Savolitinib Medicine 03 June 2025 Extended indication Savolitinib in combination with durvalumab for first line treatment of unresectable and locally advanced or metastatic MET-driven papillary renal cell carcinoma, clear cell papillary renal cell carcinoma in adults and elderly. Therapeutic value No estimate possible yet Total cost € 280,000.00 Registration phase Clinical trials Product Active substance Savolitinib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Kidney cancer Extended indication Savolitinib in combination with durvalumab for first line treatment of unresectable and locally advanced or metastatic MET-driven papillary renal cell carcinoma, clear cell papillary renal cell carcinoma in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks MET-receptor tyrosinekinase-remmer. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date December 2025 Expected Registration January 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er loopt nog een driearmige fase 3 studie in combinatie met immuuntherapie. Er zijn nog geen uitkomsten van bekend. Duration of treatment Frequency of administration 1 times a day Dosage per administration 600mg References NCT05043090 (SAMETA) Additional remarks Expected patient volume per year Patient volume 5 - 15 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); Choueiri et al. JAMA Oncol. 2020 (2); Kanker.nl (3); Expert opinie (4); Additional remarks In 2022 waren er 930 diagnoses niercelcarcinoom, stadium III en IV (1). 80% van de gevallen is een clear cell carcinoom (744) (2). Bij ongeveer 1 of 2 op de 10 mensen met niercelkanker is de kanker papillair (74 tot 150) (3). Ongeveer 13% van de patiënten met PRCC type I hebben een MET mutatie. In type II pRCC ligt dit percentage veel lager. Ongeveer 55% van de patiënten met pRCC is type I. Dit betekent dat er naar schatting ongeveer 5 tot 15 patiënten in aanmerking zullen komen (4). Expected cost per patient per year Cost € 10,000.00 - 46,000.00 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 GIPdatabank Additional remarks De gemiddelde vergoeding per gebruiker van een tyrosinekinaseremmer ligt tussen de €10.000 en €46.000 per jaar. Potential total cost per year Total cost € 280,000.00 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