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New HTA Decisions in France
December 2019
Drug name
ALUNBRIG® (brigatinib)
Company
Takeda
Decision date
23/10/2019
Therapeutic area
Cancer
Therapeutic sub area
Lung cancer
Official notice date
25/11/2019
Reimbursement %
100
Decision (SMR)
Weak
Decision (ASMR)
No improvement (V)
Indication
ALUNBRIG® is indicated as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ALK gene rearrangement (ALK positive) previously treated with crizotinib.
Decision Type
New technology assessment
Summary
The committee considered the actual benefit of ALUNBRIG® to be 'low' in the indication of the Marketing Authorisation. Taking into account: - data from a non-comparative phase II study evaluating two dosing regimens for brigatinib; - the profile of patients included in the pivotal study that does not correspond to that of patients currently treated in clinical practice; - the evolution of the therapeutic strategy; it was concluded that ALUNBRIG® does not provide any improvement in the medical service rendered (ASMR V) in the therapeutic strategy of patients with advanced non-small cell lung cancer (NSCLC) with ALK gene rearrangement (positive ALK ) previously treated with crizotinib. The committee proposed 100% reimbursement.