NIVOLUMAB

The PBAC recommended the listing of nivolumab solution for subcutaneous injection 600 mg in 5 mL for use across the existing PBS‑listed indications for nivolumab, except where nivolumab is administered 3-weekly or where nivolumab is used in combination with ipilimumab. The PBAC agreed that nivolumab subcutaneous injection should be included in the existing multi‑indication (broad) listing for the treatment of immunotherapy‑sensitive advanced or metastatic cancers, and that a dual Section 100 (Efficient Funding of Chemotherapy – Related Benefits) and Section 85 (General Schedule) listing was appropriate.

The PBAC considered evidence from a head‑to‑head clinical trial and supporting pharmacokinetic studies and concluded that subcutaneous nivolumab was non‑inferior to intravenous nivolumab in terms of effectiveness and safety. The PBAC accepted that subcutaneous nivolumab offers a less invasive mode of administration and may reduce treatment time and infusion chair utilisation, without increasing system burden.

The PBAC recommended listing on a cost‑minimisation basis, accepting that 600 mg every two weeks or 1200 mg every four weeks of subcutaneous nivolumab is equi‑effective to 240 mg every two weeks or 480 mg every four weeks of intravenous nivolumab, respectively. The PBAC noted that the estimated financial impact to the PBS was a net cost saving, with modest savings over time.

The PBAC considered that the proposed prescribing instructions differentiating use to flat dosing regimens were appropriate and would support alignment with the existing broad listing arrangements. The PBAC considered that it would be appropriate for NIVO SC to join the existing risk-sharing arrangements in place for NIVO IV without any changes to caps.