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Trifluridine / tipiracil

Lonsurf

Extended indication Extension of indication to include treatment of patients with refractory metastatic colorectal cance
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.
Proprietary name Lonsurf
Manufacturer Servier
Route of administration Oral
Therapeutical formulation Film-coated tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date February 2023
Expected Registration December 2023
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
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.
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
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

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.

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.