Subject: Truqap SGM 6252-A P2025a

Drug

TRUQAP  (capivasertib)

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

HR-positive, HER2-negative locally advanced or metastatic breast cancer

In combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alteration as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostrate cancer

In combination with abiraterone and prednisone, is indicated for treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.

Compendial Uses²

Breast cancer

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, where applicable:

·        Documentation of test confirming presence of at least one of the following alterations: PIK3CA, AKT1, or PTEN

·        Documentation of HR and HER2 status

Coverage Criteria

Breast Cancer^1-3

Authorization of 12 months may be granted for treatment of HR-positive, HER2-negative locally advanced, recurrent unresectable, or metastatic breast cancer when all of the following criteria are met:

·        The disease has alterations in at least one of the following: PIK3CA, AKT1, or PTEN.

·        The requested medication will be used in combination with fulvestrant.

·        The member had disease progression or recurrence after at least one prior line of endocrine therapy plus a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor (e.g., abemaciclib [Verzenio], palbociclib [Ibrance], ribociclib [Kisqali]).

Prostate Cancer¹

Authorization of 12 months may be granted for treatment of metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer when all of the following criteria are met:

·        The disease is PTEN-deficient.

·        The requested medication will be used in combination with abiraterone and prednisone.

·        The member has had a bilateral orchiectomy or will be using the requested medication with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin, leuprolide, triptorelin) or antagonist (e.g., degarelix, relugolix).

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.      Truqap [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; June 2026.

2.     The NCCN Drugs & Biologics Compendium® © 2026 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed June 24, 2026.

3.   National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 5.2025. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed November 4, 2025

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.

August 20, 2026