CurrentNeighborhood Health Plan of Rhode IslandPolicy 2342-A

Verzenio Sgm 2342 A P2025

Defines coverage, prior authorization documentation, and authorization durations for Verzenio (abemaciclib) for FDA-approved and compendial oncology indications (early breast cancer, advanced/metastatic breast cancer, and endometrial carcinoma) when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVerzenio Sgm 2342 A P2025

Policy CodePolicy 2342-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of HR and HER2 status for breast cancer indications, and estrogen receptor status for endometrial carcinoma to initiate review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes

3Primary Covered Indications

12 moStandard Authorization Duration

2 yrsMax early breast cancer treatment noted

Coverage Summary

Defines coverage, prior authorization documentation, and authorization durations for Verzenio (abemaciclib) for FDA‑approved and compendial oncology indications when approval criteria are met. Covered indications include early (adjuvant) HR‑positive, HER2‑negative, node‑positive high‑risk breast cancer (in combination with endocrine therapy), advanced/metastatic HR‑positive, HER2‑negative breast cancer (as initial endocrine‑based therapy in combination with an aromatase inhibitor, in combination with fulvestrant after progression on endocrine therapy, or as monotherapy after progression on endocrine therapy and prior chemotherapy), and recurrent/metastatic ER‑positive endometrial carcinoma when used in combination with letrozole per compendial guidance; prior authorization with documentation of receptor/HER2 status is required and authorization durations and reauthorization rules apply as specified in policy.

Covered Indications and General Requirement

Verzenio is covered for the indications below when ALL of the following are met:

ALL of the following

Covered indication: Indication is one of the listed covered uses: Early breast cancer (adjuvant), advanced/metastatic breast cancer (specified regimens), or recurrent/metastatic endometrial carcinoma (ER-positive)
Documentation: Submission of required documentation confirming receptor/HER2 status as applicable (HR and HER2 for breast cancer; ER for endometrial carcinoma)
See Documentation section for required laboratory results
Exclusions: Member has no exclusions to the prescribed therapy

Initial Therapy Criteria

Recurrent or Metastatic Breast Cancer - Initial Authorization

Authorization of 12 months may be granted when ANY of the following regimens are used and other general requirements are met:

Recurrent/Metastatic regimens

Monotherapy after progression: Verzenio as monotherapy for a member who has experienced disease progression following endocrine therapy and prior chemotherapy in the metastatic setting
With fulvestrant after progression: Verzenio in combination with fulvestrant for disease progression following endocrine therapy
With aromatase inhibitor as initial endocrine-based therapy: Verzenio in combination with an aromatase inhibitor (e.g., letrozole, anastrazole, exemestane) as initial endocrine-based therapy for HR+, HER2- advanced or metastatic breast cancer

Endometrial Carcinoma

Authorization of 12 months may be granted when ALL are met:

Endometrial carcinoma criteria

ER positive: Diagnosis of recurrent or metastatic endometrial carcinoma with estrogen receptor (ER) positive tumors
Combination with letrozole: Verzenio used in combination with letrozole

Compendial Uses

Covered compendial uses when documentation supports the indication:

Compendial uses

Breast cancer compendial: Breast cancer: therapy for recurrent HR-positive, HER2-negative disease
Endometrial compendial: Endometrial carcinoma (as described in Endometrial Carcinoma criteria)

Early Breast Cancer - Initial Authorization

Authorization of 12 months may be granted when ALL of the following are met:

Early breast cancer initial

Adjuvant combination: Requested medication is used as adjuvant treatment in combination with endocrine therapy (tamoxifen or an aromatase inhibitor)
Lymph node / risk features
- >=4 positive nodes: Four or more positive lymph nodesLymph node count >= 4
- 1-3 nodes plus risk
  - Risk features
    Grade 3 disease
    >=5 cm tumor: Tumor size of 5 cm or greaterTumor size >= 5 cm

Continuation / Reauthorization Criteria

Early Breast Cancer - Reauthorization

Authorization of 12 months may be granted for continued treatment when ALL are met:

Early breast cancer reauth

Member receiving adjuvant Verzenio: Member is receiving Verzenio for early breast cancer as adjuvant therapy
Reauthorization duration criteria: Reauthorization requested until completion of 2 years of treatment OR until disease recurrence OR unacceptable toxicity while on the current regimen
Maximum early breast cancer treatment duration noted for reauthorization

Recurrent or Metastatic Breast Cancer - Reauthorization

Authorization of 12 months may be granted for continued treatment when ALL are met:

Recurrent/metastatic reauth

On therapy for indicated disease: Member is receiving Verzenio for recurrent/metastatic breast cancer or endometrial carcinoma
No progression/toxicity: There is no evidence of unacceptable toxicity or disease progression while on the current regimen

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required with documentation

Submit prior authorization with documentation of hormone receptor (HR) and HER2 status for breast cancer indications, and estrogen receptor (ER) status for endometrial carcinoma to initiate review.

Documentation Required

Required pathology/lab documentation

Provide laboratory results confirming hormone receptor (HR) status and HER2 status for breast cancer, and estrogen receptor (ER) status for endometrial carcinoma.

Billing Rule

Authorization duration

Initial and reauthorization approvals are issued for up to 12 months. For early breast cancer, reauthorization may be granted until completion of 2 years of total therapy or until disease recurrence or unacceptable toxicity.

Surface thresholds

Lymph node countFour or more positive lymph nodes OR one to three positive lymph nodes with at least one additional risk feature (grade 3 disease or tumor size ≥ 5 cm)

Tumor size≥ 5 cm (tumor size of 5 cm or greater)

Standard Authorization Duration12 months

Max early breast cancer treatment duration2 years (total treatment duration for reauthorization)

Background

Verzenio (abemaciclib) is a CDK4/6 inhibitor indicated for HR‑positive, HER2‑negative early and advanced/metastatic breast cancer in specified combinations (for example, with tamoxifen or an aromatase inhibitor in the adjuvant setting; with an aromatase inhibitor as initial endocrine‑based therapy in the metastatic setting; with fulvestrant after progression on endocrine therapy) and as monotherapy in later‑line metastatic disease. Compendial uses include therapy for recurrent HR‑positive, HER2‑negative breast cancer and use in recurrent/metastatic ER‑positive endometrial carcinoma in combination with letrozole.

HR‑positive: Hormone receptor positive; requires documented laboratory confirmation.

HER2‑negative: Human epidermal growth factor receptor 2 negative; requires documented laboratory confirmation.

ER‑positive: Estrogen receptor positive; required for the endometrial carcinoma indication and must be documented.