CurrentmhnPolicy CP.PHAR.355

Abemaciclib (Verzenio)

Defines medical necessity criteria, initial and continued therapy, approved and off-label covered indications (breast cancer, endometrial carcinoma, dedifferentiated liposarcoma), dosing limits, prescriber and documentation requirements, and approval durations for commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyAbemaciclib (Verzenio)

Policy CodePolicy CP.PHAR.355

Change TypeAdded off-label indications; approval duration updates; clarifications

Effective DateDec 1, 2017

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member has met all approval criteria and current therapy response; required for initial and continued approvals.

SourceLink

POLICY UPDATE CHANGES

Added criteria for endometrial carcinoma as off-label indication supported by NCCN compendium and guidelines.

Added criteria for soft tissue sarcoma (dedifferentiated liposarcoma) as off-label indication supported by NCCN compendium and guidelines.

Clarified that combination use with an aromatase inhibitor should be for initial endocrine based therapy and premenopausal women require ovarian ablation/suppression.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

3Covered Indications (including off-label per criteria)

>=18Minimum Age (years)

Typical Approval Duration (Medicaid/HIM)

12 monthsCommercial Approval Duration

Coverage Summary

Coverage stance: covered_with_criteria. Scope: policy defines medical necessity criteria for initial and continued therapy, prescriber/documentation requirements, dosing limits, approved and selected off-label indications, and approval durations by line of business.

Covered indications: FDA‑labeled indications for adult patients with HR‑positive, HER2‑negative breast cancer across settings (adjuvant for node‑positive, advanced/metastatic in combination with endocrine therapy or fulvestrant, and monotherapy after progression following endocrine therapy and chemotherapy) per the criteria. Off‑label indications covered when criteria met include endometrial carcinoma (ER‑positive) in combination with letrozole and dedifferentiated liposarcoma (soft tissue sarcoma) as a single agent; these off‑label uses require supporting evidence and regimen must be FDA‑approved or recommended by NCCN.

Typical approval durations by line of business: Medicaid/HIM: 12 months; Commercial: 12 months or duration of request, whichever is less (applies to initial and continued authorizations per policy sections).

Minimum age: ≥ 18 years for all covered and off‑label indications. Dosing framework: combination therapy capped at ≤ 300 mg/day and monotherapy capped at ≤ 400 mg/day, with continued therapy in breast cancer requiring ≥ 100 mg/day.

Key thresholds & quick facts

Minimum age>= 18 years

Breast cancer continued therapy dose (minimum)>= 100 mg/day

Combination therapy maximum dose<= 300 mg/day (two 150 mg tablets/day)

Monotherapy maximum dose<= 400 mg/day (two 200 mg tablets/day)

Typical approval duration (Medicaid/HIM)12 months

Typical approval duration (Commercial)12 months or duration of request (whichever is less)

Initial Therapy Criteria

I. Initial Approval Criteria - A. Breast Cancer

must meet all

Core requirements
- Diagnosis of breast cancer
- Prescriber: Prescribed by or in consultation with an oncologist
- Age ≥ 18 years>= 18 years
- Disease characteristics (both required)

Continuation Therapy Criteria

Unapproved / Not Authorized Indications

III. Diagnoses/Indications for which coverage is NOT authorized

III. Diagnoses/Indications for which coverage is NOT authorized: Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents is provided

See CP.CPA.09, HIM.PA.154, CP.PMN.53 for off-label criteria

Applicable Codes & Product Availability

Product Availability (NDC not specified)mixed

50 mg	Tablet strength available
100 mg	Tablet strength available
150 mg	Tablet strength available
200 mg	Tablet strength available

Provider Actions

Documentation Required

Submit documentation of clinical status

Provider must submit office chart notes, laboratory results, or other clinical information supporting that the member has met all approval criteria. Documentation is required for both initial and continued approvals.

Prior Authorization

Prescriber specialty requirement

Verzenio must be prescribed by or in consultation with an oncologist.

Clinical Evidence & Guidelines

Evidence sources cited in the policy include the Verzenio Prescribing Information, Eli Lilly; February 2025 and NCCN compendia/guidelines (2025 versions referenced).

The policy states that off‑label uses included (endometrial carcinoma and dedifferentiated liposarcoma) are supported by the NCCN compendium/guidelines and that prescribed regimens for off‑label uses must be FDA‑approved or recommended by NCCN; prescribers must submit supporting evidence from practice guidelines or peer‑reviewed literature for off‑label indications or doses outside FDA maxima.

Evidence / guideline quick-reference

FDA Prescribing InformationVerzenio Prescribing Information, Eli Lilly; February 2025

Guideline sourceNCCN Breast Cancer and other relevant NCCN compendia (2025)

Background & Definitions

Background: Abemaciclib (Verzenio) is a CDK4/6 inhibitor indicated primarily for adult patients with hormone receptor (HR)‑positive, HER2‑negative breast cancer in multiple settings (adjuvant for high‑risk node‑positive disease, initial endocrine‑based therapy in combination with an aromatase inhibitor for advanced/metastatic disease, combination with fulvestrant after endocrine therapy progression, and monotherapy after progression following endocrine therapy and chemotherapy).

The policy incorporates selected off‑label uses supported by NCCN compendia/guidelines (notably endometrial carcinoma in combination with letrozole and dedifferentiated liposarcoma as a single agent) and aligns requirements such as ovarian ablation/suppression for premenopausal women when used in combination regimens per NCCN recommendations.

Term	Definition
High risk breast cancer	NCCN-defined: ≥ 4 positive lymph nodes, or 1-3 positive lymph nodes with grade 3 disease or tumor > 5 cm.
HR-positive	Hormone receptor positive: ER and/or PR positive.

Revision History

07.15.24 / 4Q 2024 (P&T Approval Date 11.24)added

Added criteria for endometrial carcinoma as an off-label indication supported by NCCN compendium and guidelines; Appendix D high-risk breast cancer definition updated to align with NCCN; references reviewed and updated.

01.20.22revised

Revised approval duration for Commercial line of business to '12 months or duration of request, whichever is less.'

06.30.21 / 4Q 2021 (P&T Approval Date 08.21.21)revised

Clarified that combination use with an aromatase inhibitor should be for initial endocrine-based therapy and that premenopausal women require ovarian ablation/suppression when receiving combination therapy; added requirement for no concurrent CDK4/6 inhibitor use and added oral oncology generic redirection language.

Policy Summary

Payermhn

PolicyAbemaciclib (Verzenio)

Policy CodePolicy CP.PHAR.355

Change TypeAdded off-label indications; approval duration updates; clarifications

Effective DateDec 1, 2017

Next Review Date

SourceLink

On This Page

HR-positive (i.e., estrogen receptor (ER) and/or progesterone receptor (PR) positive)

Verzenio prescribed in one of the following ways

For advanced, recurrent, or metastatic disease (one of)
- Combination with fulvestrant: In combination with fulvestrant
- Monotherapy after progression: As a single agent after disease progression on an endocrine therapy and chemotherapy in the metastatic setting
- Combination with aromatase inhibitor (if selected): In combination with an aromatase inhibitor (e.g., letrozole, anastrozole, exemestane) as part of initial endocrine based therapy
  If male, also require an agent that suppresses testicular steroidogenesis (e.g., gonadotropin-releasing hormone agonists)
Node-positive, early breast cancer (both required)
- Adjuvant: As adjuvant treatment
- With endocrine therapy: In combination with endocrine therapy (tamoxifen or an aromatase inhibitor)

Additional requirements

Premenopausal ovarian suppression: If prescribed as part of combination therapy and member is a premenopausal female, member has been treated with ovarian ablation or is receiving ovarian suppression
See Appendix D for methods
No prior CDK4/6 progression: Member has not previously experienced disease progression on a CDK 4/6 inhibitor therapy (e.g., Ibrance, Kisqali)
No concurrent CDK4/6: Verzenio is not prescribed concurrently with another CDK 4/6 inhibitor therapy (e.g., Ibrance, Kisqali)
Generic redirection: For brand name Verzenio requests, member must use generic abemaciclib, if available, unless contraindicated or clinically significant adverse effects are experienced
Dose limits or support
- Dose does not exceed
  - Combination max: For combination therapy: 300 mg per day (two 150 mg tablets per day)<= 300 mg/day
  - Monotherapy max: For monotherapy: 400 mg per day (two 200 mg tablets per day)<= 400 mg/day
- Dose supported by guidelines: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Prior Authorization

No concurrent CDK4/6 inhibitor

Requests will not be approved if Verzenio is prescribed concurrently with another CDK4/6 inhibitor (e.g., Ibrance, Kisqali).

Billing Rule

Generic redirection for brand requests

For brand Verzenio requests, the member must use generic abemaciclib if available unless contraindicated or clinically significant adverse effects are experienced.

Prior Authorization

Dose support for off-label use

For off-label indications or doses outside the FDA maximum, the prescriber must submit supporting evidence from practice guidelines or peer‑reviewed literature. The prescribed regimen must be FDA‑approved or recommended by NCCN.

Prior Authorization

Ovarian suppression requirement

If Verzenio is prescribed as part of combination therapy for a premenopausal female, documentation that the patient has undergone ovarian ablation or is receiving ovarian suppression is required.

4Q 2024 (material change)added

Added in 4Q 2024 annual review; updated approval durations and Appendix D definitions; Added criteria for endometrial carcinoma as off-label indication supported by NCCN compendium and guidelines.

4Q 2025 (P&T Approval Date 11.25)addedLatest

Added in 4Q 2025 annual review; added criteria for soft tissue sarcoma (dedifferentiated liposarcoma) as an off-label indication supported by NCCN compendium and guidelines; extended approval duration for HIM and Medicaid initial authorizations to 12 months and updated commercial wording for endometrial carcinoma initial therapy to '12 months or duration of request, whichever is less.'

undated / policy historyrevised

Previously varied revisions and clarifications over multiple reviews (e.g., RT4 updates, template/appendix updates, removal of Ki-67 requirement) captured in earlier annual reviews.