CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Kisqali (ribociclib) coverage for HR-positive, HER2-negative advanced/metastatic breast cancer

Defines coverage criteria, documentation, initial and continuation authorization durations for Kisqali (ribociclib) for FDA-approved and compendial uses in HR-positive, HER2-negative advanced or metastatic breast cancer when used in combination with an aromatase inhibitor or fulvestrant.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKisqali (ribociclib) coverage for HR-positive, HER2-negative advanced/metastatic breast cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must submit HR and HER2 receptor status documentation to initiate the prior authorization review for Kisqali.

POLICY UPDATE CHANGES

No material changes to clinical coverage or policy criteria.

2FDA-approved indication groups described

1Compendial use listed

12Standard authorization duration (months)

Coverage Summary & Indications

Initial Authorization / Covered Indications

Covered when ALL of the following are met:

ALL of the following

ONE of
- FDA‑approved indication: Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine‑based therapy for adult patients with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative advanced or metastatic breast cancer.
- FDA‑approved indication: Kisqali (ribociclib) in combination with fulvestrant for the treatment of postmenopausal women or in men with HR‑positive, HER2‑negative advanced or metastatic breast cancer, as initial endocrine‑based therapy or following disease progression on endocrine therapy.
- Compendial use: Recurrent HR‑positive, HER2‑negative advanced or metastatic breast cancer when supported by an authoritative compendium (e.g., NCCN Drugs & Biologics Compendium).
Documentation of tumor receptor status: medical record must include documentation of hormone receptor (ER and/or PR) positivity and HER2‑negative status prior to initiation.
No exclusion to the prescribed therapy: member must not have any plan‑specified exclusion that would preclude coverage of Kisqali for the requested indication.
Authorized duration: initial authorization may be granted for up to 12 months.

Coverage stance: Covered with criteria. Scope summary: Coverage is restricted to the FDA‑approved and compendial uses listed above for HR‑positive, HER2‑negative advanced or metastatic breast cancer when Kisqali is used in combination with an aromatase inhibitor or fulvestrant. All other uses are considered investigational and not medically necessary.

Authorization, Duration & Required Documentation

Authorization Duration

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

12-month approval period stated

Continuation / Reauthorization

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

Prior Authorization

Prior authorization required with documentation

Providers must submit HR and HER2 receptor status documentation to initiate the prior authorization review for Kisqali.

Submit HR and HER2 receptor status documentation
This initiates prior authorization review

Documentation Required

Document indication and lack of exclusions

Document that the indication is FDA-approved or compendial (recurrent HR-positive, HER2-negative breast cancer) and that the member has no exclusions to therapy.

Confirm FDA-approved or compendial indication; confirm no member exclusions

Billing Rule

Authorization duration

Initial and reauthorization approvals may be granted for 12 months when criteria are met; ensure reauthorization requests demonstrate no unacceptable toxicity or disease progression.

Initial and reauthorization approvals may be granted for 12 months; reauthorization must show no progression or unacceptable toxicity

Background

Background: Kisqali (ribociclib) is indicated in combination with endocrine therapy for treatment of HR-positive, HER2-negative advanced or metastatic breast cancer per the FDA-approved indications and listed compendial use. Covered FDA indications include use with an aromatase inhibitor as initial endocrine-based therapy and use with fulvestrant for postmenopausal women or men as initial therapy or following progression on endocrine therapy. The compendial use includes recurrent HR-positive, HER2-negative breast cancer. The policy requires submission of documented hormone receptor (HR) and HER2 status to initiate prior authorization review, restricts coverage to the listed FDA-approved and compendial indications, and deems all other indications investigational and not medically necessary. Initial and reauthorization approvals may be granted for 12 months when criteria are met and there is no unacceptable toxicity or disease progression.

Definitions

HRHormone receptor

HER2Human epidermal growth factor receptor 2

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKisqali (ribociclib) coverage for HR-positive, HER2-negative advanced/metastatic breast cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must submit HR and HER2 receptor status documentation to initiate the prior authorization review for Kisqali.

On This Page

OpenPayer

Kisqali (ribociclib) coverage for HR-positive, HER2-negative advanced/metastatic breast cancer

Coverage Summary & Indications

Authorization, Duration & Required Documentation

Not Medically Necessary / Exclusions

Applicable Codes

Clinical Evidence & References

Background

Revision History