Subutex leaving Australia by 2027 — opioid treatment options keep narrowing

Pharmaceutical company Indivior has announced it will discontinue Subutex — sublingual buprenorphine — from the Australian market by end of 2027. For GPs and addiction medicine specialists managing patients with opioid use disorder, this is the second Indivior product to leave within a short window: Sublocade, the long-acting injectable formulation, was removed from the PBS previously.

The announcement has drawn concern from addiction medicine specialists about a treatment landscape that is narrowing rather than expanding. The Pharmaceutical Benefits Advisory Committee must still formally consider the delisting request before the removal proceeds — but the direction of travel is set.

What Subutex does that other products do not

Subutex is sublingual buprenorphine without naloxone. It is available on the PBS in doses of 0.4, 2, and 8 mg. The existence of the 0.4 mg dose is not a minor detail.

Dr Hester Wilson, Chair of the RACGP Specific Interests Addiction Medicine group, described the loss as “deeply disappointing,” and specifically named the 0.4 mg dose as particularly effective for treatment completion and for transitioning patients from methadone to buprenorphine. That transition period — moving a patient between opioid agonists at low doses — is a clinically vulnerable time. Fine dose titration matters.

The other scenario where Subutex is preferred over Suboxone is in patients who cannot tolerate the naloxone component — most relevantly, during pregnancy. Suboxone is not recommended in pregnancy because naloxone’s safety profile in that context has not been sufficiently established; Subutex is the PBS-listed alternative. That gap will need to be managed ahead of 2027, and for pregnant patients on buprenorphine, the planning horizon is compressed.

Both-and: options remain, but the direction concerns specialists

Framing this as a crisis overstates the immediate situation. Buvidal (long-acting injectable buprenorphine), available in weekly and monthly formulations, remains on the PBS. Suboxone remains available. For many patients currently stable on Subutex, a managed transition to Suboxone is clinically straightforward — the pharmacology is closely related, with naloxone added to reduce the risk of intravenous misuse.

The concern raised by Dr Wilson and others is not that treatment options disappear entirely on 31 December 2027. It is that the range of tools continues to contract, and that each withdrawal creates friction at the margins — for patients with specific clinical needs, for those in regions with limited specialist access, and for the clinical relationships built around particular formulations.

Dr Wilson’s question — “What if they then decide that Suboxone… what’s to say they won’t remove that one?” — names the underlying structural worry: when commercial decisions by a single pharmaceutical company determine which formulations remain on the PBS, the treatment landscape becomes dependent on profitability rather than clinical need. Generic sublingual buprenorphine is available in other countries and could theoretically enter the PBS via a different sponsor, but that pathway is not confirmed.

2 cents

The practical steps for GPs this week are forward-looking rather than urgent.

For patients currently stable on Subutex, no change is needed now. The PBS listing is active until the PBAC formally approves a delisting, which has not yet occurred. For patients on the 0.4 mg dose or who are naloxone-intolerant, the time to start a conversation — with the patient and, where appropriate, with an addiction medicine specialist — is before the 2027 clock becomes tight. Transition planning for complex cases takes time: building that plan in 2025 or 2026 is easier than in late 2027.

For patients who are pregnant and currently on Subutex, the situation warrants a more immediate discussion with their specialist about whether their management plan accounts for the expected withdrawal.

The RACGP’s Specific Interests Addiction Medicine network is a practical resource for GPs managing complex buprenorphine cases. If your patient’s presentation is beyond your usual caseload for opioid use disorder, early referral or a case discussion with an addiction medicine physician is appropriate.

Verdict: yes — GPs should flag this with relevant patients now and begin transition planning for complex cases well ahead of 2027.

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Sources cited

1. Concern over removal of another opioid use disorder treatment — newsGP / RACGP