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Trifluridine / tipiracil

Lonsurf

Extended indication Gastric cancer, metastatic, refractory, 3L
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Trifluridine / tipiracil
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Stomach cancer
Extended indication Gastric cancer, metastatic, refractory, 3L
Proprietary name Lonsurf
Manufacturer Servier
Route of administration Oral
Therapeutical formulation Film-coated tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Substantiation Primair eindpunt gehaald
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.

Expected patient volume per year

Patient volume

< 185

Market share is generally not included unless otherwise stated.
References IKNL
Additional remarks In 2016 waren er gemiddeld 555 nieuwe patiënten met cardia of non-cardia maagadenocarcinoom stadium IV. Ongeveer een derde van deze patiënten werd behandeld in de 2e lijn en verder (185 patiënten). Gezien het een derdelijnsbehandeling betreft zal slechts een deel van deze patiënten in aanmerking komen voor Lonsurf.

Expected cost per patient per year

References medicijnkosten.nl
Additional remarks Lonsurf, tablet 14 mg €31,80 en tablet 20 mg €42,40. Ongeveer €2.700 per cyclus.

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.