EmblemHealth Rituximab Coverage & Prior Auth

Coverage Criteria for Rituximab Products

CD20-positive B-cell NHL and B-ALL coverage

Covered when ANY of the following are met for CD20-positive B-cell NHL or B-ALL:

CD20+ NHL/B-ALL uses: Member is ≥ 6 months of age with CD20-positive B-cell NHL (e.g., follicular, diffuse large B-cell, mantle cell, pediatric aggressive mature B-cell lymphomas) or B-ALL, and rituximab or a rituximab biosimilar is used as single agent or in combination with chemotherapy for initial therapy (combination with chemotherapy only), treatment of relapsed/refractory disease, or maintenance therapy per specified duration limits

Includes DLBCL, follicular, mantle cell, pediatric aggressive mature B-cell lymphomas

Maintenance duration - Indolent B-Cell Lymphomas: Maintenance therapy permitted for up to two years for Indolent B-Cell Lymphomas (Follicular B Cell Lymphoma and all subtypes of Marginal Zone Lymphoma)2 years

Maintenance duration - Mantle Cell Lymphoma: Maintenance therapy permitted until disease progression or intolerable toxicity for Mantle Cell Lymphoma

First-line regimen for DLBCL/HGBL with IPI≥2: Use of polatuzumab-CHP (rituximab + polatuzumab + cyclophosphamide + doxorubicin + prednisone) is supported as first-line treatment for DLBCL or High-Grade B-Cell Lymphoma with an International Prognostic Index (IPI) score ≥ 2IPI ≥2

Relapsed/refractory LBCL combination coverage

Covered when ALL of the following are met for relapsed/refractory LBCL (including DLBCL) ineligible for auto-HSCT or CAR T:

Rituximab with lenalidomide and brentuximab: Rituximab (or biosimilar) may be used in combination with lenalidomide (Revlimid) and brentuximab vedotin (Adcetris) in adult members with relapsed or refractory large B-cell lymphoma (including DLBCL NOS, DLBCL arising from indolent lymphoma, or HGBL) after two or more lines of systemic therapy who are ineligible for autologous HSCT or CAR T-cell therapy≥2 prior lines

CLL/SLL coverage

Covered for CLL/SLL when ANY of the following are met:

CLL/SLL uses: Rituximab (or biosimilar) may be used for first-line or subsequent-line therapy in combination with chemotherapy, or as maintenance therapy for up to 2 years2 years for maintenance

Hodgkin's Lymphoma (NLP) coverage

Covered for nodular lymphocyte predominant Hodgkin's lymphoma when ANY are met:

NLP Hodgkin coverage: Rituximab (or biosimilar) may be used as a single agent or in combination with chemotherapy for initial or subsequent therapy, or as maintenance therapy for up to 2 years2 years for maintenance

Idiopathic Thrombocytopenic Purpura (ITP)

Covered for ITP when ALL are met:

Acute ITP coverage: Member has acute ITP and rituximab (or biosimilar) is used as a single agent AND the member has ITP refractory to corticosteroids AND the platelet count is less than 30 x 10^9/L OR there are other clinical indications for therapyplatelets < 30 x 10^9/L

Waldenstrom Macroglobulinemia/LPL coverage

Covered for Waldenstrom Macroglobulinemia/Lymphoplasmacytic Lymphoma when ANY are met:

Waldenstrom coverage: Member has Waldenstrom Macroglobulinemia/Lymphoplasmacytic Lymphoma and rituximab (or biosimilar) may be used in combination with chemotherapy and/or a BTK inhibitor (e.g., ibrutinib + rituximab) as primary therapy or for relapsed/refractory disease

Maintenance rituximab following completion of primary therapy for Diffuse Large B‑Cell Lymphoma (DLBCL) is explicitly excluded from coverage. Requests for single‑agent rituximab used as maintenance after primary treatment of DLBCL are not supported and may be denied.

When rituximab is used in combination with venetoclax (Venclexta) for treatment of Chronic Lymphocytic Leukemia (CLL), coverage is limited by a maximum treatment duration. Treatment that exceeds 2 years in this combination is excluded and may be denied.

Investigational or off‑label uses of rituximab products that lack sufficient supporting evidence are excluded. Sufficient evidence is defined by acceptance in CMS‑recognized compendia or acceptable peer‑reviewed literature; uses not meeting those standards — including indications not adequately represented in published evidence, regimens not represented in the literature, or evidence limited to case reports or abstracts without full peer‑reviewed articles — may be considered investigational and may be denied.

Certain specified regimens are identified as not supported due to lack of Level 1 evidence (randomized clinical trials and/or meta‑analyses). Examples include: gemcitabine + vinorelbine ± rituximab for relapsed/refractory DLBCL, lenalidomide + rituximab as initial therapy for marginal zone lymphoma, and combinations such as ibrutinib + lenalidomide + rituximab or venetoclax + rituximab in mantle cell lymphoma. These regimens are not supported by policy and may be considered not medically necessary.

Line of therapy - first-line | second-line | salvage

Lines: Rituximab may be used for initial (first-line) therapy in combination with chemotherapy, for relapsed or refractory disease (second-line or subsequent), and for maintenance per the duration limits specified in individual disease criteria

Regimens and Evidence Basis

Regimen	Indication	Coverage
Rituximab + polatuzumab + cyclophosphamide + doxorubicin + prednisone (polatuzumab-CHP)	First-line/initial treatment for diffuse large B‑cell lymphoma (DLBCL) or high‑grade B‑cell lymphoma (HGBL) in members with International Prognostic Index (IPI) score ≥2	Covered

Regimen	Indication	Coverage
Rituximab in combination with lenalidomide (Revlimid) and brentuximab vedotin (Adcetris)	Relapsed or refractory large B‑cell lymphoma (LBCL), including DLBCL or HGBL, after ≥2 lines of systemic therapy in adult members who are ineligible for autologous HSCT or CAR T‑cell therapy	Covered

Example Regimen	Context / Note	Coverage
Gemcitabine + vinorelbine ± rituximab	Listed for relapsed/refractory DLBCL; identified as not supported due to lack of Level 1 evidence	Not covered
Lenalidomide + rituximab	Listed as initial therapy for marginal zone lymphoma; identified as not supported due to lack of Level 1 evidence	Not covered
Ibrutinib + lenalidomide + rituximab	Listed as second‑line or subsequent therapy for mantle cell lymphoma; identified as not supported due to lack of Level 1 evidence	Not covered
Venetoclax + rituximab	Listed as second‑line or subsequent therapy for mantle cell lymphoma; identified as not supported due to lack of Level 1 evidence	Not covered

Billing and Code Limits

Listed drug injection codesHCPCS

J9311	Injection, rituximab 10 mg and hyaluronidase
J9312	Injection, rituximab, 10 mg
Q5115	Injection, rituximab-abbs, biosimilar, (truxima), 10 mg
Q5119	Injection, rituximab-pvvr, biosimilar, (ruxience), 10 mg
Q5123	Injection, rituximab-arrx, biosimilar, (riabni), 10 mg

Single dose limits

Single-dose limit — CLL (rituximab products)500 mg/m²

Single-dose limit — NHL (rituximab products)375 mg/m²

Rituxan Hycela single-dose — CLL1600 mg

Rituxan Hycela single-dose — NHL1400 mg

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for rituximab products. Requests must cite the covered indication and include supporting documentation demonstrating that the requested use aligns with FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature. Evolent processes medication requests for network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Note

Unsupported Regimens Guidance

Certain regimens are identified as not supported due to lack of Level 1 evidence (randomized clinical trials and/or meta-analyses) demonstrating superior outcomes or lower toxicity compared to alternatives. Providers should follow Evolent Pathways or choose supported regimens. Examples of unsupported uses include: gemcitabine + vinorelbine +/- rituximab in relapsed/refractory DLBCL; lenalidomide + rituximab as initial therapy for marginal zone lymphoma; and specified combination regimens in mantle cell lymphoma.

Key Definitions and Safety Notes

Indolent B‑Cell Lymphomas

DefinitionIndolent B-Cell Lymphomas (examples)

ExamplesFollicular B‑cell lymphoma; Marginal Zone Lymphoma (all subtypes)

Maintenance duration guidanceMaintenance therapy permitted for up to two years for indolent B‑cell lymphomas

Boxed warnings and serious safety risks

Boxed warnings — infusion reactionsRituximab can cause serious, including fatal, infusion-related reactions; monitor closely and discontinue for severe reactions

Boxed warnings — HBV reactivationHepatitis B virus reactivation can occur; screen all patients before initiation and monitor during and after treatment; discontinue rituximab if reactivation occurs

Background on Rituximab Products

Rituximab and its biosimilars are monoclonal antibodies that target CD20‑positive B cells and are used across a range of B‑cell malignancies and select immune‑mediated hematologic conditions. The policy supports use in multiple settings — including initial therapy, relapsed/refractory disease, and specified maintenance use — and lists tumor types such as diffuse large B‑cell lymphoma (DLBCL), follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, high‑grade B‑cell lymphomas, and B‑cell acute lymphoblastic leukemia (B‑ALL). The document also highlights that some regimen uses are not supported when Level 1 evidence is lacking.

Policy Revision History

March 2025template_conversion_and_supersessionLatest

Converted to new Evolent guideline template and replaced prior UM ONC_1132 Rituximab Products; added a new indication and updated references.

June 2024verbiage_update

Updated NCH verbiage to Evolent.

OpenPayer

Rituximab Products — Coverage Criteria