TARLATAMAB

The PBAC did not recommend tarlatamab for the treatment of extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after first line treatment of platinum-based chemotherapy. The PBAC noted there is a high clinical need for patients in this therapeutical area, as ES-SCLC is a rapidly progressive disease and there are limited effective treatments in the second- and later-line settings.

The PBAC noted and welcomed comments from health care professionals, individuals who would like access to tarlatamab, and medical/consumer organisations. The PBAC noted comments highlighting that there was a high clinical need for effective therapies for ES-SCLC, noting that patients currently have few effective treatment options, with only modest clinical benefit, and typically face rapidly progressive disease, substantial symptom burden, and short survival.

The PBAC noted that the trial evidence suggested that tarlatamab was associated with benefits in terms of progression free survival (PFS) and overall survival (OS) compared to standard of care (SOC) chemotherapy. However, the PBAC noted significant safety concerns, including the high risk of immune effector cell-associated neurotoxicity syndrome (ICANs) and cytokine release syndrome (CRS), which were likely to have to a large impact in clinical practice. The PBAC noted key uncertainties related to the economic model and considered that the OS projections were overly optimistic. The PBAC considered that changes to the model assumptions and a substantial price reduction were required to achieve a cost-effective listing that reflected more realistic estimates of benefits and costs. The PBAC considered that a risk sharing arrangement was required to mitigate the risk that people would access the subsidy outside the proposed criteria. The PBAC advised that the remaining issues could be addressed in an early re-entry submission.