Arachis hypogaea (pinda) allergenen (pleister) Medicine 13 December 2018 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 No registration expected 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. Current proprietary name Already available biosimilars / generics Proprietary name Viaskin Peanut Manufacturer DBV Technologies Portfolio holder Mechanism of action Allergen Route of administration Transdermal Therapeutical formulation Band Aid Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date October 2020 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks FDA fast track designation De fabrikant heeft de indiening teruggetrokken in januari 2022. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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 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%-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 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 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 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Alle leeftijden References Clinicaltrials.gov Additional remarks Other information Additional remarks