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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 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.
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 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). 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 remarks 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 remarks Lopende fase 3 studies.

Other information

There is currently no futher information available.