Sunitinib Medicine 09 January 2018 Extended indication Adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy. Therapeutic value No judgement Total cost € 333,576.00 Registration phase Unknown Product Active substance Sunitinib Domain Oncology and Hematology Reason of inclusion Main indication Kidney cancer Extended indication Adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy. Current proprietary name Already available biosimilars / generics Proprietary name Sutent Manufacturer Pfizer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule 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 July 2018 Expected Registration March 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een 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 Dosage per administration References Additional remarks Expected patient volume per year Patient volume 5 - 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; NKR; Chin et al. Rev Urol. 2006 Winter;8(1):1-7 Additional remarks Fabrikant: Op basis van de richtlijnen en het te verwachten CieBOM advies zal het om een zeer gelimiteerd aantal hoogrisico patiënten per jaar (5-10) gaan. NKR: 2316 patienten met niercarcinomen in 2015. Terugkeren niercarcinoom na nefrectomie is 20-40%. Expected cost per patient per year Cost € < 41,697.00 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 Taxeprijs Sutent 50mg is €4632,98. Uitgaande van maximale behandeling van 9 cycli met maximale dosering (50mg) per jaar. Potential total cost per year Total cost € 333,576.00 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