Trifluridine / tipiracil Medicine 13 December 2018 Extended indication Gastric cancer, metastatic, refractory, 3L Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Trifluridine / tipiracil Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Stomach cancer Extended indication Gastric cancer, metastatic, refractory, 3L Current proprietary name Already available biosimilars / generics Proprietary name Lonsurf Manufacturer Servier Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Primair eindpunt gehaald Duration of treatment Frequency of administration 2 times a day Dosage per administration 35 mg/m2 References NCT02500043 Additional remarks Twee maal per dag op dagen 1 t/m 5 en dagen 8 t/m 12 van iedere 28-dagen cyclus. Expected patient volume per year Patient volume < 185 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL Additional remarks In 2016 waren er gemiddeld 555 nieuwe patiënten met cardia of non-cardia maagadenocarcinoom stadium IV. Ongeveer een derde van deze patiënten werd behandeld in de 2e lijn en verder (185 patiënten). Gezien het een derdelijnsbehandeling betreft zal slechts een deel van deze patiënten in aanmerking komen voor Lonsurf. Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks Lonsurf, tablet 14 mg €31,80 en tablet 20 mg €42,40. Ongeveer €2.700 per cyclus. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks