| Medical Drug Policy Name | Revised Criteria |
|---|---|
| Denosumab (Prolia®, Xgeva®) and Denosumab Biosimilars “Notification” (PDF) | Added new to market Prolia (denosumab) biosimilars Bildyos (denosumab-nxxp) and Bosaya (denosumab-kyqq) to policy for the same FDA approved indications as Prolia and with the same coverage criteria requirements. For Prolia, Bildyos, Bosaya, Conexxence, and Ospomyv: added additional corresponding criteria as a non-preferred denosumab product with requirement of trial and failure of both Jubbonti AND Stoboclo (preferred denosumab biosimilar products), or presence of a documented serious adverse event requiring medical intervention from both preferred denosumab biosimilar products that is not anticipated with the requested non-preferred denosumab product, with required submission of an FDA MedWatch Adverse Event Reporting Form. Added new to market Xgeva (denosumab) biosimilars Aukelso (denosumab-kyqq) and Bilprevda (denosumab-nxxp) to policy for the same FDA approved indications as Xgeva and with the same coverage criteria requirements. For Xgeva, Aukelso, Bilprevda, Bomyntra, and Xbryk: added additional corresponding criteria as a non-preferred denosumab product with requirement of trial and failure of both Osenvelt AND Wyost (preferred denosumab biosimilar products), or presence of a documented serious adverse event requiring medical intervention from both preferred denosumab biosimilar products that is not anticipated with the requested non-preferred denosumab product, with required submission of an FDA MedWatch Adverse Event Reporting Form. For Xgeva and Xgeva biosimilar products: added requirement of trial and failure of an IV bisphosphonate to multiple myeloma and solid tumor with bone metastases indications; added indication for breast cancer with bone metastases with requirement of trial and failure of an IV bisphosphonate; added indication for castration-resistant prostate cancer with bone metastases; added indication for systemic mastocytosis with requirement of trial and failure of an IV bisphosphonate. For all restricted products and indications, added requirement of no use in combination with a bisphosphonate, another form of denosumab (e.g., Prolia or Xgeva), romosozumab-aqqg, or a parathyroid hormone analog for osteoporosis. Adjusted maximum units for oncologic indications according to FDA labeled dosing. Consolidated FDA label reference table for clarity. Other minor formatting adjustments made throughout policy for clarity. Policy notification given 10/1/2025 for effective date 1/1/2026. |
| Preferred Injectable Oncology Program “Notification” (PDF) | Changed requirement for trial and failure of preferred rituximab biosimilar products to include Riabni in addition to existing preferred Ruxience and Truxima; adjusted non-preferred rituximab products to include Rituxan and Rituxan Hycela. Removed Riabni (Q5123) from restricted products within this policy (unrestricted for oncologic indications). Changed requirement for trial and failure of preferred trastuzumab biosimilar products to include Ogivri and Ontruzant in addition to existing preferred Trazimera; adjusted non-preferred trastuzumab biosimilar products to include Hercessi, Herzuma, and Kanjinti. Added Kanjinti (Q5117) to restricted products; removed Ogivri (Q5114) and Ontruzant (Q5112) from restricted products (unrestricted). Other minor formatting adjustments made throughout policy for clarity. Policy notification given 10/1/2025 for effective date 1/1/2026. |
| White Blood Cell Growth Factors “Notification” (PDF) | Changed requirement for trial and failure of preferred pegfilgrastim biosimilar products to include Fylnetra in addition to existing preferred Fulphila; adjusted non-preferred pegfilgrastim biosimilar products to include Nyvepria, Stimufend, Udenyca/Udenyca Onbody and Ziextenzo. Added Nyvepria (pegfilgrastim-apgf) to restricted products; removed Fylnetra (pegfilgrastim-pbbk) from restricted products (now unrestricted). Policy notification given 10/1/2025 for effective date 1/1/2026. |
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