Pharmacy Prior Authorization Criteria

Itovebi (inavolisib)

Indications for Prior Authorization

Itovebi (inavolisib)

• For diagnosis of Breast Cancer
  Indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (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

Itovebi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Breast Cancer

• Diagnosis of breast cancer
AND
• Disease is one of the following:
• Locally advanced
• Metastatic
AND
• Disease is all of the following (as detected by a U.S. Food and Drug Administration [FDA]-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments [CLIA]):
• PIK3CA-mutated
• Hormone receptor (HR)-positive
• Human epidermal growth-factor receptor 2 (HER2)-negative
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:
• Ibrance (Palbociclib)
• Fulvestrant

Itovebi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Breast Cancer

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

P & T Revisions

2025-01-15

References

1. Itovebi Prescribing Information. Genentech USA, Inc. South San Francisco, CA 94080-4990. October 2024.
2. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Breast Cancer. V6.2024. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf Accessed November 29, 2024

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Revision History

• 2025-01-15: New program

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