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Upadacitinib

Rinvoq

Extended indication

RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who haverespon

Therapeutic value

Possible added value
Total cost

€ 3,436,800.00
Registration phase

Registration application pending

Product

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.​
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.
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

€ 3,436,800.00

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; Ulcerative colitis; Vasculitis
References 
Adisinsight.
Additional comments 
Lopende fase 3 studies.

Other information

There is currently no futher information available.