Effective March 1, 2026, Premera updated coverage for multiple immune checkpoint inhibitors used in hepatobiliary and related cancers, adding new indications, clarifying regimen‑ and biomarker‑specific criteria, and applying site‑of‑service review designations. Key additions include durvalumab (Imfinzi) coverage for resectable gastric/gastroesophageal junction adenocarcinoma with perioperative FLOT and single‑agent adjuvant durvalumab, Imjudo (tremelimumab‑actl) plus Imfinzi and nivolumab/ipilimumab combinations for unresectable HCC, and numerous label‑driven expansions for agents such as Opdivo, Keytruda, Jemperli, and Tecentriq (including Hybreza). The policy emphasizes FDA‑approved biomarker requirements (PD‑L1, MSI‑H/dMMR, TMB‑H), regimen‑ and line‑of‑therapy specificity, and documents removal or modification of prior indications (e.g., an Opdivo HCC indication). Several IV/injection agents are now subject to site‑of‑service review and administration clarifications tied to FDA dosing and concurrent infusion exceptions.
March 2026 Revision: New Indications, Site‑of‑Service Designations, and Coverage Clarifications
This revision (effective 2026-03-01) updates and expands coverage criteria across multiple immune checkpoint inhibitors with a number of new and clarified indications noted in the policy's 2024–2026 update history. Key additions called out include: durvalumab (Imfinzi) coverage criteria for resectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) used with FLOT chemotherapy in neoadjuvant and adjuvant settings followed by single‑agent durvalumab; new site‑of‑service review designations for several agents (including Imfinzi, Jemperli, Opdivo Qvantig, Tecentriq, and Tecentriq Hybreza); and multiple indication expansions or clarifications for Opdivo (nivolumab), Yervoy (ipilimumab), Keytruda (pembrolizumab), and others documented in the 2024–2026 Update entries.
The policy history also documents removal and modification of prior indications (for example, removal of a prior Opdivo indication for HCC previously treated with sorafenib), product‑specific dose/administration clarifications, and added indications such as neoadjuvant/adjuvant combinations (e.g., in resectable NSCLC neoadjuvant setting and for specific HNSCC and MIBC regimens). The updates emphasize both new FDA‑labeled uses and site‑of‑service review applicability for multiple infusion and injection agents.
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