Concern over removal of another opioid use disorder treatment

US-based pharmaceutical company Indivior is planning to remove another opioid use disorder treatment, Subutex, from the Australian market by the end of next year.
 
Subutex, a sublingual form of buprenorphine, is currently listed on the Pharmaceutical Benefits Scheme (PBS) in doses of 0.4, 2 and 8 milligrams, but is set to be discontinued in Australia and removed from the PBS by the end of next year.
 
It follows the company’s decision to remove Sublocade, a long-acting, slow-release buprenorphine injection, from the PBS by the end of this year.
 
Dr Hester Wilson, Chair of RACGP Specific Interests Addiction Medicine, told newsGP the move is ‘deeply disappointing’.
 
While the treatment is not prescribed as much as Suboxone, which contains buprenorphine and opioid antagonist Naloxone, she is concerned the removal of Subutex could have an impact on a group of vulnerable people ‘with significant health issues’.
 
In particular, she said the smallest 0.4 mg dose is ‘highly effective’ for those looking to complete treatment, while noting Subutex is also used to help patients switch from methadone to buprenorphine treatments. 
 
She hopes the advanced notice will leave enough time for appropriate alternatives to be listed on the PBS to treat opioid use disorder.
 
‘Subutex has been around long enough that it’s no longer in patent,’ Dr Wilson said. ‘So there are generic sublingual buprenorphine that are available overseas.
 
‘Let’s look at this now so that we’re not racing at the last moment to look for other options to ensure we still have access to this medication, which is an effective life-saving treatment.’
 
The Department of Health, Disability and Ageing (DoHDA) confirmed Indivior has advised the Therapeutic Goods Administration of Subutex’s discontinuation in Australia, and its removal from the PBS at the end of next year.
 
A spokesperson told newsGP Indivior is also required to apply to the Pharmaceutical Benefits Advisory Committee (PBAC) to delist this product from the PBS. PBAC is yet to consider a request for delisting of Subutex.
 
‘Following PBAC consideration, particularly in instances where a delisting may result in unmet clinical need, the department may negotiate with the sponsor to retain the listing on the PBS,’ they said.
 
‘The department knows how important it is for Australians to continue to have access to affordable medicines, especially when they are receiving treatment for serious conditions such as opioid dependence.
 
‘Medicines are occasionally removed or delisted from the PBS, generally at the request of the sponsoring pharmaceutical company responsible for the supply of the medicine in Australia.
 
‘Sponsors are private entities that make their own decisions regarding their medicines and cannot be compelled by the Government to continue to list a product on the PBS or on the Australian market more broadly.’
 
Subutex was removed from the US market in 2011 but has remained available in Australia.
 
DoHDA’s spokesperson said the listing of any alternative brand would be ‘a commercial decision for any other company, and would require those brands to be registered on the Australian Register of Therapeutic Goods’.
 
They also noted other buprenorphine treatments, including long-acting formulations such as Buvidal, remain available in Australia.
 
‘Suboxone, also sponsored by Indivior, remains listed on the PBS and is an established and commonly used first line pharmacotherapy for opioid use disorder,’ they said.
 
 However, Dr Wilson remains concerned about the future of treatments on the PBS.
 
‘What if they then decide that Suboxone, which is their major one [and] has got the share of the market – what’s to say they won’t remove that one?,’ she said.
 
‘Australia has been very good at getting really competitive prices for our medicines.
 
‘Let’s see what we can access in terms of generics to ensure that we can continue to provide care.’
 
Log in below to join the conversation.

buprenorphine Indivior opioid dependence treatment Sublocade Subutex