WHA

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
    • 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:
    1. Zejula Prescribing Information. GlaxoSmithKline, LLC. Research Triangle Park, NC. March 2021.
    2. 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