CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Palbociclib (Ibrance) — Coverage Criteria

Defines prior authorization, covered indications, documentation, and continuation criteria for Ibrance (palbociclib) for members of Neighborhood Health Plan of Rhode Island when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPalbociclib (Ibrance) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documented HR and HER2 status; approvals may be granted for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

2FDA combo contexts

2compendial uses

Coverage Criteria

Initial and single-agent compendial indications

Covered when ALL of the following are met for each indication group

Continuation of therapy

Covered when ALL of the following are met for reauthorization

No progression or unacceptable toxicity: There is no evidence of unacceptable toxicity and no disease progression while on the current regimen.

Authorization of 12 months may be granted for continued treatment when this condition is met.

All indications other than the FDA-approved indications and the specified compendial uses listed in this policy are considered experimental/investigational and not medically necessary. This includes any use of Ibrance (palbociclib) outside the listed breast cancer and soft tissue sarcoma contexts.

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization required; authorization of up to 12 months may be granted for FDA‑approved and listed compendial uses when criteria are met.

Authorization up to 12 months for breast cancer when used in combination with an aromatase inhibitor or with fulvestrant.
Authorization up to 12 months for soft tissue sarcoma when used as single‑agent for unresectable well‑differentiated/dedifferentiated retroperitoneal liposarcoma.

Step Therapy

Combination Therapy Requirement

For breast cancer, Ibrance must be used in combination therapy as specified to meet coverage criteria.

Combination with an aromatase inhibitor (e.g., anastrozole, exemestane, letrozole).
Combination with fulvestrant.

Documentation Required

Required Clinical Documentation

Submission of hormone receptor (HR) and HER2 status is required to initiate the prior authorization review, where applicable.

Denial Risk

Non‑Covered Indications

Use for indications other than the listed FDA‑approved or compendial uses is considered experimental/investigational and not medically necessary.

Non‑covered: any indication other than HR‑positive, HER2‑negative recurrent/advanced/metastatic breast cancer and unresectable well‑differentiated/dedifferentiated retroperitoneal liposarcoma.

Background

Ibrance (palbociclib) has listed compendial uses in oncology: as therapy for recurrent HR-positive, HER2-negative breast cancer and as single-agent therapy for unresectable well-differentiated/dedifferentiated retroperitoneal liposarcoma. Coverage under this policy requires that treatment fall within those specified indications; all other uses are considered experimental and not medically necessary.

Definitions

HR-positive, HER2-negative — Definition and requirements

DefinitionHormone receptor–positive (HR-positive) and human epidermal growth factor receptor 2–negative (HER2-negative) tumor status required for the FDA-indicated breast cancer uses of Ibrance (palbociclib).

Clinical contextIbrance is indicated for HR-positive, HER2-negative advanced or metastatic breast cancer when used in combination with an aromatase inhibitor as initial endocrine-based therapy or with fulvestrant after progression on endocrine therapy.

Documentation requirementSubmission of HR and HER2 status is necessary to initiate the prior authorization review, where applicable.

Patient populationsIncludes postmenopausal women and men for use with an aromatase inhibitor; includes patients with disease progression following endocrine therapy for use with fulvestrant.

Implication for coverageMembers must have documented HR-positive, HER2-negative status to meet FDA-indicated coverage criteria for Ibrance in breast cancer.

Initial Therapy Criteria

Initial authorization

Breast cancer initial: Authorization of 12 months may be granted when Ibrance is used in combination with an aromatase inhibitor or with fulvestrant for HR-positive, HER2-negative recurrent, advanced, or metastatic breast cancer.

Sarcoma initial: Authorization of 12 months may be granted when Ibrance is used as a single agent for unresectable well-differentiated/dedifferentiated liposarcoma of the retroperitoneum.

Continuation Criteria

Continuation

Reauthorization conditions

Reauthorization requirement: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Step	Requirement
1
Ibrance must be used in combination with an aromatase inhibitor (e.g., anastrozole, exemestane, letrozole) or with fulvestrant for treatment of HR-positive, HER2-negative recurrent, advanced, or metastatic breast cancer.