Subject: Lynparza SGM 1810-A P2024a_R

Drug

LYNPARZA  (olaparib)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-APPROVED INDICATIONS

Ovarian Cancer

• First-Line Maintenance Treatment of BRCA-mutated Advanced Ovarian Cancer

Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) 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.

• Maintenance Treatment of BRCA-mutated Recurrent Ovarian Cancer

Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza

• First-Line Maintenance Treatment of HRD-positive Advanced Ovarian Cancer in Combination with Bevacizumab
  Lynparza is indicated in combination with bevacizumab for 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.

Breast Cancer

• Lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
• Lynparza is indicated 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.

Pancreatic Adenocarcinoma

Lynparza is indicated 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.

Prostate Cancer

• Lynparza is indicated 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 (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
• Lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza

Compendial Uses

• Breast cancer
  • Recurrent or metastatic HER2-negative, BRCA 1/2-germline mutated breast cancer
  • Recurrent or metastatic HER2-positive, BRCA 1/2-germline mutated breast cancer
  • Adjuvant therapy for early-stage, HER2-negative, BRCA 1/2-germline mutated breast cancer with high-risk of recurrence, after completion of neoadjuvant/adjuvant chemotherapy and local treatment
• Ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer
  • As a single-agent maintenance therapy for patients with BRCA1/2 germline or somatic mutations who are in complete or partial response after primary treatment for stage II-IV disease
  • In combination with bevacizumab for maintenance therapy for stage II-IV disease if in complete or partial response after primary therapy that includes bevacizumab.
• Uterine Leiomyosarcoma (uLMS)

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

• Documentation of laboratory report confirming BRCA mutation status, where applicable.
• Documentation of laboratory report confirming germline or somatic HRR gene mutation, where applicable.
• Documentation of hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status, where applicable.

Coverage Criteria

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Authorization of 12 months may be granted for the maintenance treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that is in a complete or partial response to chemotherapy when any of the following criteria are met:

• Member has completed two or more lines of platinum-based therapy for recurrent disease and will be using the requested medication as a single agent
• Member has a deleterious or suspected deleterious germline or somatic BRCA mutation and will be using the requested medication as a single agent or in combination with bevacizumab for advanced (stage II-IV) disease
• Member has received primary therapy that includes bevacizumab for advanced (stage II-IV) disease and will be using the requested medication in combination with bevacizumab

Breast Cancer

Authorization of 12 months may be granted for the treatment of breast cancer with no response to preoperative systemic therapy, or for recurrent unresectable (local or regional)  or metastatic breast cancer as a single agent in members with deleterious or suspected deleterious germline BRCA mutations.

Authorization of 12 months may be granted for use as adjuvant therapy for the treatment of HER2-negative, germline BRCA mutated breast cancer after completion of neoadjuvant/adjuvant chemotherapy in any of the following settings:

• Hormone receptor-negative breast cancer with any residual disease; OR
• Hormone receptor-negative breast cancer with either tumor size greater than or equal to 2 cm or any involved axillary nodes; OR
• Hormone receptor-positive breast cancer with greater than or equal to 4 positive lymph nodes; OR
• Hormone receptor-positive breast cancer with any residual disease and a CPS+EG (clinical stage, pathologic stage, estrogen receptor status and tumor grade) score greater than or equal to 3 following preoperative therapy

Pancreatic Adenocarcinoma

Authorization of 12 months may be granted for the maintenance treatment of deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma as a single agent, in members whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.

Prostate Cancer

Authorization of 12 months may be granted for treatment of metastatic castration-resistant prostate cancer (mCRPC) when either of the following criteria are met:

• The requested medication will be used as a single agent (concurrent use with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix) GnRH analog is allowed) and all of the following criteria are met:
  • Member has deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutation, which includes BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L
  • Member has progressed on prior androgen receptor-directed therapy
  • Member is receiving therapy concurrently with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix) a gonadotropin-releasing hormone (GnRH) agonist or degarelix or has had a bilateral orchiectomy
• The requested medication will be used in combination with abiraterone or fine-particle abiraterone (Yonsa) and concurrent steroids (prednisone, prednisolone, or methylprednisolone) and all of the following criteria are met:
  • Member has deleterious or suspected deleterious BRCA mutation
  • Member has not had treatment in the setting of castration-resistant prostate cancer
  • Member is receiving therapy concurrently with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix) or has had a bilateral orchiectomy

Uterine Leiomyosarcoma

Authorization of 12 months may be granted for treatment of BRCA2-altered uterine leiomyosarcoma (uLMS) as subsequent therapy when used as a single agent for advanced, recurrent, metastatic, or inoperable disease.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

• For the first-line maintenance treatment of BRCA-mutated advanced ovarian cancer in a complete response (no radiological evidence of disease), the maximum treatment duration is 2 years.
• For the first-line maintenance treatment of advanced ovarian cancer in combination with bevacizumab in a complete response (no radiological evidence of disease), the maximum treatment duration is 2 years.
• For use as adjuvant treatment of early-stage, HER2-negative, BRCA-mutated breast cancer with high-risk of recurrence, the maximum treatment duration is 1 year.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Lynparza® Tablets [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2023.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org.  Accessed August 1, 2024.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 01, 2025