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Tocilizumab (Actemra)

Section: Injections
Effective Date: April 01, 2020

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

J3262

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

J3262

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

M05.00 M05.011 M05.012 M05.019 M05.021 M05.022 M05.029
M05.031 M05.032 M05.039 M05.041 M05.042 M05.049 M05.051
M05.052 M05.059 M05.061 M05.062 M05.069 M05.071 M05.072
M05.079 M05.09 M05.111 M05.112 M05.121 M05.122 M05.131
M05.132 M05.141 M05.142 M05.151 M05.152 M05.161 M05.162
M05.171 M05.172 M05.19 M05.20 M05.211 M05.212 M05.219
M05.221 M05.222 M05.229 M05.231 M05.232 M05.239 M05.241
M05.242 M05.249 M05.251 M05.252 M05.259 M05.261 M05.262
M05.269 M05.271 M05.272 M05.279 M05.29 M05.30 M05.311
M05.312 M05.319 M05.321 M05.322 M05.329 M05.331 M05.332
M05.339 M05.341 M05.342 M05.349 M05.351 M05.352 M05.359
M05.361 M05.362 M05.369 M05.371 M05.372 M05.379 M05.39
M05.40 M05.411 M05.412 M05.419 M05.421 M05.422 M05.429
M05.431 M05.432 M05.439 M05.441 M05.442 M05.449 M05.451
M05.452 M05.459 M05.461 M05.462 M05.469 M05.471 M05.472
M05.479 M05.49 M05.50 M05.511 M05.512 M05.519 M05.521
M05.522 M05.529 M05.531 M05.532 M05.539 M05.541 M05.542
M05.549 M05.551 M05.552 M05.559 M05.561 M05.562 M05.569
M05.571 M05.572 M05.579 M05.59 M05.60 M05.611 M05.612
M05.619 M05.621 M05.622 M05.629 M05.631 M05.632 M05.639
M05.641 M05.642 M05.649 M05.651 M05.652 M05.659 M05.661
M05.662 M05.669 M05.671 M05.672 M05.679 M05.69 M05.70
M05.711 M05.712 M05.719 M05.721 M05.722 M05.729 M05.731
M05.732 M05.739 M05.741 M05.742 M05.749 M05.751 M05.752
M05.759 M05.761 M05.762 M05.769 M05.771 M05.772 M05.779
M05.79 M05.80 M05.811 M05.812 M05.819 M05.821 M05.822
M05.829 M05.831 M05.832 M05.839 M05.841 M05.842 M05.849
M05.851 M05.852 M05.859 M05.861 M05.862 M05.869 M05.871
M05.872 M05.879 M05.89 M05.9 M06.00 M06.011 M06.012
M06.019 M06.021 M06.022 M06.029 M06.031 M06.032 M06.039
M06.041 M06.042 M06.049 M06.051 M06.052 M06.059 M06.061
M06.062 M06.069 M06.071 M06.072 M06.079 M06.08 M06.09
M06.1 M06.20 M06.211 M06.212 M06.219 M06.221 M06.222
M06.229 M06.231 M06.232 M06.239 M06.241 M06.242 M06.249
M06.251 M06.252 M06.259 M06.261 M06.262 M06.269 M06.271
M06.272 M06.279 M06.28 M06.29 M06.30 M06.311 M06.312
M06.319 M06.321 M06.322 M06.329 M06.331 M06.332 M06.339
M06.341 M06.342 M06.349 M06.351 M06.352 M06.359 M06.361
M06.362 M06.369 M06.371 M06.372 M06.379 M06.38 M06.39
M06.4 M06.80 M06.811 M06.812 M06.819 M06.821 M06.822
M06.829 M06.831 M06.832 M06.839 M06.841 M06.842 M06.849
M06.851 M06.852 M06.859 M06.861 M06.862 M06.869 M06.871
M06.872 M06.879 M06.88 M06.89 M06.9 M08.00 M08.011
M08.012 M08.019 M08.021 M08.022 M08.029 M08.031 M08.032
M08.039 M08.041 M08.042 M08.049 M08.051 M08.052 M08.059
M08.061 M08.062 M08.069 M08.071 M08.072 M08.079 M08.08
M08.09 M08.20 M08.211 M08.212 M08.219 M08.221 M08.222
M08.229 M08.231 M08.232 M08.239 M08.241 M08.242 M08.249
M08.251 M08.252 M08.259 M08.261 M08.262 M08.269 M08.271
M08.272 M08.279 M08.28 M08.29 M08.3 M08.40 M08.411
M08.412 M08.419 M08.421 M08.422 M08.429 M08.431 M08.432
M08.439 M08.441 M08.442 M08.449 M08.451 M08.452 M08.459
M08.461 M08.462 M08.469 M08.471 M08.472 M08.479 M08.48
M08.80 M08.811 M08.812 M08.819 M08.821 M08.822 M08.829
M08.831 M08.832 M08.839 M08.841 M08.842 M08.849 M08.851
M08.852 M08.859 M08.861 M08.862 M08.869 M08.871 M08.872
M08.879 M08.88 M08.89 M08.90 M08.911 M08.912 M08.919
M08.921 M08.922 M08.929 M08.931 M08.932 M08.939 M08.941
M08.942 M08.949 M08.951 M08.952 M08.959 M08.961 M08.962
M08.969 M08.971 M08.972 M08.979 M08.98 M08.99 M31.5
M31.6 R65.10 R65.11 T45.1X5A T45.1X5D T45.1X5S T80.90XA
T80.90XD T80.90XS

Professional Statements and Societal Positions Guidelines

NA

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