Clascoterone Medicine 13 December 2018 Extended indication Acne, moderate-to-severe Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Clascoterone Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Skin diseases Extended indication Acne, moderate-to-severe Current proprietary name Already available biosimilars / generics Proprietary name Winlevi Manufacturer Cassiopea Portfolio holder Mechanism of action Unknown Route of administration Local Therapeutical formulation Cream Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Anti-androgeen. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion date safety trial in september 2018 Therapeutic value Current treatment options Benzoylperoxide, lokale retinoïden, lokale of orale antibiotica Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Meerwaarde nog onduidelijk. Cassiopea heeft bekend gemaakt dat Winlevi erg positieve top-line fase III resultaten heeft geboekt. Duration of treatment Frequency of administration 2 times a day Dosage per administration 1% References NHG standaard acne; Cassiopea.com; NCT02608476 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NHG-Standaard Acne; GIPdatabank Additional remarks Acne is een veelvoorkomende aandoening, ongeveer 1:100 patiënten vertoond in meer of mindere mate acne. In 2016 werden bij 194.603 patiënten acnepreparaten voorgeschreven (170.810 lokaal en 23.793 systemisch). Retinoiden voor acne lokale behandeling: zo'n 55 duizend gebruikers per jaar. Mogelijk betreft dit dus een grote patiëntenpopulatie maar dit aantal zal sterk afhangen van de indicatie en de therapeutische waarde ten opzichte van de huidige behandelopties. Expected cost per patient per year Cost € 5.00 - 20.00 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 GIP databank. Additional remarks De prijs voor retinoiden voor acne lokale behandeling zo'n 5-20 euro per patient per jaar. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions References Clinicaltrials.gov Additional remarks Androgenetic Alopecia in fase II Other information Additional remarks