Upadacitinib

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 psoriatic arthritis in adult patients who haveresponded inadequately to, or who are intolerant to one or more DMARD. RINVOQ may be used as monotherapy or in combination with nonbiologic DMARDs.​

Product

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

June 2020

Expected Registration

May 2021

Orphan drug

No

Registration phase

Registration application pending

Additional comments
Fabrikant verwacht registratie in mei 2021.

Therapeutic value

Current treatment options

adalimumab, golimumab, ixekizumab, secukinumab infliximab, certolizumab pegol, etanercept, tofacitinib, ustekinumab, apremilast, abatacept.

Therapeutic value

Potential added value

Substantiation

De verwachting is dat upadacitinib de concurrentie aan zal gaan met de andere JAK remmers. Upadacitnib is even effectief als tofacitinib en baricitnib, maar heeft mogelijk minder nadelige bijwerkingen zoals het ontstaan van trombose. Hierdoor zal waarschijnlijk eerder upadacitnib voorgeschreven worden.

Duration of treatment

Not found

Frequency of administration

1 times a day

Dosage per administration

15 mg

References
NCT03104374

Expected patient volume per year

Patient volume

200 - 400

Market share is generally not included unless otherwise stated.

References
IQVIA
Additional comments
Naar schatting zijn er ongeveer 18.544 mensen in Nederland met psoriatrische artritis die in ziekenhuizen behandeld worden. Hiervan wordt ~26% met een biological behandeld (4.914). Er zijn veel verschillende behandelopties voor deze indicatie. De verwachting is dat er maximaal 400 patiënten in aanmerking zullen komen voor deze behandeling. En dat deze patiënten verdeeld zullen worden over upadacitinib en tofacitinib.

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

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; Ulcerative colitis; Vasculitis

References
Adisinsight.
Additional comments
Lopende fase 3 studies.

Other information

There is currently no futher information available.