Version 1

Certolizumab pegol

Medicine

Extended indication Psoriasis
Therapeutic value Possible added value
Registration phase Unknown

Product

Active substance Certolizumab pegol
Domain Chronic immune diseases
Main indication Skin diseases
Extended indication Psoriasis
Proprietary name Cimzia
Manufacturer UCB
Mechanism of action Unknown
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Expected Registration April 2018
Orphan drug No
Registration phase Unknown
Additional remarks Indicatie-uitbreiding

Therapeutic value

Current treatment options TNF-alfaremmers: adalimumab, etanercept, infliximab; Il12/23 remmer: ustekinumab; IL17 remmers: secukinumab, ixekizumab, brodalumab; IL23 remmers: guselkumab (wacht op add-on status).
Therapeutic value Possible added value

This assessment does not indicate any potential inclusion in the package.
Substantiation Meerwaarde effectiviteit tov etanercept (bij dosering 400 mg per 2 weken), meerwaarde mogelijk bij zwangerschap en borstvoeding. Gelijke waarde wat betreft veiligheid als etanercept (mogelijke uitzondering zwangerschap/borstvoeding).
Frequency of administration 2 times a month
Dosage per administration 400 mg in week 0, 2 en 4; daarna 200 mg
References Reich et al, Br J Dermatol. 2012 Jul;167(1):180-90.
Additional remarks Toediening 1 maal per 2 weken

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
Additional remarks Komt in principe beschikbaar voor alle patienten met matige tot ernstige psoriasis, in NL zijn dat er ca. 165.000. Middel zal zijn plek moeten veroveren tov andere reeds aanwezige biologicals. Verwachting is een paar honderd patiënten. Aantallen afhankelijk van toekomstig label.

Expected cost per patient per year

Cost € 15,000.00 - 20,000.00

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 Medicijnkosten.nl; Fabrikant
Additional remarks Gelijke kosten. Huidige prijs is € 525,80 per 200 mg. Dit komt neer op 3*2*525,80+23*525,80= €15.248,20 pppj. Fabrikant (nov 2017): 20.000 euro/jaar op basis van AIP.

Potential total cost per year

Off label use

Off label use No

Indication extension

Indication extensions No

Other information