VenetoclaxVenclexta

1.3 In addition to the 100 mg strength requested in the previous submission, the resubmission also requested listing for a 50 mg strength, which would be used by patients requiring a reduced dose, due to the increased risk for Tumour Lysis Syndrome (TLS) at initiation and ramp-up when taking concomitant VTX and strong or moderate CYP3A inhibitors.PSD · Jul 2021

Summary Document (PSD), March 2021 PBAC  An average of 1.9 AZA vials per infusion meeting):  Alternative extrapolations for EFS and OS  An average of 1.9 AZA vials per infusion  10-year time horizon Partially  Revised extrapolations for EFS and OS  No change to ICER weightings  10-year time horizon  An ICER of < $''''''''''''''''1/QALY  ICER weighted towards the LoDAC comparison  An ICER of approximately $''''''''''''''''1/QALY Financial …PSD · Jul 2021

4.5 A comparison of the PBAC specified model revisions and those included in the resubmission is summarised in Table 3. The model time horizon and number of vials of AZA were revised as specified by the PBAC. Alternative approaches were presented in the resubmission for the extrapolation of the event-free survival (EFS) and overall survival (OS) data, and for the weighting of the ICER across the AZA and LoDAC comparisons.PSD · Jul 2021

4.6 At its March 2021 meeting, the PBAC noted (paragraph 6.71 and Table 12, PBAC PSD):  the lognormal function was selected to extrapolate OS beyond the duration of the key trials and that this resulted in per cycle mortality rates that were lower than Australian general population mortality estimates (for a cohort of patients aged 75-79 years); and  the extrapolated OS and EFS curves suggested a relatively long duration in the post-event state which …PSD · Jul 2021

Venetoclax with azacitidine is associated with superior efficacy and inferior safety compared to low-dose cytarabine monotherapy. Source: Table 1-1, p.3 of the March 2021 submission.PSD · Jul 2021

4.2 The PBAC noted and welcomed the input from individuals (1), health care professionals (9) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with VTX and AZA including the induction of meaningful responses in patients with poor prognosis, especially in older age groups where patients may be otherwise unfit for treatment.PSD · Jul 2021

The comments also considered that the oral form would be beneficial for use in rural settings, and that it would help preserve quality of life by reducing hospitalisation needs in older patients. 4PSD · Jul 2021

4.26 The PBAC advised in March 2021 that a resubmission should outline a Risk-Sharing Arrangement (RSA) to manage the risk of use in patients previously considered fit for standard intensive remission reduction regimens (paragraph 7.13, VTX, PSD, PBAC PSD, March 2021 PBAC meeting).PSD · Jul 2021