CommercialPrior AuthMedium impact
Margetuximab-cmkb (Margenza) (CPB 0985, reviewed 2026-05-27)
Aetna·Oncology·Medical Policy
Effective date
May 27, 2026
We identified it
Aug 16, 2026
Summary
Aetna has updated its clinical policy for Margetuximab-cmkb (Margenza), a HER2-positive breast cancer treatment, effective immediately. The policy establishes coverage criteria requiring precertification for all uses, limits approval to patients with metastatic or unresectable HER2-positive breast cancer who have failed two or more prior anti-HER2 regimens, and specifies dosing at 15 mg/kg IV every 3 weeks. Billing teams must implement mandatory prior authorization requirements and ensure claims are submitted only for qualifying diagnoses.
Action Required
Immediately: Billing team must implement mandatory precertification for Margetuximab-cmkb (Margenza) claims. Update billing system to require prior authorization before claim submission through Aetna at (866) 752-7021 or fax (888) 267-3277. Configure system to enforce coverage criteria: claims only approved for HER2-positive breast cancer patients with either (1) no response to preoperative systemic therapy OR (2) recurrent/unresectable/metastatic disease, AND who have received two or more prior anti-HER2 regimens. Reject claims that do not meet these criteria or lack precertification authorization. Update provider encounter forms to include documentation of prior anti-HER2 treatment regimens (must show ≥2 prior regimens). Train oncology and billing staff on new authorization process and clinical criteria. Update denial management protocols to indicate 'precertification not obtained' for any claims submitted without prior authorization. Failure to obtain precertification will result in claim denials per Aetna policy requirements.