Extended indication Upadacitinib monotherapy for treatment of moderately to severely active Systemic lupus erythematosus in adults.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Upadacitinib
Domain Chronic immune diseases
Reason of inclusion Indication extension IND
Main indication Rheumatism
Extended indication Upadacitinib monotherapy for treatment of moderately to severely active Systemic lupus erythematosus in adults.
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 June 2027
Expected Registration January 2028
Registration phase Clinical trials
Additional remarks Tijdslijn op basis van IHSI-inschatting.

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

References NCT05843643 (SELECT-SLE)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Cost 9,500.00 - 9,600.00

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.

References medicijnkosten.nl
Additional remarks Een tablet Rinvoq 15mg kost €26,1 (exclusief BTW). Uitgaande van een dagelijkse behandeling zouden de kosten per patiënt per jaar uitkomen op €9.526,83.

Potential total cost per year

Off label use

Indication extension

Other information