CurrentUnitedHealthcarePolicy 2025 P 1215-11

Kisqali_Prior_Authorization_Criteria

UnitedHealthcare prior authorization/notification policy for Kisqali (ribociclib) defining initial and reauthorization clinical criteria for pediatric (<19) automatic approval, early-stage (II/III) high-risk adjuvant use, advanced/recurrent/metastatic HR-positive HER2-negative breast cancer combinations, endometrial carcinoma use with letrozole, recognition of NCCN-supported regimens, authorization durations, and additional clinical/billing rules.

Policy Summary

PayerUnitedHealthcare

PolicyKisqali_Prior_Authorization_Criteria

Policy CodePolicy 2025 P 1215-11

Change TypeRevised criteria (breastendometrial)

Effective DateAug 1, 2025

Next Review Date

Key ActionSubmit prior authorization with required documentation of diagnosis, receptor status, combination agent, and tumor/node/tumor-size/grade/genomic risk or Ki67 as applicable; authorizations are issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Updated breast cancer criteria based on NCCN recommendations (6/2025).

Added clinical criteria for endometrial carcinoma per NCCN (2/2024).

Annual review and background/reference updates (multiple prior dates).

3Covered Indications (early-stage breast; advanced/metastatic breast; endometrial carcinoma)

12 moAuthorization duration

Age <19 auto-approvePediatric processing

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Coverage Summary

Scope: UnitedHealthcare prior authorization/notification policy for Kisqali (ribociclib) covering: Early-stage (Stage II or III) breast cancer at high risk of recurrence as adjuvant therapy in combination with an aromatase inhibitor; advanced, recurrent, or metastatic HR-positive, HER2-negative breast cancer in combination with an aromatase inhibitor or with fulvestrant (Faslodex); and recurrent or metastatic ER-positive endometrial carcinoma in combination with letrozole. The policy recognizes NCCN-recommended regimens and references product labeling.

Authorization: When approved, authorizations are issued for 12 months. For members under 19 years of age, the prescription will automatically process without a coverage review (pediatric auto-approval).

Key thresholds and quick facts

Covered Indications3

Authorization duration12 months

Pediatric processingAge <19 auto-approve

Ki67 threshold≥ 20%

Tumor size rules> 5 cm; or 2-5 cm with grade/genomic risk

Early-Stage (II or III) Breast Cancer — Initial Authorization

Early-Stage (II or III) Breast Cancer at High Risk of Recurrence - Initial Authorization

Kisqali will be approved based on all of the following criteria:

ALL of the following

Diagnosis of early-stage (II or III) breast cancer at high risk of recurrence
ONE of
- Disease is node-positive
- ALL of the following
  - Disease is node-negative
  - ANY of the following

Early-Stage (II or III) Breast Cancer — Reauthorization

Early-Stage (II or III) Breast Cancer at High Risk of Recurrence - Reauthorization

Kisqali will be approved based on the following criterion:

Patient does not show evidence of progressive disease while on Kisqali therapy

Authorization will be issued for 12 months

Denial Risk

Reauthorization requirement

Reauthorization requires the absence of evidence of progressive disease while on Kisqali therapy; claims may be denied if progressive disease is documented.

Advanced, Recurrent, or Metastatic Breast Cancer — Initial Authorization

Advanced, Recurrent, or Metastatic Breast Cancer - Initial Authorization

Kisqali will be approved based on all of the following criteria:

ALL of the following

Diagnosis of advanced, recurrent, or metastatic breast cancer
Disease is hormone receptor (HR)-positive
Disease is human epidermal growth factor receptor 2 (HER2)-negative
ANY of the following
- Used in combination with an aromatase inhibitor (e.g., anastrozole, letrozole, exemestane)

Advanced, Recurrent, or Metastatic Breast Cancer — Reauthorization

Advanced, Recurrent, or Metastatic Breast Cancer - Reauthorization

Kisqali will be approved based on the following criterion:

Patient does not show evidence of progressive disease while on Kisqali therapy

Authorization will be issued for 12 months

Billing Rule

Automated approvals permitted

UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim or medication history, diagnosis codes (ICD-10), and/or automated claim logic without additional review.

Endometrial Carcinoma — Initial Authorization

Documentation Required

Clinical documentation of tumor and receptor status

Providers must document estrogen receptor (ER) status (as applicable) and the combination agent used (aromatase inhibitor, fulvestrant, or letrozole) in the medical record.

Endometrial Carcinoma — Reauthorization

Endometrial Carcinoma - Reauthorization

Kisqali will be approved based on the following criterion:

Patient does not show evidence of progressive disease while on Kisqali therapy

Authorization will be issued for 12 months

NCCN Recognition / Regimen Acceptance

NCCN Recommended Regimens

Authorization will be issued when recognized by NCCN Drugs and Biologics Compendium:

The drug has been recognized for treatment of the cancer indication by The NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2BCategory 1, 2A, or 2B

Evidence summary: Coverage decisions reference recognition by the National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium and the Kisqali product labeling. The policy specifically cites the NCCN compendium acceptance criteria and the Kisqali package insert (Novartis) September 2024 as sources supporting indications and regimen recommendations.

Applicable Codes

ICD-10 diagnostic codes referenced (general)ICD-10

No codes listed

Provider Actions / Billing Notes

Prior Authorization

Prior authorization required

UnitedHealthcare prior authorization/notification is required; members under age 19 automatically process without review. Authorizations, when approved, are issued for 12 months.

Documentation Required

Clinical documentation of tumor and receptor status

Require documentation of staging, receptor status (HR and HER2 for breast; ER for endometrial), the combination therapy agent (aromatase inhibitor, fulvestrant, or letrozole), and tumor/node/tumor-size/grade/high genomic risk or Ki67 (≥20%) as applicable.

Denial Risk

Reauthorization requirement

Reauthorization requires that the patient does not show evidence of progressive disease while on Kisqali; claims may be denied if progressive disease is documented.

Clinical Evidence & References

Background and evidence: Kisqali (ribociclib) is indicated for HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant, and as adjuvant therapy for HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence in combination with an aromatase inhibitor. The National Comprehensive Cancer Network (NCCN) recommends Kisqali similarly for recurrent unresectable or metastatic HR-positive, HER2-negative breast cancer in combination with an aromatase inhibitor or fulvestrant, and also recommends Kisqali plus letrozole for ER-positive recurrent or metastatic endometrial carcinoma. The policy references the Kisqali package insert (Novartis) September 2024 and the NCCN Drugs and Biologics Compendium acceptance criteria.

Evidence

NCCN recognitionNCCN Drugs and Biologics Compendium Category 1, 2A, or 2B accepted for authorization

Product labelingKisqali package insert (Novartis) September 2024 referenced

Definitions

Definitions: High genomic risk — Not specifically defined in the policy; documentation is required when referenced as part of the early-stage (grade 2) tumor criteria. Policy thresholds: Ki67 of ≥ 20% and tumor size criteria of > 5 cm or 2–5 cm with additional grade/genomic risk or Ki67 criteria are used in the early-stage (II/III) high-risk recurrence definition.

Revision History

6/2025materialLatest

Updated breast cancer criteria to align with NCCN recommendations and separated breast cancer into two sections.

2/2024material

Added clinical criteria for recurrent or metastatic ER-positive endometrial carcinoma in combination with letrozole per NCCN.

11/2024administrative

Policy Summary

PayerUnitedHealthcare

PolicyKisqali_Prior_Authorization_Criteria

Policy CodePolicy 2025 P 1215-11

Change TypeRevised criteria (breastendometrial)

Effective DateAug 1, 2025

Next Review Date

SourceLink

On This Page

Tumor size > 5 cm> 5 cm

ALL of the following

Grade 2 with high genomic risk or Ki67 ≥ 20% OR Grade 3Ki67 ≥ 20% or Grade 3 or high genomic risk
High genomic risk requires documentation

Disease is hormone receptor (HR)-positive

Disease is human epidermal growth factor receptor 2 (HER2)-negative

Used in combination with an aromatase inhibitor (e.g., anastrozole, letrozole, exemestane)

Documentation Required

Clinical documentation of tumor and receptor status

Providers must document diagnosis (stage II/III high-risk or advanced/recurrent/metastatic), hormone receptor (HR) and HER2 or ER receptor status as applicable, the combination therapy agent (aromatase inhibitor, fulvestrant, or letrozole), and tumor/node/tumor-size/grade/high genomic risk or Ki67 (≥20%) when applicable.

Used in combination with Faslodex (fulvestrant)

Prior Authorization

Prior authorization required

UnitedHealthcare prior authorization/notification is required for Kisqali. For members under age 19 the prescription will automatically process without a coverage review. When approved, authorization is issued for 12 months.

Billing Rule

Automated approvals permitted

Authorizations may be issued via automated processes based on prior claims/medication history, ICD-10 diagnosis codes, and/or claim logic.

Step Therapy

Step therapy / supply limits may apply

Step therapy and/or supply limits may apply to Kisqali. Providers should verify member-specific plan rules prior to prescribing or submitting claims.

Annual review with updated background and clinical criteria for a new indication; updated references.

2/2023administrative

Updated background to align with NCCN recommended use and updated references; no change to clinical criteria.

2/2022administrative

Updated background and references with no change to clinical criteria.

4/2021administrative

Annual review without change to clinical intent; updated references.

4/2020administrative

Updated background and criteria removing use in combination with tamoxifen per NCCN.

9/2019administrative

Annual review; updated background and criteria to align with NCCN recommended use in premenopausal patients and added general NCCN recommended review criteria.

9/2018administrative

Updated background and criteria to include new indication in combination with fulvestrant.

5/2018administrative

Program update (annual/background formatting) without change to clinical intent.

5/2017administrative

Original program approval following FDA approval of Kisqali (ribociclib).