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Risankizumab

Skyrizi

Extended indication Indicated for UC (collitis ulcerosa) with demonstrated intolerance or inadequate response to conven
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
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.
Proprietary name Skyrizi
Manufacturer Abbvie
Portfolio holder Abbvie
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Submission date 2023
Expected Registration 2024
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options o.a. Tofacitinib
Therapeutic value No estimate possible yet
Duration of treatment continuous
Frequency of administration 1 times every 8 weeks
Dosage per administration 600 mg inductietherapie en 180 of 360 mg onderhoudstherapie
References NCT03398148

Expected patient volume per year

Patient volume

150

Market share is generally not included unless otherwise stated.
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
References Fabrikant
Additional remarks AIP van €2.312 per dosis. Dit geldt zowel voor de 600 mg i.v. 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

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.