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.