Tildrakizumab

Active substance Tildrakizumab
Domain Chronic immune diseases
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Skin diseases
Extended indication Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Product

Proprietary name Ilumetri
Manufacturer Almirall
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date April 2017
Expected Registration September 2018
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP-opinie juli 2018. Geregistreerd in september 2018.

Therapeutic value

Current treatment options TNF-alfaremmers: adalimumab, etanercept, infliximab; Il12/23 remmer: ustekinumab; IL17 remmers: secukinumab, ixekizumab, brodalumab; IL23 remmers: guselkumab.
Therapeutic value Potential added value
Substantiation Effectiviteit waarschijnlijk gelijke waarde ten opzichte van guselkumab, superieur ten opzichte van etanercept. Veiligheid is een mogelijke meerwaarde ten opzichte van IL17 remmers, met name wat betreft candida-infecties die in de praktijk optreden. Alle Il23 remmers (guselkumab, tildrakizumab, risankizumab) blijken in de studies vrijwel geen verhoogde kans op candida mucosaal danwel van de huid te geven ten opzichte van 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 ten opzichte van andere reeds aanwezige biologicals.
Duration of treatment Not found
Frequency of administration 1 times every 12 weeks
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 comments Week 0, 4, daarna iedere 12 weken

Expected patient volume per year

Patient volume

350

Market share is generally not included unless otherwise stated.

Additional comments Komt in principe beschikbaar voor alle patiënten met matige tot ernstige psoriasis, in Nederland zijn dat er circa 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 Prescribing outlook 2017
Additional comments 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

Total cost

6,125,000

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 Atritis psoriatica

Other information

There is currently no futher information available.