1. Category: Threshold

Threshold procedures and therapies are those in which a clinical threshold has been set which needs to be met before funding will be made available for treatment.

For patients who DO NOT meet the eligibility criteria, the ICB will only consider funding the treatment if an Individual Funding Request (IFR) detailing the patient’s clinical presentation is submitted to the ICB

2. Background

Treatment of moderate or severe Obstructive Sleep Apnoea / Hypopnoea Syndrome (OSAHS) with CPAP should be in accordance with NICE technology appraisal guidance 139 https://www.nice.org.uk/guidance/ta139 – August 2021

This policy is based on the NICE guideline NG202; Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s Published August 2021 – accurate at the point of publication: https://www.nice.org.uk/guidance/ng202/chapter/obstructive-sleep-apnoeahypopnoea-syndrome#prioritising-people-for-rapid-assessment-by-a-sleep-service

Obstructive sleep apnoea / hypopnoea syndrome (OSAHS) is a condition in which the upper airway is narrowed or closes during sleep when muscles relax, causing under breathing (hypopnoea) or stopping breathing (apnoea)

The person wakes or lightens sleep to stop these episodes, which can lead to disrupted sleep and potentially excessive sleepiness

For people with symptomatic mild OSAHS whose symptoms affect their usual daytime activities, the evidence suggested that CPAP was more clinically and cost effective than conservative management, including lifestyle changes and sleep hygiene.

However, the quality of the evidence means that there is some uncertainty about the cost effectiveness

CPAP was found to be beneficial in improving sleepiness, fatigue, vitality and quality of life, which confirmed the committee’s experience that there are benefits to giving CPAP to people with symptomatic mild OSAHS. While some people could try lifestyle modification first, they noted that these changes take time to work and may not always be effective

Delaying offering CPAP to people with any of the priority factors for rapid referral (listed in recommendation 1.2.1) could adversely affect quality of life, associated medical conditions, or the person’s ability to carry out their work, by failing to control their symptoms

The committee agreed that in their experience offering CPAP to these groups helped control their symptoms and reduced the risks described in the committee discussion of the evidence report for prioritisation (Evidence report C)

Therefore, the committee agreed that for these people, CPAP should be offered as a first-line treatment alongside lifestyle changes, as soon as mild OSAHS is diagnosed.

They also agreed that CPAP would be beneficial to control symptoms in people for whom lifestyle changes alone are unsuccessful or are not appropriate (further information about priority factors is in the Evidence report C Prioritisation review).

The evidence showed fixed-level CPAP and auto CPAP to be equally effective, and auto – CPAP to be more costly. Therefore, the committee agreed to recommended fixed-level CPAP as the first- choice treatment. However, some people, particularly those in whom high pressures are only needed part of the time, find auto-CPAP more comfortable and effective than fixed-level CPAP

For others, tele-monitoring may not be possible because of technological constraints such as the lack of availability of internet or poor internet connection, auto-CPAP should be an option in these cases

The committee were also aware that some hospitals get significant discount on auto-CPAP devices which might make them more cost effective. Therefore, the committee agreed that if auto-CPAP is available at the same or lower cost than fixed-level CPAP, auto-CPAP could be considered

This is discussed in more detail in Evidence report F on PA variants for discussion of the evidence on types of CPAP

Mild OSAHS (NICE guideline NG202 1.5)

Lifestyle Advice Alone

• For those with no symptoms of symptoms that do not affect daytime activities Treatment not needed

o Changes to lifestyle and sleep habits

o Stop smoking services

o Preventing excess weight gain

o Obesity interventions

• Alcohol prevention

CPAP for Mild OSAHS

• For people with mild OSAHS who have symptoms that affect their quality of life and usual daytime activities offer fixed level CPAP
• Priority factors:

o Vocational driving job

o Job for which vigilance is critical for safety

o Unstable cardiovascular disease’ poorly controlled arrhythmia, nocturnal angina, treatment resistant hypertension

o Pregnant

o Currently under pre-op for major surgery

o Non-arteritic anterior ischaemic optic neuropathy

• Offer tele-monitoring for up to 12 months
• Consider use of telemonitoring beyond 12 months
• Consider auto – CPAP as an alternative in people with mild OSAHS if:

o High pressure only needed for certain times during sleep

o Unable to tolerate fixed level CPAP

o Telemonitoring cannot be used for technological reasons

o Auto CPAP is available at the same or lower cost than fixed level

• Heated humidification to be considered for those having upper airway side effects; nasal and mouth dryness, CPAP induced rhinitis

This policy applies to over 16s

3. Indication

Mild obstructive sleep apnoea/hypopnoea syndrome (OHAHS) and obesity hypoventilation syndrome in over 16s

4. Eligibility Criteria

Funding for treatment for mild OSAHS, including the issuing of a single CPAP device will only be provided by the NHS for patients meeting the criteria set out below:

• Patients with mild OSAHS who have symptoms that are affecting their quality of life, in line with NICE guideline NG202, should be offered fixed level CPAP as first line treatment as soon as mild sleep apnoea is diagnosed
• Patients with priority factors, in line with NICE guideline NG202, should be considered for rapid referral to the CPAP service
• The patient must sign an agreement to appropriately insure and maintain the CPAP device and return it to the service upon cessation of treatment or reimburse the full replacement cost of the device to the NHS

For patients who DO NOT meet the eligibility criteria, the ICB will only consider funding the treatment if an Individual Funding Request (IFR) detailing the patient’s clinical presentation is submitted to the ICB

5. Treatment Cessation

Patients will have been considered to have failed to comply with treatment with a CPAP if over a six month period:

➢ The patient has failed to use the device on average for 70% of days, AND

➢ The patient has failed to use the device on average for 4 hours per night when used

Patients who fail to comply with these treatment requirements, must cease treatment and return the device to the provider for refurbishment and reissue to another patient where appropriate or reimburse the NHS the full replacement cost of the device

Patients who do not receive adequate benefit from the treatment (i.e. there is little or no improvement in their AHI or ESS scores) should also be assessed to establish whether it is appropriate for their treatment to continue

6. Guidance/References

https://www.nice.org.uk/guidance/ng202/chapter/obstructive-sleep-apnoeahypopnoea-syndrome#prioritising-people-for-rapid-assessment-by-a-sleep-service

https://www.nice.org.uk/guidance/ta139