CurrentNeighborhood Health Plan of Rhode IslandPolicy 1726-A

Palbociclib (Ibrance) coverage criteria

Defines prior authorization, documentation, and coverage criteria for Ibrance (palbociclib) for breast cancer and certain sarcoma indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPalbociclib (Ibrance) coverage criteria

Policy CodePolicy 1726-A

Change TypeRoutine review

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit documentation of HR/HER2 status (and PIK3CA mutation when applicable).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

HR+/HER2-primary FDA-covered breast cancer phenotype

PIK3CA-mutatedcompendial biomarker-specified indication

WD/DD liposarcomacompendial sarcoma indication

Coverage Criteria

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 endocrine-based therapy: Patient is an adult with HR-positive, HER2-negative advanced or metastatic breast cancer AND palbociclib is requested in combination with an aromatase inhibitor as initial endocrine-based therapy.

FDA-approved indication; authorization of up to 12 months may be granted.

Breast cancer - after endocrine therapy progression: Patient is an adult with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy AND palbociclib is requested in combination with fulvestrant.

FDA-approved indication; authorization of up to 12 months may be granted.

Breast cancer - PIK3CA-mutated endocrine-resistant (compendial): Patient has endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative locally advanced, recurrent, or metastatic breast cancer AND palbociclib is requested in combination with inavolisib and fulvestrant; documentation of PIK3CA mutation is required.

Compendial use; authorization of up to 12 months may be granted.

Soft tissue sarcoma - unresectable retroperitoneal liposarcoma (compendial): Patient has unresectable retroperitoneal well-differentiated or dedifferentiated liposarcoma AND palbociclib is requested as single-agent therapy.

Compendial use; authorization of up to 12 months may be granted.

inv-02: Not Medically Necessary

Non-covered indications: Any indication not explicitly listed (other than the FDA-approved and specified compendial uses) is considered experimental/investigational and not medically necessary.

Document states all other indications are not medically necessary.

Covered Regimens

Regimen	Indication	Coverage
Palbociclib in combination with an aromatase inhibitor
HR-positive, HER2-negative advanced or metastatic breast cancer as initial endocrine-based therapy
Covered when used in combination with an aromatase inhibitor; prior authorization may be granted for up to 12 months.
Palbociclib in combination with fulvestrant
HR-positive, HER2-negative advanced or metastatic breast cancer following progression on endocrine therapy
Covered when used in combination with fulvestrant after endocrine therapy progression; prior authorization may be granted for up to 12 months.

Regimen	Indication	Coverage
Palbociclib in combination with inavolisib and fulvestrant
Endocrine-resistant, PIK3CA‑mutated, HR-positive, HER2‑negative locally advanced, recurrent, or metastatic breast cancer
Covered as a compendial use when PIK3CA mutation is documented; prior authorization may be granted for up to 12 months.

Regimen	Indication	Coverage
Palbociclib as single‑agent therapy
Unresectable retroperitoneal well‑differentiated or dedifferentiated liposarcoma
Covered as a compendial single‑agent use for unresectable retroperitoneal WD/DD liposarcoma; prior authorization may be granted for up to 12 months.

Provider Actions and Requirements

Prior Authorization

Combination therapy requirements

Coverage is for breast cancer when used in combination as follows: • In combination with an aromatase inhibitor (e.g., anastrozole, exemestane, letrozole) as initial endocrine‑based therapy; or • In combination with fulvestrant for patients with disease progression following endocrine therapy. For endocrine‑resistant, PIK3CA‑mutated, HR‑positive, HER2‑negative locally advanced, recurrent, or metastatic breast cancer, coverage is available when used in combination with inavolisib and fulvestrant.

Prior Authorization

Prior authorization and duration

Prior authorization is required. Authorization of up to 12 months may be granted for covered indications when the combination therapy requirements are met. Continuation/reauthorization of up to 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression on the current regimen.

Documentation Required

Required clinical documentation

Submit documentation of hormone receptor (HR) and HER2 status, where applicable. When requesting coverage for endocrine‑resistant disease with suspected PIK3CA‑directed combinations, submit documentation confirming presence of a PIK3CA mutation.

Denial Risk

Non‑covered indications

Requests for Ibrance for indications other than those listed (e.g., any non‑approved or non‑compendial uses) are considered experimental/investigational and not medically necessary.

Line of Therapy

inv-12: first-line

First-line endocrine-based: Use in combination with an aromatase inhibitor as initial endocrine-based therapy for advanced/metastatic HR-positive, HER2-negative breast cancer.

Authorization of up to 12 months may be granted.

inv-13: second-line

Second-line after endocrine progression: Use in combination with fulvestrant for patients with HR-positive, HER2-negative advanced/metastatic breast cancer with disease progression following endocrine therapy.

Authorization of up to 12 months may be granted.

Biomarker and Testing Requirements

PIK3CA — biomarker requirement details

Required biomarkerDocumented PIK3CA mutation is required when coverage is requested for the compendial indication combining palbociclib with inavolisib and fulvestrant.

When applicableSubmit the test confirming presence of a PIK3CA mutation as part of prior authorization documentation.

Indication linkedThis biomarker requirement applies specifically to endocrine‑resistant, PIK3CA‑mutated, HR‑positive, HER2‑negative locally advanced, recurrent, or metastatic breast cancer used with inavolisib and fulvestrant.

HR and HER2 status — biomarker requirement details

Required status for all breast cancer indicationsDocumentation of hormone receptor (HR) and HER2 status must be submitted when applicable for all breast cancer indications.

FDA‑approved contextsHR and HER2 status determine eligibility for use in combination with an aromatase inhibitor (initial endocrine therapy) or with fulvestrant after endocrine progression.

Documentation sourceSubmit pathology or test results showing HR (estrogen/progesterone receptor) and HER2 status as part of the prior authorization request.

Definitions

HR-positive, HER2-negative — definition used to determine eligibility for Ibrance

DefinitionHR‑positive, HER2‑negative denotes hormone receptor–positive and HER2‑negative breast cancer phenotype used to determine eligibility for palbociclib (Ibrance) combinations.

FDA‑approved uses tied to this phenotypeIbrance is indicated for adults with HR‑positive, HER2‑negative advanced/metastatic breast cancer in combination with an aromatase inhibitor (initial endocrine therapy) or with fulvestrant after endocrine therapy progression.

Authorization durationAuthorization of up to 12 months may be granted for covered uses in HR‑positive, HER2‑negative advanced or metastatic breast cancer.

PIK3CA-mutated — presence of a PIK3CA mutation must be documented when coverage is requested for the compendial indication combining palbociclib

DefinitionPIK3CA‑mutated indicates presence of a PIK3CA mutation that must be documented when requesting coverage for the compendial regimen combining palbociclib with inavolisib and fulvestrant.

Applicable indicationThis requirement applies to endocrine‑resistant, PIK3CA‑mutated, HR‑positive, HER2‑negative locally advanced, recurrent, or metastatic breast cancer.

Documentation to submitProvide the test report confirming the PIK3CA mutation as part of prior authorization materials.

Background

Palbociclib (Ibrance) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor used in oncology. It is indicated for HR-positive, HER2-negative advanced or metastatic breast cancer in combination with endocrine therapy; compendial uses include combination therapy for endocrine-resistant, PIK3CA-mutated HR-positive, HER2-negative disease (with inavolisib and fulvestrant) and single-agent use for unresectable retroperitoneal well-differentiated/dedifferentiated liposarcoma. Documentation of the specific phenotype or biomarker (for example, PIK3CA-mutated where applicable) is required when coverage is requested for the compendial indications.