On 18 October 2024, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes of its September 2024 intracycle meeting. This included consideration of proposals for broad Pharmaceutical Benefits Scheme (PBS) listings for PD-(L)1 inhibitors, including MSD’s pembrolizumab and BMS’ nivolumab, to allow expanded access to all current and future indications registered by the Therapeutic Goods Administration (TGA) without review of the clinical- and cost-effectiveness of each indication. Consideration of these proposals had been deferred from the PBAC’s December 2023 meeting.
The PBAC determined that any broad subsidy proposal would need to address a list of parameters, including: “the potential risk of causing harm either directly (forgoing effective current standard treatments, adverse events) or intangibly (false hope, not resolving patient needs, inadequate provision of palliative care)”; the high level of uncertainty in cost-effectiveness when a PD-(L)1 inhibitor is not assessed for a specific listing based on clinical trial data for that use; the potential impact on other medicines (including PD-(L)1 inhibitors) that may already be in the market; and “biosimilar policies that might be in place, noting that multiple biosimilars for pembrolizumab and nivolumab are in the late phase of clinical development, with patents due to expire in some jurisdictions within the next five years”. PBAC noted that, to date, it had not received an acceptable proposal for an expanded listing to facilitate broad access to PD-(L)1 inhibitors.
However, the PBAC said it is “supportive of implementing simplified listings for PD-(L)1 inhibitors within a specific tumour type if this would facilitate appropriate and timely access for patients”. It is encouraging sponsors to make submissions for simplified PBS listings within tumour types “via the standard process”.
PD-(L)1 inhibitors currently listed on the PBS include MSD’s Keytruda® (pembrolizumab), BMS’ Opdivo® (nivolumab), AstraZeneca’s Imfinzi® (durvalumab), Merck Healthcare’s Bavencio® (avelumab), Medison Pharma Australia’s Libtayo® (cemiplimab) and GSK’s Jemperli® (dostarlimab). BeiGene’s Tevimbra® (tislelizumab) and AA-Med’s toripalimab are under evaluation by the TGA.