Xyrem (sodium oxybate) is available in Australia, but it is not registered.
Xyrem (sodium oxybate) is available for use in Australia under specific circumstances. Xyrem isn’t a registered product in Australia, but is able to be prescribed as it is no longer illegal to import or possess. 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, began importing Xyrem to Australia and it can be accessed as a treatment for narcolepsy under very specific circumstances, 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 are completed online by the prescribing doctor via the SAS online system.
My 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 12 month period, is emailed 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 methyphenidate.
Applications for schedule 8 permits are available from:
- Victoria – Drugs and Poisons Unit
- New South Wales – Ministry of Health
- Queensland Government
- South Australia – SA Health
- Western Australia – Department of Health
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 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. (Here is a video discussing common side effects). 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, pharmacies may 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 use is complex and it is an unregistered product, 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.
Related posts & links:
- Xyrem: Getting started and managing side effects
- Information on Xyrem from US National Library of Medicine / Medline Plus
- Clinical trial results of sodium oxybate (Xyrem) for sleepiness in narcolepsy
- Clinical trial results of once nightly sodium oxybate (FT218) – REST-ON study
- Stanford Center for Narcolepsy
- What is narcolepsy?
NOTE: Dr David Cunnington or SleepHub do not have any association with UCB Pharma (a 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.
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