13 January 2021 - The case for improved clarity and transparency gets stronger.

In July 2020, the PBAC considered a major submission from BMS for nivolumab for use in combination with ipilimumab for the first-line treatment of patients with stage IV non-small cell lung cancer. Keen observers will note that the Department of Health published an outcome for this submission on 21 August; today the PBS website states the PBAC outcome for this submission cannot be made public until the TGA outcome is known. 

In November 2020, the PBAC considered a major submission from BMS for nivolumab for use in combination and ipilimumab and two cycles of platinum-based doublet chemotherapy for the first-line treatment of patients with stage IV non-small cell lung cancer. The PBAC recommended the listing of nivolumab for use in combination with ipilimumab and two cycles of platinum-based doublet chemotherapy for the treatment of patients with previously untreated stage IV squamous cell non-small cell lung cancer; it  did not recommend the listing of nivolumab and ipilimumab and platinum-based chemotherapy for the treatment of patients with previously untreated stage IV non-squamous non-small cell lung cancer.

In March 2021, the PBAC will consider a minor submission from BMS for nivolumab for use in combination with ipilimumab for the treatment of patients with non-small cell lung cancer. The resubmission addresses the PBAC’s concerns about the incremental effectiveness of nivolumab in patients 75 years or older. Does it relate to the July 2020 submission or the November 2020 rejected submission?  The published outcomes from the November 2020 meeting make no reference to the cost effectiveness of nivolumab (for use in combination with ipilimumab) in patients 75 years of age and above.

Non-astute readers and consumers must surely be confused by all of this. The time for reform is nigh.