Tepotinib Medicine 08 December 2020 Extended indication Indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Tepotinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations. Current proprietary name Already available biosimilars / generics Proprietary name Tepmetko Manufacturer Merck 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 Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2020 Expected Registration February 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Primary completion date in December 2021. Therapeutic value Current treatment options Therapeutic value No estimate possible yet 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 In 2018 waren er 10.190 diagnoses NSCLC in Nederland, hiervan heeft 10% stadium IIIb (1.090) en 50% stadium IV (5.095). Hier komen nog patiënten bij uit eerdere stadia die verslechteren naar stadium IIIb/IV. Binnen een jaar is de inschatting dat dit 20% van stadium I/II bedraagt (529) en 50% van stadium IIIa (713). In totaal bedraagt deze groep dus 7.427 patiënten. Hiervan heeft 77% een adenocarcinoom (5.719). 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. Expected cost per patient per year Cost References NKR; R Heist. MET Exon 14 Skipping in Non-Small Cell Lung Cancer. Oncologist. 2016; https://pubmed.ncbi.nlm.nih.gov/32642122/; Bubendorf L, Dafni U, Schobel M, Finn SP, Tischler V, Sejda A, et al. Prevalence and clinical association of MET gene overexpression and amplification in patients with NSCLC: Results from the European Thoracic Oncology Platform (ETOP) Lungscape project. Lung cancer (Amsterdam, Netherlands). 2017;111:143-9 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