Xgeva® (denosumab) and biosimiliars (Revised)

By January 1, 2026 (or immediately if already past this date): (1) Billing team must update prior authorization system to enforce step-therapy requirements for all seven denosumab products (Xgeva, Wyost, Osenvelt, Bomyntra, Bilprevda, Xtrenbo, Aukelso) across four indications: hypercalcemia of malignancy, osteolytic bone metastases, multiple myeloma, and giant cell tumor of bone. (2) For Medicare Osenvelt/Bomyntra/Bilprevda/Xtrenbo/Aukelso requests, system must require evidence of prior treatment with or intolerance to Xgeva or Wyost before approval. (3) For Medicare Part B requests only: Configure system to bypass step-therapy requirements if prior therapy with these products occurred within the past 365 days (do NOT apply exemption to Medicare Part D, Individual PDP, or Group PDP members). (4) For hypercalcemia and multiple myeloma indications, system must document albumin-corrected calcium >12.5 mg/dL and prior zoledronic acid therapy/intolerance/contraindication before approval. (5) For breast cancer and prostate cancer with bone metastases: Remove zoledronic acid step-therapy requirement (approved without prior zoledronic acid exposure). (6) For all indications: Add rejection logic to deny claims with concurrent bisphosphonate therapy (zoledronic acid). (7) Providers and front desk staff must be notified to collect documentation of prior denosumab therapy, albumin-corrected calcium levels, and bisphosphonate history on encounter forms. Failure to implement step-therapy requirements will result in claim denials for non-Medicare or Medicare Part D beneficiaries, and potential approval delays.