Upadacitinib

Extended indication	Extension of indication to include treatment of giant cell arteritis (GCA) in adult patients
Therapeutic value	No estimate possible yet
Total cost	6,447,600.00
Registration phase	Registration application pending

Product

Active substance	Upadacitinib
Domain	Chronic immune diseases
Reason of inclusion	Indication extension
Main indication	Rheumatism
Extended indication	Extension of indication to include treatment of giant cell arteritis (GCA) in adult patients
Proprietary name	Rinvoq
Manufacturer	Abbvie
Portfolio holder	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
ATMP	No
Submission date	July 2024
Expected Registration	June 2025
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	Indiening juli 2024. Fabrikant verwacht registratie juni 2025.

Therapeutic value

Current treatment options	Glucocorticosteroïden, MTX en tocilizumab
Therapeutic value	No estimate possible yet
Substantiation	De effectiviteit van upadactinib bij GCA zal nog moeten blijken. Het is wel de verwachting dat dit mogelijk een plek zal kunnen krijgen binnen de behandeling. Maar resultaten uit de studies dienen afgewacht te worden.
References	NCT03725202 (SELECT-GCA, M16-852)

Expected patient volume per year

Patient volume	< 600 Market share is generally not included unless otherwise stated.
References	1:Expertopinie;
Additional remarks	Er wordt verwacht dat er mogelijk minder dan 600 patiënten in aanmerking zullen komen voor deze behandeling.

Patient volume

< 600

Market share is generally not included unless otherwise stated.

References

1:Expertopinie;

Additional remarks

Er wordt verwacht dat er mogelijk minder dan 600 patiënten in aanmerking zullen komen voor deze behandeling.

Expected cost per patient per year

Cost	10,746.00
References	Lijstprijs rinvoq 15mg op basis van G-standaard juli 2024

Potential total cost per year

Total cost	6,447,600.00 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.

Total cost

6,447,600.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.