BlueCross BlueShield of Tennessee Medical Policy Manual
Rituximab and Hyaluronidase Human (Rituxan Hycela®)
Requires Step Therapy See “Step Therapy Requirements for Provider Administered Specialty Medications” Document at: https://www.bcbst.com/docs/providers/Comm_BC_PAD_Step_Therapy_Guide.pdf
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Limitations of Use
Initiate treatment with Rituxan Hycela only after patients have received at least one full dose of a rituximab product by intravenous infusion.
Rituxan Hycela is not indicated for the treatment of non-malignant conditions.
Compendial Uses
All other indications are considered experimental/investigational and are not medically necessary.
DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: Testing or analysis confirming CD20 protein on the surface of the B-cell
COVERAGE CRITERIA
Prior to initiating therapy, all members must receive at least one full dose of a rituximab product by intravenous infusion without experiencing severe adverse reactions.
Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)
Authorization of 12 months may be granted for treatment of CD20 positive CLL or SLL.
Hairy Cell Leukemia (HCL)
Authorization of 12 months may be granted for treatment of CD20 positive HCL.
B-cell Lymphomas
Authorization of 12 months may be granted for treatment of any of the following oncologic disorders that are CD20-positive as confirmed by testing or analysis:
Primary Cutaneous B-cell Lymphoma
Authorization of 12 months may be granted for treatment of CD20 positive primary cutaneous B-cell lymphoma (e.g., cutaneous marginal zone lymphoma or cutaneous follicle center lymphomas).
Waldenström Macroglobulinemia/ Lymphoplasmacytic Lymphoma
Authorization of 12 months may be granted for treatment of CD20 positive Waldenström macroglobulinemia/ lymphoplasmacytic lymphoma
Hodgkin Lymphoma, Nodular Lymphocyte-Predominant
Authorization of 12 months may be granted for treatment of CD20 positive Hodgkin lymphoma, nodular lymphocyte-predominant.
CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section III when there is no evidence of unacceptable toxicity.
MEDICATION QUANTITY LIMITS
|
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
B-Cell Lymphomas: Castleman's Disease |
Route of Administration: Subcutaneous 1400/23,400mg-units (frequency and cycle length varies by regimen; should not be more frequent than once a week) |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
B-Cell Lymphomas: Diffuse Large B-Cell Lymphoma, High-Grade B-Cell Lymphomas, |
Route of Administration: Subcutaneous 1400/23,400mg-units (frequency and cycle length varies by regimen; should not be more frequent than once a week) |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
B-Cell Lymphomas: Follicular Lymphoma |
Route of Administration: Subcutaneous 1400/23,400mg-units (frequency and cycle length varies by regimen; should not be more frequent than once a week) |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
B-Cell Lymphomas: Histological Transformation of Indolent Lymphomas to Diffuse Large B-cell Lymphoma |
Route of Administration: Subcutaneous 1400/23,400mg-units (frequency and cycle length varies by regimen; should not be more frequent than every 14 days) |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
B-Cell Lymphomas: Mantle Cell Lymphoma |
Route of Administration: Subcutaneous 1400/23,400mg-units (frequency and cycle length varies by regimen; should not be more frequent than once a week) |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
B-Cell Lymphomas: Marginal Zone Lymphomas [Nodal Marginal Zone Lymphoma, Gastric Mucosa Associated Lymphoid Tissue (GMALT) Lymphoma, Nongastric MALT Lymphoma, Splenic Marginal Zone Lymphoma] |
Route of Administration: Subcutaneous 1400/23,400mg-units (frequency and cycle length varies by regimen; should not be more frequent than once a week) |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
B-Cell Lymphomas: Post-Transplant Lymphoproliferative Disorders |
Route of Administration: Subcutaneous 1400/23,400mg-units (frequency and cycle length varies by regimen; should not be more frequent than once a week) |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) |
Route of Administration: Subcutaneous 1600/26,800mg-units (frequency and cycle length varies by regimen; should not be more frequent than once a week) |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
Hairy Cell Leukemia |
Route of Administration: Subcutaneous 1400/23,400mg-units (frequency and cycle length varies by regimen; should not be more frequent than once a week) |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
Hodgkin Lymphoma - Nodular Lymphocyte-Predominant |
Route of Administration: Subcutaneous ≥18 Year(s) 1400/23,400mg-units (frequency and cycle length varies by regimen; should not be more frequent than once a week) |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
Primary Cutaneous B-Cell Lymphomas |
Route of Administration: Subcutaneous 1400/23,400mg-units on Days 8, 15, and 22 of a 28-day cycle for 1 cycle |
|
Rituxan Hycela (Rituximab-Hyaluronidase Human) |
Waldenström Macroglobulinemia/ Lymphoplasmacytic Lymphoma |
Route of Administration: Subcutaneous 1400/23,400mg-units (frequency and cycle length varies by regimen; should not be more frequent than once a week) |
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
ORIGINAL EFFECTIVE DATE: 9/29/2017
MOST RECENT REVIEW DATE: 11/11/2025
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.