PBAC's latest decision on Doxorubicin hydrochloride, pegylated liposomal: Not recommended (2008). Considered for treatment of refractory multiple myeloma in combination with bortezomib.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
$100k/QALY
Range: $50k/QALY–$100k/QALY
Submissions
1
first 2008
Submissions
1
2008 → 2008
Eligible population
patients 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
Therapy area
Haematology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
OS
Pivotal trial size
324 patients
Key trials
Trial 3001, Trial 3001 (subgroup analysis)
Comparator
bortezomib monotherapy
Economic model
CUA
ICER note
ICER ranged over $50,000–$100,000 in several sensitivity analyses; substantial uncertainty about clinical benefit means unacceptably large uncertainty about cost-effectiveness.
Why PBAC said no
Reasons cited in the latest PSD: 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