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New HTA Decisions in Germany
December 2019
Drug name
LIBTAYO® (cemiplimab)
Company
Sanofi-Aventis
Decision date
04/11/2019
Therapeutic area
Cancer
Therapeutic sub area
Skin cancer
G-BA decision date
01/02/2020
Orphan Drug?
No
Decision
No additional benefit
Indication
Adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma, for which one curative surgery or curative radiotherapy is not eligible, and who have not yet received drug treatment Main comparator therapy: a systematic antineoplastic therapy
Decision
No additional benefit
Indication
Adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma, for which one curative surgery or curative radiotherapy is not eligible, and whose cancer has progressed after previous drug treatment Main comparator therapy: best supportive care
Decision Detail
Main study: Study R2810-ONC-1540 and a bibliographic literature review by the Dermatologic Cooperative Oncology Group (DeCOG) Main driver of decision: The company did not provide comparative data and the non comparative retrospective data provided was not considered certain enough to demonstrate additional clinical benefit of cemiplimab over comparator.
Summary
IQWiG concluded that the non comparative data provided by the company did not demonstrate an additional benefit of cemiplimab over the identified comparator therapy.