Tegafur / gimeracil / oteracil Medicine 08 December 2020 Extended indication Extension of indication to include treatment of metastatic colorectal cancer in adult patients where it is not possible to initiate or continue treatment with another fluoropyrimidine. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Tegafur / gimeracil / oteracil Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Colon cancer Extended indication Extension of indication to include treatment of metastatic colorectal cancer in adult patients where it is not possible to initiate or continue treatment with another fluoropyrimidine. Current proprietary name Already available biosimilars / generics Proprietary name Teysuno Manufacturer Nordic Pharma Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks DNA synthese remmer. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date November 2020 Expected Registration September 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options 5FU/capecitabine Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Indien de therapeutische waarde gelijk blijkt aan 5FU/capecitabine zal het ingezet worden op het moment dat dit niet veilig is om te toe te dienen. In het geval van bijvoorbeeld symptomen van hartfalen of cardiovasculaire bijwerkingen. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 71 - 1,071 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Ongeveer 1%-15% van de patiënten is intolerant voor capecitabine. In 2019 waren er 7.142 declaraties met betrekking tot een colorectale indicatie. Dit betekent dat er ongeveer 71 tot 1.071 patiënten in aanmerking komen voor een behandeling. Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks Capsule 15mg/4,35mg/11,8mg is €3,40 per stuk en een capsule van 20mg/5,8mg/15,8mg is €5,18 per stuk. 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