Solriamfetol Medicine 13 December 2018 Extended indication Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy) Therapeutic value No judgement Total cost Registration phase Registered Product Active substance Solriamfetol Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Sleep disorders Extended indication Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy) Current proprietary name Already available biosimilars / generics Proprietary name Sunosi Manufacturer Jazz Portfolio holder Mechanism of action Other Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks selective dopamine and norepinephrine reuptake inhibitor Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2018 Expected Registration January 2020 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in november 2019. Geregistreerd in januari 2020. Therapeutic value Current treatment options Modafinil, gammahydroxyboterzuur (xyrem) en in de toekomst ook JZP-258. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Resultaat Tones 3 studie liet een significant gunstig effect zien met gering bijwerkingen profiel. Omdat het middel zowel dopaminerg als noradrenerg aangrijpt zou het zich onderscheiden van andere beschikbare middelen. Ook een lange termijn studie TONES 5 liet een gunstig effect zien en weinig of geen serieuze AE's. Duration of treatment Frequency of administration 1 times a day Dosage per administration 75-300 mg References NCT02348632 Additional remarks Expected patient volume per year Patient volume 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nederlands Vereniging Narcolepsie; GIPdatabank. Additional remarks In Nederland lijden er ongeveer 6.000-8.000 mensen aan narcolepsie. In 2016 gebruikten 406 mensen Xyrem (voor de indicatie narcolepsie met kataplexie). Het aantal patiënten wat behandeld zal worden met solriamfetol is afhankelijk van de therapeutische meerwaarde. Uitgaande van volledige substitutie van Xyrem, inschatting: 500 patiënten. Expected cost per patient per year Cost References GIPdatabank Additional remarks In 2016 werd €8.108 vergoed per gebruiker van Xyrem. 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 Expertopinie Additional remarks Het is complex om de overlopende indicaties en ziektebeelden te onderscheiden wat kan leiden tot off-label gebruik. Indication extension Indication extensions Yes Indication extensions Excessive sleepiness in Parkinson's disease References Clinicaltrials.gov; Jazz pipeline Additional remarks Other information Additional remarks