Xyrem (sodium oxybate) is available in Australia, but it is not licensed or approved for use.

Xyrem in Australia

Xyrem (sodium oxybate) is now available for use in Australia under specific circumstances. However, the change that has occurred, meaning Xyrem is available isn’t that it is licensed or approved for use, just that it is now no longer illegal to possess Xyrem. In October 2014, Xyrem was changed to a Schedule 8 poison (controlled drug), from a Schedule 9 poison (prohibited substance). Following that change, UCB Pharma, has begun importing Xyrem to Australia and it can be accessed as a treatment for narcolepsy under very specific circumstances and after completing a number of steps.

This post aims to outline the current steps that need to be taken to access and use Xyrem in Australia, to help facilitate that process for people with narcolepsy and their treating doctors. This post does not recommend that you use Xyrem or trial it, as that is a decision that needs to be discussed carefully with your treating doctor, to see if Xyrem is suitable for you and appropriate to use.

Steps needed to access Xyrem

There are a number of steps that need to be taken once you and your treating doctor decide that a trial of Xyrem is appropriate for you. Some steps are required by the federal government, others by state government and UCB Pharma who sell and distribute Xyrem. The steps need to be undertaken in order as outlined below:

1. Permission to prescribe Xyrem for an individual from the TGA

As Xyrem is not approved for use in Australia, each patient treated with Xyrem needs to be granted specific permission for Xyrem to be imported and supplied for that individual on a case by case basis. This approval is given by the Therapeutic Goods Administration (TGA) under the Special Access Scheme (SAS), category B.  Forms requesting this permission need to be completed by your treating specialist and can be found here.

Our experience has been that these forms take around a week to be approved, and a letter of approval, usually granting permission for treatment for an initial 3 month period, will be posted to the doctor who has submitted the application.

2. Permit to prescribe a schedule 8 substance from State Government

As Xyrem is a schedule 8 poison (controlled drug), for a doctor to issue a prescription, that doctor needs to apply for and be granted a permit to prescribe Xyrem for each patient. The exact process for this differs from state to state, but the principle remains the same in each state. Only one doctor can hold a permit at any one time, which means that prescriptions can’t be issued by other doctors, and doctors face harsh penalties for issuing prescriptions for schedule 8 substances without a permit. This also applies to other schedule 8 poisons used for treating narcolepsy such as dexamphetamine and Ritalin.

Applications for schedule 8 permits are available from:

3. Complete pre-treatment briefing and signing of consent

As Xyrem is not approved for use in Australia, both the TGA and UCB Pharma (the distributor) require people to sign a consent form agreeing to the use of Xyrem and stating that they understand that Xyrem is not approved for use. These documents are available from UCB Pharma, together with additional information on Xyrem, a DVD showing how to draw up and take the drug, and a card for your wallet saying that you are on Xyrem. These documents need to be completed during a face-to-face appointment with your sleep physician. At the same appointment your doctor will go over side-effects of Xyrem and what to watch out for. It’s also important to review your current medications with your doctor to ensure you are not on drugs that will interact with Xyrem, or if you are, there is a plan for managing potential interactions.

4. Order drug in to be picked up from designated pharmacy

Once your doctor has SAS approval from the TGA, a schedule 8 permit and signed consent, they can write a prescription and forward it to the pharmacy you have designated. The prescription needs to be endorsed and written like other schedule 8 prescriptions, generally with the quantity and number of repeats written in both numbers and words. It’s important that the senior pharmacist from the pharmacy and your doctor have a good working relationship as there are a number of specific requirements the pharmacist also needs to complete that often requires communicating with your doctor.

Once the pharmacy has copies of the SAS Category B approval, Schedule 8 permit and prescription, the pharmacy can then order in Xyrem. As Xyrem is not subsidised via the PBS, most pharmacies will ask you to pay for Xyrem before they order it in. Xyrem is an expensive drug, with the cost from most pharmacies being $600 per 90gm/180ml bottle. The dose used varies a lot from person to person, but for someone using the highest dose of 9gm per day, one bottle would last 10 days.

5. Close follow-up and contact with your treating team

As Xyrem has not been available for use in Australia up until now, few doctors have experience using it, and pharmacists are not familiar with it. That means there are likely to be challenges along the way with forms not being completed correctly or people being unsure of the process.

It also takes time to work out the correct dose of Xyrem, and work through side effects, so it’s important to work closely with your treating team to troubleshoot any problems you may be having and adjust the dose accordingly.

NOTE: Dr David Cunnington or SleepHub do not have any association with UCB Pharma (the distributor of Xyrem in Australia) or Avadel Pharmaceutical (the manufacturer of a once nightly form of sodium oxybate – FT218) and do not benefit from the sale of sodium oxybate. Dr David Cunnington is a Principal Investigator in a research study of the effectiveness of FT218 in narcolepsy and will be reimbursed by Avadel Pharmaceutical for clinical work and testing performed as part of that research study.

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Showing 14 comments
  • Mark
    Reply

    Can xyrem be prescribed for people with narcolepsy without cataplexy who cannot tolerate other medications for eds, or is xyrem restricted to treatment of narcolepsy with cataplexy?

    • Dr David Cunnington
      Reply

      Mark, It can be used in narcolepsy without cataplexy. But, without cataplexy, the diagnosis of narcolepsy is often less definitive and can overlap with other causes of sleepiness that may not respond as well to Xyrem.

  • Carol-Anne Howlett
    Reply

    Hi David, I have NwC, symptoms starting at 49, diagnosis at 51, so two yrs ago. Meds only work at best 60% of the time outside of the usual ‘bad days’. For a number of reasons I’d like to trial Xyrem and wondered if it has gone down in price.

    • Dr David Cunnington
      Reply

      Carol-Anne, Unfortunately the price hasn’t changed. It’s still $600 for 90 grams, with the average dose being between 4.5-8grams per day.

  • Max
    Reply

    Hi, I live in Auckland, New Zealand, my question is: is Xyrem simply only used for Narcolepsy? I am a person who suffers from Borderline Personality Disorder who struggles with my sleep pattern. I have done quite a bit of reading on Xyrem and knowing the tight rules around eligibility of the product, does the criteria allow for circumstances beyond the Narcolepsy spectrum or would my situation (which I’ve only simply summarized) not even be close to being a person who would be able to have access to Xyrem? I believe there is a huge relationship between low serotonin being produced and knowing i rely on anti-depressants I have only just learnt about Xyrem and want to investigate it as an alternative for myself and I also am not sure if it is even approved in New Zealand. Any information to assist my broad question would be wonderful as I want to try make a case to my general practitioner.

  • Jim Swim Smith
    Reply

    Can i just say that ghb and gbl, for people like me with aspergers, anxiety, ptsd, depression and alcoholism, in restricted dosing these chemicals are a life saver release from the shakes in the morning, my overwhelming over stimulation issues and the night terrors. I hope the goverment of Australia looks at doing more research and losening some of the hoops that you have to jump through. Unfortunately im stuck doing things through the black market.

  • Wendy Ring
    Reply

    I was diagnosed with NwC in 1995 at the age of 28. Originally prescribed dexamphetamine, but was fortunate enough to be part of the drug trial for Modavigil under Dr Frank Maccioni, POWH, Sydney in 2002. I remained on Modavigil at my own expense after the trial until it became PBS approved in 2005. Over the years my tolerance to Modavigil increased to the point that 600mg/day was barely effective at providing a functioning level of wakefulness. I also take Anafranil daily for cataplexy. In 2020, under Dr Shelia Sivam of the Woolcock Clinic, Sydney, reviewed my stimulant medication regime, and I now take a combination of dexamphetamine 5mg and Modavigil 200mg daily. I also commenced taking Amlodipine at some point during this time (need to check with GP). Also, my grandmother passed away from a stroke at the age of 68. I am acutely aware that continuation of treatment with stimulants may in fact be detrimental my health/longevity. My question is, are any trials for Xyrem currently available? If not, how long is it expected to be before Xyrem is PBS approved?

    • Dr David Cunnington
      Reply

      Hi Wendy, unfortunately there aren’t any clinical trials running with sodium oxybate at the moment. Whilst the long term aim is to have it listed on the PBS this has been a slow process which has been delayed by the pandemic.

  • Sharon
    Reply

    I am struggling massively without Sodium Oxybate. I had been taking it for narcolepsy from 2013 (while living in the UK), at a cost of £9.35 per month (approx. $17.50 AUS), but since moving back to Australia in 2019 I have been, perhaps unsurprisingly, unable to afford the $1800 per month it would cost. This has had a massive effect on my health, both physically and mentally. Despite being on the maximum daily dose of dexamphetamine my symptoms are not very well controlled and I now find myself unable to work.

    So having experienced the wonders of Sodium Oxybate for 7 years I can tell my fellow narcoleptics that we are seriously missing out. I find it utterly disgusting that this life-changing medication is, to all intents and purposes, unavailable in this country. I have been trying to tackle this issue through governmental channels, and recently received a reply from the office of Greg Hunt, Minister for Health, via my MP. In this letter he states “it is a priority of the Australian Government to provide all Australians access to safe, effective and affordable medicines.”

    Am I missing something? Is there some kind of loophole I have not yet discovered to enable me actual affordable access to this safe and effective medication? Or is Mr Hunt so out-of-touch that he considers $1800/month affordable? If there is anyone out there who can provide any kind of advice or help with this please, please let me know!

    • Dr David Cunnington
      Reply

      Hi Sharon, the situation with sodium oxybate in Australia is frustrating. There are a number of steps needed for it to become available that are being worked through, but are slow and keep coming up against a range of different barriers. Advocacy is an important part of what is needed, so by all means keep lobbying your local members and politicians. It depends on what state you are in, but most states have the capacity via local hospitals to fund medications that aren’t usually available for people. Your local sleep physicians are likely to be aware of what is possible via your local health service.

    • Wendy
      Reply

      Narcoleptics unite and petition for PBS listing of Xyrem. I’d happily put my hand up to be involved in a trial to confirm it’s effectiveness. I did the same for Modavigil, , but had to pay $300/month between the end of the trial until it was PBS listed. Of course now I have developed a tolerance to it after many years and an back on dexamphetamine, which in all seriousness is a bandaid solution.

    • Ash
      Reply

      Hi Sharon,

      Is it seriously that cheap to get Xyrem in the UK, even if you’re not a UK citizen!? I always thought I’d stay in Australia… But maybe I should consider taking my next work contract there!

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