Savolitinib Medicine 03 June 2025 Extended indication Savolitinib in combination with osimertinib for second line or later treatment of locally advanced or metastatic epidermal growth factor receptor mutated, MET-overexpressed and/or amplified non-small cell lung cancer in adults and elderly who have progressed on treatment with osimertinib. Therapeutic value No estimate possible yet Total cost € 7,280,000.00 Registration phase Clinical trials Product Active substance Savolitinib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Savolitinib in combination with osimertinib for second line or later treatment of locally advanced or metastatic epidermal growth factor receptor mutated, MET-overexpressed and/or amplified non-small cell lung cancer in adults and elderly who have progressed on treatment with osimertinib. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder Mechanism of action Other, see general comments 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 ATMP No Submission date December 2026 Expected Registration January 2028 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 Tepotinib, amivantimab en crizotinib. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de SAFFRON studie (NCT05261399) wordt de effectiviteit van savolitinib en osimertinib vergeleken met chemotherapie met platinum. De verwachting is dat de studie afgerond zal worden in eind 2026. Resultaten dienen nog afgewacht te worden. Duration of treatment Frequency of administration Dosage per administration 300mg oraal eenmaal daags, 300mg oraal tweemaal daags of 600mg oraal eenmaal daags. References NCT05261399 (SAFFRON) Additional remarks Expected patient volume per year Patient volume 50 - 469 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); Expertopinie (2); Park et al. Histol. Histopathol. 2012 (3). Additional remarks In 2022 waren er 9.099 diagnoses NSCLC in Nederland. Dit betrof 1.567 stadium 1, 760 stadium 2, 2.052 stadium 3 (waarvan ongeveer 55% stadium 3a en ongeveer 45% stadium 3b), 4.720 stadium 4. Uitgaande van stadium 3b en 4 komt dat neer op ongeveer 5.634 patiënten (1). Hierbij komen nog patiënten uit eerdere stadia die verslechteren naar stadium 3b en 4. Binnen een jaar is de inschatting dat dit 20% van stadium 1 en 2 bedraagt (465) en 50% van stadium 3a (564). In totaal bedraagt deze groep dus zoʼn 6.700 patiënten. Het aantal NSCLC patiënten met EGFR betreft zoʼn 5 tot 10% van deze patiënten (2). MET-over expressie komt voor bij 15 tot 70% van alle gevallen (3). 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 tyrosinekinase remmer ligt tussen de €10.000 en €46.000 per jaar. Potential total cost per year Total cost € 7,280,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks