Subject: Piqray 3089-A SGM P2023
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 Indication
Piqray is indicated in combination with fulvestrant for the
treatment of postmenopausal women, and men, with
hormone receptor (HR)-positive, human epidermal growth
factor receptor 2 (HER2)-negative, PIK3CA-mutated,
advanced or metastatic breast cancer as detected by an
FDA-approved test following progression on or after an
endocrine-based regimen.
B. Compendial Uses
Breast cancer: Therapy for recurrent HR-positive, HER2-
negative, PIK3CA mutated disease
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 test confirming presence of PIK3CA
mutation
B. Documentation of HR and HER2 status
III. CRITERIA FOR INITIAL APPROVAL
Breast cancer
Authorization of 12 months may be granted for treatment of
HR-positive, HER2-negative, PIK3CA-mutated recurrent,
advanced or metastatic breast cancer when all of the following
criteria are met:
A. The requested drug is used in combination with fulvestrant
B. Disease has progressed while on or after an endocrine-based
regimen
V. 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:
- Piqray [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2022.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed November 6, 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.
June 18, 2023
