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 primary obstructive sleep apnoea therapy such as CPAP or 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. It is also uncertain how much pitolisant hydrochloride improves quality of life because of how it was measured in the trials.
Because of the uncertainty in the clinical evidence and economic model, the cost-effectiveness estimates are also 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.