Sunitinib Medicine 09 January 2018 Extended indication Adjuvante behandeling van volwassen patiënten met een hoge risico op terugkerende niercelcarcinoom na nefrectomie. Therapeutic value No judgement Total cost € 336,000.00 Registration phase Negative CHMP opinion Product Active substance Sunitinib Domain Oncology and Hematology Reason of inclusion Main indication Kidney cancer Extended indication Adjuvante behandeling van volwassen patiënten met een hoge risico op terugkerende niercelcarcinoom na nefrectomie. 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 Proteïnekinaseremmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date March 2017 Expected Registration Orphan drug No Registration phase Negative CHMP opinion Reimbursement Medicine sluice Additional remarks Negatieve CHMP opinie februari 2018. Fabrikant heeft een herbeoordeling aangevraagd. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 54 week / weeks Frequency of administration 1 times a day Dosage per administration 50 mg References Ravaud, A., et al. N Engl J Med (2016): 2246-54. Additional remarks Toedieningsfrequentie eenmaal per dag voor 4 weken en dan 2 weken rust (9 cycli) 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: 565 patiënten in 2016 met niercarcinoom stadium 4. Terugkeren niercarcinoom na nefrectomie is 20-40%. Expected cost per patient per year Cost € 42,000.00 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 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 € 336,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks