Pharmacy Prior Authorization Criteria

Talzenna (talazoparib) - PA, NF

Indications for Prior Authorization

Talzenna (talazoparib)

• For diagnosis of Breast Cancer
  Indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.

• For diagnosis of HRR Gene-mutated mCRPC
  Indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

Criteria

Talzenna

Prior Authorization (Initial Authorization)

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

• Diagnosis of breast cancer
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to Lynparza
OR
• For continuation of prior therapy

Talzenna

Prior Authorization (Initial Authorization)

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

• Diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
AND
• Presence of homologous recombination repair (HRR) gene mutation 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)
AND
• Taken in combination with Xtandi (enzalutamide)

Talzenna

Prior Authorization (Reauthorization)

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

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

Talzenna

Non Formulary

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

• Diagnosis of breast cancer
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to Lynparza
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy

P & T Revisions

2024-09-20, 2023-09-21, 2023-08-01, 2023-06-22, 2023-06-08, 2023-03-03, 2023-02-02, 2022-08-02, 2022-03-04, 2021-10-04, 2020-10-23, 2019-10-31

References

1. Talzenna Prescribing Information. Pfizer Labs. New York, NY. March 2024
2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Breast Cancer. v4.2024. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed September 16, 2024.

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Revision History

• 2024-09-20: 2024 Annual Review. Revised verbiage and added requirement for genetic testing 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)
• 2023-09-21: 2023 UM Annual Review. No changes
• 2023-08-01: New indication for Talzenna for prostate cancer
• 2023-06-22: Removed oncology specialist requirement
• 2023-06-08: Program update to remove disease descriptions, BRCA mutation confirmation, and HER-2 status criterion.
• 2023-03-03: Program update.
• 2023-02-02: Update to extend the effective date of policy GL-109649 through end of march 2023
• 2022-08-02: Addition of NF criteria and embedded-step requirement
• 2022-03-04: GPI update to include new strengths
• 2021-10-04: 2021 UM Annual Review.
• 2020-10-23: UM Annual Review.
• 2019-10-31: 2019 Annual Review - SL - 10.29.19

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