Palonosetron HydrochloridePalonosetron Dr Reddy's
Recommended OncologyRestrictedLater-line line
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
1
Submissions
2010–10
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2010 Recommended Prevent or treat nausea and vomiting following cancer chemotherapy
Access path
- TGA registered · Palonosetron Dr Reddy's
TGA label narrower than the PBS population
- Mar 2010Recommended · restricted
vs ondansetron
- PBS listing · Restricted
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated as submission assumed therapeutic equivalence
Cost-effectiveness accepted
Decision context
Populationpatients receiving moderately or highly emetogenic chemotherapy
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2010 | Recommended · restricted | ondansetron | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to moderately/highly emetogenic chemotherapy, later-line, and acute onset (within 48 hours); TGA label covers all cytotoxic chemotherapy without these restrictions.