BlueCross BlueShield of Tennessee Medical Policy Manual

Rituximab and Hyaluronidase Human Injection

NDC CODE(S)

50242-0108-XX Rituxan Hycela 1400-23400 MG -UT/11.7ML SOLN (GENENTECH)

 

50242-0109-XX Rituxan Hycela 1600-26800 MG -UT/13.4ML SOLN (GENENTECH)

DESCRIPTION

Rituximab is a genetically engineered monoclonal IgG1 kappa antibody directed against the CD20 antigen.  Recombinant human hyaluronidase is a glycosylated single-chain protein (an endoglycosidase).  Hyaluronidase human increases permeability of the subcutaneous tissue by temporarily depolymerizing hyaluronan.  It is used to increase dispersion and absorption of the rituximab when used subcutaneously.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Individual must receive at least ONE dose of the intravenous formulation of rituximab prior to initiating therapy with the subcutaneous formulation

Follicular Lymphoma (FL)

1,400 mg/23,400 Units at a fixed dose irrespective of patient’s BSA, according to the following schedules:

Relapsed or Refractory - Weekly for 3 or 7 weeks (i.e., 4 or 8 weeks in total)

Retreatment for Relapsed or Refractory - Weekly for 3 weeks (i.e., 4 weeks in total)

Previously Untreated - Day 1 of Cycles 2–8 of chemotherapy (every 21 days), for up to 7 cycles (i.e., up to 8 cycles in total). In patients with complete or partial response, initiate maintenance treatment 8 weeks following completion of initial therapy. Administer Rituxan Hycela every 8 weeks for 12 doses.

Non-progressing after first line CVP chemotherapy - Following completion of 6–8 cycles of chemotherapy, administer once weekly for 3 weeks (i.e., 4 weeks in total) at 6 month intervals to a maximum of 16 doses.

Diffuse Large B-Cell Lymphoma (DLBCL)

1,400 mg/23,400 Units at a fixed dose irrespective of patient’s BSA

Administer on Day 1 of Cycles 2–8 of chemotherapy for up to 7 cycles (i.e., up to 6-8 cycles in total).  Cycle length is 21 days.

Chronic Lymphocytic Leukemia (CLL)

1,600 mg/26,800 Units, at a fixed dose, irrespective of patient’s BSA.

Administer on Day 1 of Cycles 2–6 (every 28 days) for a total of 5 cycles (i.e., 6 cycles in total). Cycle length is 28 days.

B-Cell NHLs

1,400 mg/23,400 Units, at a fixed dose, irrespective of patient’s BSA.

Administer up to once weekly for 3-7 doses in a 6-month period

Maintenance treatment -  Administer once every 8 weeks

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months and may be renewed for a maximum of 2 years unless otherwise specified

Click here to view DOSAGE 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.

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, the express terms of the health plan will govern.

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).

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). Uses of Monoclonal Antibodies for the Treatment of Non-Hodgkin Lymphoma (2.03.05). Retrieved December 11, 2017 from BlueWeb.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, August). Rituximab/hyaluronidase human, recombinant. Retrieved December 11, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Rituximab and hyaluronidase human. Retrieved December 11, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, June). Center for Drug Evaluation and Research. Rituxan Hycela™ (rituximab and hyaluronidase human) injection, for subcutaneous use. Retrieved June 27, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  2/26/2003

MOST RECENT REVIEW DATE:  2/16/2018

ID_MRx

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.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

INDICATION(S)

MAXIMUM UNITS/DOSE

Follicular Lymphoma (FL)

Relapsed-Refractory - 1,400 mg/23,400 U weekly up to 7 doses

Retreatment for Relapsed/Refractory - 1,400 mg/23,400 U weekly x 3 doses

Previously Untreated - 1,400 mg/23,400 U every 21 days x 7 doses

1,400 mg/23,400 U every 8 weeks x 12 doses (maintenance)

Non-progressing after first line CVP chemotherapy

1,400 mg/23,400 U weekly x 3 doses at 6 month intervals (up to maximum of 16 doses)

Diffuse Large B-Cell Lymphoma (DLBCL)

1,400 mg/23,400 U every 21 days x 7 doses

Chronic Lymphocytic Leukemia (CLL)

1,600 mg/26,800 U every 28 days x 5 doses

B-Cell NHLs

1,400 mg/23,400 U weekly for 3-7 doses in a 6-month period

maintenance treatment -1,400 mg/23,400 U every 8 weeks