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.

• For diagnosis of Urothelial Cancer
  Indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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 (Initial Authorization)

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

• Diagnosis of urothelial cancer
AND
• Disease is one of the following:
• Locally advanced
• Metastatic
AND
• Patient has previously received both of the following:
• Platinum-containing chemotherapy (e.g., cisplatin, carboplatin)
AND
• One of the following:
• Programmed death receptor-1 (PD-1) inhibitor [e.g., Keytruda (pembrolizumab)]
• Programmed death-ligand 1 (PD-L1) inhibitor [e.g., Bavencio (avelumab)]

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

2024-06-05, 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. February 2023.
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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Revision History

• 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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