CurrentNeighborhood Health Plan of Rhode IslandPolicy 2342-A

Abemaciclib (Verzenio) coverage for HR+/HER2- breast and endometrial cancer

Defines prior authorization, documentation, and coverage criteria for Verzenio (abemaciclib) for early, recurrent/metastatic HR-positive, HER2-negative breast cancer and ER-positive endometrial carcinoma for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAbemaciclib (Verzenio) coverage for HR+/HER2- breast and endometrial cancer

Policy CodePolicy 2342-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of HR/HER2 or ER status to request up to 12 months of coverage when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

HR+/HER2-primary breast cancer subtype covered

Endometrial (ER+)compendial non-breast indication

HR/HER2 or ERrequired lab documentation

Coverage Criteria for Abemaciclib (Verzenio)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Early (adjuvant) breast cancer

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

Early breast cancer criteria: Requested medication is used as adjuvant treatment in combination with endocrine therapy (tamoxifen or an aromatase inhibitor).adjuvant use required

12-month authorization

Nodal and tumor risk features (ONE of the following): Four or more positive lymph nodes; OR One to three positive lymph nodes AND at least one of: grade 3 disease OR tumor size ≥ 5 cm.see node text

Defines high-risk node-positive disease

Recurrent or metastatic breast cancer

Authorization of 12 months may be granted for the treatment of HR-positive, HER2-negative, recurrent or metastatic breast cancer when ANY of the following regimens apply:

Metastatic breast cancer regimens: (1) Monotherapy for a member who has experienced disease progression following endocrine therapy and prior chemotherapy in the metastatic setting; (2) In combination with fulvestrant following progression on endocrine therapy; (3) In combination with an aromatase inhibitor (e.g., letrozole, anastrozole, exemestane) as initial endocrine-based therapy.regimen-specific

12-month authorization

Endometrial carcinoma (ER+)

Authorization of 12 months may be granted for recurrent or metastatic endometrial carcinoma when ALL of the following are met:

Endometrial carcinoma criteria: Tumor is estrogen receptor (ER) positive AND the requested medication is used in combination with letrozole.ER positive required

12-month authorization

Regimen	Indication / Key criteria
Verzenio in combination with endocrine therapy (tamoxifen or an aromatase inhibitor)	Adjuvant treatment for HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence — member must have either ≥4 positive lymph nodes, or 1–3 positive lymph nodes plus grade 3 disease or tumor ≥5 cm. Authorization of 12 months may be granted.
Verzenio with tamoxifen	Used as adjuvant therapy in combination with tamoxifen for HR+/HER2- node-positive high-risk early breast cancer; meets the same lymph node and tumor risk criteria above.
Verzenio with an aromatase inhibitor (e.g., letrozole, anastrozole, exemestane)	Used as adjuvant therapy in combination with an aromatase inhibitor for HR+/HER2- node-positive high-risk early breast cancer; meets the same lymph node and tumor risk criteria above.

Regimen	Indication / Key criteria
Verzenio in combination with an aromatase inhibitor	Initial endocrine-based therapy for HR-positive, HER2-negative advanced or metastatic breast cancer. Authorization of 12 months may be granted when used as first-line endocrine-based therapy in combination with an AI.
Verzenio plus letrozole (example)	Representative combination for initial endocrine-based therapy in HR+/HER2- advanced/metastatic disease; 12-month authorization per policy.

Regimen	Indication / Key criteria
Verzenio as monotherapy	For adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer who have experienced disease progression following endocrine therapy and prior chemotherapy in the metastatic setting; authorization of 12 months may be granted.
Verzenio in combination with fulvestrant	For HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy; authorization of 12 months may be granted.

Regimen	Indication / Key criteria
Verzenio in combination with letrozole	Treatment of recurrent or metastatic endometrial carcinoma with estrogen receptor–positive tumors when used in combination with letrozole; authorization of 12 months may be granted.

Reauthorization

Reauthorization criteria

Early breast cancer reauthorization: Continued treatment may be authorized until completion of 2 years of treatment or until disease recurrence or unacceptable toxicity while on the current regimen.up to 2 years total

12-month renewals expected

Recurrent/metastatic breast cancer or endometrial carcinoma reauthorization: Continued treatment may be authorized for 12 months when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.clinical stability required

12-month renewals

All indications other than the FDA-approved indications and listed compendial uses are considered experimental/investigational and therefore not medically necessary for coverage purposes.

Indications that are not specified within the policy’s listed FDA-approved indications or the referenced compendial uses are considered not medically necessary and will not be approved through prior authorization.

Provider Actions, Documentation, and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization may be granted for up to 12 months when clinical criteria are met. See therapy-specific authorization rules for initial and continuation treatment durations.

Authorization duration: up to 12 months
Applicable settings: early breast cancer, recurrent/metastatic breast cancer, endometrial carcinoma

Step Therapy

Therapy Sequencing and Regimen Notes

For recurrent or metastatic breast cancer, Verzenio may be used as monotherapy only for patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. Verzenio is also indicated in combination with fulvestrant after progression on endocrine therapy, or in combination with an aromatase inhibitor as initial endocrine-based therapy for HR-positive, HER2-negative advanced/metastatic breast cancer. For early (adjuvant) breast cancer, Verzenio is used in combination with endocrine therapy (tamoxifen or an aromatase inhibitor).

Monotherapy allowed only after endocrine therapy AND prior chemotherapy in the metastatic setting
Combination regimens: with fulvestrant (post-endocrine therapy) or with an aromatase inhibitor (initial endocrine-based therapy)
Adjuvant use: only in combination with endocrine therapy (tamoxifen or an aromatase inhibitor)

Documentation Required

Required Diagnostic Documentation

Submit diagnostic test results to support the request. For breast cancer, provide laboratory documentation confirming hormone receptor (HR) status and HER2 status. For endometrial carcinoma, provide estrogen receptor status results.

Breast cancer: HR status and HER2 status (laboratory results)
Endometrial carcinoma: estrogen receptor (ER) status

Denial Risk

Experimental / Investigational Exclusions

Compendial or off‑label uses outside the listed indications are considered experimental/investigational and are not medically necessary.

All other indications not specifically listed under indications/compendial uses are considered experimental/investigational and not covered

Covered Regimens and Combinations

Covered regimen	Coverage stance / Notes
Verzenio with endocrine therapy (tamoxifen or an aromatase inhibitor)	Adjuvant use for HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence (≥4 positive nodes, or 1–3 nodes plus grade 3 disease or tumor ≥5 cm). Authorization of 12 months may be granted.

Covered regimen	Coverage stance / Notes
Verzenio in combination with an aromatase inhibitor	Initial endocrine-based therapy for HR-positive, HER2-negative advanced or metastatic breast cancer; authorization of 12 months may be granted.

Covered regimen	Coverage stance / Notes
Verzenio with fulvestrant	For HR-positive, HER2-negative advanced or metastatic breast cancer following progression on endocrine therapy; authorization of 12 months may be granted.
Verzenio monotherapy after prior chemotherapy	For patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting; authorization of 12 months may be granted.

Covered regimen	Coverage stance / Notes
Verzenio in combination with letrozole	For recurrent or metastatic endometrial carcinoma with estrogen receptor–positive tumors when used in combination with letrozole; authorization of 12 months may be granted.

OpenPayer

Abemaciclib (Verzenio) coverage for HR+/HER2- breast and endometrial cancer

Coverage Criteria for Abemaciclib (Verzenio)

Provider Actions, Documentation, and Authorization Requirements

Biomarker and Diagnostic Requirements

Line-of-Therapy Definitions and Application

Covered Regimens and Combinations

Definitions and Clinical Criteria

Background