CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rituximab Products (Rituxan and biosimilars) - Coverage Criteria

Defines accepted indications, duration limits, dosing limits, contraindications, and coding for rituximab and its biosimilars for oncology and select non-malignant hematologic conditions; applies to providers submitting medication requests to Evolent on behalf of Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRituximab Products (Rituxan and biosimilars) - Coverage Criteria

Policy CodePolicy N/A

Change TypeReplaced prior UM ONC_1132template conversion and content updates

Effective DateMarch 2025

Next Review DateN/A

Key ActionObtain prior authorization from Evolent with supporting FDA labeling, compendia, or guideline evidence.

SourceLink

POLICY UPDATE CHANGES

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

5HCPCS/Q-code entries

2 yearsmaintenance duration (most indolent)

500/375 mg/m²single-dose upper limits

Commercial; Medicaidlines of business

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CD20-positive B-cell NHL and B-ALL

Covered when ANY of the following clinical scenarios are met for CD20-positive disease:

CD20-positive B-cell NHL or B-ALL

Maintenance - Indolent B‑Cell Lymphomas: Maintenance allowed for up to two years for indolent B‑cell lymphomas (follicular B‑cell lymphoma and all subtypes of marginal zone lymphoma).<= 2 years
Maintenance - Mantle Cell Lymphoma: Maintenance allowed until disease progression or intolerable toxicity for mantle cell lymphoma.N/A
DLBCL/HGBL first‑line polatuzumab‑CHP: Use of polatuzumab‑CHP (rituximab + polatuzumab + cyclophosphamide + doxorubicin + prednisone) with rituximab is allowed as first‑line/initial treatment for members with an International Prognostic Index (IPI) score of >= 2.IPI >= 2

Relapsed/Refractory LBCL combinations

Covered for select relapsed/refractory large B‑cell lymphoma combinations when criteria met:

Relapsed/Refractory LBCL combination (lenalidomide + brentuximab vedotin): Rituximab 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 hematopoietic stem cell transplantation (auto‑HSCT) or CAR T‑cell therapy.>= 2 prior systemic therapy lines

Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma

Covered for CLL/SLL:

CLL/SLL therapy: Rituximab or a rituximab biosimilar may be used for first‑line or subsequent therapy in combination with chemotherapy, or as maintenance therapy for up to 2 years.<= 2 years for maintenance

Certain regimens are not supported due to lack of Level 1 evidence (see exclusions).

Nodular lymphocyte predominant Hodgkin lymphoma

Covered for nodular lymphocyte predominant Hodgkin lymphoma:

Nodular lymphocyte predominant Hodgkin lymphoma: Member has nodular lymphocyte predominant CD20‑positive Hodgkin lymphoma and rituximab or a rituximab biosimilar may be used as a single agent or in combination with chemotherapy for initial or subsequent therapy; maintenance therapy is allowed for up to 2 years.<= 2 years for maintenance

Idiopathic Thrombocytopenic Purpura (ITP)

Covered for Idiopathic Thrombocytopenic Purpura (ITP):

Acute ITP refractory to corticosteroids: Member has acute ITP that is refractory to corticosteroids AND the platelet count is < 30 x 10^9/L OR there are other clinical indications for therapy; rituximab may be used as a single agent.platelet count < 30 x 10^9/L

Waldenstrom Macroglobulinemia / Lymphoplasmacytic Lymphoma

Covered for Waldenstrom Macroglobulinemia / Lymphoplasmacytic Lymphoma:

Waldenstrom / LPL: Member has Waldenstrom macroglobulinemia or lymphoplasmacytic lymphoma and rituximab or a rituximab biosimilar may be used in combination with chemotherapy and/or a BTK inhibitor (for example, ibrutinib + rituximab) as primary therapy or for relapsed/refractory disease.N/A

Requests for rituximab products will be excluded when they fall within specific coverage limits. Maintenance rituximab after primary treatment of DLBCL is excluded and will not be approved. For chronic lymphocytic leukemia (CLL) therapy given in combination with venetoclax, treatment durations that exceed 2 years are also excluded. Additionally, dosing that surpasses the policy's single-dose maximums is not allowed (see coding thresholds). Finally, investigational or off‑label uses lacking sufficient evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature will be denied.

Certain rituximab-containing regimens are specifically noted as not supported because they lack Level 1 evidence (randomized trials or meta-analyses) demonstrating superior outcomes or lower toxicity versus alternatives. Examples called out by the policy include: gemcitabine + vinorelbine ± rituximab for relapsed/refractory DLBCL, single‑agent rituximab maintenance for DLBCL, lenalidomide + rituximab as initial therapy for marginal zone lymphoma, and selected mantle cell combinations such as ibrutinib + lenalidomide + rituximab and venetoclax + rituximab. Providers should exercise caution and rely on recommended alternatives (for example, those in Evolent Pathways) because these regimens are considered not medically necessary under this policy when Level 1 evidence is absent.

Specific Regimens and Positioning

Regimen	Indication / Comment	Coverage Status
Gemcitabine + vinorelbine +/- rituximab (any rituximab product)
Relapsed/refractory diffuse large B-cell lymphoma (DLBCL) — specifically called out as not supported due to lack of Level 1 evidence.
Maintenance single‑agent rituximab (any rituximab product)
Maintenance after primary treatment of DLBCL — listed as not supported (lack of Level 1 evidence).
Lenalidomide + rituximab (any rituximab product)
Initial therapy for marginal zone lymphoma — called out as not supported due to lack of Level 1 evidence.
Ibrutinib + lenalidomide + rituximab (any rituximab product)
Second-line or subsequent therapy for mantle cell lymphoma — listed among regimens not supported for lack of Level 1 evidence.
Venetoclax + rituximab (any rituximab product)
Second-line or subsequent therapy for mantle cell lymphoma — listed among regimens not supported for lack of Level 1 evidence.

Regimen	Population / Criterion	Coverage Status
Polatuzumab-CHP (polatuzumab + cyclophosphamide + doxorubicin + prednisone) with rituximab
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.
Notes
Policy specifies use of polatuzumab‑CHP with rituximab is allowed as first‑line/initial therapy when IPI ≥ 2.

Line of therapy nodes

Line of therapy:

Initial therapy: Rituximab may be used as initial therapy in combination with chemotherapy for eligible CD20‑positive B‑cell malignancies.

Relapsed/Refractory therapy: Rituximab may be used for relapsed or refractory disease as a single agent or in combination per the indication‑specific criteria.

Post‑second‑line LBCL combination: For large B‑cell lymphoma, use with lenalidomide and brentuximab vedotin is permitted after >= 2 lines of systemic therapy for adults who are ineligible for auto‑HSCT or CAR T‑cell therapy.

Provider Actions, Documentation & Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required for all rituximab products processed by Evolent. Medication requests must be submitted to Evolent for review; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Applies to Rituxan, Rituxan Hycela, Truxima, Ruxience, Riabni and biosimilars
Requests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS standards

Step Therapy

Unsupported Regimens / Pathway Guidance

Certain regimens are not supported by Evolent due to lack of Level 1 evidence (randomized clinical trials and/or meta-analyses) showing superior outcomes or lower toxicity compared to alternatives. Providers should follow Evolent Pathways and preferred regimen guidance when selecting therapies.

Unsupported in relapsed/refractory DLBCL: gemcitabine + vinorelbine ± rituximab (any rituximab product)
Maintenance for DLBCL: single-agent rituximab (any rituximab product) is not supported
Initial therapy for Marginal Zone Lymphoma: lenalidomide + rituximab (any rituximab product) is not supported
Second-line or subsequent therapy for Mantle Cell Lymphoma: ibrutinib + lenalidomide + rituximab and venetoclax + rituximab (any rituximab product) are not supported

Documentation Required

Evidence and Documentation Standards

The use of rituximab products must be supported by one of the following sources: FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Documentation submitted with requests should demonstrate that the patient population, regimen, and clinically meaningful outcomes are adequately represented in the published evidence.

Evidence should reflect applicable clinical characteristics and therapy regimens
Clinically meaningful outcomes generally follow ASCO recommendations (e.g., HR < 0.80; ≥3 months benefit for OS/PFS where applicable)
Non-randomized trials with adequate subject numbers may be supportive; case reports and abstracts without full peer-reviewed articles are generally insufficient

Denial Risk

Denial Triggers / Exclusion Criteria

Requests will be denied or excluded when criteria are met including use as maintenance after primary DLBCL treatment, exceeding authorized maximum durations or dosing limits, or investigational/off-label use lacking sufficient evidence. Providers should confirm dosing, indication, and duration against policy limits before submission.

Use of rituximab as maintenance therapy after primary DLBCL treatment — excluded
Treatment exceeding maximum duration of 2 years when used with venetoclax for CLL — excluded
Dosing limits: rituximab single-dose limits 500 mg/m² (CLL) and 375 mg/m² (NHL); Rituxan Hycela 1600 mg (CLL) and 1400 mg (NHL) — exceeding these may lead to denial
Investigational/off-label uses not supported by CMS compendia or acceptable peer-reviewed evidence — excluded

Definitions and Biomarker Requirements

CD20-positive B-Cell NHL and B-ALL — definitions

Age criterionMember ≥ 6 months of age

Disease scopeCD20-positive B-cell Non-Hodgkin lymphomas (e.g., follicular, diffuse large B-cell, mantle cell, pediatric aggressive mature B‑cell lymphomas) and B‑ALL

Allowed therapy settingsInitial therapy (with chemotherapy), relapsed/refractory disease, or maintenance therapy with limits specified

Maintenance duration — Indolent B‑cell lymphomasUp to 2 years for follicular and marginal zone lymphoma subtypes

Maintenance duration — Mantle cell lymphomaUntil disease progression or intolerable toxicity

DLBCL/HGBL first‑line notePolatuzumab‑CHP (with rituximab) allowed as first‑line for IPI ≥ 2

CD20 biomarker requirement

Biomarker requirementCD20 positive status is required for covered B‑cell malignancy indications

Testing implicationApplicable to initial, relapsed/refractory, and maintenance therapy indications specified for CD20‑positive disease

Age applicabilityApplies to members ≥ 6 months when disease is CD20 positive

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

OpenPayer

Rituximab Products (Rituxan and biosimilars) - Coverage Criteria

Coverage Criteria for Rituximab Products

Specific Regimens and Positioning

Coding and Dose Limits

Provider Actions, Documentation & Denials

Definitions and Biomarker Requirements

Background

Revision History