Pitolisant hydrochloride for treating excessive daytime sleepiness caused by obstructive sleep apnoea: Appraisal consultation document

DRAFT guidance does not recommend use to improve wakefulness and reduce excessive daytime sleepiness in adults with obstructive sleep apnoea whose sleepiness has not been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 CPAP) or who cannot tolerate it.

SPS commentary:

The draft negative recommendation was based on 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 was also uncertainty about the assumptions around reduced cardiovascular risk. Therefore, the cost-effectiveness estimates are uncertain and likely to be higher than what NICE normally considers an acceptable use of NHS resources.

National Institute for Health and Care Excellence