Tegafur / gimeracil / oteracil

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
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 remarks	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 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.

Patient volume

71 - 1,071

Market share is generally not included unless otherwise stated.

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

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

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.