Tocilizumab Medicine 07 December 2022 Extended indication Extension of indication to include treatment of new indication for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) Therapeutic value No estimate possible yet Total cost € 2,710,800.00 Registration phase Registration application pending Product Active substance Tocilizumab Domain Lung diseases Reason of inclusion Indication extension IND Main indication Lung diseases other Extended indication Extension of indication to include treatment of new indication for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) Current proprietary name Already available biosimilars / generics Proprietary name RoActemra Manufacturer Roche Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Unknown Centre of expertise Additional remarks Bekostigingskader hangt af van de plaats in de behandeling. Eerstelijns producten worden veelal vanuit het GVS bekostigd. Producten bij ernstiger vormen van SSc-ILD zijn of GVS of MSZ bekostigd. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2022 Expected Registration September 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a week Dosage per administration 162 mg References NCT02453256 (focuSSced) Additional remarks Expected patient volume per year Patient volume 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) Bergamasco et al ; Clin Epidemiol 2019 (2) Dougherty et al; Rheumatology 2018 (3) Vonk et al; Annu Rheum Dis 2009 Additional remarks De prevalentie van SSc-ILD is ongeveer 1,7-4,2 per 100.000 inwoners in Europa (1). Uit de SPIN en CSRG cohorten blijkt dat 36% van de SSc patiënten ILD heeft (2). Voor Nederland komt dit overeen met 306 tot 756 mensen. In een studie specifiek in de Nederlandse populatie is aangetoond dat de prevalentie 8,9 per 100.000 inwoners is. Op 18 miljoen inwoners zijn dit 1602 patiënten. Van deze groep heeft 19-47% ILD. Dat zijn 304-753 patiënten. Uitgaande van de patiëntkenmerken in de klinische studies lijkt een subgroep van ongeveer 200 patiënten in aanmerking te komen. Expected cost per patient per year Cost € 13,554.00 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 De kosten voor een 162 mg RoActemra spuit bedragen €260,66. Patiënten krijgen 1 injectie per week. Potential total cost per year Total cost € 2,710,800.00 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