Extended indication Ixekizumab monotherapy for treatment of active enthesitis-related or psoriatic juvenile idiopathic a
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Ixekizumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Rheumatism
Extended indication Ixekizumab monotherapy for treatment of active enthesitis-related or psoriatic juvenile idiopathic arthritis in children and adolescents
Proprietary name Taltz
Manufacturer Eli Lilly
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date August 2024
Expected Registration June 2025
Orphan drug No
Registration phase Registration application pending
Additional remarks Verwachte registratie op basis van gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding.

Therapeutic value

Current treatment options NSAIDs, glucocorticosteroiden, csDMARDS en TNFi (In-label adalimumab en etanercept en off-label golimumab)
Therapeutic value No estimate possible yet
References NCT04527380 (I1F-MC-RHCG)

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 9,902.61
References GIPdatabank (1)
Additional remarks In 2021 was de vergoeding per gebruiker van Taltz €9.902,61 (1). De verwachte kosten p.p.p.j. voor deze indicatie zal rond dit getal liggen.

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.