Arachis hypogaea (pinda) allergenen Medicine 05 December 2023 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. Therapeutic value No estimate possible yet Total cost € 48,825,000.00 Registration phase Registered 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 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. 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. Dit betreft de uitbreiding van de huidige indicatie van vier jaar naar een jaar en ouder. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date October 2023 Expected Registration January 2025 Orphan drug No Registration phase Registered 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 Het verlagen van de leeftijdsgrens van vier jaar naar een jaar en ouder zal niet leiden tot significante veranderingen in de behandeling. Duration of treatment Frequency of administration Dosage per administration References NCT03736447 (ARC005, POSEIDON); Expertopinie 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 vier tot elf 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 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 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