Anthem Rituximab Oncologic Coverage Update

Coverage Criteria and Step Therapy

Agent / Indication	Coverage Status / Notes
Rituxan (rituximab) - Follicular lymphoma
Truxima (rituximab-abbs) - Follicular lymphoma
Ruxience (rituximab-pvvr) - Follicular lymphoma
Riabni (rituximab-arrx) - Follicular lymphoma
Rituxan (rituximab) - Extranodal marginal zone (MALT) / Nodal-splenic marginal zone
Truxima (rituximab-abbs) - Extranodal marginal zone (MALT) / Nodal-splenic marginal zone
Ruxience (rituximab-pvvr) - Extranodal marginal zone (MALT) / Nodal-splenic marginal zone
Riabni (rituximab-arrx) - Extranodal marginal zone (MALT) / Nodal-splenic marginal zone
Rituxan (rituximab) - DLBCL, pediatric aggressive mature B-cell lymphomas, Burkitt lymphoma
Truxima (rituximab-abbs) - DLBCL, pediatric aggressive mature B-cell lymphomas, Burkitt lymphoma
Ruxience (rituximab-pvvr) - DLBCL, pediatric aggressive mature B-cell lymphomas, Burkitt lymphoma
Riabni (rituximab-arrx) - DLBCL, pediatric aggressive mature B-cell lymphomas, Burkitt lymphoma
Rituxan (rituximab) - Chronic lymphocytic leukemia / SLL (in combination with fludarabine + cyclophosphamide)
Truxima (rituximab-abbs) - Chronic lymphocytic leukemia / SLL
Ruxience (rituximab-pvvr) - Chronic lymphocytic leukemia / SLL
Riabni (rituximab-arrx) - Chronic lymphocytic leukemia / SLL
Rituxan (rituximab) - Post-transplant lymphoproliferative disorder, Mantle cell lymphoma, Hodgkin lymphoma, primary CNS lymphoma, hematopoietic cell transplantation, other oncologic indications listed in NCCN
Truxima (rituximab-abbs) - Post-transplant lymphoproliferative disorder, Mantle cell lymphoma, Hodgkin lymphoma, primary CNS lymphoma, hematopoietic cell transplantation
Ruxience (rituximab-pvvr) - Post-transplant lymphoproliferative disorder, Mantle cell lymphoma, Hodgkin lymphoma, primary CNS lymphoma, hematopoietic cell transplantation
Riabni (rituximab-arrx) - Post-transplant lymphoproliferative disorder, Mantle cell lymphoma, Hodgkin lymphoma, primary CNS lymphoma, hematopoietic cell transplantation

COVERAGE CRITERIA — details

COVERAGE CRITERIA — initial coverage and step therapy

Initial Coverage / Step Therapy — Covered when ALL of the following are met:

Agent is prescribed for an FDA‑approved oncologic indication or an indication supported by NCCN guidelines and listed in this policy.
The requested agent aligns with the plan's step-therapy table (preferred agent trial completed unless a plan-specific exception applies).
See plan formulary for preferred agent list and step requirements.
For non-preferred agent requests, documentation of trial and failure, intolerance, or contraindication to preferred agent(s) is provided, OR documentation of allergy/severe intolerance to an inactive ingredient in preferred agent(s).
When applicable, combination regimens required by the indication (e.g., rituximab with fludarabine + cyclophosphamide for CLL) are documented in the medical record.

First-line — Preferred Agents

First-line / Preferred agent determinations

First-line

Preferred agents as listed on the plan formulary for the specific benefit (see plan-specific preferred agent list).

First-line — Evidence for Biosimilars

Trials and evidence supporting biosimilar use

Evidence supporting biosimilars

Randomized trials and comparative studies have demonstrated equivalent efficacy and safety of approved rituximab biosimilars versus the reference product across oncologic and rheumatologic indications (see references).
When clinical criteria are met, biosimilars approved by the FDA (Truxima, Ruxience, Riabni) are considered acceptable alternatives to the reference product for covered oncologic indications.

Formulary Coverage by Benefit — operational notes

COVERAGE CRITERIA — benefit-specific non-medical rules

Formulary Coverage by Benefit

Medicaid Medical Benefit: Preferred and non-preferred designations vary by state and effective date. Examples: Effective 04/15/2022 (MD, NJ, NV until 01/01/2026), SC, VA, WI, WNY and others listed; Preferred Agent = Riabni for certain states; Non-Preferred Agents = Rituxan, Ruxience, Truxima for specified states and dates; see state-specific effective dates and plan documents for details.
Plan formularies and utilization management programs may require use of a preferred rituximab agent; when a rituximab agent is approvable based on clinical criteria, the member's benefit and state program rules determine whether additional prior authorization or preferred‑agent requirements apply.
Exceptions to preferred-agent requirements: documented allergy or severe intolerance to an inactive ingredient in preferred agent(s), or other documented clinical contraindication to preferred agents. Clinical documentation supporting the exception must be provided.

Billing and Diagnosis Codes

Prior Authorization

Provider Action Summary

Prior authorization is required consistent with the member's benefit formulary. Requests for non-preferred rituximab agents for oncologic indications may be approved when documentation shows trial and allergy or severe intolerance to an inactive ingredient in one preferred agent that interferes with use and the same allergy/intolerance is not expected with the requested non-preferred product. Failure to meet the policy criteria or to provide required documentation may result in claim denial or delay.

Prior authorization required per benefit formulary
Denial risk if coverage criteria or documentation not provided
Required documentation: diagnosis matching listed ICD-10 codes; evidence of trial and intolerance/allergy to preferred agent when requesting non-preferred agent; clinical rationale for agent selection
Supporting clinical references: manufacturer product labeling (black box warnings for rituximab and biosimilars) and standard oncology practice guidelines
Step therapy: preferred-agent stepping required; non-preferred agent exception allowed for documented intolerance/allergy
Formulary-preferred agent stepping: when medically appropriate, use one of the preferred rituximab agents prior to non-preferred agents

Covered HCPCS CodesHCPCSCovered

J9312	Injection, rituximab, 10 mg [Rituxan]
Q5115	Injection, rituximab-abbs, biosimilar, (Truxima), 10 mg
Q5119	Injection, rituximab-pvvr, biosimilar, (RUXIENCE), 10 mg
Q5123	Injection, rituximab-arrx, biosimilar, (Riabni), 10 mg [RIABNI]

Referenced ICD-10 Diagnosis CodesICD-10

B20	Human immunodeficiency virus [HIV] disease
C79.32	Secondary malignant neoplasm of cerebral meninges
C81.00-C84.99	Various Lymphoma diagnoses
C85.10-C85.19	Unspecified B-cell lymphoma
C85.20-C85.29	Mediastinal (thymic) large B-cell lymphoma
C85.80-C85.89	Other specified types of non-Hodgkin lymphoma
C88.00	Waldenström macroglobulinemia not having achieved remission
C88.40	Extranodal marginal zone B-cell lymphoma of MALT not having achieved remission
C91.0-C91.02	Acute lymphoblastic leukemia [ALL]
C91.10-C91.12	Chronic lymphocytic leukemia of B-cell type

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Formulary Affected Agents (Medical Benefit)mixed

Preferred Agents	Commercial & Medicare: Rituxan, Riabni; Medicaid: Riabni (selected markets)
Non-Preferred Agents	Ruxience, Truxima (and Rituxan for some Medicaid markets)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization required for Rituxan and listed biosimilars

Prior authorization is required for Rituxan and the listed biosimilar rituximab products for oncologic indications; submit diagnostic documentation and the indication to support medical necessity at the time of request.

Prior Authorization

Obtain prior authorization consistent with the member's benefit formulary

Follow the plan-specific prior authorization process and the benefit's formulary design—rituximab products are designated preferred or non-preferred by benefit and state, and prior authorization must be consistent with those designations.

Check the member's benefit (Commercial, Medicare, or state-specific Medicaid) for preferred agent listings before requesting a non-preferred product.

Step Therapy

Comply with step therapy table and provide intolerance exception documentation

Step therapy requirements apply per the policy's step therapy table, which designates preferred (X) or non-preferred (Y) rituximab agents by indication; non-preferred agents may be approved only when the individual has an allergy or severe intolerance to an inactive ingredient in a preferred agent.

Definitions and Biomarker Requirements

Rituxan and biosimilars — product description & boxed warnings

Products namedRituxan (rituximab) — reference product; biosimilars: Truxima (rituximab-abbs), Ruxience (rituximab-pvvr), Riabni (rituximab-arrx)

FDA approvals / indicationsFDA-approved for CD20-positive B‑cell malignancies including follicular lymphoma, non‑progressing low‑grade NHL, DLBCL, CLL (in combination with fludarabine + cyclophosphamide), and certain pediatric CD20‑positive malignancies (aged ≥6 months) when combined with chemotherapy

Boxed warnings (most actionable)Black box warnings for fatal infusion reactions, severe mucocutaneous reactions, hepatitis B virus (HBV) reactivation, and progressive multifocal leukoencephalopathy (PML). Screen all individuals for HBV before initiation and monitor during/after treatment; discontinue for HBV reactivation; monitor and stop infusion for severe infusion reactions.

Infusion reaction guidanceInfusion reactions can be severe or fatal, most frequently with the first infusion — monitor closely and discontinue for severe reactions; provide medical treatment for grade 3–4 reactions.

HBV and PML risk management

Line of Therapy Designations

first-line

First-line — labeled adult indications: Rituxan (rituximab) is FDA‑approved for treatment of CD20‑positive non‑Hodgkin lymphomas including relapsed/refractory low‑grade or follicular NHL, previously untreated follicular lymphoma, non‑progressing low‑grade NHL, and previously untreated diffuse large B‑cell lymphoma (DLBCL); it is also approved for chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide.

Use in these labeled adult indications is considered first‑line when consistent with the step therapy table and clinical judgment.

first-line

First-line — step therapy per indication: Per the step therapy table, specific oncologic indications are designated as preferred (X) or non‑preferred (Y) for each rituximab product; first‑line use should follow the per‑indication designation (examples: follicular lymphoma, DLBCL, CLL, Burkitt lymphoma, pediatric aggressive mature B‑cell lymphomas listed in the table).

Refer to the step therapy table for the X/Y assignment by product and indication; when an agent is approvable based on clinical criteria, the benefit plan may still require the use of preferred agent(s).

Regimens and Supported Combinations

Regimen	Indication	Coverage Determination	Notes / Source
Rituximab + fludarabine + cyclophosphamide
Chronic lymphocytic leukemia (CLL)
Covered
Rituxan is FDA approved to treat CLL in combination with fludarabine and cyclophosphamide (policy source referencing product approvals)

Agent (biosimilar)	Reference Product	Indications with Supporting Trial Evidence	Key Trial / Reference
ABP 798
Rituximab (Rituxan)
Follicular lymphoma; other indications supported by extrapolation per regulatory approval
JASMINE trial and related ABP 798 publications (see chunk 19) comparing ABP 798 with rituximab reference product

Background and Clinical Context

Rituximab (Rituxan) and its FDA‑approved biosimilars (Truxima, Ruxience, Riabni) are anti‑CD20 monoclonal antibodies used to treat a range of CD20‑positive B‑cell malignancies, including many non‑Hodgkin lymphomas and chronic lymphocytic leukemia. The agents are used across first‑line and relapsed settings, and biosimilars have been studied in randomized and non‑inferiority trials supporting comparable efficacy. Important safety considerations noted in product labeling include boxed warnings for fatal infusion reactions, severe mucocutaneous reactions, hepatitis B reactivation, and progressive multifocal leukoencephalopathy (PML); screening for hepatitis B is required prior to initiation. Clinical trial citations and package‑insert sources are referenced in the policy to support biosimilarity and indication-specific use.

Policy Revision History

2026-01-01Step therapy updateLatest

Step therapy table updated on 01/01/2026 (per document history).

2025-12-01Step therapy update

Step therapy table updated on 12/01/2025 (per document history).

2025-08-15Annual review / coding update

OpenPayer

Rituximab Agents for Oncologic Indications

Coverage Criteria and Step Therapy

Billing and Diagnosis Codes

Prior Authorization, Documentation, and Provider Requirements

Definitions and Biomarker Requirements

Line of Therapy Designations

Regimens and Supported Combinations

Background and Clinical Context

Policy Revision History