Expand all sections

Arachis hypogaea (pinda) allergenen

Palforzia

Extended indication Palforzia is indicated for the treatment of patients aged 1 to 17 years with a confirmed diagnosis o
Therapeutic value No estimate possible yet
Total cost 48,825,000.00
Registration phase Positive CHMP opinion

Product

Active substance Arachis hypogaea (pinda) allergenen
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Other chronic immune diseases
Extended indication Palforzia is indicated for the treatment of patients aged 1 to 17 years with a confirmed diagnosis of peanut allergy. Palforzia may be continued in patients 18 years of age and older.
Proprietary name Palforzia
Manufacturer Aimmune
Mechanism of action Allergen
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks Ook bekend als AR101. Dit betreft de uitbreiding van de huidige indicatie van 4 naar 1 jaar en ouder.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date October 2023
Expected Registration January 2025
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP opinie november 2024

Therapeutic value

Therapeutic value No estimate possible yet
References NCT03736447 (ARC005, POSEIDON)

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 tot 1% van de kinderen in westerse landen. In 2017 bedroeg het totaal aantal kinderen in de leeftijd van 4 tot 11 in Nederland ongeveer 1.500.000. 0,5 tot 1% hiervan bedraagt 7.500 tot 15.000.

Expected cost per patient per year

Cost 4,340.00
References https://www.swissinfo.ch/eng/business/food-allergies-can-be-deadly-but-also-costly-for-those-concerned/48775396
Additional remarks In het Verenigd Koninkrijk kost Palforzia £10,12 per dag. Dit zou voor Nederland betekenen dat dit per jaar €4.340 zou kosten.

Potential total cost per year

Total cost

48,825,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.