Extended indication

Treatment of peanut allergy in peanut-allergic children 4 through 11 years of age.

Therapeutic value

No estimate possible yet

Total cost

65,250,000.00

Registration phase

Registration application pending

Product

Active substance

Arachis hypogaea (pinda) allergenen (pleister)

Domain

Chronic immune diseases

Reason of inclusion

New medicine (specialité)

Main indication

Other chronic immune diseases

Extended indication

Treatment of peanut allergy in peanut-allergic children 4 through 11 years of age.

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)

Type of trajectory

Normal trajectory

Submission date

October 2020

Expected Registration

March 2022

Orphan drug

No

Registration phase

Registration application pending

Additional comments
FDA fast track designation

Therapeutic value

Therapeutic value

No estimate possible yet

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. In 2017 bedroeg het totaal aantal kinderen in de leeftijd van 4-11 in Nederland ongeveer 1.500.000. 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

5,800.00

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

65,250,000.00

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

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.