Imfinzi (durvalumab) (Revised)

REQUIREMENTS: By January 1, 2025 or immediately if already in effect: (1) Billing team must implement prior authorization process for HCPCS code J9173 (Imfinzi/durvalumab) across all applicable plan lines: Medicare, Florida Medicaid, Kentucky Medicaid, and South Carolina Medicaid. (2) Update billing software and prior auth submission system to enforce Imfinzi coverage criteria by indication: verify diagnosis matches one of nine approved cancer types; confirm appropriate combination therapy regimen per indication (e.g., gemcitabine + cisplatin for biliary tract, carboplatin + paclitaxel for endometrial, FLOT for gastric); confirm no prior anti-PD-1/PD-L1 therapy disease progression (applies to most indications except perioperative NSCLC which has different exclusions). (3) For NSCLC (metastatic) on Medicare Part B only: add step therapy requirement to verify Libtayo (cemiplimab-rwlc) cannot be used OR document medical reason why prior agent cannot be used; exception: do not require step therapy if continuation of prior therapy within past 365 days. (4) Create prior auth request templates for clinical team specifying required documentation: cancer diagnosis confirmation, stage/resectability status, prior treatment history (especially prior checkpoint inhibitor exposure), intended combination therapy regimen. (5) Configure system to set initial approval duration at 6 months with requirement for renewal submission at 6-month intervals. (6) Train billing, clinical, and authorization staff on nine distinct indication-specific criteria sets. (7) Add denial reason tracking for claims submitted without prior authorization or failing to meet specific indication criteria. CONSEQUENCES: Claims for Imfinzi without prior authorization or not meeting specified criteria will be denied; incorrect combination therapy coding will trigger claim rejections.