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New HTA Decisions in Germany
March 2021
Drug name
IMFINZI® (durvalumab + chemotherapy)
Company
AstraZeneca GmbH
Decision date
04/01/2021
Therapeutic area
Cancer
Therapeutic sub area
Lung cancer
G-BA decision date
01/04/2021
Orphan Drug?
No
Decision
Considerable additional benefit
Indication
Men with advanced small cell lung cancer. Main comparator: Cisplatin in combination with etoposide or carboplatin in combination with etoposide.
Decision
Additional benefit not quantifiable
Indication
Women with advanced small cell lung cancer. Main comparator: Cisplatin in combination with etoposide or carboplatin in combination with etoposide.
Decision Detail
Main study: CASPIAN. Main driver of decision: This study demonstrated significant benefit of durvalumab over the comparator in terms of overall survival, with no difference in morbidity or health-related quality of life. There was no significant difference between durvalumab and comparator in the studied side effects except greater harm associated with durvalumab with regards to hypertension. Importantly, there is clear disadvantage in terms of immune-mediated severe AEs for women.
Summary
IQWiG concluded that there was considerable added benefit in men with small cell lung cancer but that benefit was not quantifiable (at most considerable) in women.