Doxorubicin Hydrochloride, Pegylated Liposomal

ICER ranged over $50,000–$100,000 in several sensitivity analyses; substantial uncertainty about clinical benefit means unacceptably large uncertainty about cost-effectiveness.

The PBAC noted that the model was most sensitive to efficacy within the trial duration. Decreasing the difference in overall survival during the trial by 90% (as a surrogate of using 95% CI values), resulted in an ICER of greater than $200,000 per life year saved (LYS), whilst increasing the difference by 50% resulted in a reduction of the ICER (in the range of $15,000 - $45,000/LYS). The updated analysis (median follow-up 18.0 months) did not reveal a statistically significant difference in overall survival between the two treatment arms. PBAC · 2008

Populationpatients with refractory multiple myeloma who have received at least one prior therapy other than thalidomide, a WHO performance status of 0-2, and are unsuitable for stem cell transplant

• uncertain overall survival benefit (lost significance at 18-month follow-up), increased toxicity (Grade 3/4 adverse events more frequent), no improvement in quality of life, high and uncertain cost-effectiveness with ICER ranging $50,000–$100,000/LYS

Label narrower than PBS population — PBAC restricted to refractory disease, prior non-thalidomide therapy, PS 0-2, and unsuitable for stem cell transplant.