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

1. Product

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

2. Registration

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

3. 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

4. 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.

5. 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.

6. 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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Alle leeftijden
References
Clinicaltrials.gov

9. Other information

There is currently no futher information available.