CurrentCignaPolicy N/A

Oncology - Kisqali and Kisqali Femara Co-Pack Prior Authorization Policy

Cigna prior authorization policy defining medical necessity criteria, approval durations, and covered indications for Kisqali (ribociclib) and Kisqali Femara Co-Pack (ribociclib + letrozole) across FDA-approved and selected evidence-supported uses (early breast cancer adjuvant, recurrent/metastatic breast cancer in women and men, and endometrial cancer).

Policy Summary

PayerCigna

PolicyOncology - Kisqali and Kisqali Femara Co-Pack Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified / Added (non-material and material)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended/required for Kisqali and Kisqali Femara Co-Pack; document menopausal status and ovarian suppression/GnRH use as specified for indicated combinations and durations.

POLICY UPDATE CHANGES

Requirement that patient is receiving a GnRH analog was changed to only apply if Kisqali is used in combination with anastrozole, exemestane, or letrozole.

Endometrial cancer indication (Kisqali + letrozole) was added as 'Other Uses with Supportive Evidence'.

Early breast cancer (adjuvant) indication added with 3-year approval duration.

4Covered Indications (per product)

3Approval duration (early breast cancer, years)

1Approval duration (recurrent/metastatic & endometrial, years)

Coverage Summary & Indications

This policy is a Cigna prior authorization policy for Kisqali (ribociclib) and Kisqali Femara Co-Pack (ribociclib + letrozole). It defines medical necessity criteria and approval durations for FDA-approved and selected evidence-supported uses, including: early (adjuvant) high-risk breast cancer, recurrent/metastatic HR+, HER2-negative breast cancer in women and men, and endometrial cancer listed as an other use with supportive evidence. The overall coverage stance is covered_with_criteria.

Kisqali - FDA-Approved Indications

Coverage of Kisqali is considered medically necessary when ONE of the following 1-4 is met:

ref': 'b0_1

title": "Kisqali - FDA-Approved Indications"}

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Conditions Not Covered

Excluded uses

Conditions Not Covered: Kisqali and Kisqali Femara Co-Pack are considered experimental, investigational or unproven for ANY other use(s) not listed above

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for prescription benefit coverage of Kisqali and Kisqali Femara Co-Pack. Approvals align with the indicated durations by indication: 3 years total for early (adjuvant) high-risk breast cancer; 1 year for recurrent/metastatic disease and for endometrial cancer when specified therapy combinations are used.

Early (adjuvant) breast cancer (high risk): Approve for 3 years (total).
Recurrent or metastatic breast cancer (women and men): Approve for 1 year.
Endometrial cancer (ER-positive, Kisqali + letrozole): Approve for 1 year.

Documentation Required

Documentation of menopausal status and GnRH use

For pre/perimenopausal women and for men where applicable, document ovarian suppression/ablation or use of a GnRH agonist/analog as specified by indication and combination therapy (e.g., when Kisqali is used with an aromatase inhibitor or in some male indications).

Applicable Codes

No specific procedure/drug billing codes listedmixed

No codes listed

Evidence & Guidelines

Key evidence sources include the Novartis Kisqali and Kisqali Femara Co-Pack prescribing information (September 2024) and NCCN guidelines: Breast Cancer (v1.2025) and Uterine Neoplasms (v2.2025). NCCN lists Kisqali combinations with aromatase inhibitors or fulvestrant as preferred regimens in relevant HR+, HER2-negative settings and supports adjuvant use of Kisqali + AI for 3 years in certain high-risk early breast cancers.

Background & Definitions

Background: Kisqali is a CDK4/6 inhibitor indicated for HR+, HER2-negative breast cancer when used in combination with an aromatase inhibitor or with fulvestrant. The Kisqali Femara Co-Pack includes letrozole (an aromatase inhibitor). NCCN guidance aligns with these uses, listing Kisqali combinations as preferred regimens in applicable recurrent/metastatic and adjuvant settings.

Term	Definition
High risk of recurrence
{"text":"Any lymph node involvement; tumor size > 5 cm; or tumor size 2-5 cm with either grade 2 (and high genomic risk or Ki67 64; 20%) or grade 3","status":""}
GnRH agonist/analog (examples)
Examples include leuprolide acetate (Lupron Depot), triptorelin (Trelstar), goserelin (Zoladex), degarelix (Firmagon), relugolix (Orgovyx)
Specified gender
Woman = individual with biological traits of a woman; Man = individual with biological traits of a man, regardless of gender identity or expression

Policy Revisions

2025-02-26clarificationLatest

Clarified that the requirement for the patient to be receiving a gonadotropin-releasing hormone (GnRH) analog applies only when Kisqali is used in combination with anastrozole, exemestane, or letrozole; moved related qualifiers into the Early and Recurrent/Metastatic sections as appropriate.

2024-10-16added

Added Early Breast Cancer (adjuvant) condition of approval for Kisqali with a total approval duration of 3 years; moved adjuvant-specific qualifiers into the Breast Cancer - Early condition and removed 'according to the prescriber' wording from the qualifier.

2023-02-22added

Quick Reference: Eligibility & Approval Durations

Thresholds

Age≥ 18 years

Approval duration for Early Breast Cancer3 years (total)

Approval duration for Recurrent/Metastatic and Endometrial1 year

High risk of recurrence - tumor size and grade criteriaany lymph node involvement; tumor size > 5 cm; or tumor size 2-5 cm with either grade 2 (and high genomic risk or Ki67 ≥ 20%) or grade 3