Netupitant/PalonosetronAkynzeo
Prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients treated with highly emetogenic chemotherapy for malignancy, and in breast cancer patients treated with anthracycline plus cyclophosphamide based regimens.
Decision on record
- Meeting Mar 2015 Not recommended Acute and delayed chemotherapy induced nausea and vomiting no PSD
Access path
- TGA registered · Akynzeo
TGA label narrower than the PBS population
- Mar 2015Not recommended
unclear clinical place particularly for moderately emetogenic chemotherapy population, lack of clinical evidence for…
- Jul 2015Not recommended
Comparator changed: aprepitant plus 5-HT3 receptor antagonist (palonosetron or…
From the public summary
7.1 The PBAC decided not to recommend that netupitant with palonosetron (NEPA) fixed dose combination tablet be made available on the PBS for chemotherapy induced nausea and vomiting. In making its recommendation, the PBAC considered that there was still an uncertain clinical need for this population of patients, and that a number of concerns raised in its previous consideration in March 2015 had not been adequately addressed in the re-submission.PSD · Jul 2015
7.2 The PBAC noted the updated NCCN guidelines but considered the clinical need for the FDC in Australia was not established by the re-submission.PSD · Jul 2015
6.6 The major submission for NEPA considered by the PBAC in March 2015, presented a cost-minimisation analysis against aprepitant plus a 5-HT RA. The PBAC 3 considered the economic evaluation presented to be a cost comparison, rather than a cost-minimisation analysis (paragraph 7.7 of the March 2015 PSD).PSD · Jul 2015
6.7 The PBAC was concerned that the fixed dose combination guidelines were not addressed in the major submission for NEPA. The PBAC guidelines for listing fixed dose combination products express a preference for components to be individually listed on the PBS, as well as avoiding unnecessary proliferation of products or dose forms (paragraph 7.4 of the March 2015 PSD).PSD · Jul 2015
6.17 The overall claim of the submission was that NEPA was therapeutically equivalent to aprepitant in combination with a 5-HT RA. However the following limitations were 3 noted by ESC: Highly emetogenic populationPSD · Mar 2015
• In NETU-07-07, for the comparison arm, ondansetron (intravenous, 32 mg) was prescribed at a higher dose than recommended in Australian practice.PSD · Mar 2015
6.2 The PBAC noted and welcomed the input from health care professionals (8) via the Consumer Comments facility on the PBS website. The comments described some of the perceived benefits of netupitant and palonosetron, including its potential compliance advantage over injectable treatment options.PSD · Jul 2015
Cost-effectiveness
Cost-minimisation analysis presented; no ICER calculated. PBAC considered the economic evaluation to be a cost comparison rather than a true cost-minimisation analysis.
The PBAC noted that the economic evaluation presented is not a cost-minimisation analysis but rather a cost comparison. PBAC · 2015
Decision context
PopulationAdult patients scheduled to receive highly emetogenic chemotherapy for malignancy, and breast cancer patients scheduled to receive anthracycline plus cyclophosphamide based regimens, in combination with dexamethasone.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Not recommended | aprepitant plus 5-HT3 receptor antagonist | — | RCT · Complete response (acute, delayed, and overall nausea and vomiting) |
| Mar 2015 | Not recommended | aprepitant plus 5-HT3 receptor antagonist (palonosetron or ondansetron) with dexamethasone; alternatively aprepitant wit | — | RCT · Complete response (no emesis and no use of rescue medication) |
Consumer voice
Healthcare professionals provided input highlighting perceived benefits of netupitant and palonosetron, particularly its potential compliance advantage over injectable treatment options.
The comments described some of the perceived benefits of netupitant and palonosetron, including its potential compliance advantage over injectable treatment options. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts moderately emetogenic chemotherapy subsidy to breast cancer patients receiving anthracycline plus cyclophosphamide regimens only.