Difelikefalin Medicine 10 December 2019 Extended indication Kapruvia is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis. Therapeutic value No estimate possible yet Total cost € 13,436,670.00 Registration phase Registered Product Active substance Difelikefalin Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Skin diseases Extended indication Kapruvia is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis. Current proprietary name Already available biosimilars / generics Proprietary name Kapruvia Manufacturer Cara Portfolio holder Vifor Mechanism of action Receptor agonist Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Opioïd kappa receptor agonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2021 Expected Registration April 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen op Februari 2022. Therapeutic value Current treatment options UVB lichttherapie, topicaal creme. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De fase 3 studie genaamd KALM-2 heeft zijn primaire eindpunten op basis van de (WI-NRS) schaal gehaald. Duration of treatment Frequency of administration 3 times a week Dosage per administration 0,5 µg/kg References NCT03422653; NCT03636269; Nierstichting Additional remarks Toediening na iedere nierdialyse. Voor hemodialyse komt een patiënt meestal drie keer per week een halve dag naar het ziekenhuis. Expected patient volume per year Patient volume < 2,630 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nierstichting (1). Van der Willik, E. M., Hemmelder, M. H., Bart, H. A. J., van Ittersum, F. J., Hoogendijk-van den Akker, J. M., Bos, W. J. W., … Meuleman, Y. (2020). Routinely measuring symptom burden and health-related quality of life in dialysis patients: first results from the Dutch registry of patient-reported outcome measures. Clinical Kidney Journal. doi:10.1093/ckj/sfz192 (2). Additional remarks Op 31 december 2020 dialyseerden in totaal 6.292 mensen. Zo’n 16 procent daarvan dialyseert thuis met peritoneale dialyse, 84 procent wordt behandeld met hemodialyse (5.260), 270 mensen daarvan doen hemodialyse thuis (1). 50% (2630) van deze patiënten krijgen last van jeuk (2). Expected cost per patient per year Cost € < 5,109.00 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 fabrikant Additional remarks De AIP betreft 393 euro ex VAT voor een verpakking van 12 stuks van 0,5mg (KAPRUVIA INJVLST 50 MCG/ML FLACON 1ML) Potential total cost per year Total cost € 13,436,670.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Prutitus CKD stages 3-4; Pruritus CLD; Atopic dermatitis; Acute postoperative pain References Website Cara Therapeutics Additional remarks Other information Additional remarks