CurrentNeighborhood Health Plan of Rhode IslandPolicy 1639-A

Ribociclib (Kisqali) — Coverage Criteria

Defines prior authorization, documentation, and coverage criteria for ribociclib (Kisqali) for HR-positive, HER2-negative breast cancer and ER-positive endometrial carcinoma for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRibociclib (Kisqali) — Coverage Criteria

Policy CodePolicy 1639-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit diagnostic documentation confirming HR/HER2 or ER status; authorization may be granted for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

2 cancer typesindications listed

biomarker confirmationdocumentation required

Coverage Criteria for Ribociclib (Kisqali)

Adjuvant (early) breast cancer — Initial and continuation

Covered when ALL of the following are met

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.

Adjuvant early breast cancer criteria: Member has HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence; ribociclib (Kisqali) is prescribed in combination with an aromatase inhibitor; documentation of hormone receptor (HR) and HER2 status is provided; no contraindications or exclusions to therapy are present.

Authorization up to 12 months; continued treatment may be authorized until completion of 3 years of treatment or until disease recurrence or unacceptable toxicity.

Recurrent/Advanced/Metastatic breast cancer — Initial and continuation

Covered when ALL of the following are met

Advanced/metastatic breast cancer criteria: Member has HR-positive, HER2-negative advanced or metastatic breast cancer; ribociclib (Kisqali) is prescribed in combination with an aromatase inhibitor as initial endocrine-based therapy OR with fulvestrant as initial endocrine-based therapy or following progression on endocrine therapy; documentation of hormone receptor (HR) and HER2 status is provided; no evidence of unacceptable toxicity or disease progression for reauthorization.

Authorization up to 12 months; reauthorization contingent on absence of progression or unacceptable toxicity.

Endometrial carcinoma — Initial and continuation

Covered when ALL of the following are met

Endometrial carcinoma criteria: Member has advanced, recurrent, or metastatic endometrial carcinoma with estrogen receptor (ER)-positive tumors; ribociclib (Kisqali) is prescribed in combination with letrozole per compendial use; documentation of ER status is provided; no evidence of unacceptable toxicity or disease progression for reauthorization.

Authorization up to 12 months.

Approved Combination Regimens

Regimen	Indication	Coverage status
Ribociclib in combination with an aromatase inhibitor	Adjuvant: HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence; Advanced/metastatic: HR-positive, HER2-negative advanced or metastatic breast cancer as initial endocrine-based therapy	Covered when used in indicated combinations
Ribociclib in combination with fulvestrant	Advanced/metastatic: HR-positive, HER2-negative advanced or metastatic breast cancer as initial endocrine-based therapy or following progression on endocrine therapy	Covered when used in indicated combinations

Regimen	Indication	Coverage status
Ribociclib in combination with letrozole	Advanced, recurrent, or metastatic endometrial carcinoma with ER-positive tumors (compendial use)	Covered when used per compendia for ER-positive endometrial carcinoma

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization and Duration

Prior authorization required. Authorization of up to 12 months may be granted for eligible members when ribociclib (Kisqali) is used in the specified settings below.

Authorization duration: up to 12 months

Prior Authorization

Combination Therapy Requirement

Kisqali must be used in combination with an approved endocrine therapy that matches the indication: an aromatase inhibitor or fulvestrant for breast cancer, and letrozole for endometrial carcinoma where specified.

Breast cancer: combination with an aromatase inhibitor or fulvestrant as indicated
Endometrial carcinoma: combination with letrozole for ER-positive tumors

Documentation Required

Required Diagnostic Documentation

Required diagnostic documentation must be submitted to initiate prior authorization.

For initiation in breast cancer: laboratory results confirming hormone receptor (HR) status and HER2 status
For initiation in endometrial carcinoma: laboratory results confirming estrogen receptor (ER) status

Denial Risk

Non‑covered Indications

All other indications not explicitly listed (outside of the compendial uses: breast cancer and endometrial carcinoma as described) are considered experimental/investigational and are not medically necessary and therefore not covered.

Non‑covered: any indication other than the approved or listed compendial uses (breast cancer and endometrial carcinoma)

Biomarker and Laboratory Requirements

inv-14: HR, HER2

Required tumor markersHormone receptor (HR) positive and HER2-negative status must be documented for breast cancer initiation

Source indication (adjuvant)FDA‑indicated in combination with an aromatase inhibitor for HR‑positive, HER2‑negative stage II or III early breast cancer at high risk of recurrence

Source indication (advanced/metastatic)FDA‑indicated for HR‑positive, HER2‑negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant

inv-15: ER

Required tumor markerEstrogen receptor (ER) positive status must be documented for endometrial carcinoma initiation

Covered indication (endometrial)Compendial use: advanced, recurrent, or metastatic endometrial carcinoma with ER‑positive tumors when used in combination with letrozole

Documentation requirementSubmission must include laboratory results confirming ER status for endometrial carcinoma

Key Definitions

inv-12: Hormone receptor positive, HER2 negative

DefinitionHormone receptor (HR)–positive, HER2–negative disease status denotes tumors that are positive for estrogen and/or progesterone receptors and negative for HER2

Clinical relevanceRequired biomarker profile for initiation of ribociclib (Kisqali) in breast cancer indications

DocumentationLaboratory confirmation of HR and HER2 status must be submitted with prior authorization requests for breast cancer

Background and Drug Information

Ribociclib (Kisqali) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor used in combination with endocrine therapy for hormone receptor–positive, HER2–negative breast cancer in adjuvant and advanced/metastatic settings, and — per compendia — for use in endometrial carcinoma. Coverage decisions in this policy tie to the specified tumor biomarker status (HR/ER and HER2) and to the listed, compendial indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRibociclib (Kisqali) — Coverage Criteria

Policy CodePolicy 1639-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit diagnostic documentation confirming HR/HER2 or ER status; authorization may be granted for up to 12 months.

SourceLink

On This Page

OpenPayer

Ribociclib (Kisqali) — Coverage Criteria

Coverage Criteria for Ribociclib (Kisqali)

Approved Combination Regimens

Drug and Billing Codes

Provider Requirements and Prior Authorization

Biomarker and Laboratory Requirements

Line of Therapy Specifications

Key Definitions

Background and Drug Information