Description

Tocilizumab (Actemra®) is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody that works to inhibit IL-6 mediated actions at soluble and membrane bound IL-6 receptors. Inhibiting the signaling pathway can lead to inhibition of activated T- and B-cells, lymphocytes, monocytes, and fibroblasts. IL-6 is also produced by synovial and endothelial cells which has an effect on the inflammatory process in rheumatoid arthritis(RA).

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Rheumatoid Arthritis (RA)

Tocilizumab (Actemra) may be considered medically necessary for the treatment of adults with moderately to severely active RA when the individual meets the following:

• Treatment with at least one (1) non-biologic disease-modifying antirheumatic drugs (DMARDs) (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, or cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated; and
• Medication history indicated separate trials and failure of two preferred biologic agents, Humira (adalimumab), Enbrel (etanercept) or Rinvoq (upadacitinib), or there is a documented intolerance, FDA-labeled contraindication or hypersensitivity to two of the preferred agents.

Systemic Juvenile Idiopathic Arthritis (SJIA)

Tocilizumab (Actemra) may be considered medically necessary for the treatment of SJIA in individuals greater than or equal to two (2) years of age and when the individual meets one of the following:

• The individual has tried and had an inadequate response to NSAIDs (e.g., ibuprofen, celecoxib) used in the treatment of SJIA for at least 1-month or
• The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to all NSAIDs used in the treatment of SJIA or
• The individual has tried and had an inadequate response to another conventional agent (e.g., methotrexate, leflunomide, systemic corticosteroids) used in the treatment of SJIA for at least 3-months or
• The individual has a documented intolerance, FDA labeled contraindication or hypersensitivity to all conventional agents used in the treatment of SJIA or
• The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of SJIA

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

Tocilizumab (Actemra) may be considered medically necessary for the treatment of PJIA in individuals greater than or equal to two (2) years of age with moderately to severely active PJIA when the individual meets the following:

• Medication history indicates separate trials and failure of the two preferred biologic agents, Humira (adalimumab) and Enbrel (etanercept), or there is a documented intolerance, FDA labeled contraindication or hypersensitivity to the two preferred biologic agents.

Giant Cell Arteritis (GCA)

Tocilizumab (Actemra) may be considered medically necessary for the treatment of GCA in adult individuals when the individual meets one of the following:

• The individual has tried and has an inadequate response to systemic corticosteroids (e.g. prednisone, methylprednisolone) used in the treatment of GCA for at least 7-10 days or
• The individual has a documented intolerance, FDA labeled contraindication or hypersensitivity to ALL systemic corticosteroids or
• The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of GCA

Cytokine Release Syndrome (CRS)

Tocilizumab (Actemra) may be considered medically necessary for the treatment of CRS for adults and pediatric individuals two (2) years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.

The use of tocilizumab (Actemra) is considered experimental/investigational and, therefore, non-covered for any other indication. Scientific evidence has not established the effectiveness for any other indication.

Procedure Codes

Reauthorization Criteria

Continuation of therapy with tocilizumab (Actemra) may be considered medically necessary when the following criteria are met:

• The individual has been previously approved for tocilizumab (Actemra) through Blue Cross Blue Shield of North Dakota's precertification process; and
• The provider has provided documentation that individual has demonstrated disease stability or beneficial response to therapy;
  
  Reauthorization valid for 12 months.

Tocilizumab (Actemra) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

Procedure Codes

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code: J3262

Professional Statements and Societal Positions Guidelines

NA