Extended indication

RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult pa

Therapeutic value

Possible added value

Total cost

2,864,000.00

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 non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Proprietary name

Rinvoq

Manufacturer

Abbvie

Portfolio holder

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

ATMP

No

Submission date

January 2022

Expected Registration

August 2022

Orphan drug

No

Registration phase

Registered and reimbursed

Additional comments
Positieve CHMP opinie ontvangen op juni 2022.

Therapeutic value

Current treatment options

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

Therapeutic value

Possible added value

Substantiation

Dit geneesmiddel zal waarschijnlijk ingezet worden na falen op anti-TNF of anti-IL17 therapie. Upadacitinib is reeds geïndiceerd voor axiale SPA. Ook in de fase 3 studie voor non-radiographische axial SPA werden in vergelijking met placebo significante resultaten gevonden.

Frequency of administration

1 times a day

Additional comments
NCT04169373

Expected patient volume per year

Patient volume

< 250

Market share is generally not included unless otherwise stated.

References
Landewé en Van der Heijde. Ned Tijdschr Geneeskd. 2011(1);  Expert opinie(2);
Additional comments
De prevalentie van nrSpA wordt ingeschat tussen de 0,3%-0,4% (1). Ongeveer 50% van de patiënten wordt behandeld met een biological (2) . De inschatting is dat het met name gebruikt gaat worden na falen op een TNF-blokker en dat er ongeveer 450 patiënten voor in aanmerking zullen komen.

Expected cost per patient per year

Cost

11,456.00

References
G-standaard
Additional comments
Gebaseerd op kosten van andere behandelingen met Rinvoq. AIP 15mg : €879 per pack 28 tabletten, €11.456 per jaar

Potential total cost per year

Total cost

2,864,000.00

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

Off label use

No

Indication extension

Indication extension

Yes

Indication extensions

Crohn's disease; Ulcerative colitis; Hidradenitis suppurativa

Other information

There is currently no futher information available.