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Market Access Alerts >December 2021>Germany
New HTA Decisions in Germany
December 2021
Drug name
OPDIVO® (nivolumab / ipilimumab)
Company
Bristol-Myers Squibb GmbH & Co. KGaA
Decision date
16/12/2021
About PHMR
Therapeutic area
Cancer
Therapeutic sub area
Cancer: general and other
G-BA decision date
16/12/2021
Orphan Drug?
No
Decision
No additional benefit
Indication
First-line treatment, in adults, with non-resectable malignant pleural mesothelioma with epitheloid tumour histology. Appropriate comparator therapy: Therapy as prescribed by a doctor
Decision
Considerable additional benefit
Indication
First-line treatment, in adults, with non-resectable malignant pleural mesothelioma without epitheloid tumour histology. Appropriate comparator therapy: Therapy as prescribed by a doctor
Decision Detail
Main study: CA209-743 Main driver of decision: In this addendum to commission, re-evaluation of the LCSS meso and EQ-5D VAS data did not change the decision of no added benefit for indication 1, and considerable added benefit for indication 2, from the original dossier assessment (A21-89).
Summary
In this addendum to commission, the decision made in September 2021 (A21-89) of no added benefit for indication 1, and considerable added benefit for indication 2 was unchanged. The G-BA supported the decision.


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