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Pembrolizumab products (Keytruda, Keytruda Qlex) (Revised)
Act
by Jan 1, 2025
Effective date
Jan 1, 2025
Identified
Aug 27, 2026
Summary
Humana revised its Pembrolizumab (Keytruda, Keytruda Qlex) pharmacy coverage policy effective January 1, 2025, with updates through August 26, 2026. The policy clarifies prior authorization requirements for 26 cancer indications across Medicare and three state Medicaid programs (Florida, Kentucky, South Carolina), specifying detailed clinical criteria, required biomarkers, combination therapy requirements, and treatment sequencing. Key exclusion: patients with disease progression on prior anti-PD-1/PD-L1 therapy will not be approved.
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What to do
by Jan 1, 2025 · 6 steps
01Billing and clinical teams must implement prior authorization requirements for all Pembrolizumab claims.
02Update billing software to flag all J9271 (Keytruda IV) and J9228 (Keytruda Qlex) claims for Humana Medicare Advantage, Florida Medicaid, Kentucky Medicaid, and South Carolina Medicaid requiring prior auth submission.
03Providers must document: (1) specific cancer diagnosis matching one of 26 approved indications, (2) required biomarker testing results (CPS score, PD-L1 status, MSI-H/dMMR status, TMB-H status as applicable to indication), (3) treatment regimen (monotherapy vs. combination with specific chemotherapy agents), (4) disease stage/status (advanced, metastatic, recurrent, locally advanced, adjuvant, neoadjuvant as required), and (5) confirmation member has NOT progressed on prior anti-PD-1/PD-L1 therapy.
04Add prior auth checklist to EMR templates for oncology encounters.
05Failure to obtain prior auth before claim submission will result in claim denials.
06Route all initial requests through Humana's pharmacy prior authorization portal with supporting clinical documentation and biomarker results.
Codes mentioned
J9271J9228
Original notice
Pembrolizumab products (Keytruda, Keytruda Qlex) (Revised)
mcp.humana.com · Always check the source before changing claims.
Related changes
See all Humana changes →Pembrolizumab products (Keytruda, Keytruda Qlex) (Revised)HighEffective Jan 1, 2025 · MedicaidPembrolizumab products (Keytruda, Keytruda Qlex) (New)HighEffective Nov 1, 2026 · MedicaidPembrolizumab products (Keytruda, Keytruda Qlex) (New)HighEffective Nov 1, 2026 · MedicaidPembrolizumab products (Keytruda, Keytruda Qlex) (New)HighEffective Nov 1, 2026 · MedicaidBrowse every Humana change in the policy list