Extended indication Extension of indication to include treatment of Juvenile Idiopathic Arthritis (Enthesitis Related Ar
Therapeutic value Possible added value for a subgroup
Total cost 4,036,800.00
Registration phase Registration application pending

Product

Active substance Secukinumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Rheumatism
Extended indication Extension of indication to include treatment of Juvenile Idiopathic Arthritis (Enthesitis Related Arthritis and Juvenile Psoriatic Arthritis) in patients 2 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
Proprietary name Cosentyx
Manufacturer Novartis
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Monoklonaal antilichaam gericht tegen IL-17A.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date February 2022
Expected Registration December 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options NSAID’s , Glucocorticosteroiden, csDMARDS en TNFi (In-label adalimumab en etanercept en off-label golimumab)
Therapeutic value Possible added value for a subgroup
Substantiation Anti-TNF zal waarschijnlijk vooralsnog de eerste keuze blijven. Dit is al gevestigd in de behandelrichtlijn en hier is de meeste ervaring mee in de praktijk.
Duration of treatment continuous
Frequency of administration 1 times a month
Dosage per administration 75 mg per dosering bij kinderen < 50Kg en 150 mg bij kinderen > 50Kg lichaamsgewicht
References NCT03769168

Expected patient volume per year

Patient volume

< 8

Market share is generally not included unless otherwise stated.

References Record Abatacept; ReumaNederland; Ringold S et al. Arthritis Care Res. 2019;71:717–34; Mistry RR et al. Open Acc Rheum. 2019;11:19–31; Thierry S et al. Joint Bone Spine (2014) 112-117; Swart et al. Arthritis Res Ther 20, 285 (2018)
Additional comments JIA komt bij ongeveer 4.000 kinderen in Nederland voor; 30-40 nieuwe JIA diagnoses per jaar. De twee subtypen (Psoriatic arthritis en Enthesitis related arthritis) omvatten 20% van alle subtypen. Dit betekent dat er mogelijk substitutie bij een deel van de 800 prevalente patiënten plaats zal vinden plus 6 tot 8 nieuwe patiënten per jaar.

Expected cost per patient per year

Cost 336,400.00 - 672,800.00
References G-standaard
Additional comments Afhankelijk van de dosering (per lichaamsgewicht) betreffen de kosten per patient per jaar € 3364,20 (<50kg) of € 6728,40 (>50kg). De AIP van Cosentyx betreft € 560,70 per 150mg.

Potential total cost per year

Total cost

4,036,800.00

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 Hidradenitis Suppurativa

Other information

There is currently no futher information available.