CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rituximab Products — Coverage Criteria and Authorization Rules

Defines accepted indications, limits, coding, and evidence standards for use of rituximab and specified biosimilars for cancer and selected hematologic conditions; applies to providers submitting medication requests to Evolent for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRituximab Products — Coverage Criteria and Authorization Rules

Policy CodePolicy N/A

Change TypeMinor / no material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for rituximab products; continuation requests may be exempt if no progression, authorization active within past year without >30-day lapse, and no additional drugs added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5listed products

2 yrsmax maintenance

J9311+codes

Commercial/Medicaidlines of business

Coverage Criteria for Rituximab Products

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CD20-positive B-cell NHL and B-ALL

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

CD20+ B-cell NHL/B-ALL indications: Member is an adult or pediatric >= 6 months with CD20-positive B-cell NHL (e.g., follicular, diffuse large B-cell, mantle cell, pediatric aggressive mature B-cell lymphomas) or B-ALL; rituximab or a rituximab biosimilar may be used as a single agent or in combination with chemotherapy for initial therapy (in combination with chemotherapy only), for treatment of relapsed or refractory disease, or for maintenance therapy

Maintenance durations: up to 2 years for indolent B-cell lymphomas (follicular and marginal zone subtypes); until disease progression or intolerable toxicity for mantle cell lymphoma

Relapsed/Refractory Large B-Cell Lymphoma (post >=2 lines)

Covered when ALL of the following are met for relapsed/refractory large B-cell lymphoma patients ineligible for auto-HSCT or CAR T:

R/R LBCL eligibility: Adult member with relapsed or refractory large B-cell lymphoma (including DLBCL NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma) after two or more lines of systemic therapy AND ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy

Regimen requirement: Use of rituximab/rituximab biosimilar is in combination with lenalidomide (Revlimid) and brentuximab vedotin (Adcetris)

Supports rituximab + lenalidomide + brentuximab vedotin in this specific population

Unsupported regimens note: Certain regimens are not supported due to lack of Level 1 evidence, including gemcitabine + vinorelbine +/- rituximab in relapsed/refractory DLBCL, single-agent rituximab maintenance for DLBCL, lenalidomide + rituximab as initial therapy for marginal zone lymphoma, and specified combinations for mantle cell lymphoma

See policy exclusions and Evolent Pathways for alternatives

Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma

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

CLL/SLL therapy lines: Rituximab/rituximab biosimilar may be used for first-line or subsequent line of therapy in combination with chemotherapy OR as maintenance therapy for up to 2 years

Regimens lacking Level 1 evidence (e.g., initial ibrutinib + rituximab; subsequent lenalidomide +/- rituximab) are not supported

Nodular Lymphocyte Predominant Hodgkin's Lymphoma

Covered when ALL of the following are met for nodular lymphocyte predominant Hodgkin lymphoma:

NLP Hodgkin lymphoma: Member has nodular lymphocyte predominant Hodgkin's lymphoma; rituximab/rituximab biosimilar may be used as single agent or in combination with chemotherapy for initial or subsequent therapy OR for maintenance therapy for up to 2 years

Idiopathic Thrombocytopenic Purpura (ITP)

Covered when ALL of the following are met for Idiopathic Thrombocytopenic Purpura (ITP):

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

Waldenstrom Macroglobulinemia / Lymphoplasmacytic Lymphoma

Covered when ALL of the following are met for Waldenstrom Macroglobulinemia/Lymphoplasmacytic Lymphoma:

Waldenstrom therapy: Member has Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma; rituximab/rituximab 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

Example supported combination: ibrutinib + rituximab

The policy defines specific exclusionary caveats for rituximab products. Notably, use of any rituximab product as maintenance therapy after primary treatment of Diffuse Large B‑Cell Lymphoma (DLBCL) is excluded. Requests where treatment duration exceeds the maximum of 2 years when rituximab is used in combination with venetoclax (Venclexta) for chronic lymphocytic leukemia (CLL) will be denied. The policy also excludes requests that exceed established single‑dose limits: 500 mg/m2 for CLL and 375 mg/m2 for NHL, and for Rituxan Hycela 1600 mg (CLL) and 1400 mg (NHL). Finally, investigational or off‑label uses lacking sufficient evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature are excluded.

The policy identifies several regimens and uses that are considered not supported due to lack of Level 1 evidence (randomized trials or meta‑analyses demonstrating superior outcomes). Examples called out include: gemcitabine + vinorelbine +/- rituximab in relapsed/refractory DLBCL; single‑agent rituximab maintenance for DLBCL; lenalidomide + rituximab as initial therapy for marginal zone lymphoma; and combinations listed for mantle cell lymphoma such as ibrutinib + lenalidomide + rituximab or venetoclax + rituximab. The policy explains that uses not represented adequately in the published evidence, supported only by case reports or abstracts without full peer‑reviewed articles, or lacking clinically meaningful outcomes per ASCO standards, are considered not medically necessary/ not supported.

Coverage stance	Example supported regimens (indication/line)	Example unsupported regimens
Covered	Rituximab in combination with lenalidomide (Revlimid) and brentuximab vedotin (Adcetris) for adult patients with relapsed/refractory large B‑cell lymphoma (including DLBCL NOS, DLBCL arising from indolent lymphoma, or high‑grade B‑cell lymphoma) after two or more lines of systemic therapy who are ineligible for autologous HSCT or CAR T-cell therapy.	Gemcitabine + vinorelbine ± rituximab for relapsed/refractory DLBCL (not supported).
Covered	Rituximab used with chemotherapy as initial (first‑line) therapy for CD20‑positive B‑cell NHL or B‑ALL (rituximab as combination agent with chemo).	Single‑agent rituximab as maintenance after primary treatment of DLBCL (maintenance for DLBCL not supported).
Covered	Rituximab used as maintenance therapy for up to two years for indolent B‑cell lymphomas (e.g., follicular and marginal zone lymphomas) or until progression/toxicity for mantle cell lymphoma per indication.	Lenalidomide + rituximab as initial therapy for marginal zone lymphoma (not supported).

Prior Authorization, Documentation, and Exclusions

Prior Authorization

Prior Authorization Required

Prior authorization is required for all rituximab products. Medication requests not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Continuation requests may be exempt from prior authorization when ALL of the following are true: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request.

Documentation Required

Required Supporting Documentation

Use of rituximab products must be supported by one of the following: FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS standards. Requests lacking adequate supporting evidence (for investigational or off-label indications not generally accepted by the medical community) may be excluded.

Acceptable sources: FDA product labeling; CMS-recognized compendia; NCCN and ASCO guidelines; peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Documentation Required

Safety Screening Requirements

Prior to initiation of therapy, providers must perform and document safety screening per FDA labeling and boxed warnings. At minimum, document HBV screening and monitoring, assessment for prior severe infusion reactions, and awareness of risks for PML and severe mucocutaneous reactions. Monitor and document patient status during and after infusion; discontinue therapy and provide appropriate treatment if severe infusion-related reactions or HBV reactivation occur.

Screen all patients for hepatitis B virus (HBV) infection before treatment initiation and monitor during and after treatment; discontinue rituximab and concomitant medications if HBV reactivation occurs.
Assess for history of severe infusion-related reactions; monitor closely during infusion and be prepared to discontinue infusion and treat grade 3–4 reactions.
Be aware of risk for progressive multifocal leukoencephalopathy (PML) and severe mucocutaneous reactions; document counseling and monitoring plans.

Denial Risk

Unsupported Regimens

Evolent does not support certain regimens due to lack of Level 1 evidence; check Evolent Pathways for preferred alternatives where applicable. Examples of unsupported regimens include: gemcitabine + vinorelbine +/- rituximab in relapsed/refractory DLBCL; maintenance rituximab for DLBCL; lenalidomide + rituximab as initial therapy for marginal zone lymphoma; and certain combinations in mantle cell lymphoma and CLL/SLL as noted in policy.

Unsupported regimens are excluded from authorization when they lack Level 1 evidence as specified by the policy.

Denial Risk

Exclusion Triggers

Requests that meet any exclusion criteria in policy may be denied. Common exclusion triggers include dosing or duration limits exceeded, maintenance use after primary DLBCL treatment, and investigational or off‑label indications without sufficient evidence.

Exclusions include: maintenance therapy after primary DLBCL treatment; treatment exceeding maximum duration limits (e.g., >2 years when combined with venetoclax for CLL); dosing above single‑dose limits (rituximab products 500 mg/m² for CLL and 375 mg/m² for NHL; Rituxan Hycela 1600 mg for CLL and 1400 mg for NHL); investigational/off‑label uses without sufficient evidence.

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 — Coverage Criteria and Authorization Rules

Coverage Criteria for Rituximab Products

Therapy Line, Continuation, and Maintenance Rules

Coding and Dosing Limits

Prior Authorization, Documentation, and Exclusions

Definitions and Eligibility Criteria

Background