Arachis hypogaea (pinda) allergenen (pleister)

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	Allergy
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	November 2021
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	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 remarks	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.

Patient volume

7,500 - 15,000

Market share is generally not included unless otherwise stated.

References

Stichting voedselallergie; CBS

Additional remarks

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	5,800.00
References	Oral Immunotherapy and Viaskin® Peanut for Peanut Allergy: Effectiveness and Value, ICER 2019
Additional remarks	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.

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.