Status Active Medical and Behavioral Health Policy Section: Medicine Policy Number: II-161 Effective Date: 04/20/2015 Blue Cross and Blue Shield of Minnesota medical policies do not imply that members should not receive specific services based on the recommendation of their provider. These policies govern coverage and not clinical practice. Providers are responsible for medical advice and treatment of patients. Members with specific health care needs should consult an appropriate health care professional. ABATACEPT (ORENCIA®) Description: Abatacept (Orencia®) is a selective co-stimulation modulator that inhibits T cell activation. Activated T cells are implicated in the development of rheumatoid arthritis (RA). Abatacept (Orencia®) has received FDA approval for the following indications: Moderately to severely active RA in adults. Abatacept may be used as a monotherapy or concomitantly with disease modifying antirheumatic drugs (DMARDs) other than TNF antagonists. Abatacept is approved in intravenous and subcutaneous formulations for treatment of RA in adults. Moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in pediatric patients 6 years of age and older. Abatacept may be used as monotherapy or concomitantly with methotrexate. Only the intravenous formulation is approved for treatment of JIA. FDA labeling includes a limitation on use stating that abatacept should not be given concomitantly with TNF antagonists. Definitions: Disease Modifying Antirheumatic Drug (DMARD): This term refers to a group of drugs that are not related by drug class or mechanism of action, but are each used to treat RA and other inflammatory diseases to slow damage to joints. Non-Biologic DMARDs: The most common DMARDs are chemical or non-biologic and include methotrexate, sulfasalazine, hydroxychloroquine, and leflunomide. Less frequently used medications include gold salts, azathioprine, and cyclosporine. Biologic DMARDs: Biologic agents are biologic response modifiers that target a particular protein that contributes to RA. In addition to abatacept, biologic DMARDs include B-cell inhibitors [e.g., rituximab (Rituxan®)], interleukin-1 inhibitors [e.g., anakinra (Kineret®)], and tumor necrosis factor (TNF) antagonists which belong to a class of biologics that block TNF alpha, a cytokine produced by macrophages and T cells. TNF alpha is a key mediator of inflammation and is produced in response to infection and immunologic injury. TNF antagonists include: Adalimumab (Humira®) Certolizumab pegol (Cimzia®) Etanercept (Enbrel®) Golimumab (Simponi®) Infliximab (Remicade®) Policy: I. Abatacept may be considered MEDICALLY NECESSARY for treatment of the following: A. Rheumatoid Arthritis 1. Intravenous or subcutaneous formulation as monotherapy or concomitantly with a non-biologic disease modifying antirheumatic drug (DMARD) when ALL of the following indications are met: a. Moderately to severely active rheumatoid arthritis in adults (e.g., swollen, tender joints with limited range of motion); and b. After consultation with a rheumatologist; and c. Failure, contraindication, or intolerance to at least one non-biologic disease modifying anti-rheumatic drug (DMARD); and d. Abatacept is not used in combination with another biologic DMARD; OR 2. Moderately to severely active rheumatoid arthritis in adults when the patient has a history of beneficial response to abatacept. B. Polyarticular Juvenile Idiopathic Arthritis (JIA) 1. Intravenous formulation as monotherapy or concomitantly with methotrexate when ALL of the following indications are met: a. Moderately to severely active polyarticular juvenile idiopathic arthritis ( e.g., swollen, tender joints with limited range of motion); and b. Patient is six years of age or older; and c. After consultation with a rheumatologist; and d. Failure, contraindication, or intolerance to at least one non-biologic DMARD; and e. Abatacept is not used in combination with another biologic DMARD; OR 2. Moderately to severely active polyarticular JIA when the patient has a history of beneficial response to abatacept. II. Coverage: Abatacept is considered INVESTIGATIVE for all other indications, including but not limited to the following due to a lack of published clinical evidence establishing the role of abatacept in the treatment of these conditions. A. Rheumatoid arthritis in patients under age 18 B. Juvenile idiopathic arthritis in patients under age 6 C. Concomitant administration of abatacept with a TNF antagonist D. Ankylosing spondylitis E. Behçet’s disease F. Crohn’s disease G. Giant cell arteritis H. Graft versus host disease I. Multiple sclerosis J. Polymyalgia rheumatica K. Psoriasis vulgaris L. Psoriatic arthritis M. Sarcoidosis N. Scleroderma O. Systemic lupus erythematosus P. Systemic vasculitis (e.g., Wegener’s granulomatosis and Takayasu’s arteritis) Q. Type I diabetes R. Ulcerative colitis S. Uveitis Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. Medicaid products and some self-insured plans may have additional policies and prior authorization requirements. Receipt of benefits is subject to all terms and conditions of the member’s summary plan description (SPD). As applicable, review the provisions relating to a specific coverage determination, including exclusions and limitations. Blue Cross reserves the right to revise, update and/or add to its medical policies at any time without notice. For Medicare NCD and/or Medicare LCD, please consult CMS or National Government Services websites. Refer to the Pre-Certification/Pre-Authorization section of the Medical Behavioral Health Policy Manual for the full list of services, procedures, prescription drugs, and medical devices that require Pre-certification/Pre-Authorization. Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met. Coding: The following codes are included below for informational purposes only, and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. CPT: J0129 Injection, abatacept, 10 mg Policy History: Developed February 13, 2013 Most recent history: Reviewed February 12, 2014 Revised February 11, 2015 Cross Reference: Infliximab, II-97 Current Procedural Terminology (CPT®) is copyright 2014 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. Copyright 2015 Blue Cross Blue Shield of Minnesota.
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