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18 Aug. 2021

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

The Department of Health would like to inform you that public consultation on the Post-market Review (PMR) of Opiate Dependence Treatment Program (OTDP) medicines is now open for public submissions.

In March 2021, the Department of Health announced it will conduct a post-market review of the medicines listed on the Pharmaceutical Benefits Scheme (PBS) Opiate Dependence Treatment Program (the ODTP PMR). The Pharmaceutical Benefits Advisory Committee (PBAC) considered comments from stakeholders and endorsed the final Terms of Reference (ToR) in August 2021. Following endorsement by the PBAC, the Minister for Health and Aged Care approved the ToR for the ODTP PMR.

The 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 will examine important issues such as barriers to access and the future delivery of opioid dependence treatment.

There are currently three medicines available for the treatment of opioid dependence under the PBS ODTP. Medicines to be included in the ODTP PMR are buprenorphine (tablets and modified release injections), buprenorphine with naloxone (films) and methadone (oral liquid).

This ODTP PMR will follow the Post-market Review Framework, which includes public consultation on the draft Terms of Reference, an opportunity to provide submissions to the review, and an opportunity to comment on the draft Review Report.

Public submissions to the ODTP PMR are now open and will close at 23:30 AEST on Friday, 1 October 2021.  Further information on the ODTP PMR, including the process for providing a submission to the Review, is available on the PBS Reviews website.

Comments received on the draft ToR will be published on the Draft ToR consultation page. The Department appreciates the contribution of all organisations and individuals who provided feedback.

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 odpt.pmr@health.gov.au