Subject: Rubraca 2256-A SGM P2022a
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
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.
2. Prostate Cancer
Treatment of adult patients with a deleterious BRCA
mutation (germline and/or somatic)-associated
metastatic castration-resistant prostate cancer (mCRPC)
who have been treated with androgen receptor-directed
therapy and a taxane-based chemotherapy. Select
patients for therapy based on an FDA-approved
companion diagnostic test for Rubraca.
B. Compendial Uses
1. Prostate Cancer
2. Uterine Leiomyosarcoma (uLMS)
3. Pancreatic Adenocarcinoma
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:
1. Documentation of laboratory report confirming BRCA
mutation status, where applicable
2. Documentation of laboratory report confirming PALB2
mutation 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 recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer as a single
agent when all of the following criteria are met:
1. Member is in complete or partial response to platinum-
based chemotherapy
2. Member has received at least two prior platinum-
containing regimens
B. Prostate cancer
Authorization of 12 months may be granted for treatment
of metastatic castration-resistant prostate cancer when all
of the following criteria are met:
1. Tumor has a deleterious BRCA mutation (germline,
somatic, or both)
2. Member has been treated with androgen receptor-
directed therapy
3. Member has been treated with a taxane-based
chemotherapy or is not fit for chemotherapy
4. Member is receiving therapy concurrently with a
gonadotropin-releasing hormone (GnRH) analog or has
had a bilateral orchiectomy
5. The requested medication will be used as a single agent
(concurrent use with a GnRH analog is allowed)
C. 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.
D. Pancreatic Adenocarcinoma
Authorization of 12 months may be granted for the
maintenance treatment of metastatic pancreatic
adenocarcinoma when all of the following criteria are met:
1. Tumor has BRCA-mutations (germline or somatic) or
PALB2-mutations
2. Disease has not progressed on at least 16 weeks of a
platinum-based chemotherapy
3. The requested medication will be 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.
Place of Service:
Outpatient
The above policy is based on the following references:
- Rubraca [package insert]. Boulder, CO: Clovis Oncology, Inc.; June 2022.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed July 19, 2022.
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.
September 03, 2022
