CurrentViva HealthPolicy IC-0322

Rituxan Hycela (subcutaneous rituximab/hyaluronidase) coverage

This policy governs prior authorization, dosing, renewal, and clinical criteria for coverage of Rituxan Hycela (subcutaneous rituximab/hyaluronidase) for oncology and related hematologic indications for Viva Health members.

Policy Summary

PayerViva Health

PolicyRituxan Hycela (subcutaneous rituximab/hyaluronidase) coverage

Policy CodePolicy IC-0322

Change TypeNo material clinical or coverage changes

Effective DateJul 20, 2010

Next Review DateApr 1, 2026

Key ActionPrior authorization is required; initial authorization generally valid for 6 months (180 days).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9311HCPCS billing code

50242-0108/0109NDCs listed

6 moInitial PA length

Provider-adminAdministration

A56380CMS ref

Coverage and Clinical Criteria

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Initial Approval Criteria

Covered when ALL of the following are met:

Initial approval requirements: 1) Patient has a contraindication, intolerance, or failure to Riabni, Ruxience, AND Truxima prior to consideration of another rituximab product; AND 2) Member is at least 18 years of age; AND 3) Member has received at least one full dose of a rituximab product by intravenous infusion prior to initiating subcutaneous therapy; AND 4) Member does not have a severe, active infection; AND 5) Member has been screened for hepatitis B virus infection (HBsAg and anti-HBc) prior to initiating therapy and members with evidence of current or prior HBV infection will be monitored for HBV reactivation during treatment; AND 6) Member is CD20 antigen expression positive (excluding use for KSHV-Associated Inflammatory Cytokine Syndrome); AND 7) Rituxan Hycela will not be used with intravenous chemotherapy agents or intravenous radioimmunotherapy; AND 8) Member has not received a live vaccine within 28 days prior to starting treatment and live vaccines will not be administered concurrently while on treatment.

Covered Indications

Covered for the following FDA-approved and compendia-recommended indications when other criteria met:

Indication list: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL); Follicular Lymphoma (FL); Diffuse Large B-Cell Lymphoma (DLBCL); High-Grade B-Cell Lymphomas; Extranodal Marginal Zone Lymphoma (EMZL) of the stomach & nongastric sites; Nodal & Splenic Marginal Zone Lymphoma; Mantle Cell Lymphoma; Histologic transformation of indolent lymphomas to DLBCL; Post-Transplant Lymphoproliferative Disorders (PTLD); Castleman Disease; KSHV-Associated Inflammatory Cytokine Syndrome; Hairy Cell Leukemia; Primary Cutaneous B-Cell Lymphoma; Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma; Adult Hodgkin Lymphoma (nodular lymphocyte-predominant).

Renewal Criteria

Renewal may be granted when ALL of the following are met:

Renewal requirements: 1) Member continues to meet the universal and other indication-specific relevant criteria (excluding prerequisite therapy); AND 2) Duration of authorization has not been exceeded; AND 3) Absence of unacceptable toxicity from the drug (examples include severe hypersensitivity, tumor lysis syndrome, severe mucocutaneous reactions, progressive multifocal leukoencephalopathy, hepatitis B reactivation, serious infections, cardiac or renal toxicity, bowel obstruction/perforation); AND 4) Disease response with treatment as defined by stabilization of disease or decrease in tumor size or tumor spread.

Rituxan Hycela must not be administered concurrently with intravenous chemotherapy agents or intravenous radioimmunotherapy. This exclusion is part of the universal coverage criteria and applies to all indications unless otherwise specified.

Medicare beneficiaries: applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may supersede non‑Medicare coverage decisions. Compliance with these CMS policies (for example, Palmetto GBA LCA A56380) is required where applicable and may affect coverage, claims adjudication, and documentation.

Renewal of prior authorization will not be granted if the member is experiencing unacceptable toxicitysevere hypersensitivity or infusion/administration reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B virus reactivation, serious infections (bacterial, fungal, or viral), and other severe organ toxicities. Documentation of absence of these events is required for continued coverage.

Indication	Fixed subcutaneous dose	Administration schedule / notes
Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL)	1,600 mg (26,800 Units)	Administer on Day 1 of Cycles 2–6 (every 28 days) for a total of 5 doses (i.e., 6 cycles total); OR administer once every 8 weeks for maintenance.
Hairy Cell Leukemia	1,400 mg (23,400 Units)	Administer once weekly for 3–7 doses; OR administer on Day 15 of Cycle 1 (28‑day cycle), then Days 1 and 15 every 28 days for 3 cycles, then once every 28 days for 4 cycles (up to 8 cycles or 11 total doses).
KSHV‑Associated Inflammatory Cytokine Syndrome	1,400 mg (23,400 Units)	Administer on Day 1 of Cycles 2–6 (every 21 days) for a total of 5 doses (i.e., 6 cycles total).
Waldenström Macroglobulinemia / Lymphoplasmacytic Lymphoma (initial)	1,400 mg (23,400 Units)	Administer once weekly for up to 11 doses.
Waldenström Macroglobulinemia / Lymphoplasmacytic Lymphoma (renewal)	1,400 mg (23,400 Units)	Administer up to once weekly for 3–7 doses per 6‑month period; OR administer once every 8 weeks for maintenance.
All other covered indications	1,400 mg (23,400 Units)	Administer up to once weekly for 3–7 doses in a 6‑month period; OR administer once every 8 weeks for maintenance. Note: must be administered by a healthcare provider.

Billing Codes and Dosing Units

Covered HCPCS CodeHCPCSCovered

J9311

Injection, rituximab 10 mg and hyaluronidase; 1 billable unit = 10 mg

NDCsNDC

50242-0108-xx	Rituxan Hycela 1,400 mg rituximab/23,400 Units hyaluronidase human per 11.7 mL single-dose vial
50242-0109-xx	Rituxan Hycela 1,600 mg rituximab/26,800 Units hyaluronidase human per 13.4 mL single-dose vial

Covered ICD-10 Diagnosis Codes (excerpt)ICD-10Covered

C46.0	Kaposi's sarcoma of skin
C46.1	Kaposi's sarcoma of soft tissue
C46.2	Kaposi's sarcoma of palate
C46.3	Kaposi's sarcoma of lymph nodes
C46.4	Kaposi's sarcoma of gastrointestinal sites
C46.50	Kaposi's sarcoma of unspecified lung
C46.51	Kaposi's sarcoma of right lung
C46.52	Kaposi's sarcoma of left lung
C46.7	Kaposi's sarcoma of other sites
C46.9	Kaposi's sarcoma, unspecified

1–10 of 11

1/2

Unit dosing thresholds — billable units

CLL/SLL initial dosing160 billable units every 28 days x 5 doses (renewal: 160 units every 8 weeks maintenance)

Hairy Cell Leukemia dosing140 billable units once weekly (up to 7 doses); alternative: 140 units every 14 days x7, then 140 units every 28 days x4

KSHV-Associated Inflammatory Cytokine Syndrome dosing140 billable units every 21 days for up to 5 doses

Waldenström Macroglobulinemia initial dosing140 billable units weekly up to 18 doses (renewal: 140 units every 8 weeks maintenance)

All other indications140 billable units weekly up to 7 doses (renewal: 140 units every 8 weeks maintenance)

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required When Clinically Indicated

Prior authorization is required when clinically indicated based on the plan's assessment of indication, safety/efficacy, and cost. The utilization management NQTL analysis supports applying prior authorization to this drug/drug group when appropriate.

Prior authorization applied based on indication, safety/efficacy, and drug cost (see NQTL checklist).

Denial Risk

Infection and Toxicity Risks May Trigger Denial

Presence of severe active infection or evidence of unacceptable toxicity may lead to denial of authorization. Examples of unacceptable toxicity include progressive multifocal leukoencephalopathy (PML), hepatitis B virus (HBV) reactivation, serious bacterial/fungal/viral infections, severe hypersensitivity or administration reactions, tumor lysis syndrome, severe mucocutaneous reactions, cardiac or renal adverse reactions, bowel obstruction and perforation, and other life‑threatening adverse events.

Member must not have a severe, active infection.
Members with current or prior HBV infection must be monitored for HBV reactivation during treatment.
Unacceptable toxicity (e.g., PML, HBV reactivation, serious infections) may trigger denial.

Note

Prior Authorization Consideration

Consideration for prior authorization is based on clinical indication, safety and efficacy evidence, and cost considerations as documented in the NQTL checklist.

Factor conclusions: Indication = consider PA; Safety and efficacy = consider PA; Potential for misuse/abuse = not a priority; Cost = consider PA.

Note

CMS Compliance Required When Applicable

Compliance with applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) is required where relevant. Refer to the CMS Medicare Coverage Database for current NCD/LCD/LCA documents. Example: Palmetto GBA LCA A56380 may apply to Medicare Part B claims.

Search for applicable NCD/LCD/LCA: https://www.cms.gov/medicare-coverage-database/search.aspx
Example document: LCA A56380 (Palmetto GBA) — ensure compliance for Medicare Part B where applicable.

Step Therapy

Required Prior Therapies and Documentation

Prior authorization requires documentation that the member had a contraindication, intolerance, or failure to Riabni, Ruxience, AND Truxima prior to consideration of another rituximab product. Failure to document prior use or failure/intolerance/contraindication to these prerequisite rituximab biosimilars may result in denial. Additionally, the member must have received at least one full intravenous dose of a rituximab product prior to initiating therapy.

Document contraindication, intolerance, or treatment failure to Riabni, Ruxience, AND Truxima.
Document at least one prior full-dose intravenous administration of a rituximab product.
Missing documentation of prerequisite therapies may trigger denial.

Line of Therapy Requirements

Line of Therapy / Dosing (Selected)

CLL/SLL dosing: Administer 1,600 mg (26,800 Units) subcutaneously on Day 1 of Cycles 2–6 (every 28 days) for a total of 5 doses; maintenance may be administered every 8 weeks.

Hairy Cell Leukemia dosing: Administer 1,400 mg (23,400 Units) subcutaneously once weekly for 3–7 doses; alternative cycle-based regimens (e.g., every 14 days or every 28 days sequences) up to a total per guidance may be used.

KSHV-Associated Inflammatory Cytokine Syndrome dosing: Administer 1,400 mg (23,400 Units) subcutaneously every 21 days for up to 5 doses.

Other indications dosing: For Waldenström macroglobulinemia/lymphoplasmacytic lymphoma: initial therapy 1,400 mg (23,400 Units) weekly up to 18 doses; for other indications: initial therapy 1,400 mg (23,400 Units) weekly up to 7 doses with renewal/maintenance every 8 weeks as specified.

Testing and Biomarker Preconditions

HBV screening requirements

Required baseline HBV serologyScreen for hepatitis B using HBsAg and anti-HBc prior to initiating therapy

Monitoring if positiveMembers with evidence of current or prior HBV infection will be monitored for HBV reactivation during treatment

Contraindication riskPresence of severe, active infection is exclusionary for initiation

CD20 expression — requirement

CD20 expression requirementTumor/cells must be CD20 antigen expression positive for use except when indication is KSHV-Associated Inflammatory Cytokine Syndrome

Exception — KSHV-associated indicationCD20 positivity is not required for KSHV-Associated Inflammatory Cytokine Syndrome

Documentation expectationProvider must document CD20 positivity as part of initial authorization materials

Product and Term Definitions

Rituxan Hycela (subcutaneous rituximab/hyaluronidase)

Definition (package insert)Rituxan Hycela: subcutaneous formulation of rituximab combined with hyaluronidase (per product package insert).

Reference citationProduct referenced: Rituxan Hycela [package insert], Genentech, Inc.; June 2021 (accessed March 2026).

Administration formDelivered as a fixed subcutaneous dose (per dosing sections referencing the product)

CD20 antigen expression positive — definition

DefinitionCD20 antigen expression positive: tumor or cells express CD20; required for Rituxan Hycela use except for KSHV-Associated Inflammatory Cytokine Syndrome.

Role in coverageCD20 positivity is a universal criterion for authorization across listed indications (documentation required).

Exception noteKSHV-Associated Inflammatory Cytokine Syndrome is explicitly excluded from the CD20 requirement.

Background and Context

Rituxan Hycela is a fixed‑dose, subcutaneous formulation of rituximab combined with hyaluronidase intended for treatment of multiple B‑cell malignancies and related hematologic conditions. Use generally requires prior intravenous rituximab exposure and baseline screening (including HBsAg and anti‑HBc testing) and is limited to CD20‑positive disease in most indications. Administration must follow the dosing schedules and safety guidance provided in the product labeling and referenced compendia.

Policy Revision History

A56380 (LCA)CMS compliance referenceLatest

Policy updated to state that Medicare NCDs/LCDs/LCAs (for example, Palmetto GBA Local Coverage Article A56380) may apply and must be followed where applicable; Medicare guidance may override non‑Medicare coverage determinations.