CurrentNeighborhood Health Plan of Rhode IslandPolicy 2342-A

Verzenio (abemaciclib) coverage and prior authorization criteria

This policy governs coverage and prior authorization requirements for Verzenio (abemaciclib) for FDA-approved indications (early breast cancer, advanced/metastatic breast cancer) and certain compendial uses (recurrent HR+/HER2- breast cancer, endometrial carcinoma) and defines documentation and authorization durations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVerzenio (abemaciclib) coverage and prior authorization criteria

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 or estrogen receptor status for endometrial carcinoma.

POLICY UPDATE CHANGES

No material clinical or coverage changes.

3FDA Indications listed

2Compendial Uses listed

12Typical authorization duration (months)

2 yrsMax early BC treatment duration

Coverage Summary

Coverage stance: covered_with_criteria. Policy number: 2342-A. Status: CURRENT. Verzenio (abemaciclib) is covered when all listed criteria are met for FDA-approved indications and specified compendial uses. FDA-approved indications covered include: early breast cancer (in combination with endocrine therapy for adjuvant treatment of HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence) and advanced/metastatic breast cancer (in combination with an aromatase inhibitor as initial endocrine-based therapy; in combination with fulvestrant after progression on endocrine therapy; and as monotherapy after progression on endocrine therapy and prior chemotherapy in the metastatic setting). Compendial uses covered include therapy for recurrent HR-positive, HER2-negative breast cancer and treatment of recurrent or metastatic endometrial carcinoma (ER-positive) in combination with letrozole.

Key thresholds and policy stats

FDA Indications listedEarly breast cancer (adjuvant with endocrine therapy); Advanced/metastatic breast cancer (with aromatase inhibitor; with fulvestrant; as monotherapy after endocrine therapy and prior chemo)

Compendial Uses listedRecurrent HR-positive, HER2-negative breast cancer; Endometrial carcinoma (ER-positive, with letrozole)

Typical authorization duration12 months

Maximum early breast cancer treatment durationUp to 2 years (authorization of 12 months may be granted for continued treatment until completion of 2 years)

Positive lymph nodes threshold>= 4 OR 1-3 with at least one of: grade 3 disease OR tumor size >= 5 cm

Authorization duration (summary)Standard: 12 months; Early breast cancer: continued authorizations until completion of 2 years, recurrence, or unacceptable toxicity

Covered Indications / Initial Authorization Criteria

Verzenio is covered for the indications below provided all criteria are met and member has no exclusions to prescribed therapy.

ANY of the following

Early breast cancer (adjuvant)
- Adjuvant combination: Requested medication is used as adjuvant treatment in combination with endocrine therapy (tamoxifen or an aromatase inhibitor).
- High-risk node criteria
  - >=4 nodes: Four or more positive lymph nodes.
  - 1-3 nodes plus high risk
    Additional high-risk feature: At least one of: grade 3 disease OR tumor size >= 5 cm.
Advanced/metastatic: AI combination
- AI combo requirement: Requested medication is used in combination with an aromatase inhibitor (e.g., letrozole, anastrozole, exemestane) as initial endocrine-based therapy.
Advanced/metastatic: fulvestrant after progression
- Progression and fulvestrant: Disease progression following endocrine therapy.
- Fulvestrant combo: Requested medication used in combination with fulvestrant.
Monotherapy after endocrine and chemo
- Progression after endocrine: Disease progression following endocrine therapy.
- Prior metastatic chemo: Prior chemotherapy in the metastatic setting.
- Monotherapy use: Requested medication as monotherapy.
Endometrial carcinoma (compendial)
- ER positive: Tumor is estrogen receptor positive.
- Letrozole combo: Used in combination with letrozole.
Compendial recurrent breast cancer
- Recurrent HR+ HER2-: Recurrent HR-positive, HER2-negative breast cancer (compendial use).

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Authorization Duration and Reauthorization Criteria

Authorization lengths and reauthorization conditions.

ANY of the following

Initial and reauthorization period: Authorization of 12 months may be granted for treatment of HR-positive, HER2-negative recurrent or metastatic breast cancer and for endometrial carcinoma when criteria are met.12 months
Early breast cancer reauthorization: Authorization of 12 months may be granted for continued treatment until completion of 2 years of treatment or until disease recurrence or unacceptable toxicity while on the current regimen.up to 2 years total
Recurrent/metastatic or endometrial reauthorization: Recurrent/metastatic breast cancer or endometrial carcinoma reauthorization: Authorization of 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.12 months

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Prior Authorization

Authorization length and reauthorization conditions

Authorizations may be granted for 12 months. For early (adjuvant) breast cancer, continued treatment reauthorization may be granted until completion of 2 years of treatment or until disease recurrence or unacceptable toxicity while on the current regimen. Reauthorization for recurrent/metastatic breast cancer or endometrial carcinoma may be granted for 12 months when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Early breast cancer reauthorization triggers: completion of 2 years of treatment; disease recurrence; or unacceptable toxicity while on the current regimen.
Recurrent/metastatic breast cancer or endometrial carcinoma reauthorization trigger: no evidence of unacceptable toxicity or disease progression while on the current regimen.

Provider Actions / Prior Authorization Requirements

Prior Authorization

Prior authorization required with documentation

Prior authorization review requires submission of documentation: for breast cancer, laboratory results confirming hormone receptor (HR) status and HER2 status; for endometrial carcinoma, results of estrogen receptor status.

Documentation Required

Evidence of disease characteristics for early breast cancer

For adjuvant early breast cancer approvals, document the number of positive lymph nodes and tumor grade and size to demonstrate high-risk disease.

Positive lymph nodes rule: either ≥ 4 positive lymph nodes; OR 1–3 positive lymph nodes plus at least one of: grade 3 disease OR tumor size ≥ 5 cm.

Prior Authorization

Authorization length and reauthorization conditions

Authorizations may be granted for 12 months. Reauthorization requires no evidence of unacceptable toxicity or disease progression while on the current regimen; for early breast cancer, reauthorization may continue until completion of 2 years of total treatment or until disease recurrence or unacceptable toxicity.

Background

Verzenio (abemaciclib) is a CDK4/6 inhibitor. It is indicated for HR-positive, HER2-negative early breast cancer as adjuvant therapy in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for node-positive, high-risk disease, and for HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy, in combination with fulvestrant after progression on endocrine therapy, and as monotherapy after progression on endocrine therapy with prior chemotherapy in the metastatic setting. Compendial uses include therapy for recurrent HR-positive, HER2-negative breast cancer and treatment of recurrent or metastatic endometrial carcinoma (ER-positive) when used in combination with letrozole.

Definitions

HRHormone receptor

HER2Human epidermal growth factor receptor 2

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVerzenio (abemaciclib) coverage and prior authorization criteria

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 or estrogen receptor status for endometrial carcinoma.

On This Page

OpenPayer

Verzenio (abemaciclib) coverage and prior authorization criteria

Coverage Summary

Covered Indications / Initial Authorization Criteria

Authorization Duration and Reauthorization Criteria

Provider Actions / Prior Authorization Requirements

Applicable Codes

Clinical Evidence & References

Background

Revision History