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Difelikefalin

Kapruvia

Extended indication Kapruvia is indicated for the treatment of moderate-to-severe pruritus associated with chronic kid
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.
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)
Additional remarks Opioïd kappa receptor agonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2021
Expected Registration April 2022
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP opinie ontvangen op Februari 2022.

Therapeutic value

Current treatment options UVB lichttherapie, topicaal creme.
Therapeutic value No estimate possible yet
Substantiation De fase 3 studie genaamd KALM-2 heeft zijn primaire eindpunten op basis van de (WI-NRS) schaal gehaald.
Duration of treatment continuous
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.
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
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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Prutitus CKD stages 3-4; Pruritus CLD; Atopic dermatitis; Acute postoperative pain
References Website Cara Therapeutics

Other information

There is currently no futher information available.