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Upadacitinib

Rinvoq

Extended indication Rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have re
Therapeutic value No estimate possible yet
Total cost € 4,009,600.00
Registration phase Registered and reimbursed

Product

Active substance Upadacitinib
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Rheumatism
Extended indication Rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Proprietary name Rinvoq
Manufacturer Abbvie
Mechanism of action JAK tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date June 2020
Expected Registration January 2021
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP-opinie in december 2020.

Therapeutic value

Current treatment options Na falen NSAID zijn TNFi of anti-IL17A geregistreerd voor deze indicatie.
Therapeutic value No estimate possible yet
Substantiation Een recente publicatie van de fase 2-3 placebo gecontroleerde trial laat 52% ASAS40 respons zien ten opzichte van 26% in de placebo arm. De verwachting is dat patiënten die falen op anti-TNF medicatie eerst anti-IL17 therapie zullen ontvangen. Indien zij ook hier op falen zullen JAK-remmers worden ingezet, waaronder upadacitinib.
References NCT04169373; Lancet. 2019 Dec 7;394(10214):2108-2117.

Expected patient volume per year

Patient volume

300 - 400

Market share is generally not included unless otherwise stated.
References Ixekizumab record.
Additional comments Axiale spondyloartritis komt voor bij ongeveer 1 op de 400 mensen, dit zijn in Nederland ongeveer 42.500 mensen. De inschatting is dat ongeveer 3.000-4.000 patiënten anti-TNF medicatie krijgen. De verwachting is dat patiënten die falen op anti-TNF medicatie eerst anti-IL17 therapie zullen ontvangen en indien zij ook hier op falen upadacitinib ingezet zal worden. Dit zal neerkomen op zo'n 300-400 patiënten per jaar die in aanmerking komen voor upadacitinib.

Expected cost per patient per year

Cost € 11,456.00
References z-index november: 15mg.
Additional comments AIP 15mg: €879 per 28 tabletten, €11.456 per jaar.

Potential total cost per year

Total cost

€ 4,009,600.00

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 Atopic dermatitis; Crohn's disease; Giant cell arteritis; Ulcerative colitis; Vasculitis
References Adisinsight.
Additional comments Lopende fase 3 studies.

Other information

There is currently no futher information available.