Extended indication

Extension of indication to include the treatment of active ankylosing spondylitis in adult patient f

Therapeutic value

No judgement

Total cost

4,009,600.00

Registration phase

Registration application pending

Product

Active substance

Upadacitinib

Domain

Chronic immune diseases

Reason of inclusion

Indication extension

Main indication

Rheumatism

Extended indication

Extension of indication to include the treatment of active ankylosing spondylitis in adult patient for Rinvoq

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

May 2021

Orphan drug

No

Registration phase

Registration application pending

Additional comments
Fabrikant verwacht registratie in mei 2021.

Therapeutic value

Current treatment options

Na falen NSAID zijn TNFi of anti-IL17A geregistreerd voor deze indicatie.

Therapeutic value

No judgement

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 pack 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.