PHMR

England

Scotland

France

Germany

New HTA Decisions in Germany

December 2021

Drug name

OPDIVO® (nivolumab)

Company

Bristol-Myers Squibb GmbH & Co. KGaA

Decision date

01/12/2021

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Our experience

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Therapeutic area

Cancer

Therapeutic sub area

Oesophageal cancer

G-BA decision date

15/02/2022

Orphan Drug?

Decision
Minor additional benefit
Indication
Adjuvant treatment of carcinomas of the oesophagus or of the gastro-oesophageal junction, in adults with pathological residual disease after previous neoadjuvant chemoradiotherapy. 

Appropriate comparator therapy: observation

Decision Detail

Main study: CA209-577 Main driver of decision: There were positive and negative effects of varying degrees for nivolumab compared to the ACT. A considerable positive effect to the advantage of nivolumab was shown for the endpoint relapse. There was no data available for overall survival but there was no indication that nivolumab would have a disadvantage on overall survival compared to the ACT.

Summary

IQWIG concluded there was a minor added benefit.

About PHMR

Our experience