Melatonin Medicine 09 January 2018 Extended indication Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient. Therapeutic value No judgement Total cost Registration phase Registered Product Active substance Melatonin Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Sleep disorders Extended indication Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient. Current proprietary name Already available biosimilars / generics Proprietary name Slenyto Manufacturer Neurim Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date June 2017 Expected Registration September 2018 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Betreft een nieuwe formulering. Positieve CHMP-opinie juli 2018. Geregistreerd in september 2018. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Het is nog onduidelijk wat er nieuw is aan de formulering van dit middel en wat de directe vergelijkende behandeling is. Om die reden lastig in te schatten wat de therapeutische waarde is van dit geneesmiddel bij de desbetreffende indicatie. Duration of treatment Frequency of administration 1 times a day Dosage per administration 0,5 mg tot 3 mg References Farmacotherapuetisch Kompas; Sánchez-Barceló et al. Int J Pediatr. 2011;2011:892624 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 100.00 - 200.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Medicijnkosten.nl. Additional remarks Verwachting is dat het meerkosten gaat opleveren. Schatting kosten p.p.p.j.: huidige kosten melatonin. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Kinderen met andere slaapproblemen References Clinicaltrials.gov. Additional remarks Other information Additional remarks