ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Verzenio (abemaciclib)

Defines clinical and utilization management criteria for coverage of Verzenio (abemaciclib) for breast cancer indications, continuation rules, exclusions, dosing limits, and approval authority for Neighborhood Health Plan of Rhode Island (processed by Evolent).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVerzenio (abemaciclib)

Policy CodePolicy N/A

Change TypeCommittee approval; effective date update

Effective DateNov 29, 2024

Next Review Date

Key ActionAll medication requests for Verzenio must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

POLICY UPDATE CHANGES

Policy approved November 13, 2024 with effective date November 29, 2024 (committee review history updated).

2Covered breast cancer settings (adjuvant high-risk; recurrent/metastatic)

3Permitted metastatic use cases

4Exclusion reasons listed

Coverage Summary

Coverage stance: covered_with_criteria for Verzenio (abemaciclib) for both high-risk early-stage (adjuvant) and recurrent/metastatic HR+/HER2- breast cancer per the brief. Scope summary: defines clinical and utilization management criteria including indication-specific eligibility, continuation rules, dosing and quantity limits, exclusions, and approval authority for Neighborhood Health Plan of Rhode Island (processed by Evolent). Required evidence sources: supporting documentation must include one or more of the following — FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Initial Therapy Criteria

Breast Cancer - Early-stage (Adjuvant) Indication

Verzenio is covered for high-risk early-stage breast cancer when ALL of the following are met:

ALL of the following

ALL of the following
- High risk defined as ONE of
  - Greater than or equal to 4 positive axillary lymph nodes
  - 1-3 positive nodes AND tumor size greater than or equal to 5 cm
  - 1-3 positive nodes AND histologic grade 3
Verzenio (abemaciclib) will be used in combination with tamoxifen or an aromatase inhibitor as adjuvant treatment for up to 2 yearsup to 2 years

Breast Cancer - Recurrent or Metastatic Indication

Verzenio is covered for recurrent or metastatic breast cancer when ALL of the following are met:

ALL of the following

Confirmed ER/PR positive and HER2 negative breast cancer
Member is postmenopausal OR is premenopausal treated with ovarian ablation/suppression (e.g., LHRH agonist)
Verzenio will be used for any of the following
- In combination with an aromatase inhibitor (anastrozole, letrozole, exemestane) as first line therapy for recurrent unresectable/metastatic disease
- In combination with fulvestrant (Faslodex) as subsequent therapy if a CDK4/6 inhibitor (e.g., ribociclib, palbociclib) was not previously used

Continuation Therapy Criteria

Continuation Requests Exemption Criteria

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The requested medication was used within the last year
The member has not experienced disease progression and/or intolerance to the requested medication
Additional medication(s) are not being added to the continuation request

Unproven / Exclusions

Exclusion rules: requests will be excluded for disease progression on or after prior therapy with abemaciclib, palbociclib, or ribociclib-containing regimens. Investigational or off-label uses lacking sufficient evidence (i.e., not supported by CMS-recognized compendia or acceptable peer-reviewed literature meeting CMS Chapter 15 requirements) will be considered investigational and excluded. The policy’s definition of “sufficient evidence” guides these exclusions and requires evaluation of patient representation, regimen representation, clinically meaningful outcomes (ASCO-recommended thresholds such as HR <0.80 and survival benefit expectations), study design appropriateness, that non-randomized trials with substantial subjects may be supportive, and that case reports/meeting abstracts alone are insufficient.

Provider Actions & Operational Notes

Prior Authorization

Prior authorization required via Evolent

All medication requests for Verzenio must be processed by Evolent. If Evolent does not authorize the medication, the request may be deemed not approvable and not reimbursable.

Documentation Required

Clinical justification required

Use must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements. Documentation submitted should demonstrate that the patient meets the specific coverage criteria for the requested indication.

Billing Rule

Dosing and quantity limits enforced

Dosing and quantity limits are enforced. Single-dose limits are 200 mg when used as monotherapy and 150 mg when used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor. Maximum tablets per 28 days are limited to 56 tablets for each strength listed (50 mg, 100 mg, 150 mg, 200 mg). Claims exceeding these dose or quantity limits may be excluded.

Denial Risk

Exclusion for prior CDK4/6 progression

Requests will be excluded if there is disease progression on or after prior therapy containing a CDK4/6 inhibitor, specifically abemaciclib (Verzenio), palbociclib (Ibrance), or ribociclib (Kisqali).

Denial Risk

Investigational/off-label exclusions

Off-label requests lacking sufficient evidence or not generally accepted by the medical community will be considered investigational and excluded. The policy defines sufficient evidence as support from CMS-recognized compendia or acceptable peer-reviewed literature and lists factors used to assess sufficiency (patient representation, regimen representation, clinically meaningful outcomes, study design, and limitations of case reports/abstracts).

Clinical Evidence

Key evidence references cited in the brief: the MONARCH adjuvant trial reference (Johnston SRD et al.) supporting adjuvant use; MONARCH 3 (Johnston S et al.) final PFS data supporting initial therapy in advanced disease; MONARCH 2 (JAMA Oncol. 2020) for use after progression on endocrine therapy; and the Verzenio prescribing information (Lilly USA, LLC, 2024). These studies and the prescribing information are listed as the primary supporting references for the covered indications.

Supporting evidence / references

MONARCH adjuvant trial referenceJohnston SRD et al.; Abemaciclib combined with endocrine therapy for the adjuvant treatment (citation listed)

MONARCH 2Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy — MONARCH 2: JAMA Oncol. 2020;6(1):116-124

MONARCH 3 PFSJohnston S et al.; MONARCH 3 final PFS: randomized study of abemaciclib as initial therapy for advanced breast cancer (NPJ Breast Cancer. 2019)

Prescribing informationVerzenio prescribing information: Lilly USA, LLC, 2024

Background

Background: Verzenio (abemaciclib) is a CDK4/6 inhibitor indicated for HR+/HER2- breast cancer in both high-risk early-stage (adjuvant) and advanced/recurrent disease settings. Coverage under this policy requires supporting evidence consistent with Medicare policy standards (FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature meeting CMS Chapter 15 requirements) and is administered via Evolent for authorization and utilization management.

Definitions:

High risk early-stage breast cancer: Defined as any ONE of: ≥4 positive axillary lymph nodes; OR 1–3 positive nodes AND tumor size ≥5 cm; OR 1–3 positive nodes AND histologic grade 3.

Premenopausal treated with ovarian ablation/suppression: Treatment with ovarian ablation/suppression such as an LHRH agonist.

Sufficient evidence (per CMS Manual Chapter 15 criteria): Evidence supported by CMS compendia or acceptable peer-reviewed literature that demonstrates adequate representation of patient and regimen characteristics, clinically meaningful outcomes (e.g., ASCO guidance such as HR <0.80 and survival benefit thresholds), appropriate study design, recognition that non-randomized trials with adequate size may be supportive, and that case reports or meeting abstracts alone are generally insufficient.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVerzenio (abemaciclib)

Policy CodePolicy N/A

Change TypeCommittee approval; effective date update

Effective DateNov 29, 2024

Next Review Date

Key ActionAll medication requests for Verzenio must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

On This Page

OpenPayer

Verzenio (abemaciclib)

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions

Applicable Codes

Provider Actions & Operational Notes

Clinical Evidence

Background

Revision History