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.