CurrentCignaPolicy N/A

Verzenio_Medical_Necessity_Criteria

Defines prior authorization recommendation and medical necessity criteria for coverage of Verzenio (abemaciclib tablets) for FDA-approved indications (early breast cancer adjuvant, recurrent/metastatic breast cancer in women and men) and select other uses with supportive evidence (endometrial cancer, dedifferentiated liposarcoma). Specifies approval durations and exclusion of other uses.

Policy Summary

PayerCigna

PolicyVerzenio_Medical_Necessity_Criteria

Policy CodePolicy N/A

Change TypeMultiple additions and clarifications

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended and providers should document required clinical information and request approvals for the specified durations (2 years for early breast cancer; 1 year for metastatic and other uses).

SourceLink

POLICY UPDATE CHANGES

Endometrial Cancer: Condition of approval and criteria were added to 'Other Uses with Supportive Evidence'.

Breast Cancer - Early: Duration of approval clarified to 2 years (total) and note added that indication applies to both women and men.

Breast Cancer - Recurrent or Metastatic: Option added for HER2-positive disease to be used with fulvestrant and trastuzumab after at least three prior anti-HER2 regimens.

Breast Cancer - Recurrent or Metastatic: Option added for use in combination with Inluriyo (imlunestrant tablets).

Liposarcoma: Condition of approval and criteria were added to Other Uses with Supportive Evidence.

3FDA-Approved Indications (breast cancer: early, recurrent/metastatic women, recurrent/metastatic men)

2Other Supported Uses (endometrial cancer, liposarcoma)

Coverage Summary

Defines prior authorization recommendation and medical necessity criteria for coverage of Verzenio (abemaciclib tablets) for FDA-approved indications and select other uses with supportive evidence. Verzenio is covered with criteria for FDA-approved indications: Early (adjuvant) HR+, HER2-negative, node-positive high-risk breast cancer and Recurrent or metastatic HR+ breast cancer in women and men (including specified HER2-negative and HER2-positive options). Policy also includes select other uses with supportive evidence: endometrial cancer (ER-positive, with letrozole) and dedifferentiated liposarcoma. Approvals are provided for specified durations: 2 years for early (adjuvant) use and 1 year for recurrent/metastatic and other supportive uses. Requests for uses not specified in the policy are considered not medically necessary.

Quick Facts

High risk node-positive definition≥4 positive lymph nodes, or 1-3 positive lymph nodes with grade 3 disease or tumor size ≥5 cm

Approval durationsEarly (adjuvant): 2 years total; Recurrent/metastatic and other supportive uses: 1 year

Last review dateFeb 18, 2026

Initial (Adjuvant) Therapy Criteria

Recurrent or Metastatic Therapy Criteria (Women)

Recurrent or Metastatic Therapy Criteria (Men)

Other Uses with Supportive Evidence

Provider Actions

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for Verzenio (abemaciclib). Approvals are issued for the durations specified in the clinical criteria: 2 years (total) for early (adjuvant) breast cancer and 1 year for recurrent/metastatic and other supported uses.

Documentation Required

Clinical Documentation Required

Providers must document the following as applicable: patient age; hormone receptor positive (HR+) and HER2 status; nodal status and high‑risk features for adjuvant use (e.g., ≥4 positive nodes or 1–3 nodes with grade 3 disease or tumor size ≥5 cm); prior endocrine therapies and prior chemotherapy for metastatic monotherapy option; prior anti‑HER2 regimens when requesting the HER2‑positive option (at least three prior anti‑HER2‑based regimens in the metastatic setting); and the concomitant agents to be used (examples: aromatase inhibitors, tamoxifen, fulvestrant, Inluriyo/imlunestrant, trastuzumab) as applicable.

Applicable Codes

Drug/ProductNDCCovered

No codes listed

Relevant referenced drugs (examples listed in policy)mixed

anastrozole	aromatase inhibitor example for combination therapy
exemestane	aromatase inhibitor example for combination therapy
letrozole	aromatase inhibitor example for combination therapy
tamoxifen	SERM example for combination therapy
fulvestrant	estrogen receptor antagonist used in combinations
imlunestrant (Inluriyo)	selective estrogen receptor degrader; option in recurrent/metastatic disease
trastuzumab	anti-HER2 agent used with fulvestrant in HER2+ option

Clinical Evidence & Guidance

Key evidence sources include NCCN guideline recommendations and the product prescribing information. The policy cites the NCCN Breast Cancer guideline (version 1.2026, Jan 16, 2026) and related NCCN compendia for uterine neoplasms and soft tissue sarcoma, and the Verzenio prescribing information (Eli Lilly, February 2025). The policy aligns coverage criteria with FDA-approved indications described in the product labeling and with NCCN guideline-supported uses (including guideline recommendations for adjuvant duration and recommended combinations and later-line options).

Definitions

Definitions used in the policy: High risk (node-positive) for early breast cancer — ≥4 positive lymph nodes, or 1–3 positive lymph nodes with grade 3 disease or tumor size ≥5 cm. Woman/man (as used in policy) — defined by biological traits regardless of gender identity or expression.

Revision History

2026-02-18reviewLatest

Annual revision (02/18/2026): Added Endometrial Cancer as a condition of approval with criteria to 'Other Uses with Supportive Evidence' (approve 1 year, ER‑positive tumors, combination with letrozole) and added Liposarcoma (dedifferentiated liposarcoma) to Other Uses with Supportive Evidence (approve 1 year).

2025-04-08change

Policy update (04/08/2025): Added option for Verzenio use in recurrent/metastatic HER2‑negative breast cancer in combination with Inluriyo (imlunestrant tablets); added option 'not a candidate for surgery' for Endometrial Cancer. Also noted earlier additions for HER2‑positive option with fulvestrant + trastuzumab in metastatic setting and liposarcoma criteria (reflected in history).