AR101 Medicine 13 December 2018 Extended indication Pinda-allergie Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance AR101 Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Allergy Extended indication Pinda-allergie Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Aimmune Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date March 2019 Expected Registration April 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks PALISADE studie: met primary efficacy endpoint; efficacy across ages. Aimmune heeft de intentie om een registratieaanvraag in te dienen bij de EMA in de eerste helft van 2019. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Effectief middel, maar wel met bijwerkingen. Duration of treatment Frequency of administration Dosage per administration References NCT02635776 Additional remarks Expected patient volume per year Patient volume < 170,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Stichting Voedselallergie Additional remarks In Nederland wordt geschat dat meer dan 1% een pinda-allergie heeft. Dit zou dus neerkomen op 170.000 mensen. Welk deel van deze mensen in aanmerking komt voor gebruik van AR101 hangt af van de studieresultaten en de uiteindelijke indicatiestelling. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost 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