Pinda extract Medicine 13 December 2018 Extended indication Pinda-allergie bij kinderen van 4-11 jaar Therapeutic value No judgement Total cost € 65,250,000.00 Registration phase Clinical trials Product Active substance Pinda extract Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Allergy Extended indication Pinda-allergie bij kinderen van 4-11 jaar 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 Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks FDA fast track designation Therapeutic value Current treatment options Therapeutic value No judgement 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. 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 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