CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ibrance (palbociclib) coverage for HR+/HER2- breast cancer

Defines accepted indications, utilization management requirements, exclusions, and coding for Ibrance (palbociclib) for members of the plan; applies to providers submitting medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIbrance (palbociclib) coverage for HR+/HER2- breast cancer

Policy CodePolicy N/A

Change TypeExclusion criteria updatedtemplate converted

Effective DateN/A

Next Review DateJun 1, 2025

Key ActionSubmit prior authorization to Evolent; continuation requests are exempt if no disease progression and no >30-day lapse in authorization.

SourceLink

POLICY UPDATE CHANGES

Updated exclusion criteria and references.

Converted to new Evolent guideline template and replaced prior UM ONC_1272 Ibrance (palbociclib) guideline.

125 mgsingle dose maximum for Ibrance

21/monthmaximum monthly treatment limit

J8999billing code listed

Commercial, Medicaidapplicable lines of business

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Coverage Criteria for Ibrance (palbociclib)

Breast Cancer - Initial and Subsequent Therapy

Covered when ALL of the following are met:

Breast cancer indication: Member has ER/PR positive and HER2 negative recurrent unresectable or metastatic breast cancer

Supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature

First-line combination: Ibrance in combination with an aromatase inhibitor (anastrozole, letrozole, or exemestane) in postmenopausal patients or in premenopausal patients receiving ovarian ablation/suppression as first-line therapy

Subsequent therapy: Ibrance in combination with fulvestrant in postmenopausal patients or in premenopausal patients receiving ovarian ablation/suppression as subsequent therapy provided a CDK4/6 inhibitor (e.g., ribociclib, abemaciclib) has not been previously used

Coverage is not authorized when any of the following exclusion criteria apply: disease progression occurred while taking Ibrance (palbociclib) or another CDK4/6 inhibitor (for example, Kisqali or Verzenio); the prescribed dosing exceeds a single dose of 125 mg; or treatment would exceed a maximum of 21 capsules/tablets per month (applies across the 125 mg, 100 mg, or 75 mg formulations). These limits reflect the plan's maximum single-dose and monthly quantity thresholds and will be enforced during prior authorization review.

Use of Ibrance (palbociclib) for investigational or off‑label indications that are not supported by sufficient evidence is considered not medically necessary. “Sufficient evidence” is defined in this policy as support from CMS‑recognized compendia or acceptable peer‑reviewed literature addressing whether the patient and disease characteristics, the specific regimen, and clinically meaningful outcomes are adequately represented. Case reports, abstracts without full peer‑reviewed publication, or evidence that does not meet these standards will not satisfy the requirement for coverage.

Approved Regimens and Combinations

Regimen	Line of Therapy	Premenopausal Ovarian Suppression	Coverage Status
Palbociclib + aromatase inhibitor (anastrozole, letrozole, or exemestane)	First-line (initial therapy)	Required for premenopausal women (ovarian ablation/suppression)	Covered when criteria met

Regimen	Line of Therapy	Premenopausal Ovarian Suppression	Prior CDK4/6 inhibitor use	Coverage Status
Palbociclib + fulvestrant	Subsequent-line (after progression on endocrine therapy)	Required for premenopausal women (ovarian ablation/suppression)	No prior CDK4/6 inhibitor use (e.g., ribociclib, abemaciclib)	Covered when no prior CDK4/6 inhibitor used and other criteria met

Coding and Quantity Limits

Drug HCPCS CodesHCPCS

J8999

palbociclib

inv-05: Maximum single dose — 125 mg

Maximum single dose125 mg

Source detailPolicy exclusion: Dosing exceeds single dose limit of Ibrance (palbociclib) 125 mg.

Implication for requestsRequests exceeding 125 mg single dose will be excluded/denied per policy.

inv-06: Maximum monthly quantity — 21 capsules/tablets per month (125 mg, 100 mg, or 75 mg)

Maximum monthly quantity21 capsules/tablets per month (125 mg, 100 mg, or 75 mg)

Source detailPolicy exclusion: Treatment exceeds the maximum limit of 21 (125 mg, 100 mg, or 75 mg) capsules/month or tablets/month.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Evolent (on behalf of the payer) processes all medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Evolent processes medication requests for Neighborhood Health Plan of Rhode Island members.
Medications not authorized by Evolent may be denied and not reimbursable.

Note

Line of Therapy Considerations

Ibrance (palbociclib) is indicated for ER/PR positive, HER2 negative recurrent unresectable or metastatic breast cancer when used in the following lines of therapy.

First‑line: In combination with an aromatase inhibitor (anastrozole, letrozole, exemestane) in postmenopausal or premenopausal women receiving ovarian suppression/ablation.
Subsequent‑line: In combination with fulvestrant in postmenopausal or premenopausal women receiving ovarian suppression/ablation, provided a CDK4/6 inhibitor (e.g., ribociclib, abemaciclib) was not previously used.

Line of Therapy Specifications

first-line and subsequent

First-line: Combination with an aromatase inhibitor in postmenopausal patients or in premenopausal patients receiving ovarian ablation/suppression

First-line

Subsequent-line: Combination with fulvestrant in postmenopausal patients or in premenopausal patients receiving ovarian ablation/suppression provided no prior CDK4/6 inhibitor was used

Subsequent therapy

Biomarker and Disease Characteristics

inv-14: ER/PR and HER2 — ER/PR positive and HER2 negative

ER/PR status requiredER/PR positive

HER2 status requiredHER2 negative

Combined biomarker requirementER/PR positive and HER2 negative (required for covered indication)

Definitions

inv-12: HR+/HER2- advanced breast cancer — ER/PR positive, HER2 negative recurrent unresectable or metastatic disease

Disease typeER/PR positive, HER2 negative recurrent unresectable or metastatic breast cancer

Therapy setting — first-lineIn combination with an aromatase inhibitor (anastrozole, letrozole, or exemestane) in postmenopausal or premenopausal women receiving ovarian ablation/suppression as first-line therapy.

Therapy setting — subsequent-lineIn combination with fulvestrant in postmenopausal or premenopausal women receiving ovarian ablation/suppression as subsequent therapy provided a CDK4/6 inhibitor was not previously used.

Background on Palbociclib (Ibrance)

Palbociclib (Ibrance) is a cyclin‑dependent kinase 4/6 (CDK4/6) inhibitor indicated in combination with endocrine therapy for the treatment of hormone receptor–positive (ER/PR+), human epidermal growth factor receptor 2–negative (HER2‑) unresectable or metastatic breast cancer. The drug is used in first‑line settings in combination with an aromatase inhibitor or in subsequent therapy with fulvestrant (with ovarian suppression for premenopausal women), and monitoring for known toxicities such as neutropenia and interstitial lung disease/pneumonitis is required per prescribing information.