Fosnetupitant With Palonosetron

6.1 The PBAC recommended listing NEPA IV as an Authority Required STREAMLINED benefit under both the General Schedule and Section 100 (Efficient Funding of Chemotherapy – Related Benefits (Code CT)) under the same conditions as the 6PSD · Jul 2020

6.2 The PBAC considered that the clinical claim that NEPA IV was non-inferior in terms of effectiveness and safety to the nominated comparator NEPA oral to be reasonable.PSD · Jul 2020

5.8 The minor submission presented a cost-minimisation analysis of NEPA IV compared with NEPA oral, based on 1 vial of NEPA IV being equi-effective to 1 capsule of NEPA oral; and proposed the same approved ex-manufacturer price (AEMP) for NEPA IV as NEPA oral ($97.16). It also noted the proposed AEMP is equivalent to that of fosaprepitant IV.PSD · Jul 2020

5.9 The price of aprepitant with a 5HT3 RA is currently lower than NEPA oral (and fosaprepitant). Should the PBAC consider aprepitant with a 5HT3 RA a relevant comparator for NEPA IV, it may be appropriate for the cost-minimisation to be conducted against aprepitant with a 5HT3 RA.PSD · Jul 2020

5.6 The minor submission claimed that NEPA IV is non-inferior in efficacy and safety compared to NEPA oral for the prevention of nausea and vomiting in patients undergoing treatment with moderately and highly emetogenic chemotherapy.PSD · Jul 2020

5.7 This claim was accepted by the PBAC since both forms were found to have comparable effectiveness and safety, and the TGA Delegate considered that both forms had the same exposure.PSD · Jul 2020