Secukinumab Medicine 03 December 2024 Extended indication Secukinumab in combination with glucocorticoid taper regimen for treatment of giant cell arteritis in adults over 50 and elderly. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Secukinumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Cardiovascular diseases Extended indication Secukinumab in combination with glucocorticoid taper regimen for treatment of giant cell arteritis in adults over 50 and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Novartis Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks IL-17-remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De GCAptAIN studie heeft het primaire eindpunt niet gehaald. Therapeutic value Current treatment options Glucocorticosteroïden, MTX en tocilizumab. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04930094 (GCAptAIN); NCT03765788 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 14,282.00 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 Prijs op basis van apothekers inkoop prijs pen 300mg (€1.098,65) en een vier wekelijks doseringsregime in de onderhoudsfase. 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 Yes Indication extensions Polymyalgia Rheumatica References Additional remarks Other information Additional remarks