Levoketoconazole Medicine 13 December 2018 Extended indication Endogenous cushing syndrome, first or subsequent lines for persistent or recurrent disease, in patients aged ≥18 years if not suitable for surgery Therapeutic value No judgement Total cost € 1,650,000.00 Registration phase Clinical trials Product Active substance Levoketoconazole Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Hormonal disorders Extended indication Endogenous cushing syndrome, first or subsequent lines for persistent or recurrent disease, in patients aged ≥18 years if not suitable for surgery Current proprietary name Already available biosimilars / generics Proprietary name Recorlev Manufacturer Strongbridge Portfolio holder Mechanism of action Enzyme inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks (2S,4R)-ketoconazole steroïdogeneseremmer Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Twee fase III studies hebben hun primary completion date respectievelijk in april 2018 en mei 2019 Therapeutic value Current treatment options pasireotide, ketoconazol, mitotane, metyrapone, mifeproston. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Mogelijk minder bijwerkingen dan bij een behandeling met ketoconazol. Zal met name gebruikt worden als bridging therapie na radiotherapie. Duration of treatment Frequency of administration 1 times a day Dosage per administration 1200 mg References NCT01838551; NCT03277690; Scrip, 13 augustus 2018 Additional remarks SONICS trial met efficacy primary endpoint and is well tolerated Expected patient volume per year Patient volume 20 - 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nederlandse Hypofyse Stichting Additional remarks Naar schatting wordt deze diagnose in Nederland bij ongeveer bij 50 mensen per jaar gesteld. Levketoconazole zal de markt moeten delen met pasireotide en mogelijk osilodrostat. Geschat marktaandeel bedraagt 40%. Echter bij Cushing's syndroom mogelijk 60-100 patiënten. Exact aantal patiënten is dus afhankelijk van de precieze indicatiestelling. Expected cost per patient per year Cost € 20,000.00 - 35,000.00 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 GIPdatabank; fabrikant osilodrostat (Novartis) Additional remarks Pasireotide en osilodrostat zijn geprijst in de range €20.000-€35.000. Afhankelijk van de therapeutische waarde zal levoketoconazole vergelijkbaar zijn. Potential total cost per year Total cost € 1,650,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks