Entrectinib Medicine 13 December 2018 Extended indication Patiënten ROS1-positief geavanceerde of gemetastaseerde NSCLC Therapeutic value No judgement yet Total cost Registration phase Registration application pending Product Active substance Entrectinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Patiënten ROS1-positief geavanceerde of gemetastaseerde NSCLC Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Roche Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1 (coded by the gene ROS1), and ALK (coded by the gene ALK). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date January 2019 Expected Registration January 2020 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Crizotinib Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 600mg References Fabrikant; clinicaltrials.gov and Doebele et al. 2018 (IASLC) Additional remarks Expected patient volume per year Patient volume 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Bubendorf, et al., Virchows Arch. 2016; 469(5): 489–503., Epskamp PALGA/ pulmoscript 2015, expertopinie. Additional remarks Jaarlijks presenteren er ongeveer 7.500 patiënten per jaar met NSCLC stadium IIIb/IV. 1-2% van alle NSCLC patiënten is ROS1 positief (75-150). Gezien maar 25% van de patienten getest wordt op ROS1 is de verwachting dat het aantal patiënten in de praktijk lager zal zijn. Van alle tumoren met wildtype EGFR/KRAS wordt 50% getest op ROS1. Patiëntvolume zal dan ook voorlopig lager zijn, verwachting rond de 50 patiënten. Expected cost per patient per year Cost References Fabrikant Additional remarks Er is nog niets bekend over de prijs van entrectinib. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions Yes Indication extensions NTRK+ References Fabrikant Additional remarks Other information Additional remarks