Extended indication

Moderately to Severely Active Ulcerative Colitis

Therapeutic value

No estimate possible yet

Total cost

3,436,800.00

Registration phase

Clinical trials

Product

Active substance

Upadacitinib

Domain

Chronic immune diseases

Reason of inclusion

Indication extension

Main indication

Bowel diseases

Extended indication

Moderately to Severely Active Ulcerative Colitis

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

2021

Expected Registration

November 2022

Orphan drug

No

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht registratie in november 2022.

Therapeutic value

Current treatment options

Biologicals, biosimilars, JAK inhibitors

Therapeutic value

No estimate possible yet

Substantiation

In de fase 2 studie (U-Achieve) zijn de klinische eindpunten behaald. De fase 3 studie (U-Accomplish) loopt nog. Indien upadacitinib effectief blijkt zal het waarschijnlijk gaan concurreren met tofacitinib en in de toekomst mogelijk met filgotinib. Het bijwerkingenprofiel van de geneesmiddelen zal moeten uitwijzen welk geneesmiddel de voorkeur krijgt.

Frequency of administration

1 times a day

Dosage per administration

15 mg

References
NCT03653026; U-Accomplish (NCT03653026)

Expected patient volume per year

Patient volume

200 - 400

Market share is generally not included unless otherwise stated.

References
Crohn-colitis.nl; Horizonscan Alicaforsen;
Additional comments
Colitis ulcerosa komt steeds vaker voor met name in de westerse landen. Er zijn momenteel ruim 80.000 mensen in Nederland met een chronische darmontsteking. Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets meer dan de helft colitis. In 2017 werd vedolizumab voorgeschreven aan 1.658 patiënten met chronische darmontstekingen, hiervan hebben er ongeveer 800 Colitis Ulcerosa. Indien upadacitinib effectief blijkt zullen er mogelijk 200-400 patiënten voor in aanmerking komen in Nederland.

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

3,436,800.00

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

Ankylosing spondylitis; Atopic dermatitis; Crohn's disease; Giant cell arteritis; Vasculitis

References
adisinsight
Additional comments
Lopende fase 3 studies

Other information

There is currently no futher information available.