Advocates hail ‘game changing’ PBS listing of buprenorphine

Now there is a major breakthrough, with Federal Health Minister Greg Hunt announcing that long-lasting buprenorphine (sold as Buvidal) will be made free to people with an opioid dependency through the Pharmaceutical Benefits Scheme (PBS) as of 1 September.
 
While a co-payment is likely, the fact the drug can last up to a month should slash patients’ overall costs.
 
Once injected, the drug turns into a long-lasting gel and slowly releases buprenorphine.
 
This is the first new opioid-dependence drug listed on the PBS in 14 years.
 
The move is intended to reduce cost pressures on people with a dependency, which advocates say is linked to many people cycling in and out of opioid substitution therapy. Even though opioid substitution therapy drugs are provided free, dosing fees can act as a major barrier.
 
GPs working in addiction medicine and harm-reduction advocates have hailed the move as a way to free patients from the need to seek daily doses of methadone.
 
The PBS listing comes as Australia grapples with a rising tide of prescription opioid dependence, with more than 110,000 people currently dependent. This is coupled with the resurgence of heroin and a spike in opioid-related deaths.
 
The move is expected to be particularly good for rural areas, given many people with dependencies currently have to travel long distances to find a dosing point.
 
Buvidal must be administered by a doctor or nurse, in contrast to methadone, which is generally dispensed by pharmacists. However, for the first six months, only specialists can prescribe the drug.
 
John Ryan, CEO of harm-reduction organisation Penington Institute, described the new listing as a ‘really big breakthrough’.
 
‘It solves the daily dispensing fee and the need to visit the pharmacy, so it’s a potentially really significant change,’ he told newsGP.
 
‘People will often drop in and out of treatment, and this will eliminate a lot of those barriers. It’s highly probable people will be able to maintain their care with much more consistency.
 
‘Monthly dosing compared to daily will mean huge freedom to pick up employment, to get on with life, to go on holidays – there are all those barriers with daily methadone which are eliminated.’
 
Mr Ryan said there is extremely strong evidence that opioid substitution therapy works in terms of crime reduction, reduced overdose and increased chances of employment.
 
‘It’s a gold standard of treatment. That’s why this is such a game-changer,’ he said.
 
The deaths of three people daily are linked to opioids, while almost 150 people are hospitalised and 14 admitted to emergency every day due to opioid harms.
 
The PBS listing will save patients up to $92 per script.
 
Chair of the RACGP Specific Interests Addiction Medicine network Dr Hester Wilson told newsGP the listing could ‘revolutionise’ the treatment of opioid dependency.
 
‘We’ve had methadone, which has been brilliant, and now we have buprenorphine, which has the advantage that it’s a partial opioid agonist, making it better for people with respiratory illness or any issues with overdose risk,’ she said.
 
‘My feeling is that this is a great change – it will give choice to patients. It means patients don’t have to attend pharmacies [as often].’
 
Dr Wilson said the long-acting drug will be useful for people who are stable and looking to cut down or stop opioid use altogether, as well those who are less stable.
 
‘Once it’s in, it’s protective against other opioid overdoses,’ she said.
 
While GPs currently cannot prescribe buprenorphine, Dr Wilson will advocate for it to be more widely available.
 
‘Once GPs can prescribe and administer it in clinics, it will really make life a lot easier for people,’ she said.  
 
Methadone and sublingual buprenorphine are both provided free for opioid substitution therapy patients, but consumers have traditionally paid the cost of pharmacist preparation and dosing, which can be as high as $70 a week. 
 
‘The long-acting injectable form may also end up having an administration fee … but it’s very likely to be much cheaper,’ Dr Wilson said.  
 
GP and addiction medicine specialist Dr Paul Grinzi told newsGP the new formulation is proving safe and effective.
 
‘This depot formulation will not suit everybody, but it will provide an aspect of extra flexibility for those whose daily pharmacy attendance impacts on work and other responsibilities,’ he said.
 
‘This will reduce the stigma and costs of daily pharmacy attendance, but will also have the disadvantage of missing out on the input and regular review currently provided by our pharmacist colleagues.’
 
The Therapeutic Goods Administration (TGA) has ruled that GPs will not have access until next year at the earliest, and has restricted availability to specialist addiction services.
 
Dr Grinzi said each state or territory will have different rules on whether GPs will be able to prescribe the new formulation with or without specific Medication-Assisted Treatment of Opioid Dependence (MATOD) training.
 
‘Thankfully, more states are allowing GPs to prescribe buprenorphine-based treatment for their patients struggling with their opioid use,’ he said.

Buvidal won Pharmaceutical Benefits Advisory Committee (PBAC) approval after agreeing to lower the price of the product by an unspecified percentage.
 
A PBAC public summary document from March states that the overall expected cost to the PBS was less than $10 million in the first year of listing, increasing to up to $30 million by the sixth year of listing.
 
‘[T]he PBAC acknowledged there is a clinical place for a treatment that is administered through a model that is predominantly general practice-based, particularly for patients who currently choose not to be treated under the existing pharmacy-based model,’ the PBAC document states.
 
The long-lasting drug can only be used once a patient is stabilised on sublingual buprenorphine or buprenorphine/naloxone for at least a week.
 
Professor Nicholas Lintzeris, who conducted several clinical trials for the drug’s maker, Swedish pharmaceutical company Camurus AB, said in a statement that the introduction of weekly or monthly treatment had potential to improve treatment outcomes and reduce the stigma of attending a pharmacy or clinic.
 
‘Additional treatment options can increase the willingness of people to present for treatment and reduce the inconvenience and cost for patients, whilst having a positive impact upon the way that people with opioid problems are perceived,’ he said.
 
The PBS listing comes less than a year after the product was first approved by the TGA.
 
Another long-lasting injectable form of buprenorphine, Sublocade, had its PBS application deferred by the Pharmaceutical Benefits Advisory Committee in March.

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