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New HTA Decisions in Germany
December 2020
Drug name
LONSURF® (trifluridine/tipiracil)
Company
Servier Deutschland
Decision date
01/10/2020
Therapeutic area
Cancer
Therapeutic sub area
Colorectal cancer
G-BA decision date
01/10/2020
Orphan Drug?
No
Decision
Minor additional benefit
Indication
Adult patients with metastatic colorectal cancer who have been unsuccessfully treated with available therapies, or for whom available therapies are unsuitable, or who are taking part in RECOURSE and TERRA studies. Main comparator: BSC
Decision Detail
Main studies: TERRA and RECOURSE. Main driver of decision: New data submitted by the company including a meta-analysis and further subgroup analysis suggested positive effects of trifluridine/tipiracil in terms of overall survival, and serious and severe side effects including hypertension and psychiatric illness. There were negative effects in terms of myelosuppression, anaemia, neutropenia and gastrointestinal toxicity.
Summary
In this addendum to commission, IQWiG altered the statement in assessment A20-35 to minor additional benefit.