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Tocilizumab Intravenous – (M0004)

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Tocilizumab Intravenous – (M0004) Drug and Biologic Coverage Policy Effective Date ............................................... 1/1/2021 Next Review Date ......................................... 1/1/2022 Coverage Policy Number ............................... M0004 Tocilizumab Intravenous Table of Contents Related Coverage Resources Overview .............................................................. 1 COVID-19 Drug/Biologic Therapeutics Coverage Policy ................................................... 1 Immunomodulators – Oral and Subcutaneous FDA Approved Indications ................................... 3 (Employer Group Benefit Plans) Recommended Dosing ........................................ 3 Immunomodulators – Oral and Subcutaneous General Background ............................................ 5 (Individual and Family Plans) Oncology Medications Coding/Billing Information .................................... 7 References .......................................................... 7 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Overview This coverage policy addresses the use of tocilizumab intravenous (Actemra®) for non-oncology indications. The use of tocilizumab for oncology indications is addressed in a separate coverage policy (Oncology Medications). Please refer to the related coverage policy links above. Coverage Policy Tocilizumab intravenous (Actemra®) is considered medically necessary when any of the following criteria are met: • Chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) OR cytokine release syndrome (CRS) associated with COVID-19 • Inflammatory Arthritis Associated with Checkpoint Inhibitor Therapy and ALL of the following: o Documented failure or intolerance, contraindication per FDA label, intolerance, or not a candidate for ONE steroid (for example, methylprednisolone, prednisone) o Individual developed inflammatory arthritis while receiving a checkpoint inhibitor (for example, Keytruda (pembrolizumab IV infusion), Opdivo (nivolumab IV infusion), Yervoy (ipilimumab IV infusion), Tecentriq (atezolizumab IV infusion), Bavencio (avelumab IV infusion), Imfinzi (durvalumab IV infusion)) Page 1 of 8 Drug and Biologic Coverage Policy: M0004 o Prescribed by, or in consultation with a rheumatologist or an oncologist • Polyarticular Juvenile Idiopathic Arthritis (PJIA) and BOTH of the following: o Individual is 2 years of age or older o Prescribed by, or in consultation with a rheumatologist or a prescriber who specializes in PJIA • Rheumatoid arthritis and BOTH of the following: o Documented failure or inadequate response, contraindication per FDA label, intolerance, or not a candidate for ONE disease-modifying anti-rheumatic drug (DMARD) (for example, methotrexate, leflunomide, sulfasalazine)† † NOTE: An exception to this requirement can be made if the individual has already tried a biologic. These individuals are not required to “step back” and try a DMARD. o Prescribed by, or in consultation with a rheumatologist or a prescriber who specializes in rheumatoid arthritis • Still’s Disease and ALL of the following o Documented failure or intolerance, contraindication per FDA label, intolerance, or not a candidate to ONE corticosteroid (for example, prednisone)† o Documented failure or intolerance, contraindication per FDA label, intolerance, or not a candidate to ONE conventional synthetic disease-modifying antirheumatic drug (DMARD) (for example, methotrexate) given for at least 2 months† † NOTE: An exception to this requirement can be made if the individual has already tried a biologic. These individuals are not required to “step back” and try a steroid or a conventional synthetic DMARD. o Prescribed by, or in consultation with a rheumatologist or a prescriber who specializes in Still’s Disease • Systemic Juvenile Idiopathic Arthritis (SJIA) and the following: o Prescribed by, or in consultation with a rheumatologist or a prescriber who specializes in Systemic Juvenile Idiopathic Arthritis (SJIA) For Chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) OR cytokine release syndrome (CRS) associated with COVID-19, authorization is for 1 week (4 doses only) For all other covered uses, initial authorization is up to 12 months. Tocilizumab intravenous (Actemra) is considered medically necessary for continued use when the individual has had a positive response to tocilizumab intravenous. Reauthorization for up to 12 months. When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy. Tocilizumab intravenous (Actemra) is considered experimental, investigational or unproven for ANY other use including the following: • Concomitant use with any other biologic including all non-tumor necrosis factor (non-TNF) biologics, anti-TNF biologics, or oral immunomodulatory agents (for example, Otezla or Xeljanz/ Xeljanz XR) • Crohn’s Disease Note: Receipt of sample product does not satisfy any criteria requirements for coverage. Page 2 of 8 Drug and Biologic Coverage Policy: M0004 FDA Approved Indications Rheumatoid Arthritis (RA) Actemra (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) – subcutaneous only Actemra (tocilizumab) is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (PJIA) Actemra (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Systemic Juvenile Idiopathic Arthritis (SJIA) Actemra (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Cytokine Release Syndrome (CRS) Actemra (tocilizumab) is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older. Recommended Dosing FDA Recommended Dosing Rheumatoid Arthritis Actemra may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs as an intravenous infusion or as a subcutaneous injection. Recommended Intravenous Dosage Regimen: The recommended dosage of Actemra for adult patients given as a 60-minute single intravenous drip infusion is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response. • Reduction of dose from 8 mg per kg to 4 mg per kg is recommended for management of certain dose- related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see Dosage and Administration (2.9), Warnings and Precautions (5.3), and Adverse Reactions (6.1)]. • Doses exceeding 800 mg per infusion are not recommended in RA patients [see Clinical Pharmacology (12.3)]. Recommended Subcutaneous Dosage Regimen: Patients less than 100 kg weight 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response Patients at or above 100 kg weight 162 mg administered subcutaneously every week When transitioning from Actemra intravenous therapy to subcutaneous administration administer the first subcutaneous dose instead of the next scheduled intravenous dose. Interruption of dose or reduction in frequency of administration of subcutaneous dose from every week to every other week
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