Favourable opinion for reimbursement for the treatment of narcolepsy with or without cataplexy in adults.
Clinical benefit now substantial (previously it was moderate) in the abovementioned indication.
Clinical Benefit
Substantial
The clinical benefit of WAKIX (pitolisant) is substantial in the treatment of narcolepsy with or without cataplexy.
Clinical Added Value
no clinical added value
Considering:
initial data in which the non-inferiority of pitolisant was not demonstrated versus modafinil on the reduction of excessive daytime sleepiness,
new data submitted by the pharmaceutical company to support this reassessment, primarily based on an interim analysis scheduled in the protocol of an international, multicentre, prospective observational Post-Authorization Safety Study (PASS), aimed at evaluating the safety and use of WAKIX (pitolisant) in the treatment of narcolepsy with or without cataplexy in clinical practice for up to 5 years,
the medium-term safety profile (PASS study with a median follow-up of 54.5 months) similar to that having already been identified at the time of initial listing, with, however, the identification of a risk of suicidal ideation,
the absence of a prospective study demonstrating the superiority or non-inferiority of WAKIX (pitolisant), in terms of clinical efficacy and safety, versus an active comparator, despite these data having been requested by the Committee at the time of first listing,
the medical need partially met by several therapeutic alternatives already available and recommended in narcolepsy,
the Committee deems that WAKIX 4.5 mg and 18 mg (pitolisant) film-coated tablets provides no clinical added value (CAV V) in the current care pathway for the treatment of narcolepsy with or without cataplexy in adults.
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