Introduction
5.1
The diagnosis of many sleep disorders is undertaken through an overnight sleep study. Relatively simple or mild sleep disorder cases can be diagnosed through sleep studies undertaken at home but more severe cases or those involving co-morbidities are likely to require diagnosis in a sleep laboratory. In many parts of Australia there are long waiting lists to access laboratory sleep studies and these studies can be costly. These factors may contribute to the under-diagnosis of some conditions such as Obstructive Sleep Apnoea (OSA).
5.2
Effective treatment options are available for many sleep disorders, including common conditions such as OSA and insomnia. The accessibility and affordability of these treatment options can, however, act as a barrier to the greater uptake of treatment. In particular, the limited number of practising sleep specialists constrains access to sleep health services especially for paediatric care and for people living in regional, rural, and remote areas.
Diagnosis and Treatment of Sleep Health Issues
5.3
The University of Western Australia School of Psychological Science (UWA‑SPS) commented that the ‘majority of Australian adults will not seek any sort of formal assistance with sleep difficulties.’ The UWA-SPS further stated that 24 per cent of people with sleep disorders assume their sleep problems will go away, 18 per cent get advice from family, friends or self-treat, and 10 per cent do nothing.
5.4
The Canberra Sleep Clinic (CSC) stated that individuals may not be aware of the symptoms of a sleep disorder because ‘sleep by its nature involves a loss of awareness, so that disturbances to sleep quality and quantity are often not recognised.’ In addition, the CSC stated that people rapidly develop a ‘feeling of tolerance to inadequate sleep’ and so may not feel the symptoms during the day.
Diagnostic Sleep Studies
5.5
Many sleep disorders are diagnosed through a sleep study undertaken in the home or in a dedicated sleep laboratory. Relatively simple conditions can be diagnosed through at-home studies. For example, the Australasian Sleep Technologists Association (ASTA) stated that at-home sleep tests ‘can be performed for patients with a high likelihood of sleep disordered breathing, in the absence of any other significant medical condition.’
5.6
Similarly, Austin Health stated that ‘the evidence internationally [is] that home sleep studies—performed well, performed on the right people, interpreted by the right people—are sufficiently good to diagnose sleep apnoea.’
5.7
Patients with more complex sleep health conditions or co-morbidities may require a diagnostic study at a sleep laboratory. The Charles Perkins Centre (CPC) explained that laboratory sleep studies ‘generate a wealth of data from the numerous physiological signals that are collected about a person’s brain activity, eye movements, muscle activity, heart rhythm, breathing, and snoring.’
5.8
The ASTA stated that laboratory sleep studies are necessary for patients with ‘narcolepsy, parasomnias, idiopathic hypersomnolence, periodic limb movement, nocturnal hypoventilation, and [Rapid Eye Movement] behaviour disorder.’ The Australian Capital Territory (ACT) Government advised that 36 per cent of the diagnostic sleep studies it undertook were complex and thus not suitable for home-based sleep studies.
Diagnosis and Treatment of Sleep Apnoea
5.9
Associate Professor Darren Mansfield described the management of OSA in Australia as having:
... evolved over time in non-systemic fashion as resources have struggled to keep up with the high burden of the disease. The field now comprises various diagnostic and treatment models, including specialist physician, general practitioner and industry led pathways.
5.10
There are two primary treatment options for OSA, namely, Continuous Positive Airway Pressure (CPAP) therapy and Mandibular Advancement Splints (MAS). Absolute Sleep summarised the difference between the two treatment options as CPAP providing a pneumatic splint that blows the airway open and MAS a mechanical splint which stops the airway collapsing.
5.11
Neuroscience Research Australia (NeuRA) described CPAP therapy as the ‘first-line therapy’ for sleep apnoea. NeuRA added, however, that 50 per cent or more of people who are prescribed CPAP therapy are unable to tolerate it or only use the CPAP machine for a few hours each night.
5.12
In addition to CPAP therapy, sleep apnoea may be treated through the use of a MAS, which is fitted by a dentist. The Dental Sleep Medicine Council of the Australasian Sleep Association (ASA) stated that approximately 40 per cent of dentists offered this service. The Australian Dental Association (ADA) outlined MAS treatments and stated that:
...the purpose of the mandibular advancement device is to move the lower jaw forward and also the tongue and the palate, to help prevent it from falling back, which is often a cause of people’s snoring.
5.13
The ADA stated that if all patients wanted to use a MAS to treat their sleep apnoea approximately ‘one-third would get a fantastic result, about one‑third would get a reasonable result ... and one-third would fail’. The ADA added that MAS was less appropriate than CPAP for severe cases of sleep apnoea, or people with body mass indexes above 30, but that ‘for the thinner patient, the fitter patient, probably an oral appliance is better.’
5.14
The CPC stated that even when a MAS device only has a small impact on a person’s sleep apnoea the health benefits may be similar to CPAP therapy because ‘although it may not be reducing the sleep apnoea as much, people wear [the MAS] more and the health effects seem to be equivalent.
5.15
The ADA stated that MAS treatment does have a number of side effects such as increased saliva flow, soreness in the teeth, gums, or muscles, and jaw stiffness, but that these symptoms could be easily treated by the dentist. The ADA expressed greater concern about the approximately 40 per cent of patients that experience clinically relevant bite changes. The ADA added, however, that:
In the bigger picture of living better, sleeping better and having a healthier life, is a bite change as significant for [the patient]? For some it is; for some it is not.
Insomnia Treatment
5.16
Insomnia is typically treated either through the prescription of sleeping medications such as benzodiazepines or through the application of Cognitive Behaviour Therapy for Insomnia (CBT-I).
5.17
The Royal Australasian College of Physicians (RACP) cited evidence which found that, between the years 2000 and 2015, 90 per cent of patients presenting to general practitioners (GPs) with insomnia were treated with medication, 20 per cent were provided with non-pharmacological advice, and one per cent were provided with an onward referral.
5.18
The RACP expressed concern that the most common approach to insomnia treatment was to prescribe medication. The RACP suggested that the reasons GPs typically use pharmacological treatments include: a lack of time, not knowing referral paths for sleep specialists, a shortage of CBT-I providers, and pressure coming from patients.
Pharmacological Treatment
5.19
An analysis of national health surveys data for the thirty year period from 1977 to 2007 found that ‘use of sleep medications has decreased significantly since 1977 in both men and women, especially in older age groups.’
5.20
Despite this, the Australian Longitudinal Study on Women’s Health (ALSWH) found that the use of medication to sleep was prevalent among women and increased with age. The ALSWH found that seven per cent of women it surveyed born from 1946 to 1951 took sleeping medication while in their late 40s but this increased to 18 per cent when this cohort reached their mid-60s. Among the women born from 1921 to 1926, 18 per cent took sleeping medications when in their early 70s and this rose to 24 per cent when they reached their late 80s.
5.21
Reconnexion added that ‘there is a widely held view that benzodiazepines are inappropriately prescribed and dispensed’. Reconnexion described benzodiazepines as being among the most commonly prescribed drugs in Australia and estimated that between seven million and 10 million scripts for benzodiazepines are written in Australia each year.
Cognitive Behaviour Therapy for Insomnia
5.22
Emeritus Professor Dorothy Bruck and Dr Moira Junge stated that ‘a wealth of rigorous research, conducted across many countries internationally’ had found that CBT-I was a ‘highly effective treatment for chronic insomnia’. Similarly, Sleep Matters stated that 70 to 80 per cent of insomnia patients can be effectively treated with CBT-I.
5.23
Emeritus Professor Bruck and Dr Junge described CBT-I as containing the following components:
Sleep psychoeducation (understanding normal sleep and its determinants);
Sleep hygiene (environmental and lifestyle factors that may affect sleep);
Sleep restriction therapy;
Stimulus control therapy;
Cognitive therapy (dealing with dysfunctional thoughts and attitudes about sleep); and
5.24
Dr Giselle Withers stated that for insomnia patients CBT-I is a ‘superior treatment’ to the use of medications as it is longer lasting and it ‘addresses the root causes of insomnia and empowers the individual to mitigate potential relapse.’
5.25
Dr Withers called for a step-based approach to the treatment of insomnia. Dr Withers stated that people with mild insomnia and good motivation could use self-help or online programs which are ‘highly accessible and cost‑effective.’ Dr Withers stated that people with severe insomnia or co‑morbidities with other health conditions ‘should be referred to face‑to‑face treatments with suitably qualified health professionals.’
5.26
Sleep Matters advised that most straightforward cases of insomnia can be treated with four to six sessions with a psychologist. Emeritus Professor Bruck and Dr Junge also advised that an abbreviated two-session treatment focussing on sleep restriction therapy has been successful in initial studies and called for a larger scale Australian study of this therapy.
Box 5.1: Impacts of Long-Term Benzodiazepine Use
Benzodiazepines are a class of minor tranquilisers used to treat insomnia and anxiety. Benzodiazepines can be an effective treatment for cases of acute insomnia, for example when there is a contributing factor such as ‘post-operative pain or recent loss of a loved one.’
Reconnexion advised that clinical guidelines suggest benzodiazepines should ‘only be prescribed on an intermittent basis for no longer than two to four weeks in order to prevent the development of tolerance and dependency’. Similarly, Austin Health described sedative medications (such as benzodiazepines) as inappropriate for first-line treatment of insomnia stating that they have ‘limited effectiveness, have many side‑effects, and cause long-term dependency problems.’
Reconnexion described withdrawing from benzodiazepines as both difficult and dangerous and stated for some of its clients the process can take years. Ms Sandra Kirby described the process of withdrawal as a ‘nightmare’ and harder than withdrawing from heroin.
Benzodiazepine use has been found to increase the risk of car accidents, falls, and the development of dementia and Alzheimer’s disease. In addition, benzodiazepine use has been associated with drug induced deaths. Let Sleep Happen stated that benzodiazepines were the ‘most common substance present in accidental and intentional drug‑induced deaths, being identified in 663 or 36 per cent of [these] deaths’ in 2016.
Let Sleep Happen added that approximately 70 per cent of these deaths were accidental. Long-term benzodiazepine use can lead to memory loss and this combined with increasing dosage, due to the development of tolerance, can increase the risk of overdose. Alcohol or other drugs are also a factor in nearly all cases of accidental overdose involving benzodiazepines.
Diagnosis and Treatment of Other Sleep Disorders
5.27
Dr David Cunnington and Dr John Swieca stated that central disorders of hypersomnolence, such as narcolepsy are:
... poorly understood and often not recognised by healthcare providers, insurers, employers and the general public. This leads to difficulties and delays in making a diagnosis, accessing treatment and receiving appropriate accommodations in the workplace to optimise participation.
5.28
Central disorders of hypersomnolence can be difficult to diagnose and testing requires an overnight laboratory sleep study and additional daytime vigilance testing undertaken by a sleep specialist.
5.29
The Sir Charles Gairdner Hospital (SCGH) stated that narcolepsy is often misdiagnosed. The difficulties of diagnosis were illustrated by Ms Laura Thompson who has narcolepsy and stated that ‘eight years is the average time between symptom onset and diagnosis.’
5.30
The SCGH stated that narcolepsy can be well managed with the use of stimulants, particularly Sodium Oxybate (marketed as Xyrem). Narcolepsy Australia stated that there is no cure for narcolepsy but that Sodium Oxybate can provide a ‘better future [for] narcolepsy sufferers’ and ‘drastically reduces the risk of serious harm due to cataplectic episodes.’
5.31
Referring to Restless Leg Syndrome, Mr Graham Revill stated that ‘most GPs don’t understand the problem so they prescribe the standard solution which is drugs’. Mr Revill added that some of the drugs prescribed for Restless Leg Syndrome have serious side effects and can lead to dependency.
Costs and Accessibility of Sleep Medicine
Access to Sleep Medicine
5.32
The ASA advised that there are currently 470 sleep physicians working in Australia but that the majority of these physicians work in both sleep medicine and respiratory medicine. The ASA added that in the public health system there are 223 sleep medicine beds across 51 hospitals and medical clinics.
5.33
The Queensland Government stated that its Sleep Disorders Program operated sleep centres in nine public hospitals and medical clinics. The Queensland Government further stated that these centres ‘provide statewide coverage, ensuring services are available for Queenslanders in rural and remote areas.’
5.34
The ACT Government advised that, in 2011, it opened a two bed sleep laboratory at Canberra Hospital. Since the opening of the laboratory, demand for sleep health consultations has exceeded capacity and has continued to increase in the last five years. The ACT Government also advised that a lack of appropriately skilled staff was a key limiting factor in the provision of sleep medicine services.
5.35
In addition to government owned centres, private providers also operate sleep clinics and deliver services. Air Liquide Healthcare Australia (ALHA) advised that it provides sleep services in over 100 locations in Australia, including operating 32 sleep laboratories across four states. The Sleep Management Group (SMG) advised that it operates 15 sleep clinics, four of which offer sleep laboratories.
5.36
Sleep Disorders Australia and Hypersomnolence Australia (SDA-HA) stated that access to treatment and support for sleep disorders is ‘lacking across Australia.’ The SDA-HA drew attention to the example of the new Royal Adelaide Hospital (RAH) which does not have inpatient sleep diagnostic facilities. The SDA-HA stated that ‘whilst less complex cases could be managed in private facilities, having the expertise and resources to manage complex patients is essential for a hospital such as RAH.’
5.37
The SDA-HA added that, across Australia, 35 onsite sleep clinics have closed since the recent introduction of changes to the Medicare Benefits Schedule (MBS). The ASA stated that these closures were most likely in clinics that ‘were reliant on patients having in-laboratory sleep studies.’ The ASA added that with the changes to the MBS, physicians were required to provide a justification for studies to be done in a laboratory rather than at-home and this could result in the closure of clinics that did not offer home based testing.
5.38
Access to medical sleep services can be affected by long waiting times. For example, Austin Health stated that in some cases there can be wait times of 18 months to access its sleep health services.
5.39
Similarly, Dr Maree Barnes of the ASA provided an example of typical wait times for patients at her clinic. Dr Barnes stated:
I work in a relatively inner city public hospital and even in my relatively well serviced area there is a waiting time. To get a sleep study you’ve got to see me first. The waiting time for that is anything between six months and two years and then you might wait another 12 months to get a diagnostic sleep study. Then you wait another 12 months to get your CPAP titration study.
Access to Paediatric Sleep Medicine
5.40
Children with sleep health issues do not necessarily have the same level of access to sleep medicine as adults. For example, home-based diagnostic sleep studies are not available for children.
5.41
In addition, the ASA stated that, across the 51 hospitals and clinics it surveyed, 33 of the 223 public sleep medicine beds were for paediatric care. The ACT Government advised that there ‘are no publically funded [sleep medicine] services available for children and adolescents in the ACT.’
5.42
Dr Sadasivam Suresh stated that there is a small pool of paediatric sleep clinicians and as such ‘it is not unusual for children [to wait] up to 18 months to see a specialist.’ In addition, Dr Suresh stated that diagnostic testing centres, which are primarily located in hospitals, ‘across Australia are operating at maximum capacity and have a waiting time for sleep [studies] of up to 18 months.’
5.43
Professor Karen Waters highlighted the wait times in Sydney to access diagnostic sleep studies for children. Professor Waters stated that currently ‘outpatient appointments have a three to six month delay and overnight sleep tests have a 9 to 12 month wait time.’
5.44
Professor Waters stated that this was ‘indicative of insufficient services in this area’ and suggested that her sleep unit needed to double its capacity for young children. Professor Waters also suggested that for neo-natal infants the most cost‑effective option would be to establish an outreach diagnostic service that could travel to metropolitan neo-natal nurseries.
5.45
Dr Gillian Nixon also drew attention to the long waiting lists to see paediatric sleep physicians and added that children with sleep apnoea are often treated by an ear, nose and throat surgeon which required an additional waiting period.
5.46
The Canberra Sleep Clinic and Well Spoken (CSC-WS) stated that ‘untreated, sleep problems impact ... a child’s development, and compound over time.’ The Sleep Health Foundation (SHF) agreed and added that ‘the thought of a child with a fairly obvious sleep disorder waiting for some time for investigation … is a matter of serious concern.’
5.47
The CSC-WS suggested that addressing paediatric sleep health required the implementation of a national screening program delivered by professionals across the health, education, and childcare sectors. In addition, the CSC-WS recommended that treatment pathways should focus on insomnia and breathing associated with sleep disorders and, for children ‘treatment should be organised as early as possible, no matter the severity.’
Access to Sleep Medicine in Regional, Rural and Remote Areas
5.48
The ASTA stated that access to treatment and support for sleep disorders is ‘almost non-existent’ outside metropolitan areas and major regional centres. As a consequence, the ASTA suggested that the use of diagnostic sleep studies in regional and remote areas was far lower than in other parts of Australia. The ASTA advised that in regional and remote areas there are 31 sleep studies conducted per year for every 100 000 people whereas the Australian average is 575 studies per 100 000 people per year.
5.49
The CSC agreed that people living in regional and rural areas are ‘not as well served’ as people living in cities in regard to sleep medicine. The CSC added that in regional and rural areas ‘diagnosis is made by less detailed testing at home [and] clinical management is undertaken mostly by GP’s who have little opportunity for training and experience.’ Similarly, GenesisCare stated that the delivery of CPAP treatment in remote and rural regions ‘can be difficult as there is often a lack of local expertise and support.’
5.50
As an example of the challenges of providing sleep medicine in regional areas GenesisCare stated:
In Gladstone, Queensland, we have an established sleep laboratory within the private hospital, our sleep and respiratory physician visits from Brisbane monthly and also provides telehealth consultations. There is a lack of local sleep physicians within Gladstone, and access to private respiratory physicians is also quite limited in the region. As a result, oftentimes patients with significant respiratory conditions are seen as priority and therefore those with sleep disordered breathing are triaged and, consequently, left with delays to accessing specialist advice and treatment.
5.51
Emeritus Professor Bruck and Dr Junge commented on the potential role of telehealth and internet based resources to provide insomnia treatment in regional and remote areas and stated that CBT-I is:
... likely to be successfully adaptable to telehealth. There is a large volume of research on the efficacy of CBT-I using online delivery models (often therapist-guided). Thus, CBT-I can potentially be effectively delivered in rural, regional and remote areas in a low-cost manner.
5.52
Sleep Matters advised, however, that in order to claim a telehealth CBT-I session under Medicare:
People have to be living a long way from a centre and, if there is a psychologist locally, they need to see them [in person] even though that person may have zero training in behavioural sleep medicine. So it would be really helpful if patients were able to access whoever has a speciality in the disorder that they are presenting with, rather than having to access the person that is closest to them.
Sleep Health Sector
Sleep Medicine Services Available under Medicare
5.53
The Adelaide Institute for Sleep Health (AISH) stated that ‘Medicare-funded sleep studies for sleep apnoea cost the Australian taxpayer $69 million per annum’. The AISH added that this cost was ‘increasing rapidly with 14 per cent per annum growth compared to 6 per cent per annum for all other Medicare services.’
5.54
Home diagnostic tests were added to the MBS in 2008. The SMG stated that this had resulted in the expansion of ‘access to diagnostic testing to a much wider group of patients as cost to the patient was no longer a consideration and barrier for screening and diagnosis.’ Similarly, the ASTA stated that home based testing had increased access to diagnosis of sleep health issues for people living in non-metropolitan areas.
5.55
Austin Health suggested that the recent changes to the MBS had a goal of transferring the ‘majority of straightforward patients with sleep apnoea ... to a home sleep study for a diagnosis’, which it considered ‘a correct goal and supported by the evidence.’
5.56
The Melbourne Sleep Disorders Centre (MSDC) stated that the recent review undertaken by the MBS Taskforce has resulted in ‘necessary changes’ that had:
... modernised the list of item numbers to reflect clinical practice across a range of sleep related disciplines. A consequence of that is to wipe out some of the corporatised high-volume models of care that were at times hard to defend, in terms of their approach to health care. There are unintended consequences, and a number of patients who would have had a diagnosis made through those corporatised models of care are now seeking care elsewhere.
5.57
Jeffrey & Ree Psychology and Sleep Matters (Jeffrey & Ree) stated that ‘in order to obtain a Medicare rebate to see a psychologist ... [insomnia] patients must first see their GP for a Mental Health Treatment Plan.’ Jeffrey & Ree stated that the need for a Mental Health Treatment Plan acted as a barrier to people accessing CBT-I, both because of the stigma associated with mental health and because the treatment plan may ‘adversely impact life insurance premiums and occupational opportunities.’
5.58
Dr Giselle Withers called for higher Medicare rebates for psychologists to run group CBT-I sessions. Dr Withers stated that group programs are more cost-effective for the health system but ‘psychologists are [not encouraged] to run group [sessions], as they would earn less per hour than for individual sessions.’
5.59
The ADA called for ‘better regulation around the availability’ of one-size-fits-all mouthguards used to treat snoring that are available over the counter or via the internet. The ADA stated that these devices provide ‘very poor effectiveness compared with a professionally made’ device and advocated that they should be regulated ‘under the auspices of the Therapeutic Goods Administration.’
Level 3 and 4 Testing and Oximetry
5.60
The SHF suggested that there could be greater use of simpler diagnostic tests for sleep disorders, known as level 3 and level 4 sleep studies. The SHF stated that level 3 and level 4 tests were in‑home tests that measured a limited number of parameters and were ‘suitable as part of screening procedures [and] also for diagnosis of simple cases.’
5.61
The Pharmaceutical Society of Australia (PSA) added that level 3 home-based studies were being managed by pharmacists and that the studies were ‘an excellent way—appropriate to the scope of practice—for pharmacists to be able to pick up on people who can be managed or need to be referred on to more specialist assessment.’
5.62
The SMG suggested that the ‘technology for sleep testing has improved dramatically over the last five years.’ The SMG added that level 3 tests could now be done ‘at a much lower cost to government’ and that they could be interpreted by a GP who could triage simple cases and refer more complex cases to a sleep physician.
5.63
In contrast, ALHA expressed some concerns about Level 3 and Level 4 testing. The ALHA stated that these tests do not require an assessment by a GP or sleep physician and therefore ‘patients may be inappropriately referred to testing, incorrectly diagnosed, and then inappropriately treated.’
5.64
The Thoracic Society of Australia and New Zealand (TSANZ) commented on the role of oximetry testing, which measures oxygen in the blood, in diagnosing OSA. The TSANZ stated that oximetry testing is used for screening and triaging ‘especially in areas which have poor access to major laboratories’ but that it has been ‘removed from the MBS during the recent review process.’
Medicare Audits
5.65
An inquiry participant working in the field of sleep medicine raised the issue of Medicare audits of clinicians undertaking sleep studies. The inquiry participant stated that during 2018 at least 20 to 25 per cent of sleep clinicians were:
... subject to targeted Medicare compliance activity/audits over the rendering of the diagnostic sleep services ... this level of activity is unprecedented in any other disciplines in Medicine and Dentistry.
5.66
The SMG stated that 79 providers, possibly representing as many as 20 per cent of practising sleep physicians had received letters from Medicare in February 2018. The SMG suggested that this indicated that sleep physicians undertaking home diagnostic studies had ‘become a target for Medicare and the Professional Services Review committee.’
Role of Primary Care Health Workers
5.67
The SHF stated that there is a need for a greater proportion of sleep services to be provided by primary care medical staff and stated:
It is not appropriate or necessary that all patients with sleep disorders be managed by sleep physicians ... the management of uncomplicated sleep disorders should be devolved to primary care and allied and community health workers.
5.68
This view was shared by the AISH which stated that sleep specialists are ‘overburdened, dealing in many instances with unnecessarily simple cases.’ The AISH added that:
The current reliance on specialist services and corporate providers, rather than primary care, means that the community burden of sleep disorders remains largely unmet.
5.69
The SCGH stated that ongoing management is required of patients undertaking CPAP therapy. The SCGH further stated that specialist sleep physicians are not able to ‘deal with the magnitude of managing these patients’ and suggested that primary care professionals such as psychologists, GPs, and nurses could instead provide this ongoing patient support.
5.70
SleepGP stated that it provides the Royal Australian College of General Practitioners (RACGP) accredited training for GPs so that they can provide care and management for patients with uncomplicated OSA and thereby reduce ‘the pressure on, and wait times for, limited numbers of sleep specialists.’ SleepGP suggested that GP based care provides a:
… comprehensive clinically based, patient-centred [model of care] that provides an alternative to ‘commercial’ pathways which simply sell OSA sufferers a CPAP device without proper assessment of their co-morbidities, medications and anatomy.
5.71
The RACGP called for the ‘introduction of a MBS item number for organised sleep studies in general practice.’ The RACGP added that:
Integration of such studies into primary care, and away from specialist based services and tertiary care, can potentially achieve more effective results and decrease costs. However relevant standards should be in place before such studies can be undertaken.
5.72
Ms Catherine Buchan suggested that specialist sleep nurses could have a greater role in the provision of sleep health services. Ms Buchan cited research which found that specialist sleep nurses had been able to manage sleep health patient populations with ‘equivalent outcomes to sleep physicians.’ Ms Buchan added that ‘nurses access to provider numbers and Medicare rebates for fee for services needs to be reviewed in any models of care [that] utilises nurses in the workforce.’
5.73
The SHF suggested that overseas experience had shown that nurses could be trained to deliver CBT-I. The SHF stated that ‘we need to have a massive upskilling of nurses, psychologists and other allied health professionals so that they can deliver these sometimes very simple sessions.’
5.74
The CSC-WS suggested that there was a ‘big role that allied health can play, particularly in screening, and triaging in screening, to relieve the burden on the medical fraternity.’ Similarly, the PSA stated that pharmacists can also be involved in the management of patients with sleep disorders such as sleep apnoea. The PSA stated that pharmacists may screen patients and either refer them to a medical practitioner or support their use of CPAP therapy to treat sleep apnoea.
5.75
Professor Darren Mansfield stated that the barriers to primary care practitioners becoming more involved in the provision of sleep health services included: limited knowledge, short GP consultations, lack of reimbursements for GPs to gain new skills or provide complex consultations, and limited nurse practitioner pathways.
Referral Pathways
5.76
Medicare item numbers that came into force on 1 November 2018, enable GPs to directly refer patients to a laboratory sleep study. Previously an appointment with a sleep specialist was also required to access a sleep study.
5.77
To access the direct referral pathway a GP must first complete two questionnaires that determine the patient’s eligibility for a sleep study. The SMG stated that these questionnaires exclude ‘a lot of patients that may have sleep disorders’ and that ‘Medicare are making it difficult to diagnose patients rather than providing improved access to diagnosis and then treatment where necessary.’
5.78
Austin Health and the Institute for Breathing and Sleep (AH-IBS) stated that the questionnaires provide sleep physicians with more information which ‘allow us to triage more effectively’ but also highlight some potential limitations of the changes. The AH-IBS stated that:
This direct referral pathway requires that GPs be familiar with several sleep‑related questionnaires (to determine patient eligibility for this streamlined pathway) and have an understanding of patient clinical suitability for the test ... in the absence of any significant component of sleep education in the medical courses, this is likely to be beyond the capability of many GPs.
5.79
The ASA agreed and suggested that while the intention of the changes had been to make it easier for GPs to refer patients directly to sleep studies, this pathway ‘has really not been utilised.’
5.80
Mr John Malouf stated that the recent Medicare changes have altered the criteria for accessing a sleep study ‘towards typical male symptoms’ and that therefore ‘women will be disproportionately disadvantaged.’ Mr Malouf added that ‘49 per cent of women with moderate to severe OSA will no longer be eligible for a Medicare funded sleep study without having to go to the inconvenience and expense of seeing a sleep physician.’
5.81
The AISH stated that the Medicare changes were a ‘step in the right direction’ but also suggested that it is:
... possible that this measure alone is insufficient to change practice when primary care professionals are not mandated to manage patients in primary care, or recommend self-management strategies.
5.82
A related issue is the ability of patients to be directly referred between psychologists and sleep physicians. The Australian Psychological Society stated that if a psychologist believed a patient had a physiological sleep disorder they would refer the patient back to their GP for onward referral.
5.83
Similarly, the SCGH stated that if a sleep physician believes a patient needs to see a psychologist they are not able to directly refer the patient to the psychologist.
5.84
Dentists are also unable to refer patients directly to sleep physicians, although they are able to refer patients back to GPs and ear, nose, and throat surgeons. The ADA stated that following the fitting of a MAS dentists would like to refer the patient back to the sleep physician to check the effectiveness of the treatment but this is not currently possible.
Commercial Providers in the CPAP Market
5.85
The AISH stated that there was a 23 per cent per annum increase in the cost to Medicare of home-based sleep studies provided by ‘medical corporates using a vertically integrated model, i.e. diagnostic testing leading to the sale of CPAP’ devices.
5.86
Professor Ron Grunstein expressed concern regarding the ‘over‑investigation of mild sleep apnoea’ and commented that patients with mild to moderate sleep apnoea were ‘being recommended treatment with [CPAP] machines for their condition, despite no evidence of its value.’ Professor Grunstein also raised concerns regarding the vertical integration of companies offering diagnostic services and selling treatment devices.
5.87
Similarly, the SCGH stated that CPAP resellers, who buy from manufacturers and sell to consumers, often encourage patients to purchase the most expensive devices. The SCGH added that:
...in many instances commercial interests have trumped the medical interests of patients, and patients have been convinced to put their hard-earned money towards equipment that they probably don’t need.
5.88
The SCGH stated that the emergence of commercial sales of CPAP devices was in part due to the long waiting times to see sleep specialists and in part because there is no regulation, such as the need for a prescription, that limits who can buy and sell CPAP devices.
5.89
Associate Professor Darren Mansfield suggested that patients outside of metropolitan areas were receiving treatment from companies selling CPAP machines whose ‘commercial and healthcare priorities may not always be aligned.’ Professor Mansfield attributed this situation to poor access to services outside metropolitan areas which had created a ‘void [that] has been filled by the sleep apnoea device industry.’
Costs and Government Support
Sleep Apnoea Treatment
5.90
The ASTA stated that CPAP devices can be purchased for between $700 and $800 and will last three to five years. In addition, the masks required to use the device cost between $100 and $150 and last about 18 months. The SMG stated that there were many brands of CPAP devices with costs varying between $1000 and $2000.
5.91
The SHF stated that access to CPAP is ‘often constrained by its affordability to individuals, particularly those of limited means.’ Similarly, GenesisCare highlighted the difficulty some people experience funding OSA treatment, stating:
Provision of CPAP requires a substantial upfront cost to the patient. Many patients with significant sleep disordered breathing have other co-morbidities ... patients have difficulty meeting the cost of sleep disordered treatments, particularly when they are also paying for appointments, medications and therapies for their co-morbidities. State based schemes to assist in supply of sleep disordered breathing treatment are a benefit, but for some even the reduced costs are excessive. This [is] also quite evident in Indigenous patients.
5.92
The MSDC stated that upcoming changes to private health insurance requirements will result in sleep medicine being ‘in the lowest possible tier, that is, insurers will be well within their rights to exclude sleep diagnostics and treatments for anything but the gold level, the highest tier, of insurance.’ The MSDC stated that these changes ‘may make it more difficult for patients to seek care’ in the private system, but ‘at the same time the public hospitals have not been able to increase their resources to provide more diagnoses and treatment.’
5.93
Similarly, the SMG stated that:
Limiting sleep studies to the gold tier is likely to severely limit or prevent access of part of the population to an appropriate diagnosis for their sleep disorder, and put additional stress on the public hospital system, which already has demand for sleep services exceeding supply.
5.94
The ADA stated that the average fee for MAS treatment is $1450. Absolute Sleep stated there is ‘no public funding for this treatment at all’ and that the ‘current level of rebates for MAS devices across private health funds are insufficient and do not lead to patient or provider uptake of MAS.’
Government Support for CPAP Therapy
5.95
State and Territory Governments provide funding to patients for CPAP therapy if they meet a range of financial, medical, and in some cases geographical criteria.
5.96
Table 5.1 summarises information provided by the ASA on support provided by state and territory governments to assist people access CPAP equipment. The ASA added that in all jurisdictions ‘many patients are unable to afford or access [the funding programs] and remain untreated.’
Table 5.1: Government Support for CPAP Therapy
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Jurisdiction
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Key Eligibility Criteria
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Equipment Provision
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Other Notes
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ACT
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Pensioner or Health Care Card holder
OSA of ‘significant severity’
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CPAP
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Patients must demonstrate ability to use CPAP through self-funded trial
2 week waiting period
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NSW
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Permanent or long-term disability
‘Require the assistive technology to remain in a community setting’
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CPAP device and some consumable products
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4 month or more waiting period
Co-payments range from a minimum of $100 per year to 20 per cent of the device cost
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NT
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Pensioner or Health Care Card holder or disability preventing work
Significant OSA and meet clinical criteria
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Rental of CPAP device, patients purchase mask and consumables
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Patient rents CPAP at their expense for 4 to 6 weeks to demonstrate adherence
Scheme not available in Alice Springs and Central Australia
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Qld
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Pensioner or Health Care Card holder
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Loan of CPAP device
Consumables and accessories such as the mask not provided
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2 month rental period at patient’s expense
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SA
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Pensioner or Health Care Card holder
Severe OSA with ‘significant medical co‑morbidities’
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CPAP device
Replacement of consumables not provided
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Only available in 2 of the 4 Local Health Network areas
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Tas
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Health Care Card holder
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CPAP device rented at $50 per year
Initial consumables provided but patients must fund replacements
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A cap of the number diagnostic sleep studies that can be undertaken provides an effective cap on the number of devices that will be funded
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Vic
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Health Care Card holders with moderate to severe OSA
Hospital based funding and not all hospitals provide funding
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No state-wide program. People living in rural areas and some metropolitan areas have ‘no or very limited access’ to CPAP funding
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WA
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Pensioner or Health Care Card holder
At least moderate OSA
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CPAP device
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Patient must demonstrate use and benefit of CPAP through trial and own expense
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Source: Australasian Sleep Association, Submission 118.1, pp 1-5.
5.97
The SHF further explained that CPAP devices are historically funded by the states and territories as:
… under the Medicare system, provision was made to the states for appliances: walking sticks, walking frames and that sort of thing, and that’s where CPAP sat ... that is, that it’s a state-by-state responsibility. Federally, there’s no responsibility taken for the provision of appliances, and I think it shows.
5.98
Associate Professor Darren Mansfield stated that the cost of CPAP devices in Australia is amongst the highest in the world and suggested that a ‘federally based government subsidised CPAP program for low to middle income earners would significantly improve affordability.’ Associate Professor Mansfield suggested that access to the scheme should require a prescription from a medical practitioner with sleep medicine training and that a tendering process with CPAP manufacturers could reduce the cost to government.
5.99
The SHF stated that the annual cost of CPAP therapy is approximately $550 per person, but that if societal costs such as productivity are considered CPAP therapy ‘actually saves the country $440 per person treated.’ Associate Professor Mansfield provided a slightly higher figure for the benefit to society, stating that treating OSA with CPAP provides a ‘net cost saving to society of $857 per person treated.’
Hypersomnolence Disorders Treatment
5.100
The SDA-HA stated that ‘there are no medications on the Pharmaceutical Benefits Scheme (PBS) for idiopathic hypersomnia and people with idiopathic hypersomnia cannot access schedule 8 medications without a narcolepsy diagnosis.’ The SDA-HA called for the medications Dexamphetamine and Modafinil/Armodafinal to be approved for use to treat idiopathic hypersomnia.
5.101
The SHF stated that it had previously attempted to have Modafinil listed on the PBS as a first-line treatment for hypersomnolence disorders but that this had been rejected and amphetamines remain the first-line treatment. The SHF stated that ‘amphetamines are problematic drugs ... my choice would be Modafinil before amphetamines.’
5.102
In addition to Modafinil people experiencing narcolepsy may also be treated with Sodium Oxybate (marketed as Xyrem). Narcolepsy Australia, however, stated that ‘uptake [of Sodium Oxybate] has been minimal’ citing the high cost of the medication as the main factor preventing greater usage. Sodium Oxybate is currently available in Australia via import through the special access scheme but its purchase is not funded or subsidised by the Australian Government. The SDA-HA stated that the annual cost of Sodium Oxybate treatment was between $15 000 and $20 000 depending on the dose.
5.103
The Department of Health stated that the Therapeutic Goods Administration (TGA) ‘has not received an application from a potential Australian Sponsor to designate a medicine containing Sodium Oxybate as an orphan drug’, despite being aware of a public petition in 2015 aimed at achieving this goal. The Department of Health also stated that the TGA had not ‘received a registration application for any medicine containing Sodium Oxybate’, but that:
The TGA has been approached in 2018 by potential sponsors for Sodium Oxybate and has had two pre-submission discussions. Written advice to the sponsors was provided by the TGA at the time and no follow-up applications have been received to date.
5.104
In order to be approved for distribution by the TGA, the Sodium Oxybate medicine would need to have an Australian Sponsor, which is usually (but not always) the relevant pharmaceutical company. The Department of Health outlined the process and stated:
To gain approval to supply therapeutic goods in Australia, a sponsor would need to submit an application together with supporting data to the TGA for evaluation. The TGA is unable to compel a sponsor to submit an application to register therapeutic goods; and approval for marketing in Australia cannot be given in the absence of an application. As the sponsor must be able to provide scientific data to support the registration of a medicine and also commit to post-market monitoring requirements, registration applications are ordinarily submitted by pharmaceutical companies rather than other bodies. That said, other bodies are not precluded from applying for the registration of a medicine but would need to ensure they are able to fulfil the obligations of a sponsor under the Act.
Concluding Comment
Accessibility of Sleep Health Services
5.105
In many cases, people who are experiencing sleep disorders are waiting a year or more to see a specialist or undertake a sleep study. This situation is particularly troubling in the field of paediatric sleep medicine. The waiting lists for diagnosis and treatment of children’s sleep health conditions can be even longer than for adults and delays in treatment can have long-lasting impacts on childhood development.
5.106
New methods of delivering sleep health services are required as there remains an unquantified number of people with undiagnosed sleep apnoea. Combined with long waiting lists for such services add to the complication. If diagnosis rates for sleep apnoea improve, existing sleep health services may be placed under significant strain and the need for new delivery methods will only increase.
5.107
The most effective means of improving the delivery of sleep health services appears to be through the expansion of the pool of practitioners engaged in sleep medicine. It is estimated that as many as one in five Australians experience a sleep disorder with 470 practising sleep physicians in Australia. The provision of sleep health services should be a shared responsibility that involves general practitioners (GPs), nurses, psychologists, dentists, and remaining allied health professionals.
5.108
Enabling a greater role for primary care workers will improve the accessibility of sleep health services across Australia, particularly in regional and rural areas where access to specialists is limited. Examples of how primary care workers could have greater involvement in the delivery of sleep health services include: GPs taking a greater role in the diagnosis of mild or simple sleep disorders; GPs leading the ongoing management of people with obstructive sleep apnoea (OSA) following initial diagnosis and treatment; and nurse practitioners delivering Cognitive Behavioural Therapy for Insomnia (CBT-I) sessions for cases of insomnia not involving co-morbidities.
5.109
The Committee supports recent changes that enable GPs to directly refer patients for sleep studies. This pathway, however, does not appear to be frequently used and adjustments may be required.
Diagnosis and Treatment of Sleep Disorders
5.110
Medicare rebates are available for in-laboratory (level 1) and at-home (level 2) overnight sleep studies only. The Committee heard that simpler diagnostic tests (levels 3 and 4) are also available which could provide a cost-effective means of expanding the number of Australians who are tested for sleep disorders.
5.111
For some people, a simple test interpreted by a GP may provide a sufficient diagnosis to develop a treatment plan. For people with more complex or serious conditions, a simple, accessible test could act as a trigger to consult a sleep physician and undergo additional testing.
5.112
There is a need to review the diagnostic testing currently available through Medicare to increase the number of Australians tested for sleep disorders.
Treatment for Sleep Apnoea
5.113
The condition of OSA has potentially serious health implications, but is often undiagnosed and untreated. Fortunately there are two effective treatment options for OSA available: Continuous Positive Airway Pressure (CPAP) therapy and Mandibular Advancement Splints (MAS). In order to ensure that the significant benefits of treatment are realised, it is crucial that these treatment options are both accessible and affordable.
5.114
The Committee is concerned that treating OSA can be prohibitively expensive for some individuals. In addition, the systems for subsidising CPAP devices vary significantly across each state and territory. In all jurisdictions, however, there are likely to be access issues due to the prohibitive cost of the devices.
5.115
In its previous Inquiry into the Hearing Health and Wellbeing of Australia the Committee found concerning examples of hearing devices being sold on a commission basis with examples of monopoly-type sales arrangements in place.
5.116
The Committee is concerned that there are indications of a similar dynamic occurring in the provision of CPAP devices. With no regulation in the CPAP industry, devices are able to be sold independent of any diagnosis or treatment plan provided by a medical professional. This creates a situation where there is a strong likelihood of a divergence between a patient’s healthcare needs and the commercial imperatives of business.
5.117
There is a need for regulation to ensure that the provision of CPAP devices is in line with medically diagnosed need. The objective of a new regulatory framework should be to improve access to CPAP devices for people with OSA but also ensure that access is provided on the basis of a diagnosis and long term management by an appropriately trained medical practitioner.
Treatment for Insomnia
5.118
Insomnia is a common disorder that can have serious physical and mental health and wellbeing impacts. The Committee was pleased to hear that CBT‑I offers a relatively straightforward treatment that is effective in 70 to 80 per cent of cases. Despite this success rate, only a small minority of patients who present to their GP with insomnia symptoms are referred on to CBT-I treatment. Instead, approximately 90 per cent of patients leave their GP with a prescription for a sleeping medication (e.g. benzodiazepine).
5.119
In many cases, benzodiazepine use can rapidly lead to dependence which over a prolonged period can have a debilitating impact on a person’s health and wellbeing. The Committee considers that CBT-I should be reviewed as a first line therapy for insomnia, rather than a prescription for benzodiazepines.
5.120
A key component of ensuring that people experiencing insomnia are referred to CBT-I treatment is providing GPs with adequate training and knowledge about its effectiveness.
5.121
In addition, the Committee believes there needs to be greater regulation of benzodiazepines and assistance for existing dependency on benzodiazepines.
Treatment for Narcolepsy
5.122
The Committee was pleased to hear that a treatment option for Narcolepsy exists that could potentially lead to substantial reductions in the symptoms of these conditions. Sodium Oxybate (marketed as Xyrem), which is available in the United States of America, has enabled some people experiencing narcolepsy the ability to re-enter the workforce or undertake study which would otherwise not be possible.
5.123
Currently, Sodium Oxybate is only available in Australia through a limited import system at a cost of between $15 000 to $20 000 per year.
5.124
Wider availability of Sodium Oxybate may enable people experiencing narcolepsy to more fully participate in their family, social, and work lives.
5.125
Sodium Oxybate must first be listed or registered through the Therapeutic Goods Administration (TGA) as this process is an important guarantee of the safety of the drugs available in Australia. The Committee urges the Australian Government to work with relevant parties to progress an application for the consideration of this drug by the TGA.
Recommendations
5.126
The Committee recommends that the Department of Health undertake a review of the Medicare Benefits Schedule as it relates to sleep health services in Australia. The review should include, but not be limited to, the following:
Simple diagnostic sleep studies (Level 3 and Level 4) that do not currently attract Medicare rebates;
Ensuring recent changes to enable general practitioners to directly refer patients to diagnostic sleep studies are effective; and
Barriers to accessing Cognitive Behavioural Therapy for Insomnia via telehealth for patients in regional, rural, and remote areas.
5.127
The Committee recommends that the Australian Government work with the states and territories, and provides funding where necessary, to:
Ensure that all Pensioner or Health Care Card holders with moderate to severe obstructive sleep apnoea, regardless of their location, have access to a free trial of Continuous Positive Airway Pressure (CPAP) therapy and if the trial is successful free ongoing CPAP treatment; and
Undertake a review to assess the potential benefits of providing subsidised CPAP therapy across the broader Australian community.
5.128
The Committee recommends that the Australian Government and the Australian Competition and Consumer Commission monitor the Continuous Positive Airway Pressure industry to ensure that vertical integration in the industry does not result in actions that:
Limit the quality of care or clinical advice provided to patients; or
Result in anti-competitive behaviour in the industry.
5.129
The Committee recommends that if there is no distributor willing to put forward a submission, the Australian Government work with patient advocacy groups such as Narcolepsy Australia or the Sleep Health Foundation to make a submission for the listing or registration of Sodium Oxybate under the Orphan Drug Program.