Subject: Verzenio SGM 2342-A P2026

Drug

VERZENIO  (abemaciclib)

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

Verzenio is indicated:

·        Early Breast Cancer

§  In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.

·        Advanced or Metastatic Breast Cancer

§  In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

§  In combination with fulvestrant for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

§  As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

Compendial Uses^2-5

·        Breast cancer

·        Endometrial carcinoma

·        Liposarcoma

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:

·        For members requesting initiation of therapy for the treatment of breast cancer: documentation of laboratory results confirming hormone receptor (HR) status and HER2 status

·        For members requesting initiation of therapy for the treatment of endometrial carcinoma: results of estrogen receptor status

Coverage Criteria

Breast Cancer^1-4

Authorization of 12 months may be granted for the adjuvant treatment of HR-positive, HER2-negative breast cancer when all of the following criteria are met:

·        The requested medication will be used in combination with endocrine therapy (tamoxifen or an aromatase inhibitor).

·        The member has high risk disease and either of the following is met:

§  Four or more positive lymph nodes

§  One to three positive lymph nodes and at least one of the following:

·        Grade 3 disease

·        Tumor size of 5 cm or greater

Authorization of 12 months may be granted for the treatment of HR-positive, HER2-negative, recurrent unresectable or metastatic breast cancer and the requested medication is used in any of the following regimens:

·        As monotherapy for a member who has experienced disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

·        In combination with fulvestrant.

·        In combination with an aromatase inhibitor (e.g., letrozole, anastrazole, exemestane).

Endometrial Carcinoma^2,5

Authorization of 12 months may be granted for the treatment of recurrent or metastatic endometrial carcinoma with estrogen receptor (ER) positive tumors when used in combination with letrozole or fulvestrant.

Authorization of 12 months may be granted to members for adjuvant treatment of stage IV endometrial carcinoma with ER-positive tumors when used in combination with letrozole or fulvestrant.

Liposarcoma²

Authorization of 12 months may be granted for the treatment of dedifferentiated liposarcoma as a single agent.

Continuation of Therapy

Adjuvant Breast Cancer Treatment

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for adjuvant breast cancer treatment until completion of 2 years of treatment or until disease recurrence or unacceptable toxicity while on the current regimen.

Recurrent Unresectable or Metastatic Breast Cancer, Endometrial Carcinoma, or Liposarcoma

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for recurrent unresectable or metastatic breast cancer, endometrial carcinoma, or liposarcoma 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.      Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; February 2025.

2.     The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed November 13, 2025.

3.     Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer. Clin Cancer Res. 2017;23(17):5218-5224.

4.     Sledge, GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875-2884.

5.     National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Uterine Neoplasms. Version 2.2026. Available at: https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf. Accessed November 18, 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.

July 14, 2026