Decitabine With CedazuridineINQOVI 35/100

5.1 The PBAC recommended the listing of decitabine+cedazuridine for the treatment of patients with myelodysplastic syndrome (MDS) classified as intermediate-2 or high- risk according to the International Prognostic Scoring System (IPSS) and patients with chronic myelomonocytic leukaemia (CMML).PSD · Jul 2021

5.2 The PBAC again acknowledged the advantages of an oral treatment, particularly for patients in rural and remote areas, given the administration of azacitidine requires attendance at an outpatient clinic for seven days each month. The PBAC reiterated there would be a substantially reduced treatment burden with oral therapy and that this may make treatment available to more patients.PSD · Jul 2021

4.3 The resubmission proposed an effective AEMP of $'''''''''''''''' that is a 10% price reduction on the ex-manufacturer price ($'''''''''''''''''') derived from the cost- minimisation analysis presented in the sponsor’s March 2021 pre-PBAC Response, which accounted for the difference in supply chain costs (mark-ups and fees) between azacitidine and decitabine+cedazuridine.PSD · Jul 2021

The mean supply chain cost for azacitidine ($18.85) is calculated by multiplying the proportion of azacitidine PBS items from the private hospital setting (39.45%) by the mark-ups and fees associated with the Section 100 Highly Specialised Drugs (HSD) listing ($47.74 in total, comprising of $40.00 AHI mark- up and $7.74 preparation fee) b AEMP ($''''''''''''''''''''') plus wholesale mark-up ($54.14) c DPMQ ($'''''''''''''''''''''') minus wholesale mark-up …PSD · Jul 2021

4.2 The PBAC noted and welcomed the input from the Leukaemia Foundation via the Consumer Comments facility on the PBS website. The Leukaemia Foundation reiterated its support for a PBS listing of decitabine+cedazuridine, noting there are few treatment options for patients with MDS and CMML.PSD · Jul 2021

4.11 The resubmission proposed a Risk Sharing Arrangement with financial caps based on the revised financial estimates. The sponsor indicated it is willing to accept '''''''% rebate for any use above the caps however requested a final negotiation during the post-recommendation listing phase.PSD · Jul 2021

For more detail on PBAC’s view, see section 5 PBAC outcome. 6PSD · Jul 2021