Clascoterone Medicine 13 December 2018 Extended indication Acne, moderate-to-severe Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending 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 Antiandrogen Route of administration Local Therapeutical formulation Cream Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date October 2023 Expected Registration July 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Benzoylperoxide, lokale of systemische retinoïden, lokale of orale antibiotica. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Meerwaarde is nog onduidelijk. De resultaten ten opzicht van placebo zijn beperkt. De werkgroep geeft aan geen grote impact te verwachten. 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 op de 100 mensen vertoont in meer of mindere mate acne. In 2016 werden bij 194.603 patiënten acnepreparaten voorgeschreven (170.810 lokaal en 23.793 systemisch). Retinoïden voor acne lokale behandeling: zo'n 55.000 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 retinoïden voor acne lokale behandeling ongeveer €20 tot €55 per patiënt 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