‘Lifesaver’ opioid disorder treatment pulled from Australia

GPs working in addiction medicine have sounded the alarm after learning that Sublocade, described as a ‘lifesaver’ treatment for opioid use disorder, will be removed from Australian markets at the end of the year.
 
Made by US-based pharmaceutical company Indivior, the medication is one of two long-acting, slow-release buprenorphine injections on the Pharmaceutical Benefits Scheme (PBS) for opioid dependence treatment.
 
Representatives for the company confirmed the move to addiction medicine specialists last week, the latest in a series of disruptive events as commercial pressures on Australia’s flagship prescription medicines program intensify.
 
It follows the news of the forthcoming withdrawal of AstraZeneca’s breast cancer and endometriosis medication Zoladex from Australian shelves, and Eli Lilly’s rejection of a PBS listing for its tirzepatide medication to treat type 2 diabetes due to ‘unrealistic’ price demands.
 
On Wednesday, advocacy group MS Australia also warned two ‘vital’ treatments for patients living with multiple sclerosis, ocrelizumab and ofatumumab, risked being withdrawn from the PBS due to ‘government-driven policy-related price reduction’.
 
Federal Health and Ageing Minister Mark Butler recently acknowledged a global medicines market ‘in a state of enormous flux’, with policies such as the ‘Most Favoured Nations’ under President Donald Trump ‘reshaping how companies think about pricing’.
 
The news of Sublocade’s withdrawal comes after fresh data shows drug-induced deaths hitting their highest level yet, with opioids the most common drug involved.
 
While another long-acting slow-release buprenorphine injection, Buvidal, remains available on the PBS, GPs have expressed deep concerns about the effect of Sublocade’s withdrawal from the Australian market.
 
Among them is Dr Simon Holliday, a GP and addiction medicine specialist based in Taree in New South Wales, who is currently prescribing Sublocade for around 25 of his patients.
 
‘This is a really vulnerable population, and we’ve got them incredibly stable with this medication,’ he told newsGP.
 
‘If they want to go away to visit family, they can have a month away, or if you give them a big dose they can have two months or even three months away, it’s so safe.’
 
While he is only weeks away from retirement, Dr Holliday feels compelled to raise the issue due to the impact he fears its removal may have. He has written to politicians including Minister Butler warning of the ramifications.
 
‘There’s going to be a lot of people who’ll be destabilised,’ he said.
 
According to PBS statistics, the Sublocade 100 mg/0.5 mL modified release injection was prescribed 15,553 times in the 12 months to the end of April 2026, with 26,827 prescriptions for the 300 mg/1.5 mL medication during the same time.
 
A patient’s view
David is based in Melbourne and was first prescribed Sublocade shortly after it became available on the PBS in 2020.  
 
Now in his sixties, he has received various opioid use disorder treatments since becoming addicted to heroin more than two decades ago. He says medications caused him debilitating side effects of varying types, from tooth decay to severe respiratory issues, until he switched to Sublocade.
 
‘I went on Sublocade and my life has turned a corner like you would not believe,’ he told newsGP.
 
‘It has been a lifesaver to the point where I forget that I’m on the medication. I feel no different the day I have the injection as I do the day before it.
 
‘It holds me brilliantly.’
 
He says the treatment, administered to him every four weeks, is the only one that has worked without serious side effects and has also helped him reduce anti-anxiety and antidepressant medications by around 25%.
 
‘Since I’ve been on Sublocade, my life has been getting better and better, and all the medication issues are gone,’ he said.
 
‘It’s had a huge impact because I haven’t been negatively impacted by my medication.
 
‘I’m seeing my grandkids more.
 
‘My physical health’s getting better and better and better and better, and my mental health is generally too – until yesterday when I found out about this.’
 
David’s GP, Dr Owen Harris, says the slow-release treatments have made a significant difference since they were listed on the PBS.
 
‘Both Sublocade and Buvidal have been life-changing for many people, in the sense that they don’t have to go into the pharmacy every day,’ he told newsGP.
 
‘They don’t have to be reminded of their substance use issues, they’re not seeing people that they don’t want to see.
 
‘They can work, they can plan holidays, they can live their lives without the daily concerns of the buprenorphine and they just feel better because the medication is much more stable.
 
‘We are fortunate that we have Buvidal and that is an effective treatment, but Sublocade is definitely a preference for many of my patients and personally I do think it is a better option.
 
‘It’s going to be very challenging for many patients in terms of switching over.
 
‘The risk is that people will relapse on heroin or other opiates.’
 
Dr Hester Wilson, Chair of RACGP Specific Interests Addiction Medicine, called Indivior’s decision to withdraw Sublocade from the Australian market ‘terribly disappointing’.
 
‘I never thought something like this would happen,’ she told newsGP.
 
‘It’s a brilliant medication, a lifesaving, highly effective treatment for people who’ve been just getting on with their lives.’


 The decision took Dr Hester Wilson (above) by surprise.

Dr Wilson is already working on a guidance document around how to do the transfers from Sublocade to other formulations.
 
‘For us as GPs, we can advocate for this [decision to be reversed], I think we also need to put our energies into working with our patients gently over the next six months to find other options,’ she said.
 
Dr Harris strongly believes the price negotiations should be revisited.
 
‘Given it’s an area of medicine that doesn’t necessarily get the attention it deserves and there’s a lot of stigma, it’s also important to make the economic argument that people on opioid replacement live healthy, productive lives and pay taxes,’ he said.
 
‘There’s a very clear argument for the community to continue treatment and if it did cost more, then that would still be good economics as well as good medicine.’
 
The PBS currently lists Sublocade’s ‘dispensed price for maximum quantity’, which is the approved ex-manufacturer price and a 4% mark-up, at $395.84 per monthly dose. Publicly available figures on US health websites put the wholesale cost in that country at more than US $2000 (AUD $2900)
 
The Department of Health, Disability and Ageing said it is aware of Indivior’s decision and that ‘maintaining access to safe, effective and affordable medicines remains a priority’.
 
‘The Department recognises that any proposed discontinuation of a medicine can cause concern for patients and clinicians,’ a spokesperson told newsGP.
 
‘These are commercial decisions made by private companies, and the Australian Government cannot compel a company to continue supply.’
 
Indivior confirmed a ‘commercial decision’ to withdraw Sublocade from Australia and said it intends to work with authorities and experts ‘to ensure an orderly transition that minimises disruption’.
 
A spokesperson said alternatives for the treatment of opioid dependence are widely available, including methadone and buprenorphine in a variety of formulations and brands.
 
‘Indivior is committed to maintaining sufficient supply of Sublocade to support patient continuity of care in Australia until the proposed last reimbursement claim date of 31 December 2026,’ they told newsGP.

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