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New HTA Decisions in France
June 2020
Drug name
SLENYTO® (melatonin)
Company
Biocodex
Decision date
26/06/2019
Therapeutic area
Mental health and behavioural conditions
Therapeutic sub area
Autism
Therapeutic area 2
Genetic conditions
Therapeutic sub area 2
Genetic conditions: general and other
Official notice date
22/11/2019
Reimbursement %
65
Decision (SMR)
Important
Decision (ASMR)
Minor improvement (IV)
Indication
SLENYTO® is indicated for the treatment of insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome when sleep hygiene measures are insufficient.
Decision Type
New technology assessment
Summary
The committee considered the actual benefit of SLENYTO® to be 'important' in the indications of the Marketing Authorisation. Considering: - the superiority of melatonin LP demonstrated versus placebo in a randomized, double-blind phase III study with a moderate amount of effect on improvement in total sleep time at 13 weeks (+32 minutes in patients with a total sleep time of around 7:30); - exploratory data (non-hierarchical secondary criteria) suggesting an impact of melatonin LP in particular on the quality of life in this disease, for which the burden is important for patients and their entourage; - the medical need for alternative therapies in patients aged 2 to 18 years who have autism spectrum disorder and/or Smith-Magenis syndrome when sleep hygiene measures are insufficient. The committee proposed 65% reimbursement.