BrigatinibAlunbrig

7.1 The PBAC recommended the Authority Required listing of brigatinib as monotherapy for the treatment of patients with locally advanced (Stage IIIB) or metastatic (Stage IV) anaplastic lymphoma kinase (ALK)-positive non-squamous (NS) or not otherwise specified (NOS) non-small cell lung cancer (NSCLC).PSD · Nov 2019

7.2 The PBAC noted that the existing listings for ALK-tyrosine kinase inhibitors (TKI) are line-agnostic and there is a lack of evidence for the optimal sequence of ALK inhibitor therapies in ALK-positive NSCLC and therefore considered that brigatinib should not be precluded from a line-agnostic listing.PSD · Nov 2019

6.43 The submission presented a CMA comparing brigatinib to alectinib. The components and assumptions of the CMA are presented in Table 11.PSD · Nov 2019

Table 11: Summary of key components and assumptions of the cost-minimisation analysis Component Summary Based on evidence presented in the submission, effectiveness is assumed to be non- Therapeutic claim: effectiveness inferior Based on evidence presented in the submission, safety is assumed to be non-inferior, Therapeutic claim: safety with slightly different profile of adverse events Treatment naïve patients:PSD · Nov 2019

Emerging clinical data demonstrate that these therapeutic relativities are likely to hold in both ALK inhibitor naïve and prior TKI (crizotinib) experienced patients.PSD · Nov 2019

6.36 The submission stated that brigatinib provides at least similar efficacy to alectinib for the key clinical outcomes (ORR, DOR, PFS, OS and HRQoL) and is associated with a different but overall non-inferior safety and tolerability profile to that seen with alectinib and other ALK targeted TKIs.PSD · Nov 2019

6.2 The PBAC noted and welcomed the input from individuals (70), health care professionals (1) and organisations (4) via the Consumer Comments facility on the PBS website. The comments described the need for an additional treatment option with new ALK inhibitor to be on the PBS for patients who were concerned about treatment options when they become refractory to the current therapies, highlighting the benefits of treatment with ALK inhibitors that …PSD · Nov 2019

6.3 The PBAC noted the advice received from Lung Foundation Australia and Rare Cancers Australia that the use of brigatinib may provide the added survival and improved quality of life with its high response rate in patients with brain metastases that is very important in this disease as failure to control disease in the brain is often the cause of deterioration in quality of life and eventual mortality in these patients.PSD · Nov 2019