Extended indication

Extension of indication to include treatment of Juvenile Idiopathic Arthritis (EnthesitisRelated Art

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 (EnthesitisRelated Arthritis and Juvenile Psoriatic Arthritis) in patients 2 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy for Cosentyx.

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

June 2021

Expected Registration

April 2022

Orphan drug

No

Registration phase

Registration application pending

Additional comments
Cosentyx is momenteel beschikbaar voor de behandeling van plaque psoriasis (volwassenen en kinderen vanaf 6 jaar), artritis psoriatica en axiale spondylartritis.

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. Wellicht is deze behandeling een interessante keuze in geval van systemische JIA met huidcomponent.

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
https://clinicaltrials.gov/ct2/show/NCT03031782
Additional comments
Cosentyx wordt momenteel nog onderzocht in doseringen van 75mg en 150mg in klinische studies.

Expected patient volume per year

Patient volume

< 800

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

3,364.00 - 6,728.00

References
Z-Index
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

Off label use

No

Indication extension

Indication extension

Yes

Indication extensions

Hidradenitis Suppurativa

Other information

There is currently no futher information available.