Trifluridine / tipiracil Medicine 13 December 2018 Extended indication Extension of Indication to include Lonsurf indicated for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, platinum-, and either a taxane- or irinotecan-based chemotherapy. Therapeutic value No judgement Total cost € 842,400.00 Registration phase Registration application pending Product Active substance Trifluridine / tipiracil Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Stomach cancer Extended indication Extension of Indication to include Lonsurf indicated for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, platinum-, and either a taxane- or irinotecan-based chemotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Lonsurf Manufacturer Servier Portfolio holder Mechanism of action Other 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 Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2018 Expected Registration September 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Capecitabine Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Primair eindpunt gehaald. Lonsurf is nu laatste lijn behandeling bij CRC. Er lopen wel studies naar eerdere lijnen, maar zal moeilijk zijn om capecitabine te vervangen. Duration of treatment Median 16 week / weeks 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. De verwachting is een behandeling van 4 cycli. Expected patient volume per year Patient volume 78 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL; expertopinie Additional remarks Ongeveer 70 patiënten wordt behandeld in de 2e lijn voor gemetastaseerd adenocarcinoom van de maag of gastro-oesofageale overgang . Het aantal patiënten met een slokdarmcarcinoom die in de tweede lijn worden behandeld bedraagt ongeveer 60. In totaal zijn dit dus 130 patiënten. De inschatting is dat hiervan ongeveer 60% een derde lijns behandeling krijgt (78 patiënten). Expected cost per patient per year Cost € 10,800.00 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 medicijnkosten.nl Additional remarks Lonsurf, tablet 14 mg €31,80 en tablet 20 mg €42,40. Ongeveer €2.700 per cyclus. Voor 4 cycli is dit €10.800 Potential total cost per year Total cost € 842,400.00 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