Arachis hypogaea (pinda) allergenen (pleister)

Active substance Arachis hypogaea (pinda) allergenen (pleister)
Domain Chronic immune diseases
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Allergy
Extended indication Pinda-allergie bij kinderen van 4-11 jaar

Product

Proprietary name Viaskin Peanut
Manufacturer DBV Technologies
Mechanism of action Allergen
Route of administration Transdermal
Therapeutical formulation Band Aid
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials
Additional comments FDA fast track designation

Therapeutic value

Therapeutic value No judgement
Substantiation Studie loopt nog, te vroeg om uitspraken te doen over de effectiviteit. Lijkt weinig bijwerkingen met zich mee te brengen.
Duration of treatment Average 12 month / months
Frequency of administration 1 times a day
Dosage per administration 250 µg
References NCT02636699

Expected patient volume per year

Patient volume

7,500 - 15,000

Market share is generally not included unless otherwise stated.

References Stichting voedselallergie; CBS
Additional comments Volgens de Stichting Voedselallergie komt pinda-allergie voor bij 0,5-1% van de kinderen in westerse landen. Het totaal aantal kinderen van de leeftijden 4-11 in Nederland in 2017 bedroeg ongeveer 1,5 miljoen. 0,5-1% hiervan bedraagt 7.500-15.000. De precieze indicatiestelling zal moeten uitwijzen welke kinderen hier voor in aanmerking komen.

Expected cost per patient per year

Cost 5,800
References Oral Immunotherapy and Viaskin® Peanut for Peanut Allergy: Effectiveness and Value, ICER 2019
Additional comments De inschatting van de prijs door het ICER rapport is $6.500 per jaar. Dit komt neer op ongeveer €5.800.

Potential total cost per year

Total cost

65,250,000

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

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Alle leeftijden
References Clinicaltrials.gov

Other information

There is currently no futher information available.