Netupitant And PalonosetronAkynzeo
Prevention of nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy (HEC) and anthracycline plus cyclophosphamide (AC) based regimens in patients with breast cancer.
Decision on record
- Meeting Mar 2023 Recommended Nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy
Access path
- TGA registered · Akynzeo
TGA label narrower than the PBS population
- Nov 2015Recommended · restricted
vs aprepitant plus a 5-HT3 receptor antagonist
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended listing netupitant + palonosetron fixed dose combination (NEPA FDC) as an Authority Required STREAMLINED benefit on the General Schedule and under the Section 100 program Efficient Funding of Chemotherapy – Related Benefits, for the prevention of nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy and anthracycline plus cyclophosphamide based regimens in patients with breast cancer.PSD · Nov 2015
7.2 Listing was recommended at the price proposed in the submission, with the PBAC noting the lower DPMQ offered for NEPA compared with aprepitant. The PBAC noted that the economic analysis presented in the original submission was a cost comparison and the equi-effective doses were difficult to establish, however considered an assumption that each chemotherapy course would be treated with one capsule of NEPA FDC or one capsule of aprepitant 165 mg plus a …PSD · Nov 2015
4.1 The resubmission suggested, as previously, that the availability of a FDC regimen on the PBS will improve adherence to treatment guidelines at time of HEC administration, improve patient compliance in the home, and impact on resource use.PSD · Nov 2015
The resubmission proposed that the key benefits to patients and nursing staff by developing NEPA as a FDC of two mandatorily combined single agents are the reduction in pill burden, greater convenience and potentially improved compliance.PSD · Nov 2015
Cost-effectiveness
Cost-minimisation analysis presented; PBAC noted the economic evaluation was a cost comparison rather than a cost-minimisation analysis. No ICER calculated.
Decision context
PopulationAdult patients scheduled to receive initial and repeat courses of highly emetogenic chemotherapy (HEC) and patients with breast cancer scheduled to receive anthracycline plus cyclophosphamide (AC) based regimens, in combination with dexamethasone.
Risk sharingRisk sharing arrangement proposed where any usage beyond proposed estimates for NK1 RA use in HEC and AC breast cancer would be subject to a rebate of 30% of the cost of Akynzeo. PBAC advised that a risk sharing arrangement should include a subsidisation cap where higher than expected use of NEPA defaults to the equivalent cost of a 5-HT3 receptor antagonist, based on estimates of NEPA use in HEC and AC breast cancer indications.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Recommended · restricted | aprepitant plus a 5-HT3 receptor antagonist | — | RCT · Prevention of nausea and vomiting |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to HEC and AC-based regimens in breast cancer patients; TGA label includes all MEC without cancer-type specification.