Arachis hypogaea (pinda) allergenen Medicine 05 December 2023 Extended indication Children of 1 year to less than 4 years of age with peanut allergy. Therapeutic value No estimate possible yet Total cost € 48,825,000.00 Registration phase Registration application pending Product Active substance Arachis hypogaea (pinda) allergenen Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Other chronic immune diseases Extended indication Children of 1 year to less than 4 years of age with peanut allergy. Current proprietary name Already available biosimilars / generics Proprietary name Palforzia Manufacturer Aimmune Portfolio holder Mechanism of action Allergen Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Ook bekend als AR101 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2023 Expected Registration September 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 7,500 - 15,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 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. References https://www.swissinfo.ch/eng/business/food-allergies-can-be-deadly-but-also-costly-for-those-concerned/48775396 Additional remarks In het VK 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 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks