Subject: Verzenio 2342-A SGM P2022
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
Verzenio is indicated:
1. Early Breast Cancer
a. 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 and a Ki-67 score >20%
as determined by an FDA approved test.
2. Advanced or Metastatic Breast Cancer
a. In combination with an aromatase inhibitor as initial
endocrine-based therapy for the treatment of
postmenopausal women, and men, with hormone
receptor (HR)-positive, human epidermal growth
factor receptor 2 (HER2)-negative advanced or
metastatic breast cancer.
b. 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.
c. 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.
B. Compendial Uses
Breast cancer: Therapy for recurrent HR-positive, HER2-
negative 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 laboratory results confirming hormone
receptor (HR) status
B. Documentation of laboratory results confirming HER2 status
C. Documentation of test results confirming Ki-67 score, where
applicable
III. CRITERIA FOR INITIAL APPROVAL
Breast Cancer
1. Authorization of 12 months may be granted for the
treatment of HR-positive, HER2-negative, early breast
cancer when all of the following criteria are met:
a. The requested medication is used as adjuvant
treatment, in combination with endocrine therapy
(tamoxifen or an aromatase inhibitor)
b. The member has either:
i. Four or more positive lymph nodes; or
ii. One to three positive lymph nodes and at least
one of the following: grade 3 disease, tumor size
of 5 cm or greater, or a Ki-67 score of 20% or
greater
2. Authorization of 12 months may be granted for the
treatment of HR-positive, HER2-negative, recurrent,
advanced, or metastatic breast cancer and the requested
medication is used in any of the following regimens:
a. As monotherapy for a member who has experienced
disease progression following endocrine therapy and
prior chemotherapy in the metastatic setting; or
b. In combination with fulvestrant; or
c. In combination with an aromatase inhibitor (e.g.,
letrozole, anastrazole, exemestane).
IV. CONTINUATION OF THERAPY
A. Early Breast Cancer
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for early
breast cancer until completion of 2 years of treatment or
until disease recurrence or unacceptable toxicity while on
the current regimen.
B. Recurrent, Advanced, or Metastatic Breast Cancer
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for
recurrent, advanced, or metastatic breast cancer 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:
- Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; October 2021.
- The NCCN Drugs & Biologics Compendium © 2021 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed November 30, 2021.
- 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.
- 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.
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 26, 2022
