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Tildrakizumab

Medicine

Extended indication Plaque psoriasis, moderate-to-severe.
Therapeutic value Possible added value
Registration phase Unknown

Product

Active substance Tildrakizumab
Domain Chronic immune diseases
Main indication Skin diseases
Extended indication Plaque psoriasis, moderate-to-severe.
Manufacturer Almirall
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 April 2017
Expected Registration February 2018
Orphan drug No
Registration phase Unknown

Therapeutic value

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

This assessment does not indicate any potential inclusion in the package.
Substantiation Effectiviteit waarschijnlijk gelijke waarde tov guselkumab, superieur tov etanercept. Veiligheid is een meerwaarde tov IL17 remmers. Alle Il23remmers (guselkumab, tildrakizumab, risankizumab) blijken in de studies vrijwel geen verhoogde kans op candida mucosaal danwel van de huid te geven tov placebo, terwijl alle IL17 remmers dat wel doen. Komt in principe beschikbaar voor alle patiënten met matige tot ernstige psoriasis. Middel zal zijn plek moeten veroveren tov andere reeds aanwezige biologicals.
Dosage per administration 100-200 mg
References Reich et al. Lancet. 2017 Jul 15;390(10091):276-288. doi: 10.1016/S0140-6736(17)31279-5.; Papp et al, Br J Dermatol. 2015 Oct;173(4):930-9. doi: 10.1111/bjd.13932. Epub 2015 Oct 15.; Kopp et al, Nature. 2015 May 14;521(7551):222-6. doi: 10.1038/nature14175.; Beroukhim et al, J Drugs Dermatol. 2015 Oct;14(10):1093-6. Review.; Amin et al, J Eur Acad Dermatol Venereol. 2017 Oct;31(10):1627-1632. doi: 10.1111/jdv.14451. Epub 2017 Jul 17.
Additional remarks Week 0, 4, daarna iedere 12 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 Prescribing outlook 2017
Additional remarks Gelijke kosten. Prescribing Outlook 2017: 'This 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

Off label use

Off label use No

Indication extension

Indication extensions Yes
Indication extensions Atritis psoriatica

Other information