Version 1

Guselkumab

Medicine

Extended indication Tremfya is aangewezen voor de behandeling van matige tot ernstige plaque psoriasis bij volwassenen die in aanmerking komen voor systemische therapie.
Therapeutic value Possible added value
Total cost € 1,240,125,000.00
Registration phase Unknown

Product

Active substance Guselkumab
Domain Chronic immune diseases
Main indication Skin diseases
Extended indication Tremfya is aangewezen voor de behandeling van matige tot ernstige plaque psoriasis bij volwassenen die in aanmerking komen voor systemische therapie.
Proprietary name Tremfya
Manufacturer Janssen
Mechanism of action Unknown
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP Unknown
Submission date January 2017
Expected Registration November 2017
Orphan drug No
Registration phase Unknown
Additional remarks Geregistreerd in november 2017.

Therapeutic value

Current treatment options TNF-alfaremmers: adalimumab, etanercept, infliximab; Il12/23 remmer: ustekinumab; IL17 remmers: secukinumab, ixekizumab, brodalumab.
Therapeutic value Possible added value

This assessment does not indicate any potential inclusion in the package.
Substantiation Verwacht superieur wat betreft efficacy en vergelijkbaar wb safety in vergelijking met ustekinumab.
Frequency of administration 8 times a year
Dosage per administration 100 mg
References Langley et al, Br J Dermatol. 2017 Jun 21; Reich et al, J Am Acad Dermatol. 2017 Mar;76(3):405-417.; Zhuang et al, Eur J Clin Pharmacol. 2016 Nov;72(11):1303-1310.; Gordon et al, N Engl J Med. 2015 Jul 9;373(2):136-44.; Sofen et al, J Allergy Clin Immunol. 2014 Apr;133(4):1032-40.
Additional remarks Week 0, 4 en daarna iedere 8 weken

Expected patient volume per year

Patient volume 350 - 165,000

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 € 14,000.00 - 16,000.00

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 Fabrikant; Prescribing outlook 2017
Additional remarks Fabrikant (nov 2017): Kosten inductie jaar: €15.210; Kosten maintenance jaar: €14.124. Prescribing Outlook 2017: 'It will have to be competitive to other biologics (approx. £9,000-£11,000/year), although biosimilars may be 20-40% cheaper.'

Potential total cost per year

Total cost € 1,240,125,000.00

Off label use

Off label use No

Indication extension

Indication extensions Yes
Indication extensions Artritis psoriatica, Crohn

Other information