Tepotinib Medicine 08 December 2020 Extended indication Patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) naïve in first-line or pretreated patients with no more than 2 lines of prior therapy. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Tepotinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) naïve in first-line or pretreated patients with no more than 2 lines of prior therapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Merck/Pfizer Portfolio holder Mechanism of action Other Route of administration Oral Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Proto oncogene protein c-Met inhibitor Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion datum in december 2021. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat tepotinib in de toekomst mogelijk de concurrentie met capmatinib aan zal gaan. Duration of treatment Frequency of administration 1 times a day Dosage per administration 500 mg References NCT02864992 Additional remarks Once daily in cycles of 21-day duration until disease progression, death, adverse event (AE). Expected patient volume per year Patient volume 200 - 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; R Heist. MET Exon 14 Skipping in Non-Small Cell Lung Cancer. Oncologist. 2016; https://pubmed.ncbi.nlm.nih.gov/32642122/ Additional remarks Jaarlijks presenteren er ongeveer 7.500 patiënten per jaar met NSCLC stadium IIIb/IV. In 2018 registreerde IKNL 32 MET mutaties in de eerste lijn. Maar dit aantal is onvolledig omdat er nog niet standaard op MET getest werd, en er ook gevallen gediagnostiseerd kunnen worden in tweede lijn. MET exon 14 skipping ligt in de range van 1,5%-6% van alle NSCLC patiënten. Een recente Franse studie meldt 2.6% positieve uitslagen bij geteste patiënten met NSCLC-IV. Uitgaande van bovenstaande getallen is de verwachting dat er zo'n 200-300 patiënten in aanmerking zullen komen voor deze behandeling. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Liver cancer References adisinsght Additional remarks Fase 2 studie Other information Additional remarks