SelinexorXPOVIO

7.1 The PBAC recommended the listing of selinexor, for use in combination with bortezomib and dexamethasone (SBd), for the treatment of patients with relapsed and/or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The PBAC noted that MM is heterogeneous disease and that there is a clinical need for multiple treatment options, including different drug classes.PSD · Nov 2022

7.2 The PBAC recommended the listing of selinexor as part of SBd, on the basis that it should be available only under special arrangements under Section 100, through the Highly Specialised Drugs program.PSD · Nov 2022

6.38 The resubmission presented an updated CMA comparing SBd and Cd, that was a more conservative CMA compared with that provided in the March 2022 resubmission. The key revisions included once weekly and twice weekly carfilzomib doses, inclusion of bortezomib administration costs, exclusion of carfilzomib administration costs (conservative assumption which reduces the proposed price of selinexor; see paragraph 6.44) and inclusion of concomitant therapies …PSD · Nov 2022

6.39 The key components and assumptions of the CMA are presented in Table 18.PSD · Nov 2022

significant benefit for SBd compared with Bd (para 7.1, data remained immature. The resubmission selinexor (RRMM) PSD, March 2022 PBAC meeting). maintained that the claim of non-inferiority between SBd and Cd was supported by the data presented.PSD · Nov 2022

• The PBAC considered that the CMA was not The resubmission presented a CMA based on the informative given that the clinical claim was not clinical claim of non-inferiority between SBd and supported (para 7.13, March 2022 PBAC PSD). Cd. The resubmission revised the CMA to addressPSD · Nov 2022

6.2 The PBAC noted and welcomed the input from individuals (64) and organisations (3) via the Consumer Comments facility on the PBS website. It was noted that several medicines are available, but not all work for each patient, and eventually these must be discontinued because they are no longer effective or because of side-effects.PSD · Nov 2022

6.3 The PBAC noted the advice received from (i) Myeloma Australia, (ii) the Leukaemia Foundation, and (iii) Myeloma Australia's Medical and Scientific Advisory Group (MSAG), which described an ongoing need for new treatment options and supported the proposed listing for SBd. Myeloma Australia noted that the new class of drug in an effective combination would make significant impact on patients.PSD · Nov 2022