Ixazomib

The PBAC did not recommend ixazomib, in combination with lenalidomide and dexamethasone (ILd), for the treatment of relapsed and/or refractory multiple myeloma (RRMM) after at least two prior therapies. The PBAC considered that although ILd appeared to have a benefit in terms of progression free survival (PFS) over the nominated comparator, lenalidomide plus dexamethasone (Ld), the impact on overall survival (OS) was uncertain.PSD · Mar 2022

The PBAC noted that the comments from consumers and from Myeloma Australia, Myeloma Australia’s Medical and Scientific Group (MSAG) and The Leukaemia Foundation were all in support of the requested listing for ILd, describing the ongoing need for additional treatment options for RRMM patients.PSD · Mar 2022

The resubmission presented a cost-effectiveness analysis (CEA) and a cost-utility analysis (CUA). Health benefits were reported as life years (LYs) gained and quality adjusted life years (QALYs) gained. The key points from the economic evaluation are summarised in Table 12. 23PSD · Mar 2022

Outcomes LYs and QALYs gained Methods used to generate results Cohort-based partitioned survival model Three health states are included in the model: pre-progression, post-progression and Health states death Cycle length 1 week The KM estimates were derived from TMM-1 (2-3 prior lines of therapy subgroup was Allocation to health states used for OS, PFS and ToT outcomes) Adjustment of OS HR for patients who had received 2-3 prior therapies for post- …PSD · Mar 2022

In patients with RRMM, ILd is non-inferior in terms of On balance, in patients with RRMM, ILd is effectiveness and safety to DBd. at least non-inferior in terms of effectiveness and safety to Cd. Source: Table 1-1, p17 of the resubmission.PSD · Mar 2022

Underlined text refers to changes relative to the initial submission; blue shaded text refers to information previously included in the initial submission of ixazomib to the PBAC. 1PSD · Mar 2022

The PBAC noted and welcomed the input from individuals (10) and organisations (3) via the Consumer Comments facility on the PBS website. The comments from individuals described the impact of multiple myeloma, the desire for access to additional treatments and the benefits associated with ILd as it is an oral triplet regimen.PSD · Mar 2022

Clinical Study Report C16010. Data cut-off date 30 October 2014 TOURMALINE MM-1 Interim 1 TFLs. Tables and figures referred to but not included in the text. Clinical Study Report C16010 TOURMALINE MM-1 Interim 2 CSR.PSD · Mar 2022