CurrentNeighborhood Health Plan of Rhode IslandPolicy 1639-A

Kisqali (ribociclib) - coverage criteria

Covers prior authorization, documentation, and authorization duration for Kisqali (ribociclib) used in HR-positive, HER2-negative breast cancer and ER-positive endometrial carcinoma when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKisqali (ribociclib) - coverage criteria

Policy CodePolicy 1639-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of HR/HER2 or ER status and evidence of combination endocrine therapy as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical initial or reauthorization authorization period

3 yearsmaximum adjuvant treatment duration allowed

HR+, HER2-breast cancer phenotype covered

ER+endometrial carcinoma phenotype covered

Coverage Criteria for Ribociclib (Kisqali)

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Adjuvant high-risk early breast cancer criteria: Member has HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence as defined by nodal involvement (excluding microscopic), or tumor >5 cm, or tumor 2–5 cm with Grade 2 plus high genomic risk or Ki-67 >=20% or Grade 3; Kisqali (ribociclib) will be used in combination with an aromatase inhibitor; documentation supports high-risk features and HR+/HER2- status

Authorization of up to 3 years of adjuvant treatment permitted; initial and reauthorization durations typically up to 12 months per authorization

Recurrent or metastatic breast cancer

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

Recurrent/metastatic breast cancer criteria: Member has HR-positive, HER2-negative advanced or metastatic breast cancer; Kisqali will be used 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; there is no evidence of unacceptable toxicity or disease progression on the current regimen for reauthorization

Authorization duration typically 12 months

Endometrial carcinoma (compendial)

Covered when ALL of the following are met for endometrial carcinoma:

Endometrial carcinoma criteria: Member has recurrent or metastatic endometrial carcinoma that is estrogen receptor (ER)-positive; Kisqali will be used in combination with letrozole per compendial recommendation; documentation supports ER-positive status

Authorization duration typically 12 months

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Period and Conditions

Authorization may be granted for up to 12 months for eligible indications. Prior authorization for treatment or reauthorization may be approved for: 1) HR-positive, HER2-negative recurrent or metastatic breast cancer when used in combination with an aromatase inhibitor or fulvestrant; 2) adjuvant treatment of HR-positive, HER2-negative early-stage breast cancer at high risk of recurrence when used in combination with an aromatase inhibitor; 3) recurrent or metastatic endometrial carcinoma with ER-positive tumors when used in combination with letrozole. Reauthorization for recurrent or metastatic breast cancer or endometrial carcinoma may be granted for 12 months when there is no evidence of unacceptable toxicity or disease progression on the current regimen.

Authorization period: up to 12 months for initiation or reauthorization of eligible indications
Reauthorization condition: no evidence of unacceptable toxicity or disease progression while on current regimen

Documentation Required

Required Laboratory Documentation

Submit documentation of the member’s tumor receptor status with the prior authorization request. For initiation of therapy for breast cancer, include laboratory results confirming hormone receptor (HR) and HER2 status. For initiation of therapy for endometrial carcinoma, include laboratory results confirming estrogen receptor (ER) status.

Breast cancer initiation: HR and HER2 laboratory results required
Endometrial carcinoma initiation: ER laboratory results required

Denial Risk

Experimental/Investigational Exclusions

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

Not medically necessary: all indications outside the FDA-approved and compendial uses specified

Covered Drug Regimens and Combinations

Regimen	Indication	Coverage status
Ribociclib (Kisqali) + aromatase inhibitor	Adjuvant treatment of adults with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence	Covered when criteria met (adjuvant high-risk early breast cancer)

Regimen	Indication	Coverage status
Ribociclib (Kisqali) + aromatase inhibitor or fulvestrant	Treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer (with an aromatase inhibitor as initial endocrine-based therapy; or with fulvestrant as initial therapy or following progression on endocrine therapy)	Covered when criteria met (advanced/metastatic HR-positive, HER2-negative breast cancer)

Regimen	Indication	Coverage status
Ribociclib (Kisqali) + letrozole	Recurrent or metastatic endometrial carcinoma that is ER-positive (compendial use)	Covered when criteria met (recurrent/metastatic ER-positive endometrial carcinoma)

Biomarker Requirements for Coverage

inv-13: HR (hormone receptor) — positive.

RequirementHormone receptor (HR) status must be documented as positive

Documentation neededSubmit laboratory results confirming HR status at therapy initiation

Applies toBreast cancer indications (adjuvant or advanced/metastatic) per policy

inv-14: HER2 — negative.

RequirementHER2 status must be documented as negative for breast cancer indications

Documentation neededSubmit laboratory results confirming HER2 status at therapy initiation for breast cancer

Applies toAdjuvant stage II–III high‑risk and advanced/metastatic HR-positive breast cancer

inv-15: ER (estrogen receptor) — positive.

RequirementEstrogen receptor (ER) status must be documented as positive for endometrial carcinoma use

Documentation neededSubmit laboratory results confirming ER status when requesting initiation for endometrial carcinoma

Applies toRecurrent or metastatic ER-positive endometrial carcinoma treated in combination with letrozole (compendial)

Line of Therapy and Sequencing

first-line/second-line

Advanced/metastatic breast cancer combinations: Use in combination with an aromatase inhibitor as initial endocrine-based therapy, or with fulvestrant as initial therapy or following progression on endocrine therapy

Per FDA indications

Definitions and Clinical Terms

inv-11: High-risk early breast cancer (adjuvant) — HR-positive, HER2-negative early breast cancer at high risk of recurrence.

Covered phenotypeHR‑positive, HER2‑negative stage II–III early breast cancer at high risk of recurrence

Combination therapyKisqali (ribociclib) must be used in combination with an aromatase inhibitor for adjuvant high‑risk early breast cancer

High‑risk featuresExamples include any nodal involvement (excluding microscopic), tumor size >5 cm, or 2–5 cm with Grade 2 plus high genomic risk or Ki‑67 ≥20% or Grade 3

Authorization durationAuthorization may be granted for up to 12 months per prior authorization; adjuvant treatment may be authorized up to 3 years total per policy note

Background

Ribociclib (Kisqali) is a cyclin‑dependent kinase 4/6 (CDK4/6) inhibitor used in oncology practice. It is indicated for HR‑positive, HER2‑negative breast cancer in both the adjuvant (high‑risk early breast cancer) and advanced/metastatic settings, and, per compendia, in combination with letrozole for ER‑positive recurrent or metastatic endometrial carcinoma. Use should be limited to these FDA‑approved and compendial indications as specified in this policy.