CurrentNeighborhood Health Plan of Rhode IslandPolicy 1639-A

Kisqali (ribociclib) coverage and prior authorization

Defines coverage criteria, required documentation, and authorization durations for ribociclib (Kisqali) for FDA-approved and compendial indications (early-stage HR+/HER2- high-risk breast cancer; advanced/metastatic HR+/HER2- breast cancer) and compendial use in endometrial carcinoma when combined with endocrine therapy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKisqali (ribociclib) coverage and prior authorization

Policy CodePolicy 1639-A

Change Typeclarified

Effective Date

Next Review Date

Key ActionSubmission of prior authorization with required laboratory documentation (HR and HER2 status for breast cancer; ER status for endometrial carcinoma) is necessary to initiate review.

POLICY UPDATE CHANGES

Policy references Kisqali package insert (September 2024) and NCCN Drugs & Biologics Compendium (2025) as references.

3Covered Indications (listed)

1Compendial Indication (endometrial)

12Auth Duration (months)

Coverage Summary

Indication overview: Kisqali (ribociclib) is indicated for HR-positive, HER2-negative early-stage and advanced/metastatic breast cancer in combination with endocrine therapy, and has compendial use for ER-positive endometrial carcinoma in combination with letrozole. Coverage stance: covered_with_criteria.

Covered Indications and Authorization Criteria

Authorization may be granted when ALL of the following are met for each indication:

ALL of the following

Drug requested is ribociclib (Kisqali).
Member has no exclusions to the prescribed therapy.
Indication (ANY of the following):
- Adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence, in combination with an aromatase inhibitor.
- Treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy.
- Treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.
- Recurrent or metastatic endometrial carcinoma with estrogen receptor (ER)-positive tumors in combination with letrozole (compendial use).
For initiation of therapy for breast cancer: documentation of laboratory results confirming hormone receptor (HR) and HER2 status must be submitted.
For initiation of therapy for endometrial carcinoma: documentation of laboratory results confirming estrogen receptor (ER) status must be submitted.

Authorization Duration and Renewal

Authorization rules for initial and continued therapy:

ANY of the following

Initial/continued - recurrent or metastatic breast cancer: Initial or continued authorization for recurrent or metastatic HR-positive, HER2-negative breast cancer when used in combination with an aromatase inhibitor or fulvestrant: up to 12 months.12 months per authorization
Adjuvant - early-stage high risk: Adjuvant treatment of HR-positive, HER2-negative early-stage breast cancer at high risk of recurrence when used with an aromatase inhibitor: authorization of 12 months may be granted; continued treatment authorization may be granted until completion of 3 years of treatment or until disease recurrence or unacceptable toxicity.Up to 3 years total (authorization granted in 12-month increments)
Endometrial carcinoma (compendial): Recurrent or metastatic endometrial carcinoma with ER-positive tumors when used with letrozole: authorization of 12 months may be granted.12 months per authorization
Reauthorization criteria: Reauthorization for recurrent/metastatic breast cancer or endometrial carcinoma: authorization of 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.12 months per authorization

Surface thresholds

Ki-67 threshold>= 20%

Adjuvant treatment - total durationUp to 3 years total

Authorization increment (typical)12 months per authorization

Adjuvant treatment - reauthorization conditionContinued authorization granted in 12-month increments until completion of 3 years, disease recurrence, or unacceptable toxicity

Not Medically Necessary / Experimental

All other indications not listed above are considered:

Experimental/investigational and not medically necessary.

Denial Risk

Not covered if indication not listed

Requests for indications other than the listed FDA-approved or compendial uses (breast cancer, endometrial carcinoma) are considered experimental/investigational and may be denied.

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Submission of prior authorization with required laboratory documentation (HR and HER2 status for breast cancer; ER status for endometrial carcinoma) is necessary to initiate review.

Documentation Required

Document tumor receptor status

For breast cancer starts: provide laboratory results confirming hormone receptor (HR) and HER2 status. For endometrial carcinoma starts: provide laboratory results confirming estrogen receptor (ER) status.

Billing Rule

Authorization duration

Initial and reauthorization approvals are generally granted for up to 12 months. Adjuvant therapy may be authorized in 12-month increments up to a total of 3 years provided there is no disease recurrence or unacceptable toxicity.

Denial Risk

Not covered if indication not listed

Indications other than the listed FDA-approved or compendial uses (breast cancer, endometrial carcinoma) are considered experimental/investigational and not medically necessary and may be denied.

Clinical Evidence & References

References: Kisqali [package insert], Novartis; September 2024; and the NCCN Drugs & Biologics Compendium, 2025.

Evidence summary: The cited package insert and NCCN compendium support Kisqali’s FDA-approved indications for HR-positive, HER2-negative early-stage (adjuvant) and advanced/metastatic breast cancer when used with endocrine therapies, and compendial support exists for use in ER-positive endometrial carcinoma in combination with letrozole. These sources underpin the policy’s covered indications and associated authorization criteria.