CurrentCentenePolicy CP.PHAR.334

Ribociclib (Kisqali), Ribociclib/Letrozole (Kisqali Femara)

Defines medical necessity criteria, initial and continuation approval rules, dosing limits, product availability, and coverage exclusions for ribociclib (Kisqali) and the co-pack ribociclib/letrozole (Kisqali Femara) for Commercial, HIM, and Medicaid lines of business affiliated with Centene.

Policy Summary

PayerCentene

PolicyRibociclib (Kisqali), Ribociclib/Letrozole (Kisqali Femara)

Policy CodePolicy CP.PHAR.334

Change TypeMaterial updates and clarifications (indications, dosing, duration)

Effective Date05.01.17

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added requirement that Kisqali in combination with an aromatase inhibitor should be for initial endocrine-based therapy per FDA/NCCN and added ovarian ablation/suppression requirement for premenopausal women.

Added criteria for endometrial carcinoma as an off-label indication supported by NCCN compendium and guidelines.

Updated FDA approved indication for Kisqali with fulvestrant to 'adults' (population expansion).

Clarified maximum dosing for Kisqali and Kisqali Femara separating dosing into initial and continued therapy sections.

Extended approval duration from 6 months to 12 months for HIM and Medicaid (4Q2025 annual review).

2FDA-approved indications (breast cancer categories)

1Off-label supported indication (endometrial carcinoma)

12Medicaid/HIM approval duration (months)

12Commercial approval duration

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines medical necessity criteria, initial and continuation approval rules, dosing limits, product availability, and coverage exclusions for ribociclib (Kisqali) and the co-pack ribociclib/letrozole (Kisqali Femara) for Commercial, HIM, and Medicaid lines of business. Policy status: CURRENT. Subject: Ribociclib (Kisqali) and Ribociclib/Letrozole (Kisqali Femara).

High-level approved indications: FDA-approved for adults with HR-positive, HER2-negative disease as: (1) adjuvant treatment for stage II and III early breast cancer at high risk of recurrence; (2) initial endocrine-based therapy for advanced or metastatic breast cancer; and Kisqali additionally is indicated in combination with fulvestrant for adults with HR-positive, HER2-negative advanced or metastatic breast cancer (initial endocrine-based therapy or following progression after endocrine therapy). The policy also includes a select NCCN-supported off-label indication: endometrial carcinoma (ER-positive) in combination with letrozole under specified criteria.

Context / stats and timing: Policy reflects 2 FDA-approved breast cancer indications and 1 NCCN-supported off-label indication. Standard approval duration is 12 months for Medicaid/HIM and 12 months or duration of request for Commercial. Effective date: 2017-05-01; Last review date: 2025-11-25.

Thresholds and Approval Durations

Minimum supply before continued therapyMember has received medication for at least 21 days

Minimum Kisqali dose for continued therapyKisqali dose for breast cancer must be ≥ 200 mg/day

Maximum dose - advanced/metastaticKisqali: 600 mg/day (given 21 days of each 28-day cycle); Femara (if applicable): 2.5 mg/day

Maximum dose - early breast cancerKisqali: 400 mg/day (given 21 days of each 28-day cycle); Femara (if applicable): 2.5 mg/day

Approval duration - Medicaid/HIM12 months

Approval duration - Commercial12 months or duration of request, whichever is less

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions

Applicable Codes

Product availability (NDC not provided in policy)mixed

tablet_200mg	Ribociclib (Kisqali) tablet: 200 mg
ribociclib_200mg_letrozole_2.5mg	Ribociclib/letrozole (Kisqali Femara) tablets: 200 mg ribociclib, 2.5 mg letrozole

Provider Actions

Documentation Required

Submit supporting documentation

Submit office notes, laboratory results, or other clinical information that support the member meets all approval criteria for the requested therapy.

Office chart notes
Lab results
Other clinical documentation

Prior Authorization

Prescriber specialty requirement

Prescription must be written by or in consultation with an oncologist.

Clinical Evidence & References

References: Kisqali Prescribing Information (July 2025); Kisqali Femara Prescribing Information (July 2025); National Comprehensive Cancer Network (NCCN) Breast Cancer and Uterine Neoplasms guidelines (2025); NCCN Drugs & Biologics Compendium.

Policy alignment: This policy aligns coverage with FDA-approved indications per the Kisqali and Kisqali Femara PIs and with NCCN guidance and the NCCN Drugs & Biologics Compendium, and it includes select NCCN-supported off-label coverage (e.g., endometrial carcinoma) when prescriber-submitted evidence or guideline support is provided.

Background

Background: Ribociclib is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK 4/6) indicated in combination with endocrine therapy for adults with hormone receptor (HR)-positive, HER2-negative breast cancer, including adjuvant treatment for stage II/III early disease at high risk of recurrence and initial endocrine-based therapy for advanced or metastatic disease. Ribociclib is also indicated in combination with fulvestrant for adults with HR-positive, HER2-negative advanced or metastatic breast cancer.

The co-pack Kisqali Femara contains ribociclib with letrozole (an aromatase inhibitor). Dosing regimens and maximum doses are specified by indication (e.g., Kisqali 600 mg/day for advanced/metastatic; 400 mg/day for early breast cancer; Femara 2.5 mg/day when applicable).

Rationale and alignment: The policy aligns with FDA prescribing information and NCCN guidance and includes select NCCN-supported off-label coverage (such as ER-positive endometrial carcinoma in combination with letrozole) when criteria and supporting evidence are met. The policy also incorporates requirements such as ovarian ablation/suppression for premenopausal/perimenopausal females and prohibition of concurrent CDK4/6 inhibitor therapy.

Definitions

HRHormone receptor (estrogen receptor and/or progesterone receptor) positive

HER2Human epidermal growth factor receptor 2

NCCN

Revision History

06.30.21Material - Added requirement

10.15.24Material - Added indication/clarification

Added criteria for endometrial carcinoma as an off-label indication supported by NCCN compendium and guidelines; updated Kisqali fulvestrant indication language to reflect population expansion to 'adults'; added adjuvant indication for adults with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence.

07.03.23Non-material - Dosing clarification

Policy Summary

PayerCentene

PolicyRibociclib (Kisqali), Ribociclib/Letrozole (Kisqali Femara)

Policy CodePolicy CP.PHAR.334

Change TypeMaterial updates and clarifications (indications, dosing, duration)

Effective Date05.01.17

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

Prior Authorization

Concomitant CDK4/6 inhibitor exclusion

Do not prescribe concurrently with another CDK4/6 inhibitor (e.g., Verzenio, Ibrance); requests will be denied if concurrent CDK4/6 therapy is present.

Documentation Required

Premenopausal/perimenopausal ovarian suppression

Document ovarian ablation or ongoing ovarian suppression (e.g., LHRH agonists such as goserelin or leuprolide) when the member is a premenopausal or perimenopausal female receiving an aromatase inhibitor.

Billing Rule

Generic redirection

For brand Kisqali requests, require use of generic ribociclib if available unless contraindicated or clinically significant adverse effects are documented.

Prior Authorization

Dose limits enforcement

Prescribed dosing must not exceed the policy's stated maximums. For advanced/metastatic disease, do not exceed Kisqali 600 mg per day (for 21 days of each 28-day cycle) and Femara 2.5 mg per day if applicable. For early breast cancer, do not exceed Kisqali 400 mg per day (for 21 days of each 28-day cycle) and Femara 2.5 mg per day if applicable. Any dose increases must meet the policy's dose-limit criteria or be supported by practice guidelines or peer-reviewed literature with submitted evidence.

Advanced/metastatic maximum: Kisqali 600 mg/day (21 of 28 days); Femara 2.5 mg/day (if applicable)
Early breast cancer maximum: Kisqali 400 mg/day (21 of 28 days); Femara 2.5 mg/day (if applicable)
Dose increases must meet dose-limit criteria or have submitted guideline/literature support

National Comprehensive Cancer Network

LHRH agonistsAgents used for ovarian suppression (e.g., goserelin, leuprolide)

Clarified maximum dosing for Kisqali and Kisqali Femara by separating dosing into initial approval and continued therapy sections (explicit dosing limits for advanced/metastatic and early breast cancer).

07.10.25Material - Approval duration extensionLatest

Extended approval duration from 6 months to 12 months for HIM and Medicaid; for endometrial carcinoma initial therapy, added '12 months or duration of request, whichever is less' for Commercial.