Tocilizumab
DESCRIPTION
Tocilizumab is a recombinant interleukin 6 (IL-6) receptor monoclonal antibody classified as a disease modifying antirheumatic. 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.
An example of a preparation of tocilizumab is ActemraŽ.
REFER TO DECISION SUPPORT TREE
POLICY
Tocilizumab for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Rheumatoid arthritis
Systemic juvenile idiopathic arthritis (SJIA)
Tocilizumab for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Tocilizumab for the treatment of the following conditions is considered medically appropriate if ALL the following criteria are met:
Rheumatoid arthritis if ALL of the following:
Individual is 18 years of age or older
Disease is moderately- to severely-active
Individual has had inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies (e.g., etanercept, infliximab, adalimumab or anakinra)
Systemic juvenile idiopathic arthritis (SJIA) if ALL of the following:
Individual is 2 years of age or older
Disease is active
Administration is ANY ONE of the following:
Monotherapy
In combination therapy with methotrexate
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
In a review of the published literature, no controlled studies were found to validate the use of tocilizumab in the treatment or prevention of any other condition or disease.
SOURCES
Lexi-Comp Online. (2011). AHFS DI. Tocilizumab. Retrieved June 3, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2011). Tocilizumab. Retrieved June 3, 2011 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2011, May). Center for Drug Evaluation and Research. ActemraŽ (tocilizumab). Retrieved June 3, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf.
ORIGINAL EFFECTIVE DATE: 7/10/2010
MOST RECENT REVIEW DATE: 11/16/2011
ID_BT
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.
Pharmaceutical Decision Support Tree
Tocilizumab (ActemraŽ)
Does the individual have a diagnosis of rheumatoid arthritis with ALL of the following?
Individual is 18 years of age or older
Disease is moderately- to severely-active
Individual has had inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies (e.g., etanercept, infliximab, adalimumab or anakinra)
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of systemic juvenile idiopathic arthritis (SJIA) with ALL of the following?
Individual is 2 years of age or older
Disease is active
Administration is ANY ONE of the following:
Monotherapy
In combination with methotrexate
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.