Dupilumab Medicine 07 June 2022 Extended indication Extension of indication to include treatment of severe atopic dermatitis in paediatric patients from 6 months to <6 years of age. Therapeutic value Possible added value for a subgroup Total cost € 262,500.00 Registration phase Registered Product Active substance Dupilumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Extension of indication to include treatment of severe atopic dermatitis in paediatric patients from 6 months to <6 years of age. Current proprietary name Already available biosimilars / generics Proprietary name Dupixent Manufacturer Sanofi Portfolio holder Sanofi Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection liquid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2022 Expected Registration March 2023 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie in januari 2023. Therapeutic value Current treatment options Topicale cortocisterioden Therapeutic value Possible added value for a subgroup This assessment does not indicate any potential inclusion in the package. Substantiation Dupilumab zal alleen worden gebruikt bij patiënten met ernstige atopische dermatitis die in aanmerking komen voor systemische behandeling. Topicale corticosteroïden zullen de eerstelijnsbehandeling blijven. Therapeutische meerwaarde is er. Het is mogelijk dat artsen en ouders terughoudend zullen zijn met het langdurig behandelen van kinderen in deze leeftijdsgroep met biologicals. Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 300 mg References Additional remarks Expected patient volume per year Patient volume 20 - 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expert opinie(1); Additional remarks Er wordt verwacht dat er mogelijk 20-50 patiënten in deze leeftijdsgroep in aanmerking zullen komen. Het is mogelijk dat artsen en ouders terughoudend zullen zijn met het langdurig behandelen van kinderen in deze leeftijdsgroep met biologicals (1). Expected cost per patient per year Cost € 7,500.00 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 Op basis van de AIP (exclusief BTW) voor voorgevulde injectiespuiten van 300mg dupilumab Additional remarks Potential total cost per year Total cost € 262,500.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Prurigo nodularis References Additional remarks Other information Additional remarks