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CommercialPrior AuthMedium impact

Penpulimab-kcqx (CPB 1080, reviewed 2026-04-15)

Aetna·Oncology, Hematology·Medical Policy
Effective date
Apr 15, 2026
We identified it
Aug 13, 2026
Days to comply

Summary

Aetna has established new coverage criteria for penpulimab-kcqx (CPB 1080), a PD-1 blocking antibody approved for nasopharyngeal carcinoma and appendiceal neoplasms. Precertification is now required for all claims, with specific dosing protocols (200 mg IV every 3 weeks or every 2 weeks depending on indication) and a maximum 24-month treatment duration. Patients with prior disease progression on PD-1/PD-L1 inhibitors are excluded from coverage.

Action Required

Action needed
Immediately upon implementation (by 2026-04-15): (1) Billing team must configure system to require precertification for all penpulimab-kcqx claims submitted to Aetna commercial plans before claims are processed—contact (866) 752-7021 or fax (888) 267-3277 for prior authorization; (2) Update encounter forms and templates to indicate that penpulimab-kcqx requires Statement of Medical Necessity (SMN) precertification forms (available through Specialty Pharmacy Precertification); (3) Providers must document one of the approved indications: NPC non-keratinizing (first-line combination therapy OR single-agent post-platinum progression) OR appendiceal neoplasm with dMMR/MSI-H or POLE/POLD1 mutation; (4) Coding/billing staff must verify patient does NOT have prior disease progression on PD-1/PD-L1 inhibitors before submission—such patients are excluded; (5) Ensure claims include appropriate site of care documentation per Utilization Management Policy on Site of Care for Specialty Drug Infusions; (6) Program system to deny or request reauthorization after 24 months of cumulative therapy. Failure to obtain precertification will result in claim denials.

Affected Billing Codes

96413
96414
96415
J9045
J9060
J9184
J9196
J9198
J9201
J9263
C11.0
C11.1
C11.2
C11.3
C11.8
C11.9
C18.1