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New HTA Decisions in Germany
December 2020
Drug name
NUBEQA® (darolutamide)
Company
Bayer Vital GmbH
Decision date
15/10/2020
Therapeutic area
Cancer
Therapeutic sub area
Prostate cancer
G-BA decision date
15/10/2020
Orphan Drug?
No
Decision
Considerable additional benefit
Indication
Adult men with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastases. Main comparator: 'wait and see' approach
Decision Detail
Main study: ARAMIS Main driver of decision: Further data submitted by the company, including overall survival, symptomatic skeletal events, health-related quality of life suggested a positive impact of darolutamide versus the comparator. Considerable negative impact of darolutamide was observed with regards to general illnesses and administration site complaints.
Summary
in this addendum to commission, IQWiG concluded that darolutamide provides considerable additional benefit in the management of non-metastatic castration-resistant prostate cancer in adult men who are at high risk of developing metastases.