CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Verzenio (abemaciclib) Prior Authorization Criteria

Prior authorization criteria for Verzenio (abemaciclib) covering FDA-approved indications (early breast cancer; advanced/metastatic breast cancer) and compendial use for recurrent HR+/HER2- breast cancer and endometrial carcinoma. Specifies required documentation, initial authorization durations, and reauthorization conditions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVerzenio (abemaciclib) Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization review requires submission of laboratory documentation of HR and HER2 status for breast cancer, and estrogen receptor status for endometrial carcinoma; approval granted only when all coverage criteria are met.

POLICY UPDATE CHANGES

No material changes to clinical coverage criteria.

3FDA-approved Indications Listed

2Compendial Uses Listed

12 moTypical Authorization Length

2 yrsMax early breast cancer duration

Coverage Summary

Verzenio (abemaciclib) is a CDK4/6 inhibitor that is covered with criteria for FDA‑approved indications and specified compendial uses. FDA‑approved coverage includes: adjuvant treatment of HR‑positive, HER2‑negative, node‑positive early breast cancer in combination with endocrine therapy, and treatment of HR‑positive, HER2‑negative advanced or metastatic breast cancer (as initial therapy with an aromatase inhibitor, in combination with fulvestrant after progression on endocrine therapy, or as monotherapy after endocrine therapy and prior chemotherapy) when all clinical criteria are met. Compendial uses covered include therapy for recurrent HR‑positive, HER2‑negative breast cancer and advanced, recurrent, or metastatic endometrial carcinoma (ER‑positive) in combination with letrozole. Coverage is contingent on meeting the clinical criteria and submission of required documentation (see Documentation Required and criteria groups).

Surface thresholds

Positive lymph nodes threshold>= 4 OR 1-3 with grade 3 disease or tumor size >= 5 cm

Authorization duration (initial/repeat)12 months

Early breast cancer total treatment limitUp to 2 years total treatment (reauthorization allowed until completion of 2 years or earlier for recurrence/unacceptable toxicity)

Initial Therapy Criteria — Covered Indications

Covered when ANY of the following indications and accompanying criteria are met:

ANY of the following

Early Breast Cancer (adjuvant)
- The requested medication is used as adjuvant treatment in combination with endocrine therapy (tamoxifen or an aromatase inhibitor).
- Documented hormone receptor (HR)-positive and HER2-negative tumor status.
  Laboratory documentation of HR and HER2 status required.
- Node status (one of the following):
  - Four or more positive lymph nodes.
  - ALL of the following
    ANY of the following
    Grade 3 disease.
    Tumor size >= 5 cm.
- Authorization of up to 12 months may be granted for adjuvant treatment.
Advanced/Metastatic Breast Cancer
- Documented hormone receptor (HR)-positive and HER2-negative tumor status.
  Laboratory documentation of HR and HER2 status required.
- Requested regimen (one of):
  - Verzenio as monotherapy for members with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
  - Verzenio in combination with fulvestrant for disease progression following endocrine therapy.
  - Verzenio in combination with an aromatase inhibitor as initial endocrine-based therapy for advanced/metastatic disease.
- Authorization of up to 12 months may be granted.
Endometrial Carcinoma (compendial use)
- Advanced, recurrent, or metastatic endometrial carcinoma with estrogen receptor (ER) positive tumors.
- Use in combination with letrozole.
- Documentation of estrogen receptor status required.
  Laboratory documentation of ER status required for endometrial carcinoma.
- Authorization of up to 12 months may be granted.
Compendial use - Recurrent HR+/HER2- breast cancer
- Recurrent HR-positive, HER2-negative breast cancer (compendial indication).
- Documented hormone receptor (HR)-positive and HER2-negative tumor status.
  Laboratory documentation of HR and HER2 status required.
- Authorization of up to 12 months may be granted.

title

Provider Actions — Documentation & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization review is required. Submission must include laboratory documentation of hormone receptor (HR) and HER2 status for breast cancer and estrogen receptor (ER) status for endometrial carcinoma. Approval is granted only when all coverage criteria for the requested indication are met.

Documentation Required

Document HR/HER2/ER status

Submit lab results to initiate prior authorization: for breast cancer, provide documentation confirming HR status and HER2 status; for endometrial carcinoma, provide estrogen receptor status.

Prior Authorization

Authorization duration/reauthorization

Initial approvals are typically for 12 months. Reauthorization for early breast cancer may be granted for continued treatment until completion of 2 years total treatment or earlier if there is disease recurrence or unacceptable toxicity. For recurrent/advanced/metastatic breast cancer or endometrial carcinoma, reauthorization may be granted for 12 months when there is no evidence of disease progression or unacceptable toxicity while on the current regimen.

Denial Risk

Not medically necessary for other uses

Requests for indications other than the FDA-approved indications or the listed compendial uses (recurrent HR+/HER2- breast cancer and endometrial carcinoma) are considered experimental/investigational and not medically necessary and are subject to denial.

Background

Verzenio (abemaciclib) is a CDK4/6 inhibitor indicated for specified HR‑positive, HER2‑negative breast cancer settings and for compendial use in recurrent disease and endometrial carcinoma; coverage is contingent on meeting clinical criteria and required documentation.

scope_summary: Prior authorization criteria for Verzenio (abemaciclib) covering FDA‑approved indications (early breast cancer; advanced/metastatic breast cancer) and compendial use for recurrent HR+/HER2‑ breast cancer and endometrial carcinoma. Specifies required documentation, initial authorization durations, and reauthorization conditions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVerzenio (abemaciclib) Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

OpenPayer

Verzenio (abemaciclib) Prior Authorization Criteria

Coverage Summary

Initial Therapy Criteria — Covered Indications

Continuation Therapy & Reauthorization Criteria

Exclusions / Not Medically Necessary

Provider Actions — Documentation & Prior Authorization

Applicable Codes

Clinical Evidence & References

Background

Revision History