PBAC's latest decision on Carmustine: Not recommended (2008). Considered for treatment of recurrent glioblastoma multiforme (GBM) in patients for whom surgical resection is indicated and recurrence has occurred within 6 months of temozolomide or where temozolomide is contraindicated or not tolerated due to side effects.
PBAC outcome
Not recommended
2008
ICER (AUD/QALY)
$75k/QALY
Range: $45k/QALY–$75k/QALY
Submissions
3
first 2006
Submissions
3
2006 → 2008
Eligible population
patients with recurrent glioblastoma multiforme (GBM) who have failed temozolomide within the previous 6 months or are intolerant to it, or have a contraindication to temozolomide
Therapy area
Oncology
Evidence base
RCT
Primary endpoint
OS
Pivotal trial size
222 patients
Key trials
8802
Comparator
placebo implants
Economic model
CUA
ICER note
Base case ICER stated; however, PBAC noted ICER for temozolomide-treated patients (the larger part of the population targeted) could not be estimated with confidence and would likely be significantly higher. Unadjusted ICER range was $45,000–$105,000/LYG.
Why PBAC said no
Reasons cited in the latest PSD: Uncertain clinical benefit, high and uncertain cost-effectiveness, trial population markedly different from requested PBS population (participants had no prior temozolomide exposure whereas restriction targets temozolomide-failed patients), considerable uncertainty about whether prior temozolomide use would diminish benefit, post-hoc subgroup analysis introduces uncertainty about extent of effectiveness advantage, increased toxicity risk (abnormal healing and pain) compared to placebo