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New HTA Decisions in England
January 2021
Drug name
ALUNBRIG® (brigatinib)
Decision date
Therapeutic area
Therapeutic sub area
Lung cancer
Brigatinib is recommended, within its marketing authorisation, as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) that has not been previously treated with an ALK inhibitor in adults.
Decision Detail
It is recommended only if the company provides brigatinib according to the commercial arrangement (simple discount patient access scheme).
The main evidence for brigatinib came from ALTA 1L, an open-label phase 3 randomised controlled trial that compared brigatinib with crizotinib in adults with untreated ALK-positive advanced or metastatic NSCLC. Brigatinib statistically significantly extends progression-free survival compared with crizotinib, although there is uncertainty about the precise improvement in overall survival with brigatinib compared with crizotinib. There is no clinical trial evidence directly comparing brigatinib with alectinib, but there is suitable indirect evidence using data from ALTA 1L and the ALEX trial (an open-label phase 3 RCT), suggesting that brigatinib is as effective as alectinib in delaying disease progression, including in the central nervous system. However, although it appears that brigatinib could extend life as much as alectinib, there is uncertainty because of a lack of long-term data. Despite the uncertainty, the most likely cost-effectiveness estimates for brigatinib are within what NICE considers an acceptable use of NHS resources (exact ICERs are confidential and cannot be reported here). So, brigatinib is recommended.