BlueCross BlueShield of Tennessee Medical Policy Manual

Rituximab and Hyaluronidase Human Injection (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

          I.    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.

A.    FDA-Approved Indications

1.     Adult patients with follicular lymphoma (FL):

a.     Relapsed or refractory, follicular lymphoma as a single agent

b.     Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy

c.     Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line CVP (cyclophosphamide, vincristine, and prednisone) chemotherapy

2.     Adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens

3.     Adult patients with previously untreated and previously treated chronic lymphocytic leukemia (CLL), in combination with fludarabine and cyclophosphamide (FC)

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.

B.    Compendial Uses

1.     B-cell lymphomas:

a.     Castleman’s disease (CD)

b.     High grade B-cell lymphoma (including high-grade B-cell lymphoma with translocations of MYC and BCL2 and/or BCL6 [double/triple hit lymphoma], high-grade B-cell lymphoma, not otherwise specified)

c.     Histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma

d.     Marginal zone lymphomas

i.      Nodal marginal zone lymphoma

ii.     Gastric mucosa associated lymphoid tissue (MALT) lymphoma

iii.    Nongastric MALT lymphoma

iv.    Splenic marginal zone lymphoma

e.     Mantle cell lymphoma

2.     Post-transplant lymphoproliferative disorder (PTLD)

3.     Hairy cell leukemia

4.     Primary cutaneous B-cell lymphoma (e.g., cutaneous marginal zone lymphoma or cutaneous follicle center lymphomas)

5.     Small lymphocytic lymphoma (SLL)

6.     Waldenström Macroglobulinemia/ Lymphoplasmacytic Lymphoma

All other indications are considered experimental/investigational and are not medically necessary.

         II.    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

       III.    CRITERIA FOR INITIAL APPROVAL

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.

A.    Chronic lymphocytic leukemia (CLL)/ Small lymphocytic lymphoma (SLL)

Authorization of 12 months may be granted for treatment of CD20 positive CLL or SLL.

B.    Hairy cell leukemia (HCL)

Authorization of 12 months may be granted for treatment of CD20 positive HCL.

C.    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:

1.     Castleman’s disease (CD)

2.     Diffuse large B-cell lymphoma (DLBCL)

3.     Follicular lymphoma

4.     High grade B-cell lymphoma (including high-grade B-cell lymphoma with translocations of MYC and BCL2 and/or BCL6 [double/triple hit lymphoma], high-grade B-cell lymphoma, not otherwise specified)

5.     Histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma

6.     Mantle cell lymphoma

7.     Post-transplant lymphoproliferative disorder (PTLD)

8.     Marginal zone lymphomas

i.      Nodal marginal zone lymphoma

ii.     Gastric mucosa associated lymphoid tissue (MALT) lymphoma

iii.    Nongastric MALT lymphoma

iv.    Splenic marginal zone lymphoma

D.    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).

E.    Waldenström Macroglobulinemia/ Lymphoplasmacytic Lymphoma

Authorization of 12 months may be granted for treatment of CD20 positive Waldenström macroglobulinemia/ lymphoplasmacytic lymphoma

       IV.    CONTINUATION OF THERAPY  

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when there is no evidence of unacceptable toxicity.

MEDICATION QUANTITY LIMITS

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

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).

REFERENCES

1.     Rituxan Hycela [package insert]. South San Francisco, CA: Genentech, Inc.; June 2021.

2.     The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 5, 2022.

ORIGINAL EFFECTIVE DATE: 9/29/2017

MOST RECENT REVIEW DATE: 4/1/2024

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.

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