5.01.556 Rituximab: Non-oncologic and Miscellaneous Uses
Defines medical necessity criteria, site-of-service review rules, covered non-oncologic indications, investigational indications, length of approval, documentation and coding requirements for rituximab products (Riabni, Ruxience, Truxima, Rituxan and Rituxan Hycela) for commercial plan members (with a note about Alaska fully-insured members). Applies to IV/injectable administration and site-of-service for ages ≥13.
Policy revised and replaced prior policies including 5.01.550 and others; lists related policies and notes about site-of-service applicability for Alaska fully-insured members.
2020: Added Ruxience to site-of-service review; updated RA criteria to add Rinvoq as first-line option and updated pregnancy information and ASH ITP guideline references.
2021: Added biosimilar Riabni as second-line agent for all covered indications; updated guideline links and references.
2023: Reviewed prescribing information; moved Ruxience to second line (non-preferred); adjusted preferred adalimumab biosimilars list and product preferences; various formulary updates effective Jan 1, 2024.
2024: Clarified preferred Humira product for RA; added Simlandi as preferred; noted FDA dosing applies; added note about specific formularies exempted from preferred adalimumab list; announced changes effective Jan 3, 2025 to preferred status of rituximab products and requirement of trial/failure with Ruxience or Truxima for Rituxan/Ritabni/Rituxan Hycela.
2025: Added Alaska fully-insured exemption to site-of-service criteria; clarified non-formulary exception approvals up to 12 months; updated preferred product lists and step therapy exceptions; updated several rituximab and adalimumab product preferences.
2026: Updated RA criteria to include adalimumab-aaty, adalimumab-adaz, adalimumab-adbm as preferred alternatives; literature review through Aug 26, 2025.
Updated preferred rituximab and adalimumab product lists and product preference status multiple times between 2019 and 2026.
Added and removed HCPCS/J codes and Q-codes across revisions.
Clarified that site-of-service medical necessity criteria is applicable only to certain ages or membership types at various times.
Added biosimilars and biosimilar-specific coverage language over time.
Policy language standardized from 'patient' to 'individual' throughout.
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