Drug and Biologic Coverage Policy Effective Date ........................................... 1/1/2021 Next Review Date ......................................... 1/1/2022 Coverage Policy Number ............................... M0006 Abatacept Intravenous Table of Contents Related Coverage Resources Overview .............................................................. 1 Immunomodulators – Oral and Subcutaneous Coverage Policy ................................................... 1 (Employer Group Benefit Plans) FDA Approved Indications ................................... 2 Immunomodulators – Oral and Subcutaneous Recommended Dosing ........................................ 3 (Individual and Family Plans) General Background ............................................ 4 Coding/ Billing Information ................................... 6 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 intravenous abatacept (Orencia®). The use of subcutaneous abatacept is addressed in separate coverage policies [Immunomodulators – Oral and Subcutaneous (Employer Group Benefit Plans) and Immunomodulators – Oral and Subcutaneous (Individual and Family Plans)]. Please refer to the related coverage policy link above. Coverage Policy Abatacept intravenous (Orencia®) is considered medically necessary when any of the following criteria are met: • Polyarticular Juvenile Idiopathic Arthritis (PJIA) and BOTH of the following: o Individual is 6 years of age or older o Prescribed by, or in consultation with a rheumatologist or a prescriber who specializes in PJIA • Psoriatic arthritis and BOTH of the following: Page 1 of 7 Medical Benefit Injectable Clinical Criteria: M006 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, dermatologist or a prescriber who specializes in psoriatic arthritis • 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 conventional synthetic DMARD o Prescribed by or in consultation with a rheumatologist or a prescriber who specializes in rheumatoid arthritis Coverage for abatacept intravenous (Orencia) varies across plans. Refer to the customer’s benefit plan document for coverage details. Where coverage requires the use of preferred products, the following criteria apply. For Employer Group Benefit Plans and Individual and Family Plans: Documented failure or inadequate response, contraindication per FDA label, intolerance, or not a candidate for TWO self-administered immunomodulators Initial authorization is up to 12 months. Abatacept intravenous (Orencia) is considered medically necessary for continued use when the individual has had a positive response to abatcept 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. Abatacept intravenous (Orencia) 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) • Ankylosing Spondylitis (AS) • Inflammatory Bowel Disease (i.e., Crohn’s Disease [CD], Ulcerative Colitis [UC]) • Psoriasis Note: Receipt of sample product does not satisfy any criteria requirements for coverage. FDA Approved Indications Adult Rheumatoid Arthritis (RA) Orencia is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Orencia may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists. Page 2 of 7 Medical Benefit Injectable Clinical Criteria: M006 Juvenile Idiopathic Arthritis Orencia is indicated for reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Orencia may be used as monotherapy or concomitantly with methotrexate (MTX). Adult Psoriatic Arthritis (PsA) Orencia is indicated for the treatment of adult patients with active psoriatic arthritis (PsA). Important Limitations of Use Orencia should not be administered concomitantly with TNF antagonists. Orencia is not recommended for use concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra. Recommended Dosing FDA Recommended Dosing Indication FDA Recommended Dosing Adult For adult patients with RA, Orencia may be administered as an intravenous infusion or as a Rheumatoid subcutaneous injection. Orencia may be used as monotherapy or concomitantly with DMARDs Arthritis other than TNF antagonists. (RA) Intravenous Dosing Regimen Orencia lyophilized powder should be reconstituted and administered after dilution as a 30- minute intravenous infusion utilizing the weight range based dosing specified in the package insert. Following the initial intravenous administration, an intravenous infusion should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter. Dose of Orencia for Intravenous Infusion in Adult RA Patients Body Weight Dose Number of Vials Less than 60 kg 500 mg 2 60 to 100 kg 750 mg 3 More than 100 kg 1000 mg 4 Each vial provides 250 mg of abatacept for administration. Subcutaneous Dosing Regimen Orencia 125 mg in prefilled syringes or in Orenica ClickJect autoinjector should be administered by subcutaneous injection once weekly and may be initiated with or without an intravenous loading dose. For patients initiating therapy with an intravenous loading dose, Orencia should be initiated with a single intravenous infusion (as per body weight categories listed in Table 1), followed by the first 125 mg subcutaneous injection administered within a day of the intravenous infusion. Patients transitioning from Orencia intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose. Juvenile For patients with juvenile idiopathic arthritis (JIA), Orencia may be administered as an Idiopathic intravenous infusion (6 years of age and older) or a subcutaneous injection (2 years of age and Arthritis older). Intravenous dosing has not been studied in patients younger than 6 years of age. Orencia may be used as monotherapy or concomitantly with methotrexate. Intravenous Dosing Regimen Orencia should be administered as a 30-minute intravenous infusion based on body weight. Pediatric patients with: • body weight less than 75 kg should be administered Orencia at a dose of 10 mg/kg Page 3 of 7 Medical Benefit Injectable