Tralokinumab Medicine 09 January 2018 Extended indication Severe asthma in adults and adolescents inadequately controlled on ICS + LABA. Therapeutic value Possible equal value Total cost € 15,500,000.00 Registration phase Unknown Product Active substance Tralokinumab Domain Lung diseases Reason of inclusion Main indication Asthma Extended indication Severe asthma in adults and adolescents inadequately controlled on ICS + LABA. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Anti-interleukin 13 (IL13) humaan monoclonaal antilichaam. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks 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 2 times a month 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 Additional remarks Patiëntenaantallen vergelijkbaar verwacht met benralizumab (realistisch: 1000). Expected cost per patient per year Cost € 14,000.00 - 17,000.00 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 Additional remarks Gelijke kosten. kosten komen bij huidige behandeling maar zal de competitie aan gaan met mepolizumab € 1263,52 flacon 100 mg en reslizumab € 543,00 10 mg/ml 10ml flacon. Potential total cost per year Total cost € 15,500,000.00 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 moderate-to-severe atopic dermatitis in patients who are candidates for systemic therapy. References Additional remarks Other information Additional remarks