Anthem Blue Cross California Orencia (abatacept) Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of Orencia (abatacept), a selective costimulation modulator which inhibits T cell (T lymphocyte) activation. Abatacept is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis. It is available in intravenous and subcutaneous injection formulations. Rheumatoid Arthritis: The American College of Rheumatology (ACR) guidelines recommend disease-modifying antirheumatic drug (DMARD) monotherapy as first-line treatment in individuals with RA with moderate to high disease activity. Methotrexate (MTX) monotherapy, titrated to a dose of at least 15 mg, is recommended over hydroxychloroquine, sulfasalazine, and leflunomide. Methotrexate monotherapy is also recommended over monotherapy with biologics (tumor necrosis factor inhibitors [TNFi], IL-6 inhibitors, abatacept) or JAK inhibitors. For individuals taking maximally tolerated doses MTX who are not at target, the addition of a biologic or JAK inhibitor is recommended. Non-TNFi biologics or JAK inhibitors are conditionally recommended over TNFi in individuals with heart failure. Psoriatic Arthritis: The American College of Rheumatology (ACR) guidelines recommend that initial treatment of patients with active severe PsA or concomitant psoriasis should include a TNFi biologic over an oral small molecule (OSM; including methotrexate, sulfasalazine, cyclosporine, leflunomide, and apremilast). For initial therapy, OSMs are preferred over IL-17 and ustekinumab; and may be considered over TNFi biologics in mild to moderate disease without comorbid conditions or in those who prefer oral therapy. Recommendations involving biologics over OSMs as first line therapy are conditional and based on low quality evidence. Evidence cited includes indirect comparisons of placebo-controlled trials, studies with open-label design, and extrapolation from studies in plaque psoriasis. Furthermore, most pivotal trials for TNFi biologics included a study population that were DMARD experienced. Overall, there is a lack of definitive evidence for the safety and efficacy of biologic drugs over conventional therapy for the initial treatment of most patients with psoriatic arthritis. The ACR guidelines also include recommendations for patients whose disease remains active despite treatment with an OSM. Here, TNFi biologics are recommended over other therapies including IL-17 inhibitors, ustekinumab, tofacitinib, and abatacept. When TNFi biologics are not used, IL-17 inhibitors are preferred over ustekinumab; both of which are preferred over tofacitinib and abatacept. For disease that remains active despite TNFi monotherapy, switching to a different TNFi is recommended over other therapies. Juvenile Idiopathic Arthritis: The American College of Rheumatology (ACR) guidelines provide recommendations for juvenile idiopathic arthritis, including systemic disease (SJIA) and JIA with polyarthritis (PJIA). SJIA is an autoinflammatory condition marked by intermittent fever, rash, and arthritis. PJIA is marked by the presence of more than four affected joints in the first six months of illness. For SJIA, NSAIDs or glucocorticoids are conditionally recommended as initial monotherapy, depending on whether macrophage activation syndrome (MAS) is present or not. IL-1 inhibitors (anakinra or canakinumab), or tocilizumab are also conditionally recommended as initial therapy or to achieve inactive disease, with no preferred agent. For SJIA without MAS, IL-1 inhibitors (anakinra or canakinumab) and tocilizumab are strongly recommended for inadequate response to or intolerance of NSAIDs and/or glucocorticoids (ACR 2021). For children with active polyarthritis, biologic therapy including TNFi, abatacept, or tocilizumab +/- DMARD is recommended following initial DMARD therapy (preferably methotrexate) (ACR 2019). Graft Versus Host Disease (GVHD): Acute GVHD is a common complication of hematopoietic stem cell transplantation (HSCT) that frequently occurs soon after transplantation. This occurs when immune cells from the donor recognize and attack the transplant recipient, manifesting in an immune reaction present in the skin, gastrointestinal tract, and/or liver. While transplant recipients receive intensive immunosuppressive regimens, GVHD is associated with a significant decrease in survival and may not respond to treatment. There is no standard GVHD prophylaxis regimen, and clinical practice varies by institution. Agents for pharmacologic prophylaxis include methotrexate, calcineurin inhibitors (cyclosporine or tacrolimus), and mycophenolate mofetil. Orencia is FDA approved for the prophylaxis of acute GVHD in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing HSCT from a matched or 1 allele-mismatched unrelated- donor. It is administered via intravenous infusion starting the day before transplantation (Day -1), followed by administration on days 5, 14, and 28 after transplantation. Orencia is not indicated for the treatment of acute or chronic GVHD. 1 Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Orencia (abatacept) I. Initial requests for Orencia (abatacept) may be approved if the following criteria are met: Rheumatoid arthritis (RA) when each of the following criteria are met: A. B. C. Individual is 18 years of age or older with moderate to severe RA; AND Individual has had an inadequate response to methotrexate titrated to maximally tolerated dose (ACR 2021); OR If methotrexate is not tolerated, individual has had an inadequate response to, or is intolerant of other conventional therapy (sulfasalazine, leflunomide, or hydroxychloroquine); OR Individual has a contraindication to methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine; D. OR II. OR III. OR IV. OR V. OR VI. Polyarticular juvenile idiopathic arthritis (PJIA) when each of the following criteria are met: A. B. Individual has moderate to severe PJIA; AND Individual is 6 years of age and older for administration of intravenous infusion, or 2 years of age and older for administration of subcutaneous injection; AND Individual has had an inadequate response to, or is intolerant of conventional therapy [nonbiologic DMARDs, such as methotrexate)] (ACR 2019); OR Individual has a contraindication to methotrexate; C. D. Psoriatic arthritis (PsA) when each of the following criteria are met: A. B. Individual is 2 years of age or older with moderate to severe PsA; AND Individual has had an inadequate response to, or is intolerant of conventional therapy [nonbiologic DMARDs (such as methotrexate, sulfasalazine, cyclosporine or leflunomide)] (ACR 2019); OR Individual has a contraindication to methotrexate, sulfasalazine, cyclosporine, and leflunomide; C. Acute Graft Versus Host Disease (GVHD), prophylaxis, when each of the following criteria are met: A. B. Individual is 2 years of age or older using for prophylaxis of acute GVHD; AND Individual will be undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor; AND Individual is using Orencia (abatacept) in combination with a calcineurin inhibitor and methotrexate; D. Chronic Graft-versus-host disease (GVHD) when each of the following criteria are met (NCCN 2A): A. B. Individual has a diagnosis of steroid-refractory chronic GVHD; AND Individual is initiating abatacept in combination with systemic corticosteroids; Immune checkpoint inhibitor therapy-related toxicities when each of the following criteria are met (NCCN 2A): Individual is undergoing immune checkpoint inhibitor therapy for a cancer diagnosis; AND A. B. Individual is experiencing immunotherapy-related myocarditis; AND C. Myocarditis is unresponsive to high-dose systemic corticosteroids. Continuation requests for Orencia (abatacept) may be approved if the following criteria are met: I. II. Individual has been receiving and is maintained on a stable dose of Orencia; AND There is confirmation of clinically significant improvement or stabilization in clinical signs and symptoms of the disease. Requests for Orencia (abatacept) may not be approved if the following criteria are met: I. II. III. In combination with topical or oral JAK inhibitors, ozanimod, etrasimod, apremilast, deucravacitinib, or any of the following biologic immunomodulators: TNF antagonists, IL-23 inhibitors, IL-17 inhibitors, vedolizumab, ustekinumab, IL-1 inhibitors, IL-6 inhibitors, rituximab or natalizumab; OR ; OR Tuberculosis, other active serious infections, or a history of recurrent infections [repeat testing not required for ongoing authorization]; OR 2 IV. If initiating therapy, individual has not had a tuberculin skin test (TST) or a Centers for Disease Control (CDC-) and Prevention -recommended equivalent to evaluate for latent tuberculosis (unless switching therapy from another targeted immune modulator and no new risk factors); OR V. When the above criteria are not met and for all other indications. Step Therapy Note: When Orencia is deemed approvable based on the clinical criteria above, the benefit plan may have additional criteria requiring the use of a preferred1 agent or agents. Orencia Step Therapy A list of the preferred targeted immune modulators by indication is available here. Requests for Orencia may be approved if the following criteria are met: I. Individual has been receiving and is maintained on a stable dose of Orencia; OR II. OR III. OR IV. Individual has had a trial and inadequate response or intolerance to two (2) preferred agents; Orencia may be approved for polyarticular juvenile idiopathic arthritis (PJIA) or rheumatoid arthritis (RA) if individual has either concomitant clinical condition: A. Demyelinating disease; OR B. Heart failure with documented left ventricular dysfunction; Orencia may be approved if requesting for graft versus host disease (GVHD) (acute or chronic) or immune checkpoint inhibitor therapy-related toxicity. 1Preferred, as used herein, refers to agents that were deemed to be clinically comparable to other agents in the same class or disease category but are preferred based upon clinical evidence and cost effectiveness. Quantity Limits Orencia (abatacept) Quantity Limits Orencia 250 mg/vial (for IV use) Orencia 50 mg/0.4 mL, 87.5 mg/0.7 mL, 125 mg/mL prefilled syringe/ClickJect™ autoinjector (for S.C. use) Override Criteria Drug Limit 4 vials per 28 days 4 syringes/autoinjectors per 28 days *Initiation of intravenous therapy: For RA, PJIA, or PsA, May approve 4 (four) additional vials (250 mg/vial) in the first 28 days (4 weeks) of treatment. For GVHD, May approve up to 4 vials (250 mg/vial) per infusion for a total of 4 (four) infusions starting the day before transplantation (day -1), followed by administration on days 5, 14, and 28 after transplantation. Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J0129 Injection, abatacept, 10 mg [Orencia] ICD-10 Diagnosis L40.50-L40.59 Arthropathic psoriasis 3 M05.00-M05.9 Rheumatoid arthritis with rheumatoid factor M06.00-M06.09 Rheumatoid arthritis without rheumatoid factor M06.4 Inflammatory polyarthropathy M06.80-M06.9 Other specified and unspecified rheumatoid arthritis M08.00-M08.09 Unspecified juvenile rheumatoid arthritis M08.20-M08.29 Juvenile rheumatoid arthritis with systemic onset M08.3 Juvenile rheumatoid polyarthritis (seronegative) M08.40-M08.48 Pauciarticular juvenile rheumatoid arthritis Document History Revised: 11/17/2023