Version 4

Ustekinumab

Medicine

Extended indication Extension of indication to include a new population for Stelara solution for injection in children aged 6 to 12 years with moderate to severe psoriasis.
Therapeutic value Possible added value
Total cost € 1,490,000.00
Registration phase Registration application pending

Product

Active substance Ustekinumab
Domain Chronic immune diseases
Reason of inclusion Indication extension IND
Main indication Skin diseases
Extended indication Extension of indication to include a new population for Stelara solution for injection in children aged 6 to 12 years with moderate to severe psoriasis.
Proprietary name Stelara
Manufacturer Janssen
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks IL12/23 remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP Unknown
Submission date July 2019
Expected Registration July 2020
Orphan drug No
Registration phase Registration application pending
Additional remarks Fabrikant verwacht registratie in Q2 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

This assessment does not indicate any potential inclusion in the package.
Substantiation Er wordt verwacht dat Ustekinumab een mogelijke meerwaarde zal kunnen hebben en opzichte van TNF-remmers.
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 remarks Bij jonge kinderen is de prevalentie laag (ongeveer 0,4 per 1000 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.

Expected cost per patient per year

Cost € 14,900.00

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.
References o.b.v. lijstprijs en posologie onderhoudsdosering
Additional remarks 45 mg wegwerpspuit kost €2.980,69. Voor de behandeling van een patiënt 50 kg (0,75 mg/kg) betekent dit 5 spuiten per jaar.

Potential total cost per year

Total cost € 1,490,000.00

Off label use

Off label use Yes
References historisch bestand add-on van Z-index

Indication extension

Indication extensions Yes
Indication extensions hidradinitis superativa, systemische lupus erymatosis
References clinicaltrial.gov

Other information