NiraparibZejula
Maintenance therapy in patients with newly diagnosed advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that is HRD positive and BRCA wild type, who are in response to first-line platinum-based chemotherapy.
Decisions on record
- Meeting Jul 2023 Recommended Epithelial ovarian, fallopian tube, or primary peritoneal cancer no PSD
- Meeting Mar 2023 Deferred Epithelial ovarian, fallopian tube, or primary peritoneal cancer; newly diagnosed HRD positive BRCAwt advanced cancer
- Meeting Mar 2022 Recommended High grade epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Meeting Jul 2021 Not recommended Newly diagnosed advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer
- Meeting Mar 2021 Not recommended Platinum-sensitive relapsed high grade serous ovarian/fallopian tube/peritoneal cancer
Access path
- TGA registered · Zejula
TGA label narrower than the PBS population
- Mar 2021Not recommended
vs Olaparib (BRCAm population); standard medical…
- Jul 2021Not recommended
Comparator changed: Olaparib (BRCAm population); standard medical management/follow-up…
- ↻ resubmittedMar 2022Recommended · restricted
Comparator changed: Standard medical management (no active treatment); olaparib (for…
- Jul 2023Recommended
Comparator changed: olaparib (BRCAm patients); no active treatment/standard medical…
- PBS listing · Authority Required
From the public summary
6.33 Hettle 2021 performed a PAIC in the ITT and in the HRD positive populations using aggregate data from the May 2019 PRIMA data cut-off, and patient-level data from a subset of patients at the March 2019 PAOLA-1 data cut-off who met the surgery and FIGO staging eligibility criteria of PRIMA (i.e. excluded patients with stage III R0 PDS to create a modified PAOLA-1 set).PSD · Mar 2023
6.34 In the HRD positive population, Hettle 2021 reported a statistically significant difference in PFS HR favouring treatment with olaparib + bevacizumab compared to niraparib (PFS HR = 0.57, 95% CI 0.41, 0.79), with a median difference of 14.0 months.PSD · Mar 2023
6.56 The submission presented a modelled economic evaluation, based on subgroup results from PRIMA. The submission stated that as there was an absence of mature 30PSD · Mar 2023
6.57 The basis of the economic evaluation was a cost utility analysis (CUA). The model used a partitioned survival analysis with patients distributed between four mutually exclusive health states; progression-free (‘cured’), progression-free (‘not-cured’), progressed disease and death, over a base case time horizon of 20 years.PSD · Mar 2023
6.46 The submission described niraparib as superior in terms of effectiveness for PFS compared to SMM in the HRD positive BRCAwt population. While the PFS results in PRIMA demonstrated that niraparib was statistically significantly superior to placebo for the HRD positive BRCAwt population and the claim of superior clinical effectiveness may be plausible, the magnitude of PFS benefit and clinical significance may be considered uncertain as:PSD · Mar 2023
• OS data from PRIMA was immature. At the primary DCO there was no statistically significant difference in OS between treatments; 28PSD · Mar 2023
6.2 The PBAC noted and welcomed input from 2 consumers via the Consumer Comments facility on the PBS website which supported the proposed listing of niraparib. The individuals discussed the low quality of life experienced by those living with ovarian cancer, and the benefits of niraparib for patients with HRD+ tumours, and highlighted these benefits extended beyond patients with BRCA+ tumours.PSD · Mar 2023
Comments were also made regarding the cost burden of niraparib for those who have self-funded the treatment.PSD · Mar 2023
Cost-effectiveness
Redacted: prices and ICER values are commercially sensitive and shown as $ or blank in the document. The submission was based on a cost-effectiveness analysis, but specific ICER values are not disclosed in the public summary.
Decision context
PopulationPatients with newly diagnosed advanced (Stage III-IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are HRD positive and BRCA wild type, and in complete or partial response to first-line platinum-based chemotherapy.
Risk sharingSpecial Pricing Arrangements apply; financial cap proposed by sponsor to address clinical uncertainty in HRD negative subgroup.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2023 | Recommended | standard medical management | — | RCT · PFS |
| Mar 2022 | Recommended · restricted | olaparib (BRCAm patients); no active treatment/standard medical management (non-BRCAm patients) | — | RCT · PFS |
| Jul 2021 | Not recommended | Standard medical management (no active treatment); olaparib (for BRCA-mutant patients); bevacizumab (for Stage IIIB/IIIC | — | RCT · PFS |
| Mar 2021 | Not recommended | Olaparib (BRCAm population); standard medical management/follow-up (non-BRCAm population) | — | RCT · PFS |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| HRD testing (tumour tissue) for ovarian/fallopian tube/peritoneal cancer | homologous recombination deficiency (HRD) status, including BRCA1/2 variants and genomic instability | supported | 2023 |
Consumer voice
Two individual consumers and three patient support organisations (Pink Hope, Ovarian Cancer Australia, Rare Cancers Australia) supported niraparib listing, highlighting the poor quality of life with ovarian cancer, limited treatment options for non-BRCA tumours, manageable side effects, benefits of tablet formulation, and substantial financial burden of accessing HRD testing and PARPi treatment wi
The individuals discussed the low quality of life experienced by those living with ovarian cancer, and the benefits of niraparib for patients with HRD+ tumours, and highlighted these benefits extended beyond patients with BRCA+ tumours. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to HRD-positive, BRCA wild-type patients in first-line setting; TGA label includes all responders regardless of biomarker status and includes relapsed platinum-sensitive patients.