Risankizumab Medicine 07 December 2022 Extended indication Indicated for UC (collitis ulcerosa) with demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies. Therapeutic value No estimate possible yet Total cost € 2,687,700.00 Registration phase Clinical trials Product Active substance Risankizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Bowel diseases Extended indication Indicated for UC (collitis ulcerosa) with demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies. Current proprietary name Already available biosimilars / generics Proprietary name Skyrizi Manufacturer Abbvie Portfolio holder Abbvie Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options o.a. Tofacitinib Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 8 weeks Dosage per administration 600 mg inductietherapie en 180 of 360 mg onderhoudstherapie References NCT03398148 Additional remarks Expected patient volume per year Patient volume 150 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata Additional remarks In 2021 waren er 481 patiënten die tofacitinib kregen. Dit zijn de mensen die mogelijk in aanmerking komen voor gebruik van risankizumab. In de praktijk zullen alleen de mensen worden overgezet die falen op tofacitinib en zal het patiëntvolumen dus lager uitkomen. Ongeveer 150 patiënten hebben voor óf na tofacitinib nog een biological gekregen. Deze groep komt in aanmerking voor behandeling met risankizumab. Expected cost per patient per year Cost € 15,028.00 - 20,808.00 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 AIP van €2.312 per dosis. Dit geldt zowel voor de 600mg intraveneuze dosering als de 360 mg subcutane onderhoudstherapie. In jaar 1 zijn er 9 doseringen en in jaar 2 en verder 6,5 doseringen per jaar. Potential total cost per year Total cost € 2,687,700.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks