CommercialPrior AuthHigh impact
Ado-trastuzumab Emtansine (Kadcyla) (CPB 0974, reviewed 2026-01-21)
Aetna·Oncology, Hematology·Medical Policy
Effective date
Jan 21, 2026
We identified it
Aug 17, 2026
Summary
Aetna updated its Clinical Policy Bulletin (CPB 0974) for Ado-trastuzumab Emtansine (Kadcyla), effective immediately (reviewed 2026-01-21). This policy establishes coverage criteria for HER2-positive breast cancer, non-small cell lung cancer with HER2 mutations, and salivary gland tumors, while requiring precertification for all uses. Billing teams must implement prior authorization procedures and ensure claims are coded correctly for covered indications only.
Action Required
IMMEDIATELY: Billing team must implement mandatory precertification process for all Kadcyla claims. (1) Update billing system to flag CPT code 96401-96450 (chemotherapy administration) and HCPCS code J9354 (ado-trastuzumab emtansine) as requiring prior authorization before claim submission. (2) Route all precertification requests through Aetna at phone (866) 752-7021 or fax (888) 267-3277 using Statement of Medical Necessity (SMN) forms from Specialty Pharmacy Precertification. (3) Verify claims are coded ONLY for approved indications: HER2-positive metastatic/recurrent breast cancer (C50.011-C50.929), HER2-positive early breast cancer with residual disease (C50.A0-C50.A2), HER2-positive breast cancer with brain metastases (C79.31), HER2 mutations in non-small cell lung cancer (C34.00-C34.92), or HER2-positive salivary gland tumors (C07, C08.0-C08.9). (4) DENY or request resubmission for non-covered indications including HER2-negative breast cancer, gastric cancer (C16.0-C16.9), colorectal cancer (C18.0-C20), hepatobiliary cancers (C22.0-C22.9, C23, C24.0). (5) Providers must verify Site of Care policy applies; confirm infusion location is approved. (6) Monitor dosing limits per FDA-approved labeling (max 3.6 mg/kg every 3 weeks) in billing validation. Claims submitted without prior authorization will be denied.