CurrentNeighborhood Health Plan of Rhode IslandPolicy 1639-A

Coverage and prior authorization criteria for ribociclib (Kisqali)

Coverage and prior authorization criteria for ribociclib (Kisqali) for adults with HR-positive, HER2-negative breast cancer and for ER-positive endometrial carcinoma when combined with specified endocrine therapies; applies to members of Neighborhood Health Plan of Rhode Island as referenced in this document.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCoverage and prior authorization criteria for ribociclib (Kisqali)

Policy CodePolicy 1639-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of hormone receptor and HER2 (breast) or ER (endometrial) status; approvals typically granted for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

HR+/HER2-primary biomarker

adjuvant & metastaticcovered settings

endometrial (ER+)compendial tumor type

Coverage Criteria for Ribociclib (Kisqali)

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Adjuvant (early) breast cancer — high risk

Covered when ALL of the following are met for adjuvant early breast cancer at high risk of recurrence:

Adjuvant high-risk criteria: 1) Diagnosis of hormone receptor (HR)-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence (examples include: any lymph node involvement excluding microscopic nodal involvement; or node-negative with tumor >5 cm; or tumor 2–5 cm with Grade 2 and high genomic risk or Ki-67 >= 20%; or Grade 3).

Combination therapy: 2) Intended use in combination with an aromatase inhibitor (Kisqali indicated in combination with an aromatase inhibitor for this adjuvant indication).

Diagnostic documentation: 3) Documentation of HR and HER2 tumor status provided (laboratory results submitted with prior authorization).

Authorization and duration: Authorization may be granted for up to 12 months; continued adjuvant treatment may be allowed until completion of 3 years of treatment, disease recurrence, or unacceptable toxicity while on the current regimen.

Recurrent or metastatic breast cancer

Covered when ALL of the following are met for advanced or metastatic breast cancer:

Disease criteria: 1) Diagnosis of hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.

Line of therapy and combination: 2) Use in combination with either an aromatase inhibitor as initial endocrine-based therapy, or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy (per FDA indication).

Diagnostic documentation: 3) Documentation of HR and HER2 tumor status provided (laboratory results submitted with prior authorization).

Authorization and reauthorization: Authorization may be granted for up to 12 months; reauthorization allowed if there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Endometrial carcinoma (compendial)

Covered when ALL of the following are met for endometrial carcinoma (compendial use):

Disease criteria: 1) Diagnosis of recurrent or metastatic endometrial carcinoma that is estrogen receptor (ER)-positive.

Combination therapy: 2) Use in combination with letrozole (compendial use supported).

Diagnostic documentation: 3) Documentation of ER tumor status provided (laboratory results submitted with prior authorization).

All indications for ribociclib (Kisqali) that are not listed as FDA-approved or as compendial uses in this policy are considered experimental/investigational and not medically necessary.

Regimens and Indication-Specific Combinations

Regimen	Indication	Coverage status	Notes
Ribociclib + aromatase inhibitor
Adjuvant treatment of HR-positive, HER2-negative stage II–III early breast cancer at high risk of recurrence
covered
Authorization may be granted for up to 12 months; continued treatment allowed until completion of 3 years of therapy, disease recurrence, or unacceptable toxicity. High‑risk features include any lymph node involvement (excluding microscopic), or node‑negative with tumor >5 cm, or tumor 2–5 cm with Grade 2 and high genomic risk or Ki‑67 ≥20%, or Grade 3.

Regimen	Indication	Coverage status	Notes
Ribociclib + aromatase inhibitor
Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer (as initial endocrine‑based therapy)
covered
Authorization may be granted for up to 12 months; reauthorization allowed if no unacceptable toxicity or disease progression. Use in combination with an aromatase inhibitor as initial endocrine‑based therapy.

Regimen	Indication	Coverage status	Notes
Ribociclib + letrozole
Recurrent or metastatic ER‑positive endometrial carcinoma (compendial use)
covered
{"text":"Authorization may be granted for up to 12 months; reauthorization allowed if no unacceptable toxicity or disease progression. This is a compendial (non‑FDA) indication per referenced compendia."","status":""}

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Authorization Duration and Reauthorization

Prior authorization is required. Initial and reauthorization requests are typically approved for 12 months when criteria are met. Authorization durations: 12 months for adjuvant high-risk early breast cancer (when used in combination with an aromatase inhibitor) until completion of 3 years of treatment or until disease recurrence or unacceptable toxicity; 12 months for recurrent/metastatic HR-positive, HER2-negative breast cancer when used in combination with an aromatase inhibitor or fulvestrant; 12 months for continued treatment of recurrent/metastatic breast cancer or endometrial carcinoma if there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Initial and reauthorization requests typically approved for 12 months when criteria are met
Adjuvant early-stage high-risk breast cancer: approval may continue up to completion of 3 years of treatment or until recurrence/toxicity
Reauthorization allowed for recurrent/metastatic breast cancer or endometrial carcinoma if no unacceptable toxicity or disease progression

Prior Authorization

Combination Therapy Requirement

Ribociclib (Kisqali) is covered only in combination with specified endocrine therapies per indication.

Adjuvant early breast cancer: in combination with an aromatase inhibitor
Advanced/metastatic breast cancer: 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 Required

Required Diagnostic Documentation

Submit required diagnostic laboratory documentation with the prior authorization request.

Breast cancer initiation: laboratory results confirming hormone receptor (HR) and HER2 status
Endometrial carcinoma initiation: laboratory results confirming estrogen receptor (ER) status

Denial Risk

Non-covered Indications

Requests for indications other than the listed FDA-approved indications or compendial uses (breast cancer, endometrial carcinoma) are considered experimental/investigational and are not covered.

Non-covered: any indication not listed as FDA-approved or compendial (experimental/investigational)
Covered compendial uses: breast cancer, endometrial carcinoma

Biomarker and Diagnostic Definitions

HR (ER/PR) and HER2 — Biomarker requirements

Required biomarker documentationLaboratory results confirming hormone receptor (HR: ER and/or PR) and HER2 status must be submitted for breast cancer requests.

HR (ER/PR) requirementTumors must be hormone receptor–positive (HR-positive) for covered breast cancer indications.

HER2 requirementTumors must be HER2-negative for covered breast cancer indications.

Indication linkageHR and HER2 status are required for both adjuvant (stage II–III high risk) and advanced/metastatic breast cancer indications where ribociclib is used in combination with endocrine therapy.

ER — Estrogen receptor requirement/notes

Documentation requiredLaboratory results confirming estrogen receptor (ER) status must be submitted when initiating therapy for endometrial carcinoma or when ER status is relevant for breast cancer HR assessment.

ER role in HR definitionER positivity is a component of hormone receptor–positive (HR-positive) status used to determine eligibility for ribociclib in breast cancer.

Source requirementER (and overall HR) test reports should be included with the prior authorization request to demonstrate receptor status.

ER-positive endometrial carcinoma — Compendial use

Compendial indicationRibociclib plus letrozole is considered a compendial use for recurrent or metastatic ER-positive endometrial carcinoma.

Combination therapy requiredUse must be in combination with letrozole for the compendial endometrial carcinoma indication.

Documentation requiredLaboratory confirmation of ER-positive tumor status must be submitted with the prior authorization request.

HR-positive, HER2-negative — Required tumor status

Required tumor statusTumors must be hormone receptor–positive (HR-positive) and HER2-negative for the covered breast cancer indications described.

Applies to settingsThis HR-positive, HER2-negative requirement applies to both adjuvant (stage II–III high risk) and advanced/metastatic breast cancer indications.

Combination therapy contextCoverage is for ribociclib given only in combination with specified endocrine therapies (aromatase inhibitor or fulvestrant) for HR-positive, HER2-negative disease.