Niraparib

[MAF] Niraparib Tablet 100 mg

1. Maintenance monotherapy for patients with advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with BRCA mutation and/or homologous recombination deficiency (HRD) positive status. Treatment should be continued until disease progression or unacceptable toxicity or a maximum of 36 months.

[MSHL] Niraparib Tablet 100 mg

1. Maintenance monotherapy for patients with advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
   Treatment should be continued until disease progression or unacceptable toxicity or a maximum of 36 months.

2. Maintenance monotherapy for patients with platinum-sensitive relapsed BRCA-mutated high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
   Patients must not have received prior treatment with a PARP inhibitor for ovarian cancer. Treatment should be continued until disease progression or unacceptable toxicity.

3. Maintenance monotherapy for patients with advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with BRCA-mutation and/or homologous recombination deficiency (HRD) positive status. Treatment should be continued until disease progression or unacceptable toxicity or a maximum of 36 months.

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02/01/2024 PARP inhibitors and bevacizumab for treating advanced ovarian cancer

The Ministry of Health’s Drug Advisory Committee has recommended:

• Olaparib 100 mg and 150 mg tablets; and

• Niraparib 100 mg tablet

for treating advanced ovarian cancer in line with specific clinical criteria.

Funding status

[R] Olaparib 100 mg and 150 mg tablets are recommended for inclusion on the Medication Assistance Fund (MAF) with effect from 1 September 2022 for the following indications:

• As maintenance monotherapy for patients with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Treatment should be continued until disease progression or unacceptable toxicity or for a maximum of 24 months;

• In combination with bevacizumab biosimilar (subsidised brand) as maintenance treatment of patients with advanced homologous recombination deficiency (HRD) positive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab biosimilar. Treatment with olaparib should be continued until disease progression or unacceptable toxicity or for a maximum of 24 months; and

• As maintenance monotherapy for patients with platinum-sensitive relapsed BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Patients must not have received prior treatment with a PARP inhibitor for ovarian cancer. Treatment should be continued until disease progression or unacceptable toxicity.

[R] Niraparib 100 mg tablet is recommended for inclusion on the MAF with effect from 1 March 2024 for the following indication:

• As maintenance monotherapy for patients with advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with BRCA mutation and/or HRD-positive status. Treatment should be continued until disease progression or unacceptable toxicity or for a maximum of 36 months.

Clinical indications, subsidy class and MediShield Life claim limits for all drugs included in the evaluation are provided in the Annex.

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DHCPL 23/12/2022 ZEJULA (Niraparib): Important update for the maintenance treatment in relapsed ovarian cancer in the second line or higher settings (2L+)

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Note:

General availability information reflected is based on the Public Healthcare Institutions’ (PHI) formulary on what is commonly used for treating their patient population and may or may not be available for patients not under the care of that institution. It does not reflect the PHI’s actual inventory availability and is subjected to change. Please consult the Public Hospitals or Polyclinics for details on availability and supply restrictions/considerations. General availability is not tied to any brand unless otherwise stated.

Users are to consult the respective PHIs for actual inventory availability and supply restrictions/consideration