Pharmacy Prior Authorization Criteria

Ibrance (palbociclib)

Indications for Prior Authorization

Ibrance (palbociclib)

• For diagnosis of Breast Cancer
  Indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: (1) an aromatase inhibitor as initial endocrine based therapy, or (2) fulvestrant in patients with disease progression following endocrine therapy.

• For diagnosis of Breast Cancer
  Indicated in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

Criteria

Ibrance

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of PIK3CA-mutated, HR-positive, HER2-negative Breast Cancer

• Diagnosis of breast cancer
AND
• Disease is both of the following:
• Hormone receptor (HR) positive
• Human epidermal growth factor receptor 2 (HER2)-negative
AND
• Disease is confirmed by the presence of a PIK3CA mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Disease is one of the following:
• Locally Advanced
• Metastatic
AND
• Used following recurrence on or after completing adjuvant endocrine therapy (e.g. Zoladex [goserelin], Arimidex [anastrozole], Nolvadex [tamoxifen])
AND
• Used in combination with both of the following:
• Itovebi (inavolisib)
• Fulvestrant

Ibrance

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of HR-positive, HER2-negative Breast Cancer

• Diagnosis of breast cancer
AND
• Disease is both of the following:
• Hormone receptor (HR) positive
• Human epidermal growth factor receptor 2 (HER2)-negative
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to both of the following:
• Kisqali (ribociclib)
• Verzenio (abemaciclib)
OR
• For continuation of prior therapy

Ibrance

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications

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

P & T Revisions

1970-01-01, 2024-03-27, 2023-08-03, 2023-06-22, 2023-06-05, 2023-04-11, 2023-03-01, 2022-05-06, 2021-09-27, 2021-05-10, 2020-04-29

References

1. Ibrance Prescribing Information. Pfizer Inc. New York, NY. April 2025.
2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Breast Cancer. v.4.2025. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf Accessed May 6, 2025.

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Revision History

• 2024-03-27: 2024 Annual Review
• 2023-08-03: Addition of a step through Kisqali and Verzenio
• 2023-06-22: Removed oncology specialist requirement
• 2023-06-05: Program update to remove clinical criterion and leave diagnosis and prescriber requirements.
• 2023-04-11: 2023 Annual Review.
• 2023-03-01: Updated criteria to align with FDA labeling for new indication
• 2022-05-06: 2022 Annual Review- no changes
• 2021-09-27: 2021 UM Annual Review.
• 2021-05-10: 2021 UM Annual Review.
• 2020-04-29: New tablet formulation now available, approved for the same indications as the capsule. Added tablets to existing Ibrance PA

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