CommercialPrior AuthHigh impact
Sacituzumab Govitecan-hziy (Trodelvy) (CPB 0971, reviewed 2026-04-24)
Aetna·Oncology, Hematology, Internal Medicine·Medical Policy
Effective date
Apr 24, 2026
We identified it
Aug 16, 2026
Summary
Aetna has updated its clinical policy for Sacituzumab Govitecan-hziy (Trodelvy, CPB 0971), effective April 24, 2026. The policy establishes coverage criteria for HER2-negative breast cancer, urothelial carcinoma (bladder, urethra, upper GU tract, and prostate), and requires mandatory precertification for all uses. Billing teams must implement precertification workflows and ensure claims comply with specific treatment line and prior therapy requirements.
Action Required
IMMEDIATELY: Billing team must implement mandatory precertification for all J9317 (Sacituzumab Govitecan-hziy) claims submitted to Aetna commercial plans. Establish precertification submission process: contact (866) 752-7021 or fax (888) 267-3277 with Statement of Medical Necessity (SMN) forms obtained from Specialty Pharmacy Precertification portal before claim submission. Update billing system to: (1) flag all J9317 claims requiring prior auth before adjudication; (2) verify patient meets coverage criteria per diagnosis code (C50.011-C50.929 for breast cancer, C67.0-C67.9 for bladder, C68.0-C68.9 for ureteral/urethral cancers); (3) confirm prior treatment requirements are documented (for HR-positive breast cancer: endocrine therapy + CDK4/6 inhibitor + ≥2 chemotherapy lines; for urothelial cancers: platinum chemotherapy + PD-1/PD-L1 inhibitor). Update encounter templates and provider communication to include treatment history verification. Include chemotherapy administration codes 96413-96416 in precertification review to ensure dosing compliance with FDA labeling (10 mg/kg weekly on Days 1 and 8 of 21-day cycles). Failure to obtain precertification will result in claim denial.