ZEJULA (niraparib)
Self-Administration - Oral
Indications for Prior Authorization:
- Indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
- Indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy
- Indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 3 or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:
- Deleterious or suspected deleterious BRCA mutation, or
- Genomic instability and who have progressed more than 6 months after response to the last platinum-based chemotherapy.
Coverage Criteria:
1. First-Line Maintenance Treatment of Advanced Ovarian Cancer:
- Dose does not exceed 300 mg (three 100mg capsules) per day; AND
- Prescribed by or in consultation with an Oncologist; AND
- Diagnosis of ONE of the following:
- Advanced epithelial ovarian cancer
- Advanced fallopian tube cancer
- Advanced primary peritoneal cancer; AND
- Used for maintenance treatment in patients who are in a complete or partial response to first-line platinum-based chemotherapy (e.g., carboplatin with gemcitabine, carboplatin with liposomal doxorubicin, carboplatin with paclitaxel, cisplatin with gemcitabine); AND
- Will be used as monotherapy
2. Maintenance Treatment of Recurrent Ovarian Cancer:
- Dose does not exceed 300 mg (three 100mg capsules) per day; AND
- Prescribed by or in consultation with an Oncologist; AND
- Diagnosis of ONE of the following:
- Advanced epithelial ovarian cancer
- Advanced fallopian tube cancer
- Advanced primary peritoneal cancer; AND
- Used for maintenance treatment in patients who are in a complete or partial response to platinum-based chemotherapy (e.g., cisplatin, carboplatin); AND
- Will be used as monotherapy
3. Treatment of Advanced Ovarian Cancer after Three or More Chemotherapies:
- Dose does not exceed 300 mg (three 100mg capsules) per day; AND
- Prescribed by or in consultation with an Oncologist; AND
- Diagnosis of ONE of the following:
- Advanced ovarian cancer
- Advanced fallopian tube cancer
- Advanced primary peritoneal cancer; AND
- Patient’s cancer is associated with homologous recombination deficiency (HRD) positive status defined by ONE of the following:
- A deleterious or suspected deleterious BRCA mutation
- Both of the following:
- Genomic instability
- Cancer has progressed more than 6 months after response to the last platinum-based chemotherapy (e.g., cisplatin, carboplatin); AND
- Patient has been treated with 3 or more prior chemotherapy regimens; AND
- Will be used as monotherapy
Reauthorization Criteria:
For all indications:
- Dose does not exceed 300 mg (three 100mg capsules) per day; AND
- Patient does not show evidence of progressive disease while on therapy
Coverage Duration:
- Initial: 1 year
- Reauthorization: 1 year
Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:
- Dosage and administration:
- First-line maintenance treatment of advanced ovarian cancer:
- For patients weighing < 77 kg (<170 lbs) OR with a platelet count < 150,000/uL, the recommended dose is 200 mg taken orally once daily
- For patients weighing >/= 77 kg (>/= 170 lbs) AND a platelet count >/= 150,000/uL, the recommended dose is 300 mg taken orally once daily
- For other indications:
- The recommended dose is 300 mg taken orally
- First-line maintenance treatment of advanced ovarian cancer:
- For the maintenance treatment of advanced ovarian cancer, patients should start treatment with Zejula no later than 12 weeks after their most recent platinum-containing regimen
- For the maintenance treatment of recurrent ovarian cancer, patient should start treatment with Zejula no later than 8 weeks after their most recent platinum-containing regimen
Policy Updates:
- 08/16/2022 – updated policy to include new indications, criteria, and format updated
- 06/12/2017 – Original review
References:
- Zejula Prescribing Information. GlaxoSmithKline, LLC. Research Triangle Park, NC. March 2021.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer v.2.2022.
Last review date: August 16, 2022