Subject: Lynparza 1810-A SGM P2022
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 Recurrent Ovarian Cancer
Lynparza is indicated 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.
c. Advanced gBRCA-mutated Ovarian Cancer After 3 or
More Lines of Chemotherapy
Lynparza is indicated 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.
d. 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
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. Compendial Uses
1. Breast cancer
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.
c. For the treatment of persistent disease or recurrence
in patients with BRCA mutation who have been
treated with two or more lines of chemotherapy as a
single agent.
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.
III. CRITERIA FOR INITIAL APPROVAL
A. Epithelial Ovarian, Fallopian Tube, or Primary
Peritoneal Cancer
1. Authorization of 12 months may be granted for
treatment of epithelial ovarian, fallopian tube, or primary
peritoneal cancer as a single agent when all of the
following criteria are met:
a. The disease is persistent, recurrent, or advanced
(stage II-IV)
b. Tumor has deleterious or suspected deleterious
germline BRCA mutation
c. Member has received two or more prior
chemotherapies
2. 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:
a. 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
b. 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
c. 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 recurrent 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 early-stage,
HER2-negative, germline BRCA mutated breast cancer
with high-risk of recurrence, after completion of
neoadjuvant/adjuvant chemotherapy and local
treatment (e.g. radiation, surgery, etc.) in any of the
following settings:
a. Hormone receptor-negative breast cancer with either
tumor size >2 cm or any involved axillary nodes; OR
b. Hormone receptor-positive breast cancer with >4
positive lymph nodes; OR
c. Any residual disease and a CPS+EG (clinical stage,
pathologic stage, estrogen receptor status and tumor
grade) score >3 following preoperative therapy
C. Pancreatic Cancer
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 all the following criteria are met:
1. 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
2. Member has progressed on prior androgen receptor-
directed therapy
3. Member is receiving therapy concurrently with a
gonadotropin-releasing hormone (GnRH) analog or has
had a bilateral orchiectomy
4. The requested medication will be used as a single agent
(concurrent use with a GnRH analog is allowed)
E. Uterine Leiomyosarcoma
Authorization of 12 months may be granted for treatment
of BRCA altered uterine leiomyosarcoma (uLMS) as second-
line therapy when used as a single agent.
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; March 2022.
- The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed December 22, 2021.
- Tutt, A.N.J., Garber J.E., Kaufman, B., et al. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021;384:2394-2405. DOI:1056/NEJMoa2105215
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.
July 26, 2022
