Monograph

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.

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.