Fosaprepitant
Prevention of nausea and vomiting associated with cytotoxic chemotherapy. Indicated for primary prophylaxis prior to highly emetogenic chemotherapy (HEC) or breast cancer chemotherapy with cyclophosphamide and anthracycline, secondary prophylaxis prior to moderately emetogenic chemotherapy (MEC), and primary prophylaxis prior to carboplatin/oxaliplatin regimens.
Decisions on record
- Meeting Nov 2016 Recommended Nausea and vomiting
- Meeting Mar 2011 Recommended Anti-emetic no PSD
Access path
- Nov 2016Recommended · restricted
vs aprepitant one-day regimen (165 mg)
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required (Streamlined) General Schedule and Section 100 (Efficient Funding of Chemotherapy – Related Benefits) listing of fosaprepitant for the management of nausea and vomiting associated with cytotoxic chemotherapy, on a cost-minimisation basis against aprepitant (one-day regimen).PSD · Nov 2016
The PBAC considered that the equi-effective doses were 150 mg fosaprepitant and 165 mg aprepitant.PSD · Nov 2016
6.11 The submission noted that the PBAC had previously recommended fosaprepitant on a cost-minimisation basis against aprepitant three-day regimen. The PBAC previously considered that the price should take into account the increased nursing time to administer the drug.PSD · Nov 2016
6.12 The PBAC recalled its previous advice that the oral formulation would be the preferred option for patients. It also noted that there was a clinical need for fosaprepitant as an alternative option for those patients who could not use the oral form. The PBAC considered that uptake of fosaprepitant will not be large, and that the impact of any additional chair time will be negligible, and therefore agreed that no cost offset is needed.PSD · Nov 2016
6.9 The submission reiterated the March 2011 claim that fosaprepitant compared with aprepitant has non-inferior comparative effectiveness and non-inferior safety. The PBAC previously accepted this claim for the three-day regimen.PSD · Nov 2016
6.10 The PBAC considered that the claim of non-inferior comparative effectiveness and safety was reasonable when compared with aprepitant one-day regimen.PSD · Nov 2016
6.14 In the March 2016 consideration to extend the aprepitant listing to include use with carboplatin/oxaliplatin regimens from the first chemotherapy cycle, without having a prior episode of CINV, the PBAC recommended a Risk Sharing Arrangement to manage the risk for potential use beyond the estimated patient numbers.PSD · Nov 2016
6.15 The sponsor requested the same AEMP as aprepitant. This current price of aprepitant is weighted between prices for the highly emetogenic/anthracycline plus cyclophosphamide (breast cancer) indications, and the moderately emetogenic chemotherapy indication. As fosaprepitant will be listed with the same indications as for aprepitant, the PBAC considered that this was reasonable.PSD · Nov 2016
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated.
Decision context
PopulationAdult patients and children requiring prevention of nausea and vomiting associated with cytotoxic chemotherapy (highly emetogenic, moderately emetogenic, or carboplatin/oxaliplatin regimens), including those with difficulty swallowing or absorbing oral formulations.
Risk sharingFosaprepitant included in existing aprepitant Risk Sharing Arrangement for use with carboplatin/oxaliplatin regimens from the first chemotherapy cycle without prior episode of CINV, with no change to existing caps.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended · restricted | aprepitant one-day regimen (165 mg) | — | RCT · Other |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC specifies primary/secondary prophylaxis roles and particular chemotherapy regimens; TGA label permits broader use in initial and repeat courses.