Difelikefalin Medicine 10 December 2019 Extended indication Pruritus In Hemodialysis Patients Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Difelikefalin Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Skin diseases Extended indication Pruritus In Hemodialysis Patients Current proprietary name Already available biosimilars / generics Proprietary name Korsuva Manufacturer Cara Portfolio holder 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 Registration application pending Reimbursement Medicine sluice Additional remarks SPS UK: "Mar 21 · Filed in EU via centralised procedure; a regulatory decision is expected second quarter of 2022" Therapeutic value Current treatment options 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 Additional remarks Toediening na iedere nierdialyse. Expected patient volume per year Patient volume < 2,750 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nierstichting; Hu et al. Medicine (Baltimore). 2018 May; 97(21): e10633. Additional remarks Ruim 5.000 mensen in Nederland krijgen hemodialyse. De inschattingen van het aantal dialysepatiënten die last hebben van jeuk varieert, maar wordt in de literatuur ingeschat op 55%. Dit zou 2.750 mogelijke patiënten in Nederland betekenen. Welk deel van deze patiëntengroep in aanmerking komt voor deze behandeling is nog onduidelijk. 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 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