NivolumabOpdivo

7.1 The PBAC did not recommend the listing of nivolumab for the perioperative treatment of patients with resectable non-small cell lung cancer (NSCLC). The PBAC noted the perioperative use of nivolumab consisted of up to 4 doses prior to surgery in combination with chemotherapy (neoadjuvant treatment) and up to 12 months of treatment post-surgery as monotherapy (adjuvant treatment).PSD · Dec 2024

7.2 The primary reason for this outcome was due to the comparative clinical evidence.PSD · Dec 2024

6.60 The PSCR acknowledged that due to its recent PBS listing, neoNIVO was the most appropriate main comparator, for which a clinical claim of at least noninferiority, and potentially superior efficacy, for periNIVO versus neoNIVO was made by the submission.PSD · Dec 2024

6.61 The CMA presented in the PSCR was based on equivalent total costs for neoNIVO and periNIVO over the total duration of therapy for each treatment regimen. The total cost of therapy included drug costs for nivolumab and chemotherapy, and administration costs. 6.62 The proposed equi-effective doses are:PSD · Dec 2024

6.53 The submission claimed that periNIVO offers ‘at least noninferior, and potentially superior efficacy’ and noninferior safety compared with neoNIVO.PSD · Dec 2024

6.54 The ESC considered that the clinical claim of ‘at least noninferior, and potentially superior’ efficacy of periNIVO compared to neoNIVO was uncertain and likely not supported. The ESC noted the results from the ITC of periNIVO versus neoNIVO presented in the submission (HR=0.92; 95% CI: 0.59, 1.44) was associated with wide confidence intervals, indicating a high level of uncertainty around the estimated effect size.PSD · Dec 2024

6.2 The PBAC noted and welcomed the input from an individual and organisations (3) via the Consumer Comments facility on the PBS website. An individual accessing nivolumab through a clinical trial stated that there were limited treatment options for their type of lung cancer and expressed concern of exhausting treatment options.PSD · Dec 2024

6.3 The PBAC acknowledged the input from Rare Cancers Australia and Lung Foundation Australia expressing their support for the listing of nivolumab for the perioperative treatment of resectable NSCLC. The organisations emphasised the importance of additional treatment options for this patient group and considered that nivolumab as perioperative treatment could result in considerable benefits for NSCLC patients and their carers and families.PSD · Dec 2024