Subject: Lynparza 1810-A SGM P2023b
Policy:
I. 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.
A. FDA-Approved Indications
1. Ovarian Cancer
a. 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.
b. 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
c. 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
i. A deleterious or suspected deleterious BRCA
mutation, and/or
ii. Genomic instability
Select patients for therapy based on an FDA-approved
companion diagnostic for Lynparza.
2. Breast Cancer
a. 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.
b. 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.
3. 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.
4. Prostate Cancer
a. 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.
b. 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
B. Compendial Uses
1. Breast cancera.
a. Recurrent or metastatic HER2-negative, BRCA 1/2-
germline mutated breast cancer
b. Recurrent or metastatic HER2-positive, BRCA 1/2-
germline mutated breast cancer
c. 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
2. Ovarian cancer, Fallopian tube cancer, Primary peritoneal
cancer
a. 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
b. In combination with bevacizumab for maintenance
therapy for stage II-IV disease if in complete or partial
response after primary therapy that includes
bevacizumab.
3. Uterine Leiomyosarcoma (uLMS)
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review:
A. Documentation of laboratory report confirming BRCA
mutation status, where applicable.
B. Documentation of laboratory report confirming germline or
somatic HRR gene mutation, where applicable.
C. Documentation of hormone receptor (HR) and human
epidermal growth factor receptor 2 (HER2) status, where
applicable.
III. CRITERIA FOR INITIAL APPROVAL
A. 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:
1. 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
2. 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
3. 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
B. Breast Cancer
1. 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.
2. 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:
a. Hormone receptor-negative breast cancer with any
residual disease; OR
b. Hormone receptor-negative breast cancer with either
tumor size >2 cm or any involved axillary nodes; OR
c. Hormone receptor-positive breast cancer with >4
positive lymph nodes; OR
d. Hormone receptor-positive breast cancer with any
residual disease and a CPS+EG (clinical stage,
pathologic stage, estrogen receptor status and tumor
grade) score >3 following preoperative therapy
C. 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.
D. 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:
1. The requested medication will be used as a single agent
(concurrent use with a GnRH analog is allowed) and all of
the following criteria are met:
a. 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
b. Member has progressed on prior androgen receptor-
directed therapy
c. Member is receiving therapy concurrently with a
gonadotropin-releasing hormone (GnRH) agonist or
degarelix or has had a bilateral orchiectomy
2. 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:
a. Member has deleterious or suspected deleterious
BRCA mutation
b. Member has not had treatment in the setting of
castration-resistant prostate cancer
c. Member is receiving therapy concurrently with a
gonadotropin-releasing hormone (GnRH) agonist or
degarelix or has had a bilateral orchiectomy
E. 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.
IV. 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.
a. For the first-line maintenance treatment of BRCA-mutated
advanced ovarian cancer in a complete response, the
maximum treatment duration is 2 years.
b. For the first-line maintenance treatment of advanced ovarian
cancer in combination with bevacizumab in a complete
response, the maximum treatment duration is 2 years.
c. 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:
- Lynparza® Tablets [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2023.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed September 08, 2023.
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.
March 19, 2024
