Extended indication Stelera is indicated for the treatment of moderate to severe plaque psoriasis in children and adoles
Therapeutic value Possible added value
Total cost 1,296,900.00
Registration phase Registered and reimbursed


Active substance Ustekinumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Skin diseases
Extended indication Stelera is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Proprietary name Stelara
Manufacturer Janssen
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments IL12/23 remmer


Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2019
Expected Registration January 2020
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP-opinie in december 2019. Geregistreerd in januari 2020.

Therapeutic value

Current treatment options de volgende behandelingen zijn geregistreerd voor de behandeling van psoriasis, niet geselecteerd op leeftijd: brodalumab, ixekizumab, secukinumab, guselkumab, tildrakizumab, risankizumab, baricitinib, tofacitinib, apremilast, abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab
Therapeutic value Possible added value
Substantiation Er wordt verwacht dat Ustekinumab een mogelijke meerwaarde zal kunnen hebben ten opzichte van TNF-remmers.
Duration of treatment continuous
Frequency of administration 1 times every 12 weeks
Dosage per administration 0,75 mg/kg
References NCT02698475

Expected patient volume per year

Patient volume

< 100

Market share is generally not included unless otherwise stated.

References NHG-Standaard Psoriasis
Additional comments Bij jonge kinderen is de prevalentie laag (ongeveer 0,4 per 1.000 patiënten per jaar). In Nederland zijn er 1.5 miljoen kinderen in de leeftijd van 6 tot 12 jaar. Dit betekent naar schatting 600 kinderen die in aanmerking zullen komen voor deze behandeling. De werkgroep verwacht een patiëntvolume van rond de 100 patiënten.

Expected cost per patient per year

Cost 12,969.00
References fabrikant
Additional comments 90mg pen/wegwerpspuit kost € 2.992,93. Voor de behandeling van een patiënt betekent dit 4,33 spuiten per jaar.

Potential total cost per year

Total cost


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 Yes
Indications off label use Hidradenitis suppurativa, na TNFa (Kind 12-18 jaar) (therapieresistent)
References historisch bestand add-on van Z-index

Indication extension

Indication extension Yes
Indication extensions systemische lupus erymatosis
References clinicaltrial.gov

Other information

There is currently no futher information available.