I was in Sydney on Wednesday 16th October for the Australasian Sleep Association’s Sleep Downunder conference and to attend meetings with key stakeholders and also the new ASA President, Dr Alan Young and the Clinical Chair Dr Sutapa Mukherjee.
We discussed a number of things, the 3 main issues being;
Access to medications.
Doctor education and the negative consequences of using an Idiopathic Hypersomnia diagnosis (that goes on the record as a Narcolepsy diagnosis) to access medications not otherwise available to people who do not have IH, or Narcolepsy.
The recommendations of the sleep health inquiry particularly the recommendation that sleep and respiratory needs to be two separate specialities.
Both Dr Young and Dr Mukherjee are clinicians (practicing sleep and respiratory specialists). They spoke about their concerns relating to each of those 3 issues and we discussed ways that we (Sleep Disorders Australia and Hypersomnolence Australia) can work with the ASA to help address them.
People with IH (and narcolepsy) generally see a sleep and respiratory specialist. The problem with this is that quite often these specialists are more interested in the respiratory side. We also know that training and experience on the sleep side of this specialty is typically lacking compared to the respiratory side. We spoke about the need for sleep to be its own medical specialty. The benefits of having sleep medicine officially acknowledged as a separate medical specialty will mean that doctors that want to do this training will have a genuine interest in sleep medicine which is clearly not the case at the moment.
At present, training in non respiratory sleep disorders is minimal at best with many doctors not seeing one single patient with IH or Narcolepsy throughout their entire specialty training. Their first encounter with someone that may have IH or Narcolepsy can be years after their training by which point they have had no experience or education at all. This often results in various negative consequences including over-diagnosis, misdiagnosis and patients receiving no relevant, necessary or even useful information and advice at the time of diagnosis or follow up. Having a separate sleep medicine specialty will hopefully address the problem we have at the moment which is doctors who do not have any interest or indeed any relevant training diagnosing and ‘treating’ people with non respiratory sleep disorders, ie: IH and Narcolepsy.
By separating the two specialties the RACP and ASA can also work on a more sleep disorder focused curriculum and they can produce non respiratory sleep disorder educational resources that target doctors that have a genuine interest in these non respiratory conditions. It also gives other specialists like neurologists the opportunity to do the sleep specialty training (without having to do the respiratory side as well) so that they can become ‘sleep neurologists’ similar to what they have in other parts of the world.
A separate sleep specialty should also encourage more research and it should also help advocate for better treatment options and better access to medications for non respiratory sleep disorders.
Access to medications:
I wish I had some good news here however I don’t. I am pleased though that after years of me lobbying the ASA to do something about the clause attached to access to Modafinil and following my supplementary submission to the sleep health inquiry where I told the parliamentary committee that doctors are routinely being dishonest on patient medical records with regards to their supposed risk of taking the PBS first line treatment option, Dex they are finally working on an application to the PBAC to have Modafinil as an equal (to Dex) first line treatment option. This will remove the restriction that currently states that Modafinil is only available if the patient has an unacceptable medical or mental risk if they take Dex. This means doctors will be able to freely choose (under the PBS) between Modafinil and or Dex for their patients without having to fabricate an ‘unacceptable risk’ to Dex.
The bad news is people with IH will still need to go on the record as having Narcolepsy ie: there will still not be any medications approved for IH. The reason for this is that applications to the PBAC take a lot of time and are commonly refused (Modafinil has been refused as a first line treatment option for Narcolepsy twice already) so the ASA will be focusing on this change only for now. This is by no means an ideal situation, for example when the number of people diagnosed with Narcolepsy is falsely inflated Narcolepsy is no longer considered a ‘rare’ disease which means it jeopardises its ability to be eligible for the Orphan Drug Program for Xyrem so it is important that this issue is addressed.
Availability of other medications:
The manufacturers of Pitolisant (Wakix) and Solriamfetol (Sunsoi) have no plans to apply to the TGA for approval of these drugs in Australia. UPDATE, following a meeting on 29 October 2021:
The president of Narcolepsy Australia, Melissa Jose, Amanda Vernon and I had a meeting with Supata Mukherjee - Australasian Sleep Association (ASA) President, David Cunnington - ASA Clinical Chair, Shantha Rajaratnam - Sleep Health Foundation Chairperson (SHF) Shantha is also an ASA past President and Darren Mansfield - SHF Deputy Chair. We again discussed the 3 points above. With regards to access to medications:
The above application to the PBAC with regard to having modafinil an equal first line treatment option was rejected.
We were given no hope that the current situation will change for people with IH or narcolepsy with regards to access to better more affordable treatments. I will continue to work on trying to improve this.
As a side note: Jazz Pharmaceuticals has recently showed some interest in applying for TGA approval for Solriamfetol (Sunsoi) however again, this won't include IH.
Michelle Chadwick
Founder/Director - Hypersomnolence Australia
Chairperson - Sleep Disorders Australia.