CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Verzenio (abemaciclib) — Drug Policy (coverage criteria)

Defines accepted indications, continuation, exclusion criteria, and utilization management requirements for Verzenio (abemaciclib) for members receiving care under the payer's UM program. Applies to clinicians and UM staff processing medication requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVerzenio (abemaciclib) — Drug Policy (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 29, 2024

Next Review DateNov 13, 2024

Key ActionSubmit prior authorization requests demonstrating indication, dosing within limits, and supporting evidence (FDA label, recognized compendia, or guideline literature).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 yearsmax adjuvant duration

200 mgsingle-dose max (mono)

150 mgsingle-dose max (combo)

56 tabsmonthly limit

Coverage Criteria for Verzenio (abemaciclib)

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Adjuvant therapy (early-stage, high-risk)

Covered when ALL of the following are met for adjuvant high‑risk early breast cancer:

Adjuvant high-risk early breast cancer: 1) Node positive, ER/PR positive, HER2 negative high‑risk early‑stage breast cancer (high risk defined as >=4 positive axillary lymph nodes OR 1-3 nodes AND (tumor size >=5 cm OR histologic grade 3)). 2) Verzenio (abemaciclib) will be used in combination with tamoxifen or an aromatase inhibitor as adjuvant treatment for up to 2 years.

Recurrent/metastatic therapy

Covered when ALL of the following are met for recurrent or metastatic breast cancer:

Recurrent/metastatic HR+/HER2-: a) Confirmed ER/PR positive and HER2 negative breast cancer. b) The member is postmenopausal OR premenopausal treated with ovarian ablation/suppression (e.g., LHRH agonist). c) One of: i) In combination with an aromatase inhibitor as first‑line therapy for unresectable/metastatic disease; OR ii) In combination with fulvestrant as subsequent therapy if a CDK4/6 inhibitor (e.g., ribociclib, palbociclib) was not previously used; OR iii) As single agent for disease progression following endocrine therapy (that did not include a CDK4/6 inhibitor) AND chemotherapy for metastatic disease.

Requests will be excluded when there is disease progression on or after prior therapy with Verzenio (abemaciclib), Ibrance (palbociclib), or Kisqali (ribociclib). Other exclusion triggers include dosing that exceeds the specified single‑dose limits — 200 mg as monotherapy or 150 mg when used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor. Coverage is also denied when treatment would exceed the established quantity limits of 56 tablets per 28 days for any listed strength (50 mg, 100 mg, 150 mg, 200 mg).

Use of Verzenio for investigational or off‑label indications lacking sufficient supporting evidence is excluded. The policy defines insufficient evidence as lacking adequate representation of the patient/cancer population or regimen in published studies, absence of clinically meaningful outcomes (ASCO‑recommended thresholds such as a hazard ratio < 0.80 or survival benefit thresholds), inappropriate study design to answer the question, reliance solely on uncontrolled case reports, or citations limited to abstracts without a full peer‑reviewed publication.

Continuation and Exemption Criteria

Continuation request exemption

Continuation requests for previously used, not-approvable medications may be exempt from this policy when ALL are met:

Continuation exemption: 1) The requested medication was used within the last year; AND 2) The member has not experienced disease progression and/or no intolerance to the requested medication; AND 3) No additional medications are being added to the continuation request.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Verzenio (abemaciclib). Approvals are based on the indications and clinical criteria listed in the policy (see Breast Cancer indications) and must be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting Medicare standards.

Prior authorization required before initiation of therapy
Clinical justification must reference supporting guideline or compendia

Step Therapy

Therapy Sequencing and Combination Rules

When used in breast cancer, Verzenio must follow sequencing and combination rules: use in combination with tamoxifen or an aromatase inhibitor as adjuvant therapy for high‑risk, node‑positive, ER/PR+, HER2‑ disease (up to 2 years); for recurrent/metastatic disease, use in combination with an aromatase inhibitor as first‑line for unresectable/metastatic disease, or with fulvestrant as subsequent therapy only if a CDK4/6 inhibitor was not previously used, or as single‑agent after progression on endocrine therapy and chemotherapy when prior CDK4/6 inhibitors were not used.

Adjuvant: combination with tamoxifen or aromatase inhibitor — duration up to 2 years
Metastatic: combination with AI as first‑line OR combination with fulvestrant if no prior CDK4/6 inhibitor OR single‑agent use if prior endocrine/chemotherapy but no prior CDK4/6

Denial Risk

Common Denial Triggers and Documentation Requirements

Requests lacking required supporting evidence or meeting exclusion criteria are at high risk for denial. Denial triggers include disease progression on or after prior CDK4/6 inhibitor (abemaciclib, palbociclib, ribociclib), dosing above single‑dose or monthly tablet limits, treatment durations exceeding specified tablet/28‑day maximums, or investigational/off‑label uses not supported by accepted evidence.

Exclusion: progression on or after prior therapy with abemaciclib, palbociclib, or ribociclib
Dosing limits: single dose limit 200 mg (monotherapy) or 150 mg (in combination)
Quantity limits: max 56 tablets per 28 days at 50 mg, 100 mg, 150 mg, and 200 mg strengths
Off‑label/investigational uses require CMS‑recognized compendia or acceptable peer‑reviewed evidence

Step Therapy / Sequencing Table

Therapy sequence	Required context / prior therapy	Coverage stance
Combination with an aromatase inhibitor (AI) as first‑line for unresectable/metastatic disease	Member with recurrent/metastatic ER/PR+ HER2‑ disease; postmenopausal or premenopausal with ovarian suppression	Covered when criteria met
Combination with fulvestrant (Faslodex) as subsequent therapy	CDK4/6 inhibitor (e.g., ribociclib, palbociclib) was NOT previously used	Covered when criteria met
Single‑agent abemaciclib	For disease progression following endocrine therapy that did NOT include a CDK4/6 inhibitor AND following chemotherapy for metastatic disease	Covered when criteria met

Background

Abemaciclib (Verzenio) is a CDK4/6 inhibitor indicated for certain patients with hormone receptor–positive, HER2‑negative breast cancer. In the adjuvant setting it is covered for high‑risk, node‑positive, ER/PR positive, HER2‑negative early‑stage disease (high risk defined as ≥4 positive axillary lymph nodes OR 1–3 nodes plus tumor size ≥5 cm or histologic grade 3) when given in combination with tamoxifen or an aromatase inhibitor for up to 2 years. For recurrent or metastatic disease, coverage is permitted in specified sequences: in combination with an aromatase inhibitor as first‑line for unresectable/metastatic disease; in combination with fulvestrant as subsequent therapy if a CDK4/6 inhibitor was not previously used; or as a single agent for progression after endocrine therapy (without prior CDK4/6) and chemotherapy. Clinical support for these uses is drawn from pivotal MONARCH trials, FDA labeling, and recognized compendia or guidelines.