Fosnetupitant/Palonosetron

The PBAC recommended the General Schedule and Section 100 (Efficient Funding of Chemotherapy – Related Benefits) listing of fosnetupitant (FosNTP) with palonosetron (herein referred to as NEPA IV) for the prophylaxis of nausea and vomiting in patients receiving highly or moderately emetogenic chemotherapy (HEC and MEC, respectively), who are unable to swallow or are contraindicated to an oral anti-emetic regimen.PSD · Mar 2023

• Fosnetupitant 235 mg IV (as part of NEPA IV) = fosaprepitant 150 mg IV, both given once per chemotherapy cycle. For the 5-HT3 RA component:PSD · Mar 2023

The submission presented a cost-minimisation approach (CMA) comparing NEPA IV with Emend IV + a 5-HT3 RA (PALO IV was nominated as the 5-HT3 RA). While the claim of superior safety may be uncertain, the presentation of a CMA is reasonable.PSD · Mar 2023

However, the comparator applied in the cost-minimisation may not be the least costly amongst the relevant alternative therapies, as NEPA IV may also substitute for other combinations of a NK1 RA + a 5-HT3 RA, including NEPA. The PBAC previously considered that NEPA IV be cost-minimised to the lowest cost combination of a NK1 RA and a 5-HT3 RA.PSD · Mar 2023

The submission described NEPA IV as non-inferior in terms of effectiveness and superior in terms of safety compared to Emend IV plus a 5-HT3 RA for the prevention of nausea and vomiting in patients undergoing treatment with MEC and HEC. Both therapies are administered as a single dose per cycle prior to the administration of chemotherapy.PSD · Mar 2023

The therapeutic conclusion presented in the submission regarding effectiveness appeared to have been adequately supported by the direct evidence from the CONSOLE and CONSOLE-BC trials, noting that the assessment of efficacy was a secondary objective in CONSOLE-BC.PSD · Mar 2023

The PBAC noted the input from Antengene (AUS) Pty Ltd (the sponsor of the PBS-listed drug selinexor), which discussed the impact of chemotherapy-induced nausea and vomiting and highlighted the need for additional treatment options and for broader review of the structure of the listings of anti-emetic agents for this purpose. 10PSD · Mar 2023