settings*.

*Non-pharmacy settings include a range of service settings where ODT medicines are delivered in Australia including, but not limited to, correctional facilities, hospitals, public and private clinics, Aboriginal Community Controlled Health Organisations, general practices and specialist clinics.

  1. Examine the consumer experience, focussing on equity of access, geographical barriers to access, cultural safety, and affordability of ODT medicines across the different models of service delivery. This will include consideration of access to ODT for at risk population groups including people living in rural and remote areas, Aboriginal and Torres Strait Islander peoples and other populations who may have limited access to health care services, including ODT.
  2. Explore the utilisation of PBS subsidised ODT medicines in Australia, including funding, benefits (health system and societal) 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.
  3. Propose improved service delivery arrangements for access to ODT medicines, with an aim of identifying an ODTP that is equitable, timely, reliable and affordable for consumers and stakeholders involved in the supply and delivery of ODT medicines and cost-effective for the Australian Government.

Consultation on the ODTP PMR (Closed)

Public consultation addressing the ODTP PMR and final Terms of Reference closed on 1 October 2021. To view the submissions received as part of the consultation process, please go to the ODTP PMR Public Consultation page.

Stakeholder Consultation Forum

A Stakeholder Consultation Forum for the ODTP PMR was held via webinar on Thursday 24 February from 2:30pm-5:00pm AEDT. The Forum provided a further opportunity for key stakeholders to contribute to the Review.

All interested stakeholders including industry, peak bodies, consumers, prescribers, pharmacists and state and territory government representatives were invited to participate.

A summary of the discussions from the Stakeholder Consultation Forum and presentation slides from the meeting are available for download from the links below.

PBAC consideration of the Interim Review Report

In March 2023, the PBAC considered the Interim Report for the ODTP PMR addressing the Review Terms of Reference and noted the stakeholder input to the PMR, including targeted consultation with people participating in ODT programs.

The PBAC made a recommendation for the current listing of ODT medicines on the PBS Section 100 Opiate Dependence Treatment Program to be amended and the listing moved to the Section 100 HSD Program (Community Access) as Authority Required (STREAMLINED) listings.

The Web Outcome is available.

Post-market Review of Opioid Dependence Treatment Program medicines – Report to the PBAC

The Review Report is provided in two parts, in DOCX and PDF format below.

Review Process

The ODTP PMR followed the (2015) Post-market Review Framework. The Framework was updated in 2024 and is available on the PBS Review’s website. This process included public consultation on the draft Terms of Reference, and an opportunity to provide submissions to the review. Noting the positive PBAC recommendation and continued PBS subsidised access to ODT medicines, as well as the 2023-24 Budget commitment of $377.3 million over 4 years from 2023-24 (and $98.4 million ongoing) to reforming ODT access through community pharmacies.

Further Information

Further information about the reforms to ODT access, including the changes to the way ODT medicines are listed on the PBS Schedule is available on the ODT web page.

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 Review secretariat.