CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ibrance (palbociclib) authorization and coverage criteria

Defines accepted indications, continuation and exclusion criteria, and coding/standards for authorization of Ibrance (palbociclib) for Neighborhood Health Plan of Rhode Island members processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIbrance (palbociclib) authorization and coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent using billing code J8999 for palbociclib.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Breast cancer (HR+/HER2-)primary covered indication

J8999billing code listed

125 mgsingle dose maximum

≤30 day lapsecontinuation window

CHIP, Commercial, Medicaid, Medicarelines of business

Coverage Criteria for Palbociclib (Ibrance)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIbrance (palbociclib) authorization and coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent using billing code J8999 for palbociclib.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Breast Cancer — Initial/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

Combination and line: (1) In combination with an aromatase inhibitor in postmenopausal or premenopausal women treated with ovarian ablation/suppression as first-line therapy OR (2) In combination with fulvestrant in postmenopausal or premenopausal women treated with ovarian ablation/suppression as subsequent therapy

For subsequent therapy, prior use of another CDK4/6 inhibitor (e.g., ribociclib, abemaciclib) must NOT have occurred

Coverage will be denied for members with disease progression while taking Ibrance (palbociclib) or another CDK4/6 inhibitor (e.g., ribociclib, abemaciclib). Requests where the dosing exceeds the single dose limit of 125 mg will not be approved. Additionally, use of Ibrance for investigational or off‑label indications that lack sufficient supporting evidence (see evidence standards below) is excluded from coverage.

Off‑label uses of Ibrance (palbociclib) will be considered investigational and not approvable when the indication is not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. Sufficient evidence is defined by whether the patient and disease characteristics, the regimen used, and the reported outcomes are adequately represented in the published evidence. Acceptable evidence generally excludes isolated case reports and meeting abstracts without a full peer‑reviewed publication, and favors studies with clinically meaningful outcomes (for example, hazard ratio < 0.80 or survival benefits of at least 3 months for OS or PFS) and appropriate study design. Nonrandomized trials with substantial subject numbers may provide supportive evidence; single case reports or abstracts alone do not.

Regimens and Indications Covered

Regimen	Indication / Line of Therapy	Coverage Status
Palbociclib + aromatase inhibitor (anastrozole, letrozole, or exemestane)
First-line therapy for ER/PR‑positive, HER2‑negative recurrent unresectable or metastatic breast cancer (postmenopausal or premenopausal with ovarian ablation/suppression)
Covered

Regimen	Indication / Line of Therapy	Coverage Status
Palbociclib + fulvestrant
Subsequent therapy for ER/PR‑positive, HER2‑negative recurrent unresectable or metastatic breast cancer in postmenopausal or premenopausal women treated with ovarian ablation/suppression, provided no prior CDK4/6 inhibitor (e.g., ribociclib, abemaciclib) was used
Covered

Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required and managed by Evolent. All medication requests for palbociclib (Ibrance) must be submitted to Evolent for review and authorization prior to dispensing. Requests not authorized by Evolent may be deemed not approvable and not reimbursable.

Prior authorization managed by Evolent
Affected HCPCS/Code: J8999 palbociclib

Documentation Required

Line / Combination Requirements

For HR+/HER2- recurrent unresectable or metastatic breast cancer, palbociclib use must follow specified line and combination requirements.

First-line: palbociclib in combination with an aromatase inhibitor (anastrozole, letrozole, exemestane) for postmenopausal or premenopausal women receiving ovarian ablation/suppression.
Subsequent-line: palbociclib in combination with fulvestrant for postmenopausal or premenopausal women receiving ovarian ablation/suppression, only if a CDK4/6 inhibitor (e.g., ribociclib, abemaciclib) has not been previously used.

Documentation Required

Evidence Requirement

Use must be supported by one of the following: FDA-approved labeling; CMS-recognized compendia; NCCN or ASCO clinical guidelines; or acceptable peer‑reviewed literature that meets CMS standards (see Medicare Benefit Policy Manual Chapter 15).

Denial Risk

Exclusion-based Denial Triggers

Requests may be denied for specified exclusion conditions including disease progression on palbociclib or another CDK4/6 inhibitor, dosing above single‑dose limits, investigational/off‑label uses lacking sufficient evidence, or failure to meet evidentiary standards.

Denial trigger: disease progression while receiving palbociclib or another CDK4/6 inhibitor (ribociclib, abemaciclib).
Denial trigger: dosing exceeds single dose limit (Ibrance 125 mg capsule/tablet limits as specified).
Denial trigger: investigational or off‑label indications not supported by CMS compendia or adequate peer‑reviewed evidence (per listed evidence quality considerations).

Receptor and Biomarker Requirements

ER/PR, HER2 — biomarker requirements (HR+/HER2-)

Required biomarker statusEstrogen receptor (ER) and/or progesterone receptor (PR) positive AND HER2 negative (HR+/HER2-)

Clinical contextApplies to recurrent unresectable or metastatic breast cancer

Role in eligibilityBiomarker status is required to define member eligibility for palbociclib combinations

Estrogen receptor/progesterone receptor positive and HER2 negative breast cancer — shorthand HR+/HER2-

Shorthand termHR+/HER2- = Estrogen receptor/progesterone receptor positive and HER2 negative

Use in policyDefines the breast cancer subtype eligible for palbociclib therapy per coverage criteria

Applies toRecurrent unresectable or metastatic disease

OpenPayer

Ibrance (palbociclib) authorization and coverage criteria

Coverage Criteria for Palbociclib (Ibrance)

Regimens and Indications Covered

Billing Codes and Dosing Limits

Authorization, Documentation, and Denial Triggers

First-line and Subsequent Therapy Rules

Receptor and Biomarker Requirements

Background on Palbociclib