WHA

LYNPARZA (olaparib)

SELF ADMINISTRATION - ORAL

Indication for Prior Authorization:

Advanced Ovarian Cancer:

  • For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
    • Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
  • For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
    • Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
  • For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.
  • in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial 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 homologous recombination deficiency (HRD)-positive status defined by either: a deleterious or suspected deleterious BRCA mutation, AND/OR genomic instability.
    • Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. 

Metastatic Breast Cancer:

  • For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.
    • Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

Metastatic Pancreatic Cancer:

  • For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.
    • Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

Metastatic Prostate Cancer:

  • For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer.
Coverage Criteria:

For Advanced Ovarian Cancer:

  • Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer; AND
  • Prescribed by or in consultation with an oncologist; AND
  • Patient is age 18 years or older; AND
  • The patient meets ONE of the following:
    • Maintenance treatment following disease recurrence after receiving 2 or more platinum-based chemotherapy regimens, and is currently in response (complete or partial) to the most recent platinum-based chemotherapy regimen
    • Both of the following for treatment:
      • Documentation of a deleterious or suspected deleterious germline BRCA mutation (gBRCAm); AND
      • Failure at least 3 prior chemotherapy regimens, unless contraindicated or clinically significant adverse effects are experienced.
    • Both of the following for maintenance:
      • Documentation of a deleterious or suspected deleterious gBRCAm or somatic BRCA-mutation; AND
      • Completed a first-line platinum-based chemotherapy regimen and is currently in response (complete or partial).
  • Requested dose meets ONE of the following:
    • Does not exceed 600 mg per day; OR
    • Supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

For Metastatic Breast Cancer:

  • Diagnosis of breast cancer; AND
  • Prescribed by or in consultation with an oncologist; AND
  • Patient is age 18 years or older; AND
  • Disease has ALL of the following:
    • Breast cancer is metastatic or recurrent,
    • Human epidermal growth factor receptor 2 (HER2)-negative breast cancer,
    • Documentation of a deleterious or suspected deleterious germline BRCA mutation (gBRCAm); AND
  • Requested dose meets ONE of the following:
    • Dose does not exceed 600 mg per day; OR
    • Supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

For Treatment of Metastatic Prostate Cancer, Metastatic Pancreatic Cancer, or HRD-positive Advanced Ovarian Cancer:

  • Lynparza is being used to treat a condition as approved by the Food and Drug Administration (FDA) using the appropriate dose.
Dosing:

Recommended dosage is 300 mg taken by mouth twice daily.

Coverage Duration:

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 Committee.

Additional Information:
  • For moderate renal impairment (CrCL 31-50 mL/min), reduce Lynparza dosage to 200 mg orally twice daily.
  • Lynparza is available as 150mg and 100mg tablets.
Review History:
  • 12/19/2014 – Initial FDA approval.
  • 07/16/2019 – Annual review.
  • 12/27/20 – Annual review; updated format; added new FDA-approved indications to policy: metastatic prostate cancer, metastatic pancreatic cancer, and HRD-positive advanced ovarian cancer.
References:
  • Lynparza [package insert]. Wilmington, DE: AstraZeneca.; May 2020.
  • National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Breast Cancer, version 6.2020 – September 8, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed December 15, 2020.
  • National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer, version 1.2020 – March 11, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed December 15, 2020.
  • National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Pancreatic Adenocarcinoma, version 1.2021 – October 23, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed December 15, 2020.
  • National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Prostate Cancer, version 3.2020 – November 17, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed December 15, 2020.
 

Last review date: January 4, 2021