Upadacitinib

Extended indication	Rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
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 remarks	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 remarks	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.

Patient volume

300 - 400

Market share is generally not included unless otherwise stated.

References

Ixekizumab record.

Additional remarks

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 remarks	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.

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 remarks	Lopende fase 3 studies.

Other information

There is currently no futher information available.