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 remarks 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 remarks 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 remarks 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 remarks 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.