CommercialPrior AuthHigh impact
Pembrolizumab Products (Keytruda and Keytruda Qlex) (CPB 0890, reviewed 2026-07-14)
Aetna·Oncology, Hematology·Medical Policy
Effective date
Jul 14, 2026
We identified it
Aug 13, 2026
Summary
Aetna has updated its clinical policy for Pembrolizumab (Keytruda and Keytruda Qlex) effective immediately, establishing comprehensive coverage criteria across multiple cancer indications with specific molecular markers (MSI-H, dMMR, TMB-H, PD-L1 status). The policy mandates precertification for all uses and applies site-of-care utilization management. Key exclusions include pediatric patients with TMB-H CNS cancers and members with prior PD-1/PD-L1 inhibitor progression (with limited exceptions).
Action Required
Immediately effective (2026-07-14): (1) Billing team must update prior authorization workflows to require precertification for ALL pembrolizumab (Keytruda) and pembrolizumab/berahyaluronidase alfa-pmph (Keytruda Qlex) requests before claims submission. Contact numbers for precertification: (866) 752-7021 or fax (888) 267-3277. (2) Providers and billing staff must verify molecular tumor testing results (MSI-H, dMMR, TMB-H status, or PD-L1 expression levels with specific CPS thresholds) are documented in the medical record prior to authorization request. (3) Update encounter forms and billing software to capture and flag exclusion criteria: pediatric TMB-H CNS cancers and prior PD-1/PD-L1 inhibitor progression. (4) Implement site-of-care utilization management review per Aetna's specialty drug infusion policy before claim submission. (5) For all denials or questions, refer to Statement of Medical Necessity (SMN) precertification forms available on Aetna Specialty Pharmacy Precertification portal. Claims submitted without required precertification and molecular documentation will be denied. Oncology providers and billing staff responsible for implementation.