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Guselkumab

Tremfya

Extended indication Tremfya is aangewezen voor de behandeling van matige tot ernstige plaque psoriasis bij volwassenen d
Therapeutic value Possible added value
Total cost 1,240,125,000.00

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
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2017
Expected Registration November 2017
Orphan drug No
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
Substantiation Verwacht superieur wat betreft efficacy en vergelijkbaar wb safety in vergelijking met ustekinumab.
Duration of treatment continuous
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
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

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 Yes
Indication extensions Artritis psoriatica, Crohn

Other information

There is currently no futher information available.