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Pitolisant hydrochloride for treating excessive daytime sleepiness caused by obstructive sleep apnoea

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1 Recommendations

1.1 Pitolisant hydrochloride is not recommended, within its marketing authorisation, to improve wakefulness and reduce excessive daytime sleepiness in adults with obstructive sleep apnoea whose sleepiness has not been satisfactorily treated by primary obstructive sleep apnoea therapy such as continuous positive airway pressure (CPAP), or who cannot tolerate it.

1.2 This recommendation is not intended to affect treatment with pitolisant hydrochloride that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Excessive daytime sleepiness caused by obstructive sleep apnoea is usually treated with a primary obstructive sleep apnoea therapy such as CPAP. Some people might not tolerate CPAP so they are offered mandibular advancement devices.

Clinical trial evidence suggests that pitolisant hydrochloride reduces excessive daytime sleepiness, with and without CPAP. But there is uncertainty about the evidence because of the way the trials were done. They excluded some people who might be eligible for pitolisant hydrochloride in the NHS. There are also concerns about how they assessed quality of life, so it is uncertain if pitolisant hydrochloride improves quality of life. And there may be a placebo effect in the standard care group (primary obstructive sleep apnoea therapy) that has not been considered and explored sufficiently.

There are concerns about how the trial data have been modelled to take account of a potential placebo effect in the standard care group, and how health-related quality of life was assessed. There is also uncertainty about the assumptions around reduced cardiovascular risk. So, the cost-effectiveness estimates for pitolisant hydrochloride are uncertain. They are also likely to be higher than what NICE normally considers an acceptable use of NHS resources. So pitolisant hydrochloride is not recommended.