Entrectinib Medicine 13 December 2018 Extended indication Locally advanced or metastatic solid tumors with NTRK gene fusion in adult and pediatric patients Therapeutic value No judgement yet Total cost Registration phase Clinical trials Product Active substance Entrectinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Locally advanced or metastatic solid tumors with NTRK gene fusion in adult and pediatric patients 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 Unknown Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration January 2021 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Afhankelijk van tumor type en in de toekomst larotrectinib 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 600 mg References Fabrikant Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Nog niet bekend, afhankelijk van specifieke indicatie en studieresultaten. Expected cost per patient per year Cost € < 180,000.00 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 https://www.reuters.com/article/us-roche-hldg-fda-pricing/roche-cancer-treatment-priced-at-17050-a-month-lower-than-rival-vitrakvi-idUSKCN1V61G8 Additional remarks De lijstprijs voor entrectinib in de VS is gesteld op $17,050 per maand (ongeveer €15.000). Dit is ongeveer de helft van de prijs van concurrent larotrectinib (Bayer). Op jaarbasis bij behandeling van 12 maanden zou dit neerkomen op €180.000. Naar verwachting zal de EU prijs wat lager liggen. 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 Patiënten ROS1-positief geavanceerde of gemetastaseerde NSCLC References Fabrikant Additional remarks Other information Additional remarks