Subject: Piqray SGM 3089-A P2025

Drug

PIQRAY  (alpelisib)

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 Indications¹

Piqray is indicated in combination with fulvestrant for the treatment of adults 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.

Compendial Uses²

Breast cancer: Therapy for recurrent HR-positive, HER2-negative, PIK3CA mutated disease

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 test confirming presence of PIK3CA mutation
• Documentation of HR and HER2 status

Coverage Criteria

Breast Cancer^1-2

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:

• The requested drug is used in combination with fulvestrant
• Disease has progressed while on or after an endocrine-based regimen

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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:

1. Piqray [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; January 2024.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed November 6, 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.

June 02, 2025