Description

Abatacept (Orencia) is a selective co-stimulation modulator that inhibits T cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes, implicated in the pathogenesis of rheumatoid arthritis. Activated T lymphocytes are found in the synovium of patients with rheumatoid arthritis.

The intravenous formulation is covered under the medical benefit; please refer to pharmacy policies for coverage of the subcutaneous formulation.

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.

Intravenous (IV) Injection

Rheumatoid Arthritis (RA)
Abatacept (Orencia) IV may be considered medically necessary for the treatment of moderately to severely active RA 

When ALL of the following indications are met: 

• Abatacept (Orencia) IV is to be used in reducing the signs and symptoms and inhibiting the progression of structural damage in adults (greater than or equal to 18 years of age) with moderate to severe active rheumatoid arthritis; and
• Treatment with at least one non-biologic disease modifying anti-rheumatic drug (DMARD) (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, or cyclosporine) was ineffective or not tolerated, or at least one non-biologic DMARDs is contraindicated; and
• Treatment with at least two (2) of the preferred biologic products, Adalimumab (Humira), Etanercept (Enbrel) or Golimumab (Simponi) was ineffective or not tolerated, or two of these preferred products are contraindicated; and
• Medication history indicated a subsequent trial and failure of Tofacitinib/tofacitinib extented release (Xeljanz/Xeljanz XR) after separate trial and failure of two preferred biologic agents Humira, Enbrel or Simponi or there is a documented intolerance, FDA labeled contraindication or hypersensitivity to Xeljanz/Xeljanz XR. 

Juvenile Idiopathic Arthritis (JIA)/Juvenile Rheumatoid Arthritis (JRA)

Abatacept (Orencia) IV may be considered medically necessary for the treatment of moderately to severely active JIA/JRA 

When ALL of the following indications are met: 

• Abatacept (Orencia) IV is to be used for reducing the signs and symptoms of moderately to severely active JIA/JRA in patients greater than or equal to six (6) years of age; and
• Treatment with both adalimumab (Humira) or etanercept (Enbrel) has been ineffective or not tolerated, or both of these preferred products are contraindicated. 

Psoriatic Arthritis (PsA)

• Abatacept (Orencia) IV may be considered medically necessary for the treatment of active psoriatic arthritis 
• When ALL of the following are met: 
  • Abatacept (Orencia) IV is to be used in the treatment of adults with active psoriatic arthritis; and
  • Treatment with at least one (1) nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, or cyclosporine) was
    ineffective or not tolerated, or at least one nonbiologic DMARDs is contraindicated; and
  • Treatment with at least three (3) of the following preferred products was ineffective or not tolerated, or three of these preferred products are
    contraindicated: 
    • Adalimumab (Humira) 
    • Etanercept (Enbrel) 
    • Ustekinumab (Stelara) 
    • Secukinumab (Cosentyx) 
    • Golimumab (Simponi) 

Not Medically Necessary
Abatacept (Orencia) is considered not medically necessary for an individual with ANY ONE of the following: 

• Using abatacept in combination with tumor necrosis factor (TNF) antagonists or other biologic RA therapy, such as anakinra (Kineret); or
• Tuberculosis or other active serious infections or a history of recurrent infections; or
• Individual has not had a tuberculin skin test (TST) or Centers for Disease Control (CDC)-recommended equivalent to rule out latent tuberculosis; or
• The patient tests positive for the hepatitis B virus. 

Abatacept (Orencia) is considered experimental/investigational for ALL other indications not listed in this policy and therefore non-covered. Scientific evidence does not support its use for any other indications.

Procedure Codes 

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 

Links

I-90

1. Orencia® (abatacept) package insert. Bristol-Myers Squibb Company, Princeton, NJ. 06/2017.
2. Schiff M. Subcutaneous abatacept for the treatment of rheumatoid arthritis. Rheumatology. 2013;52(6):986-997.
3. Pieper J, Herrath J, Raghavan S, et al. CTLA4-Ig (abatacept) therapy modulates T-cell effector functions in autoantibody-positive rheumatoid arthritis patients. BMC Immunology. 2013;14:34.
4. Schiff M, Weinblatt M, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Annals of Rheumatic Diseases. 2013;203843.
5. Hanson R, Gannon M, Khamo N, et al. Improvement in safety monitoring of biologic response modifiers after the implementation of clinical care guidelines by a specialty pharmacy service in an academic health system. Journal of Management Care Pharmacology. 2013;19(1):49-67.
6. Alten R, Kaine J, Keystone E, et al. Long-term safety of subcutaneous abatacept in rheumatoid arthritis: Integrated analysis of clinical trial data representing more than four years of treatment. Arthritis & Rheumatology. 2014;66(8):1987–1997.
7. Nüßlein, H, Alten R, Galeazzi M, et al. Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: A 6-month interim analysis of the 2- year, observational, prospective ACTION study. BMC Musculoskeletal Disorders. 2014;15:14.
8. Emery P, Burmester G, Bykerk V, et al. Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period. Ann Rheum Dis. 2015;74(1):19-26.
9. Schiff M. Subcutaneous abatacept for the treatment of rheumatoid arthritis. Rheumatology (Oxford). 2013;52(6):986–997.
10. Rieke A, Kaine J, Keystone E, et al. Long-term safety of subcutaneous abatacept in rheumatoid arthritis: Integrated analysis of clinical trial data representing more than four years of treatment. Arthritis Rheumatology. 2014;66(8):1987–1997.
11. Tsuboi H, Matsumoto I, Hagiwara S, et al. Efficacy and safety of abatacept for patients with Sjögren’s syndrome associated with rheumatoid arthritis: Rheumatoid arthritis with orencia Trial toward Sjögren’s syndrome Endocrinopathy (ROSE) trial — an open-label, one-year, prospective study — Interim analysis of 32 patients for 24 weeks. Modern Rheumatology. 2015;25(2):187–93.
12. Ursini F, Russo E, Hribal M, et al. Abatacept improves whole-body insulin sensitivity in rheumatoid arthritis. Medicine. 2015;94(21):e888.
13. Singh J, Saag K, Bridges S, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care & Research. 2016;68(1):1-26.
14. Ringold S, Weiss P, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: Recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis & Rheumatism. 2013;65(10):2499-2512.
15. Keating G. Abatacept: A Review of its Use in the Management of Rheumatoid Arthritis. Drugs. 2013;73(10):1095-1119.
16. Smolen J, Wollenhaupt J, Westhovens R, et al. Attainment and characteristics of clinical remission according to the new ACR-EULAR criteria in abatacept-treated patients with early rheumatoid arthritis: new analyses from the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE). Arthritis Research & Therapy. 2015;17:157.
17. Wells AF, Jodat N, Schiff M. A critical evaluation of the role of subcutaneous abatacept in the treatment of rheumatoid arthritis: patient considerations. Bio Targ and Ther. 2014;41-55.
18. Malaviya AP, Ostor AJK. Drug adherence to biologic DMARDS with a special emphasis on the benefits of subcutaneous abatacept. Patient Prefer Adherence. 2012;589-596.
19. Polinski JM, Kowal MK, Gagnon M, et al. Home infusion: safe clinically effective, patient preferred, and cost saving. Healthcare. 2016.
20. ASHP Guidelines on Home Infusion Pharmacy Services, 2013. Accessed September 2, 2017.
21. MICROMEDEX®SOLUTIONS Compendia. 2017. Abatacept.
22. Clinical Pharmacology Compendia. [database online]. Tampa FL: Gold Standard, Inc. Abatacept.
23. MCG™ Care Guidelines, 21st edition, 22nd edition, 2018, Home Infusion Therapy, CMT: MT0009(SR).
24. Maggi L, Cimaz R, Capone M, et al. Immunosuppressive Activity of Abatacept on Circulating T Helper Lymphocytes from Juvenile Idiopathic Arthritis Patients. Int Arch Allergy Immunol. 2016;171:45-53.