CurrentNeighborhood Health Plan of Rhode IslandPolicy 1726-A

Ibrance (palbociclib)

Policy governs prior authorization and coverage criteria for palbociclib (Ibrance) for FDA‑approved indications and specific compendial uses including HR-positive, HER2-negative advanced/metastatic breast cancer and select sarcoma use; documents required clinical testing and authorization durations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIbrance (palbociclib)

Policy CodePolicy 1726-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of HR and HER2 status where applicable and PIK3CA mutation test results when requesting the PIK3CA‑mutated indication; authorization may be granted for 12 months if criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes to policy.

3Covered Indications (FDA + Compendia)

1Compendial Sarcoma Use

12Authorization Duration (months)

Coverage Summary & Scope

Ibrance (palbociclib) is covered_with_criteria for treatment of HR‑positive, HER2‑negative advanced or metastatic breast cancer when used in combination with endocrine therapy (an aromatase inhibitor as initial endocrine‑based therapy or with fulvestrant after progression). Compendial uses covered include combination with inavolisib and fulvestrant for endocrine‑resistant, PIK3CA‑mutated, HR‑positive, HER2‑negative locally advanced, recurrent, or metastatic breast cancer, and single‑agent use for unresectable retroperitoneal well‑differentiated/dedifferentiated liposarcoma. Coverage requires documentation of receptor status and mutation testing where applicable. Authorization may be granted for 12 months when criteria are met.

Initial Therapy Criteria (Prior Authorization)

Covered Indications / Initial Authorization

Authorization of 12 months may be granted when ALL of the following are met for the listed indications:

Indication (ONE of)

Hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer when used in combination with an aromatase inhibitor as initial endocrine-based therapy
Documentation of HR and HER2 status required where applicable
HR-positive, HER2-negative advanced or metastatic breast cancer when used in combination with fulvestrant in patients with disease progression following endocrine therapy
Documentation of HR and HER2 status required where applicable
Endocrine-resistant, PIK3CA‑mutated, HR-positive, HER2-negative locally advanced, recurrent, or metastatic breast cancer when used in combination with inavolisib and fulvestrant (compendial use)
Documentation of PIK3CA mutation test required
Unresectable retroperitoneal well-differentiated/dedifferentiated liposarcoma when used as single-agent therapy (compendial use)

Exclusions / Not Medically Necessary

Exclusions

All other indications not listed above are considered experimental/investigational and not medically necessary

Denial Risk

Not medically necessary for other indications

Claims for palbociclib for indications other than the listed FDA‑approved or compendial uses will be considered experimental/investigational and not medically necessary; risk of denial if submitted for other uses.

Continuation / Reauthorization Criteria

Continuation / Reauthorization

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

ALL of the following

Member is currently receiving palbociclib for an indication outlined in the coverage criteria
There is no evidence of unacceptable toxicity while on the current regimen
There is no evidence of disease progression while on the current regimen

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Submission of prior authorization with documentation of HR and HER2 status where applicable; documentation of PIK3CA mutation test when that indication is requested. Authorization may be granted for 12 months if criteria met.

Note: Authorization may be granted for up to 12 months when criteria are met.

Documentation Required

Required diagnostic documentation

Provide documentation of hormone receptor (HR) and HER2 status where applicable and documentation of test confirming presence of PIK3CA mutation when requested indication involves PIK3CA mutation.

Document HR and HER2 status for breast cancer indications where applicable.
Provide documentation of PIK3CA mutation test when the PIK3CA‑mutated indication is requested.

Denial Risk

Not medically necessary for other indications

Clinical Evidence & References

Primary sources supporting this policy include the FDA package inserts for Ibrance (palbociclib) capsules and tablets (September 2023), the NCCN Drugs & Biologics Compendium (2024) as the compendial reference, and the Itovebi (inavolisib) package insert (October 2024). The compendial basis supports the sarcoma single‑agent indication and the combination use with inavolisib for PIK3CA‑mutated disease.

Definitions & Background

Ibrance indications require documented hormone receptor (HR) and HER2 status where applicable; PIK3CA mutation testing documentation is required when the inavolisib combination is requested. Authorization of 12 months may be granted for eligible initial therapy and for continuation when there is no unacceptable toxicity or disease progression.

Term	Definition
{"text":"HR","status":""},{"text":"Hormone receptor","status":""}
{"text":"HER2","status":""},{"text":"Human epidermal growth factor receptor 2","status":""}
{"text":"PIK3CA","status":""},{"text":"Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene","status":""}