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Upadacitinib

Rinvoq

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 remarks 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 remarks 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 remarks 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.