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Certolizumab pegol

Cimzia

Extended indication Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Therapeutic value Possible added value
Total cost 6,125,000.00
Registration phase Positive CHMP opinion

Product

Active substance Certolizumab pegol
Domain Chronic immune diseases
Main indication Skin diseases
Extended indication Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Proprietary name Cimzia
Manufacturer UCB
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Expected Registration June 2018
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve opinie CHMP april 2018.

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
Substantiation Meerwaarde effectiviteit ten opzichte van 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).
Duration of treatment continuous
Frequency of administration 1 times every 2 weeks
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

350

Market share is generally not included unless otherwise stated.
Additional remarks Komt in principe beschikbaar voor alle patiënten met matige tot ernstige psoriasis, in Nederland zijn dat er ca. 165.000. Middel zal zijn plek moeten veroveren ten opzichte van 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
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

Total cost

6,125,000.00

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.

Off label use

Off label use No

Indication extension

Indication extension No

Other information

There is currently no futher information available.