Extended indication

Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerativ

Therapeutic value

No estimate possible yet

Total cost

3,436,800.00

Registration phase

Registered and reimbursed

Product

Active substance

Upadacitinib

Domain

Chronic immune diseases

Reason of inclusion

Indication extension

Main indication

Bowel diseases

Extended indication

Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

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

Submission date

2022

Expected Registration

July 2022

Registration phase

Registered and reimbursed

Additional comments
Fabrikant verwacht registratie in 2022. Positieve CHMP opinie ontvangen in mei 2022.

Therapeutic value

Current treatment options

Biologicals, biosimilars, JAK remmers.

Therapeutic value

No estimate possible yet

Substantiation

In de fase 2 studie (U-Achieve) zijn de klinische eindpunten behaald. In een fase 3 studie (U-Accomplish) werd resultaat ten opzichte van placebo gevonden. Upadacitinib zal waarschijnlijk gaan concurreren met tofacitinib en in de toekomst mogelijk met filgotinib. De verwachting op basis van resultaten in andere ziektebeelden is dat upadacitinib de voorkeur zal krijgen ten opzichte van deze andere JAK-remmers.

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
G-standaard;
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.