CarmustineBiCNU
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
Access path
- TGA registered · BiCNU
TGA label narrower than the PBS population
- Nov 2005Recommended · restricted
vs temozolomide
- Mar 2006Not recommended
Insufficient evidence of benefit in terms of survival gain or quality of life improvements in the broader population…
- Mar 2007Not recommended
uncertain clinical effectiveness resulting from the lack of a common reference, unequal distribution of additional…
- Jul 2008Not recommended
Uncertain clinical benefit, high and uncertain cost-effectiveness, trial population markedly different from requested…
Cost-effectiveness
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.
The PBAC concluded that the incremental cost effectiveness ratio (ICER) for temozolomide-treated patients could not be estimated with any degree of confidence and would most likely be significantly higher than the base-case ICER which was in the range of $45,000 - $75,000 per life year gained (LYG) which was based on the most favourable hazard ratios (0.64 - 0.75) i.e., those calculated after adjustment for prognostic factors. PBAC · 2008
Decision context
Populationpatients 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
Why it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2008 | Not recommended | placebo implants | $45k–75k | RCT · OS |
| Mar 2007 | Not recommended | temozolomide given orally | — | RCT · OS, PFS |
| Mar 2006 | Not recommended | — | — | — |
| Nov 2005 | Recommended · restricted | temozolomide | $75k–200k | RCT · OS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to recurrent GBM with prior temozolomide failure/intolerance; TGA label includes newly-diagnosed and recurrent without prior-therapy requirement.