Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Sacituzumab govitecan (Trodelvy) may be considered medically necessary in individuals 18 years of age and older for the following conditions:
Food and Drug Administration (FDA) Indications
Metastatic Triple-Negative Breast Cancer (mTNBC)
- As treatment for mTNBC in individuals who have received at least two prior therapies for metastatic disease; or
Bladder Cancer
- As a treatment for 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 (PDL1) inhibitor; or
National Comprehensive Cancer Network (NCCN) Recommendations
Metastatic Triple-Negative Breast Cancer (mTNBC)
- As treatment of recurrent or stage IV (M1) triple-negative disease in individuals who have received at least 2 prior therapies for metastatic disease.
Bladder Cancer
- Used as subsequent-line systemic therapy as a single agent for individuals who received first-line platinum-containing chemotherapy followed by avelumab maintenance therapy for ANY of the following:
- Cystectomy candidates with stage II (cT2, N0) or stage IIIA (cT3, N0; cT4a, N0; cT1-T4a, N1) disease if tumor is present following reassessment of tumor status 2-3 months after primary treatment with bladder preserving concurrent chemoradiotherapy; or
- Stage IIIB (cT1-T4a, N2,3) disease following partial response or progression after primary treatment with downstaging systemic therapy or concurrent chemoradiotherapy; or
- Stage IVA (cT4b, any N, M0) disease if tumor is present following reassessment of tumor status after primary treatment with first-line systemic therapy or concurrent chemoradiotherapy; or
- Stage IVA (any T, any N, M1a) disease if stable disease or progression following reassessment of tumor status after primary treatment with first-line systemic therapy; or
- Metastatic stage IVB (any T, any N, M1b) disease; or
- Muscle invasive local recurrence or persistent disease in a preserved bladder; or
- Metastatic or local recurrence post cystectomy; or
- Therapy for metastatic disease as a single agent for subsequent-line systemic therapy for individuals who received a first-line platinum-containing chemotherapy followed by avelumab maintenance therapy for ANY of the following:
- Upper genitourinary tract tumors; or
- Urothelial carcinoma of the prostate; or
- Used as a single agent for recurrent or metastatic disease as subsequent-line systemic therapy for individuals with primary carcinoma of the urethra who received a first-line platinum-containing chemotherapy followed by avelumab maintenance therapy.
Sacituzumab govitecan (Trodelvy) is considered experimental/investigational for all other indications. Scientific evidence does not support its use for any other indications not listed above.
Procedure Codes
