Extended indication Extension of indication to include treatment of metastatic colorectal cancer in adult patients where
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Tegafur / gimeracil / oteracil
Domain Oncology and Hematology
Reason of inclusion Indication extension
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.
Proprietary name Teysuno
Manufacturer Nordic Pharma
Mechanism of action Other, see general comments
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional comments DNA synthese remmer.

Registration

Registration route Centralised (EMA)
Submission date November 2020
Expected Registration September 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options 5FU/capecitabine
Therapeutic value No estimate possible yet
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.

Expected patient volume per year

Patient volume

71 - 1,071

Market share is generally not included unless otherwise stated.

Additional comments 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

References medicijnkosten.nl
Additional comments 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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.