Tocilizumab Medicine 09 January 2018 Extended indication Treatment of adult giant cell arteritis. Therapeutic value No judgement Total cost € 14,700,000.00 Registration phase Unknown Product Active substance Tocilizumab Domain Chronic immune diseases Reason of inclusion Main indication Cardiovascular diseases Extended indication Treatment of adult giant cell arteritis. Current proprietary name Already available biosimilars / generics Proprietary name RoActemra Manufacturer Roche Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2016 Expected Registration September 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Indicatie-uitbreiding Therapeutic value Current treatment options Therapeutic value No judgement 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 Lopende studies fase 3 op clinicaltrials.gov Additional remarks Expected patient volume per year Patient volume 600 - 1,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Aangezien het een grote innovatie is wordt wel verwacht dat het aantal patienten groter is dan 60 met een max. van 600 is. Werkgroep: 1000-1500 patiënten. Expected cost per patient per year Cost € < 14,000.00 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 Fabrikant Additional remarks € 155 per 80 mg flacon Potential total cost per year Total cost € 14,700,000.00 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