Netupitant With PalonosetronAkynzeo

5.1 The PBAC recommended the amendment to the restriction criteria of NEPA to align with the TGA indication: ‘Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly and moderately emetogenic cancer chemotherapy’ rather than referencing specific chemotherapy drugs. The PBAC considered that the extension to the restriction criteria would be acceptably cost- effective with a price reduction.PSD · Mar 2023

5.2 The PBAC also recommended that this amendment should be applied to other NK1 inhibitors on the PBS: [fosaprepitant (fosaprepitant 150 mg injection, 1 vial), with a price reduction to achieve an equivalent price as required for NEPA; and aprepitant capsule (aprepitant 165 mg capsule, 1)].PSD · Mar 2023

6.19 The submission presented a cost-minimisation analysis versus aprepitant in combination with a 5HT antagonist, and an analysis versus aprepitant alone. 3PSD · Nov 2016

6.20 The submission proposed that 300mg of oral netupitant with 0.5mg of oral palonosetron could be considered equivalent to 165mg of oral aprepitant with a 5HT 3 antagonist.PSD · Nov 2016

6.14 This claim may be adequately supported for carboplatin/oxaliplatin regimens when used as primary prophylaxis, given that the majority of patients in the MEC subgroup of NETU-10-29 received treatment with carboplatin or oxaliplatin. However, NETU- 10-29 was not designed as a non-inferiority trial. The carboplatin/oxaliplatin and non- carboplatin/oxaliplatin subgroup analyses were constructed post hoc, and were therefore subject to high risk of bias.PSD · Nov 2016

The submission described netupitant with palonosetron FDC as non-inferior in terms of comparative efficacy and safety to aprepitant with a 5HT antagonist, when used 3 for secondary prophylaxis of nausea and vomiting associated with moderately emetogenic chemotherapy.PSD · Nov 2016

4.2 The PBAC noted and welcomed the input from individuals (1), health care professionals (1) and organisations (2) via the Consumer Comments facility on the PBS website. The comment from the individual described the negative impact of CINV on quality of life, and the financial difficulty experienced by individuals who self-fund NEPA due to the limitations of the current clinical criteria.PSD · Mar 2023

4.3 The PBAC noted input received from Antengene AUS Pty Ltd (Antengene) in support of NEPA submission. The input emphasised that CINV remains one of the most common adverse events suffered by patients and that it negatively impacts treatment outcomes and health related quality of life as well as increasing healthcare resource utilisation.PSD · Mar 2023