50242-0135-XX Actemra 80 MG/4ML SOLN (GENENTECH)
50242-0136-XX Actemra 200 MG/10ML SOLN (GENENTECH)
50242-0137-XX Actemra 400 MG/20ML SOLN (GENENTECH)
Tocilizumab is a recombinant interleukin 6 (IL-6) receptor monoclonal antibody classified as a disease modifying antirheumatic drug. It binds specifically to soluble and membrane-bound IL-6 receptors and has been shown to block IL-6-mediated signaling through these receptors. IL-6 is a pro-inflammatory cytokine produced by a variety of cell types, including synovial and endothelial cells in joints affected by inflammatory processes.
Tocilizumab (Intravenous) for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Castleman’s disease (pol)
Cytokine Release Syndrome (CRS)
Rheumatoid arthritis (RA)
Juvenile idiopathic arthritis systemic (SJIA) or polyarticular (PJIA) disease
Immune Checkpoint Inhibitor Related Arthritis
Tocilizumab (Intravenous) for the treatment of other conditions/diseases is considered investigational.
Tocilizumab (Intravenous) for the treatment of the following is considered medically appropriate if ALL of the following:
Individual has been evaluated and screened for the presence of latent TB infection prior to initiating treatment
Individual does not have an active infection, including localized infections
Is not administered concurrently with live vaccines
Individual is not on concurrent treatment with a TNF inhibitor, other biologic response modifier, e.g., anakinra, or non-biologic agent, e.g., apremilast, tofacitinib, baricitinib
Diagnosis of ANY ONE of the following:
Castleman’s Disease (NHL) if ANY ONE of the following:
Unicentric disease if ALL of the following:
Used as second-line single agent therapy
Disease is relapsed or refractory
Individual is human immunodeficiency virus (HIV)-negative and human herpesvirus-8 (HHV-8)-negative
Multicentric disease if ALL of the following:
Used as subsequent therapy as single agent therapy
Relapsed, refractory or progressive disease
Cytokine Release Syndrome (CRS) if ALL of the following:
Individual is 2 years of age or older
Patienthas received or will be receiving chimeric antigen receptor T- cell therapy (CAR-T therapy) and ANY ONE of the following:
Tocilizumab is being ordered to have on-hand, prior to the administration of CAR-T therapy, if needed for the treatment of CRS
Individual has a confirmed diagnosis of chimeric antigen receptor T-cell (CAR-T) induced severe or life-threatening cytokine release syndrome
Immune Checkpoint Inhibitor Related Arthritis (immunotherapy-related inflammatory arthritis) management if individual has ALL of the following:
Diagnosis of inflammatory arthritis related to immunotherapy with an immune checkpoint inhibitor (e.g. nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, etc.)
Documented severe disease
Condition is refractory to corticosteroids and anti-inflammatory agents
Juvenile idiopathic arthritis systemic (SJIA) or polyarticular (PJIA) disease; if ALL of the following: Individual is 2 years of age or older
Disease is active systemic (SJIA) or polyarticular (PJIA) disease
Physician has assessed baseline disease severity utilizing an objective measure/tool
Individual has had at least a one month trial and failure (unless contraindicated or intolerant) of previous therapy with either oral non-steroidal anti-inflammatory drugs (NSAIDs) OR a systemic glucocorticoid (prednisone, methylprednisolone, etc.)
Administration is ANY ONE of the following:
In combination therapy with methotrexate
Rheumatoid arthritis if ALL of the following:
Individual is 18 years of age or older
BCBST requirement: Prior trial and failure of ANY ONE of the following agents is required:
Golimumab for intravenous infusion
Physician has assessed baseline disease severity utilizing an objective measure/tool
Disease is moderately to severely active
Individual has had inadequate response to at least a 3 month trial of one or more oral DMARD (disease modifying anti-rheumatic drug) (e.g., methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, leflunomide, etc.)
May be used alone or in combination with methotrexate
Tocilizumab (Intravenous) is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Individual is receiving ongoing monitoring for TB or other active infections
Absence of unacceptable toxicity from the agent, e.g., neutropenia (absolute neutrophil count (ANC) below 1000 per mm3), thrombocytopenia (platelet count below 100,000 per mm3), hepatotoxicity (ALT or AST above 3-5 times the upper limit of normal), gastrointestinal perforation, severe hypersensitivity reactions, demyelinating disorders, etc.
For a diagnosis of ANY ONE of the following:
Castleman’s Disease (NHL) if tumor response is indicated with stabilization of disease or decrease in size of tumor or tumor spread
Cytokine Release Syndrome may NOT be renewed
Immune-Checkpoint Inhibitor Related Arthritis Management may not be renewed
Juvenile Idiopathic Arthritis (SJIA),(PJIA) with disease response as indicated by improvement in signs and compared to baseline such as the number of tender and swollen joint counts and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Juvenile Arthritis Disease Activity Score (JADAS) or the American College of Rheumatology (ACR) Pediatric (ACR-Pedi 30) of at least 30% improvement from baseline in three of six variables]
Rheumatoid arthritis (RA) with disease response as indicated by improvement in signs and compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein,
improvement of patient global assessment, and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Disease Activity Score-28 (DAS28) of 1.2 points or more or a ≥20% improvement on the American College of Rheumatology-20 (ACR20) criteria]
DOSAGE & ADMINISTRATION
Doses exceeding 800 mg per infusion are not recommended
Adult Rheumatoid Arthritis
4 mg/kg IV every 4 weeks
May increase to 8 mg/kg every 4 weeks based on clinical response
Polyarticular Juvenile Idiopathic Arthritis
Weight ≥ 30 kg - 8 mg/kg IV every 4 weeks
Weight < 30 kg - 10 mg/kg IV every 4 weeks
Systemic Juvenile Idiopathic Arthritis
Weight ≥ 30 kg - 8 mg/kg IV every 2 weeks
Weight < 30 kg - 12 mg/kg IV every 2 weeks
Castleman’s Disease (NHL)
8 mg/kg IV every 2 weeks for 16 weeks (8 doses)
Cytokine Release Syndrome (CRS)
Weight ≥ 30 kg - 8 mg/kg IV every 8 hours, if needed, up to a maximum of 4 total doses*
Weight < 30 kg -12 mg/kg IV every 8 hours, if needed, up to a maximum of 4 total doses*
*If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, up to 3 additional doses may be administered. The interval between consecutive doses should be at least 8 hours. May be used with or without corticosteroids.
Immune-Checkpoint Inhibitor Related Inflammatory Arthritis
4 mg/kg IV ONE TIME
LENGTH OF AUTHORIZATION
Coverage will be provided for Castleman’s Disease for 4 months and may be renewed;
Coverage will be provided for Cytokine Release Syndrome for 4 doses only and may not be renewed;
Coverage will be provided for Immune Checkpoint Inhibitor related arthritis for 1 dose only and may not be renewed;
All other indications, coverage will be provided for 6 months and may be renewed.
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.
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.
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 tocilizumab for the treatment or prevention of other conditions or diseases.
Lexi-Comp Online. (2018). AHFS DI. Tocilizumab. Retrieved November 15, 2017 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, October). Tocilizumab. Retrieved November 20, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Tocilizumab. Retrieved September 17, 2018 from the National Comprehensive Cancer Network.
Ringold, S., Weiss P.F., Beukelman T., DeWitt, E.M., Ilowite, N.T., Kimura, Y., et al. (2013, October). 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis & Rheumatism 65(10), 2499-512. Retrieved June 1, 2017 from https://www.rheumatology.org/Portals/0/Files/2013%20Update%20of%20the%202011%20ACR%20Recommendations%20for%20the%20Treatment%20of%20Juvenile%20Idiopathic%20Arthritis.pdf.
U. S. Food and Drug Administration. (2018, September). Center for Drug Evaluation and Research. Actemra® (tocilizumab) injection, for intravenous or subcutaneous use. Retrieved September 17, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf.
ORIGINAL EFFECTIVE DATE: 7/10/2010
MOST RECENT REVIEW DATE: 4/2/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg