13 February 2018 - Australian Government subsidisation of ipilimumab for the treatment of patients with metastatic melanoma was conditional on the sponsor entering a ‘managed entry scheme’ to assess the 2-year overall survival rate in metastatic melanoma patients who received ipilimumab in the first year of PBS listing.
All unresectable stage IIIc / IV metastatic melanoma patients treated with at least one dose of ipilimumab therapy in Australia from the PBS listing date to a time point 12 months later (i.e. from 1-Aug-2013 to 31-Jul-2014) were invited to participate. Overall survival at 2 years post treatment initiation was measured, with Cox regression analysis used to examine the relationship between survival and patient baseline characteristics.
The 2 year overall survival rate for all patients receiving PBS subsidised ipilimumab in Australia from the first year PBS cohort is estimated to be between 23.9% and 34.2%, which is higher than the 23.5% observed in the key ipilimumab registrational trial.