BlueCross BlueShield of Tennessee Medical Policy Manual

Rituximab

NDC CODE(S)

50242-0051-XX Rituxan 100 MG/10ML SOLN (GENENTECH)

 

50242-0053-XX Rituxan 500 MG/50ML SOLN (GENENTECH)

DESCRIPTION

Rituximab is a genetically engineered monoclonal antibody which binds specifically to the human CD20 antigen. The CD20 antigen is expressed on greater than 90% of B-cell non-Hodgkin’s lymphomas and is found on the abnormal B-cells of chronic lymphocytic leukemia (CLL).  Additionally, B-cells expressing the CD20 antigen are believed to play a role in the pathogenesis of rheumatoid arthritis.

In binding with the CD-20 antigen on B lymphocytes, rituximab likely recruits immune effector functions to mediate B-cell lysis, possibly through complement-dependent cytotoxicity (CDC) or antibody-dependent cell mediated cytotoxicity (AIDCC).  Rituximab has also been shown to induce apoptosis in the DHL-4 human B-cell lymphoma line.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

CLL/SLL

Initial therapy - 375 mg/m² weekly x 8 doses; OR 375 mg/m² cycle 1, then 500 mg/m² every 28 days cycles 2-6 (6 total doses)

Renewal therapy - 375 mg/m² once weekly for 4 doses per 6 month period; OR 375mg/ m² every 8 weeks

NHL, CNS Lymphoma, PTLD, Waldenström’s, Castleman’s or HL –

Initial therapy -  375 mg/m2 once weekly for 4 - 8 doses in a 6 month period

Renewal therapy - 375 mg/m² once weekly for 4 doses per 6 month period; OR

375mg/ m² every 8 weeks

                ALL

375 mg/m2 once weekly for 4 - 8 doses in a 6 month period

                RA

1,000 mg on days 1 and 15, repeated up to every 16 weeks

Pemphigus ,GPA, WG, MPA, AIHA or Thrombocytopenia

375 mg/m² weekly x 4 doses in a 6 month period

cGVHD

375 mg/m² weekly x 4 doses, then 375 mg/m² monthly x 4 months

LENGTH OF AUTHORIZATION

Coverage will be provided for an authorization period of 6 months, with renewals not to exceed 2 years, other than for acute lymphoblastic leukemia (ALL), which is NOT eligible for renewal.

Click to see 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).

No controlled studies were found in the published literature that validate the use of rituximab for the treatment or prevention of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). Nononcologic uses of rituximab (5.01.24). Retrieved December 11, 2017 from BlueWeb.

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). Uses of monoclonal antibodies for the treatment of non-Hodgkin’s lymphoma and acute myeloid leukemia in the non-stem cell transplant setting (2.03.05). Retrieved December 11, 2017 from BlueWeb.

Joly, B. S., Coppo, P., Veyradier, A. (2017, May). Thrombotic thrombocytopenic purpura. Blood, 129 (21), 2836-2846.

Lexi-Comp Online. (2017). AHFS DI. Rituximab. Retrieved December 13, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, October). Rituximab. Retrieved December 13, 2017 from MICROMEDEX Healthcare Series.

Moghadam-Kia, S., Aggarwal, S., Oddis, C. V. (2015). Treatment of inflammatory myopathy: emerging therapies and therapeutic targets. Expert Review of Clinical Immunology. (11)11, 1265-1275.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium™. Rituximab. Retrieved December 13, 2017 from the National Comprehensive Cancer Network.

Oddis, C. V., Reed, A. M., Aggarwal, R., Rider, L. G., Ascherman, D. P., Levesque, M. C., et al. (2013, February). Rituximab in the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis: A randomized, placebo-phase trial. Arthritis Rheumatology, 65 (2), 314-324.

Trebst, C., Jarius, S., Berthele, A., Paul, F., Schippling, S., Wildemann, B., et al. (2013). Update on the diagnosis and treatment of neuromyelitis optica: Recommendations of the Neuromyelitis Optica Study Group (NEMOS). Journal of Neurology. (2014) 261, 1-16.

U. S. Food and Drug Administration. (2014, August). Center for Drug Evaluation and Research. Rituxan® (rituximab) injection for intravenous use. Retrieved December 13, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103705s5432lbl.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; 1 billable unit = 100 mg  

INDICATION(S)

MAXIMUM UNITS/DOSE

CLL/SLL

Initial therapy – Loading dose: 10 units x 1 dose,

Subsequent doses: 13 units every 28 days x 5 doses per 6 months

Renewal therapy - 10 units per dose every 8 weeks x 4 doses per 6 months

All other oncology indications

Initial therapy -  10 units per dose weekly x 8 doses per 6 months

Renewal therapy - 10 units per dose every 8 weeks x 4 doses per 6 months

RA

10 units per dose every 14 days x 2 doses in a 16 week period

cGVHD

10 units per dose weekly x 4 doses, then 10 units monthly x 4 months

All other non-oncology indications

10 units per dose weekly x 4 doses in a 6 month period