Pharmacy Prior Authorization Criteria

Trodelvy (sacituzumab govitecan-hziy)

Indications for Prior Authorization

Trodelvy (sacituzumab govitecan-hziy)

• For diagnosis of Breast Cancer
  Indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

• For diagnosis of Breast Cancer
  Indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Criteria

Trodelvy

Prior Authorization (Initial Authorization)

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

• Diagnosis of triple negative breast cancer (TNBC) [A]
AND
• Disease is one of the following:
• Unresectable locally advanced
• Metastatic
AND
• Patient has received at least two prior therapies for at least one of which is for metastatic disease (e.g., chemotherapy with or without programmed cell death protein-1 (PD-1) inhibitor [e.g., Keytruda (pembrolizumab)], neoadjuvant/adjuvant therapy, poly-ADP ribose polymerase (PARP) inhibitor [e.g., Olaparib, talazoparib], etc.) [1-3]

Trodelvy

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 one of the following:
• Unresectable locally advanced
• Metastatic
AND
• Disease is hormone-receptor (HR) - positive
AND
• Disease is human epidermal growth factor receptor 2 (HER2) - negative
AND
• Both of the following:
• Patient has received endocrine-based therapy (e.g., tamoxifen, aromatase inhibitors [e.g., Aromasin (exemestane), Femara (letrozole), Arimidex (anastrozole)], fulvestrant)
AND
• Patient has received at least two additional systemic therapies in the metastatic setting (e.g., chemotherapy, poly-ADP ribose polymerase (PARP) inhibitor [e.g., olaparib, talazoparib], fam-trastuzumab deruxtecan-nxki) [B, 3]

Trodelvy

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

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

P & T Revisions

2024-12-04, 2024-06-05, 2023-06-26, 2023-06-14, 2023-04-13, 2022-06-16, 2021-06-02, 2021-04-09, 2020-06-04

References

1. Trodelvy Prescribing Information. Immunomedics, Inc. Morris Plains, NJ. November 2024.
2. Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer. N Engl Med. 2019;380:741-51.
3. The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed March 23, 2023.

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End Notes

1. Triple-negative breast cancer is defined by a lack of tumor-cell expression of the estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2). [2]
2. Adjuvant or neoadjuvant therapy for early-stage disease will qualify as one of the required prior regimens if the development of unresectable, locally advanced or metastatic disease occurred within 12 months of adjuvant therapy. [1]

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Revision History

• 2024-12-04: Removed urothelial cancer indication
• 2024-06-05: 2024 Annual Review - no changes
• 2023-06-26: Removed specialist requirement
• 2023-06-14: 2023 Annual Review - updated chemo examples for triple negative breast cancer indication
• 2023-04-13: Update to add new FDA indication
• 2022-06-16: 2022 Annual Review. No changes
• 2021-06-02: Annual review: Updated criteria.
• 2021-04-09: Updated GPIs
• 2020-06-04: New program.

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