Pharmacy Prior Authorization Criteria

Kisqali (ribociclib), Kisqali Femara Co-Pack (letrozole and ribociclib)

Indications for Prior Authorization

Kisqali (ribociclib)

• For diagnosis of Advanced or Metastatic Breast cancer
  Indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic cancer in combination with one of the following: (1) an aromatase inhibitor as initial endocrine-based therapy, (2) fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.

• For diagnosis of Early Breast Cancer
  Indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR) – positive, human epiderma growth factor receptor 2 (HER2) – negative stage II and III early breast cancer at high risk of recurrence.

Kisqali Femara Co-Pack (letrozole and ribociclib)

• For diagnosis of Advanced or Metastatic Breast cancer
  Indicated as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

• For diagnosis of Early Breast Cancer
  Indicated for the adjuvant treatment of adults with hormone receptor (HR) – positive, human epidermal growth factor receptor 2 (HER2) – negative stage II or III early breast cancer at high risk of recurrence.

Criteria

Kisqali, Kisqali Femara Co-Pack

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of breast cancer

Kisqali, Kisqali Femara Co-Pack

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2024-11-05, 2024-09-04, 2023-08-22, 2023-06-05, 2023-06-05, 2022-08-31, 2022-02-22, 2021-08-17, 2020-07-29, 2019-09-18

References

1. Kisqali prescribing information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. September 2024..
2. Kisqali Femara Co-Pack prescribing information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. September 2024.

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Revision History

• 2024-11-05: Updated background and references
• 2024-09-04: 2024 Annual Review - updated background and references
• 2023-08-22: 2023 UM Annual Review. No criteria changes. Updated references
• 2023-06-05: Removed prescriber requirement.
• 2023-06-05: Program update to remove clinical criteria and leave diagnosis and prescriber requirement.
• 2022-08-31: 2022 Annual Review - no criteria changes
• 2022-02-22: Updated criteria to include expanded indication
• 2021-08-17: 2021 UM Annual Review.
• 2020-07-29: 2020 UM Annual Review.
• 2019-09-18: 2019 Annual Review. Updated criteria per PI.

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