Dupilumab Medicine 09 January 2018 Extended indication Asthma Therapeutic value Possible equal value Total cost € 15,000,000.00 Registration phase Unknown Product Active substance Dupilumab Domain Lung diseases Reason of inclusion Main indication Asthma Extended indication Asthma Current proprietary name Already available biosimilars / generics Proprietary name Dupixent Manufacturer Sanofi Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Anti-IL-4 en -IL-13 monoclonaal antilichaam. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration January 2019 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Indicatie-uitbreiding Therapeutic value Current treatment options Mepolizumab, Reslizumab en Benralizumab. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Concurrentie ipv uitbreiding. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume > 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References www.volksgezondheidenzorg.info Additional remarks 2015 waren er naar schatting 613.500 personen met astma die voor deze klacht zorg hebben gehad van de huisarts of waarvan de huisarts wist dat de patiënt zorg ontving in de tweede lijn (zorgprevalentie). Gezien er geen onderhoudsbehandeling is worden de patientenaantallen vergelijkbaar verwacht met benralizumab (realistisch: 1000). Expected cost per patient per year Cost € < 15,000.00 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 Medicijnkosten.nl; fabrikant Additional remarks Gelijke kosten. Kosten komen bij huidige behandeling maar zal de competitie aan gaan met mepolizumab € 1263,52 flacon 100mg fl en reslizumab € 543,00 10mg/ml 10 ml flacon. De prijs voor astma indicatie zal gelijk zijn aan de prijs die ook voor de indicatie aopische dermatitis gehanteerd wordt: €15.000,70 pppj Potential total cost per year Total cost € 15,000,000.00 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 Fase 3 studies masal polyposis and chronic sinusitis. References clinicaltrials.gov Additional remarks Other information Additional remarks