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New HTA Decisions in Germany
December 2020
Drug name
ALUNBRIG® (brigatinib)
Company
Takeda GmbH
Decision date
15/10/2020
Therapeutic area
Cancer
Therapeutic sub area
Lung cancer
G-BA decision date
15/10/2020
Orphan Drug?
No
Decision
Minor additional benefit
Indication
Patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with an ALK inhibitor with brain metastases. Main comparator: crizotinib.
Decision
Minor additional benefit
Indication
Patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with an ALK inhibitor without brain metastases. Main comparator: crizotinib.
Decision Detail
Main study: ALTA-1L Main driver of decision: Further data submitted by the company suggested positive impact of brigatinib in terms of overall survival, nausea/vomiting and health-related quality of life. Negative impact was observed with regards to side effects including diseases of the skin, increased phosphokinase and hypertension.
Summary
IQWiG concluded that brigatinib offered a minor additional benefit for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer not previously treated with an ALK inhibitor with or without brain metastases. This is an alteration of the previous assessment, which concluded that brigatinib offered no added benefit.