Octreotide

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).
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.

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.

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.

Upadacitinib