Extended indication

Patients With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One B

Therapeutic value

Possible added value

Registration phase

Registration application pending

Product

Active substance

Upadacitinib

Domain

Chronic immune diseases

Reason of inclusion

Indication extension

Main indication

Rheumatism

Extended indication

Patients With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD).

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

Possible 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.

References
NCT03104374

Expected patient volume per year

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).

Expected cost per patient per year

Cost

10,000.00 - 15,000.00

References
fabrikant; G-standaard, Z-index mei 2020
Additional comments
Gelijke kosten verwacht vergeleken met de andere JAK remmers en met een aantal andere biologische behandelingen; meerkosten vergeleken met sommige al wat oudere biologicals. Prijzen vergelijkbaar met huidige behandeling (baricitinib en tofacitinib). 
AIP van €878,82 per pak met 28 tabletten.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.