Favourable opinion for reimbursement in “the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning”.
Role in the care pathway?
QUVIVIQ (daridorexant) 25 mg and 50 mg film-coated tablets are a second-line therapy in adults for the treatment of insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.
The Committee highlights that in the event of failure of sleep hygiene measures, the use of non-medicinal treatments, such as cognitive behavioural therapy, should be favoured before initiating any medicinal treatment indicated in chronic insomnia.
Special recommendations
As regards the care pathway of patients, the Committee points out that:
in the event of failure of sleep hygiene measures, the use of non-medicinal treatments, such as cognitive behavioural therapy, should be favoured before initiating any medicinal treatment indicated in chronic insomnia,
an accurate and complete assessment of patients’ medical, psychological and social situation, and of their sleep habits, is necessary before prescribing any treatment indicated in chronic insomnia,
no other hypnotic medicinal products are recommended in the treatment of chronic insomnia,
the duration of treatment should be as short as possible. The appropriateness of continuing treatment should be assessed within 3 months and periodically thereafter.
Clinical Benefit
Moderate
The clinical benefit of QUVIVIQ (daridorexant) 25 mg and 50 mg film-coated tablets is moderate in the MA indication.
Clinical Added Value
minor
Considering:
demonstration of a superiority versus placebo after 12 weeks of treatment with daridorexant 25 mg (N=2 studies) and daridorexant 50 mg (N=1 study), with a low effect size on:
objective sleep variables, in the region of -5 to -25 minutes versus placebo depending on the doses, on wake after sleep onset (-10.3 to -22.8 minutes) and on latency to persistent sleep (-7.6 to -11.7 minutes),
the subjective sleep variable of total sleep time, in the region of 10 to 25 minutes versus placebo depending on the doses (+9.9 to +22.1 minutes),
demonstration of a superiority versus placebo after 12 weeks of treatment with daridorexant only at the 50-mg dose on the IDSIQ “sleepiness” domain score (daytime functioning) in the region of -1.75 to -1.90 points out of 40,
the acceptable safety profile of daridorexant at the two doses,
the inadequately met medical need, with no other hypnotic medicinal products being recommended in the treatment of chronic insomnia,
but in view of:
the absence of data enabling assessment of the superiority of daridorexant 25 mg and 50 mg compared to the non-medicinal therapies recommended as first-line treatment,
the debatable clinical relevance of the result for the IDSIQ “sleepiness” domain score (daytime functioning) at the 50 mg dose of daridorexant only,
the lack of evidence of maintenance of the long-term effect of daridorexant on objective and subjective sleep variables, given a lack of robust data,
the limited nature of the safety data after 12 months, on a small number of randomised patients (around 60%),
the Committee deems that QUVIVIQ (daridorexant) 25 mg and 50 mg film-coated tablets provide a minor clinical added value (CAV IV) in adults for the treatment of insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.
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