Lixivaptan Medicine 07 December 2022 Extended indication Autosomal Dominant Polycystic Kidney Disease (ADPKD). Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Lixivaptan Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Metabolic diseases Extended indication Autosomal Dominant Polycystic Kidney Disease (ADPKD). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date Expected Registration Orphan drug Yes Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De fabrikant heeft in juli 2022 aangegeven in een persbericht dat de klinische studies gestopt zijn vanwege het ontstaan van leverenzymstoornissen. Therapeutic value Current treatment options Tolvaptan Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is sterk de verwachting dat dit middel een gelijk effect heeft als de huidige standaard tolvaptan op het beloop van ADPKD. Duration of treatment Frequency of administration 2 times a day Dosage per administration References NCT04152837 Additional remarks Expected patient volume per year Patient volume < 180 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks 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 Unknown Indication extensions References Additional remarks Other information Additional remarks