Trifluridine / tipiracil Medicine 06 June 2023 Extended indication Extension of indication to include treatment of patients with refractory metastatic colorectal cancer, for LONSURF in combination with bevacizumab. Therapeutic value No estimate possible yet Total cost € 5,940,000.00 Registration phase Registration application pending Product Active substance Trifluridine / tipiracil Domain Oncology Reason of inclusion New medicine (specialité) Main indication Colon cancer Extended indication Extension of indication to include treatment of patients with refractory metastatic colorectal cancer, for LONSURF in combination with bevacizumab. 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 Normal trajectory Particularity Unknown ATMP No Submission date February 2023 Expected Registration December 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04737187 Additional remarks Tweemaal daags innemen, 5 dagen wel/2 dagen niet, over het verloop van 2 weken, gevolgd door 14 dagen niet. Expected patient volume per year Patient volume 500 - 600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL(1); Additional remarks Gemetastaseerde coloncarcinoom betreft 1.971 patiënten in stadium 4 en gemetastaseerde rectumcarcinoom betreft 630 patiënten in stadium 4 in 2020 (1). Samen gaat het dus om maximaal 2.601 patiënten in de 1L. gezien dit een 2L behandeling betreft zal het maximale aantal patiënten lager zijn. Op basis van het aantal patiënten dat op dit moment monotherapie ontvangt wordt er verwacht dat het mogelijke patiëntvolume hooguit 500 tot 600 zal bedragen. 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 G-standaard Additional remarks Lonsurf, tablet 14mg kost €28,74 en tablet 19mg kost €38,27. Ongeveer €2.700 per cyclus. Voor 4 cycli is dit €10.800. Potential total cost per year Total cost € 5,940,000.00 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