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Abatacept (Orencia)

Section: Injections
Effective Date: May 01, 2019
Revised Date: April 30, 2019

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 

J0129

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 

L40.0  L40.1  L40.2  L40.3  L40.4  L40.50  L40.51 
L40.52  L40.53  L40.59  L40.8  L40.9  M05.00  M05.011 
M05.012  M05.019  M05.021  M05.022  M05.029  M05.031  M05.032 
M05.039  M05.041  M05.042  M05.049  M05.051  M05.052  M05.059 
M05.061  M05.062  M05.069  M05.071  M05.072  M05.079  M05.09 
M05.20  M05.211  M05.212  M05.219  M05.221  M05.222  M05.229 
M05.231  M05.232  M05.239  M05.241  M05.242  M05.249  M05.251 
M05.252  M05.259  M05.261  M05.262  M05.269  M05.271  M05.272 
M05.279  M05.29  M05.30  M05.311  M05.312  M05.319  M05.321 
M05.322  M05.329  M05.331  M05.332  M05.339  M05.341  M05.342 
M05.349  M05.351  M05.352  M05.359  M05.361  M05.362  M05.369 
M05.371  M05.372  M05.379  M05.39  M05.40  M05.411  M05.412 
M05.419  M05.421  M05.422  M05.429  M05.431  M05.432  M05.439 
M05.441  M05.442  M05.449  M05.451  M05.452  M05.459  M05.461 
M05.462  M05.469  M05.471  M05.472  M05.479  M05.49  M05.50 
M05.511  M05.512  M05.519  M05.521  M05.522  M05.529  M05.531 
M05.532  M05.539  M05.541  M05.542  M05.549  M05.551  M05.552 
M05.559  M05.561  M05.562  M05.569  M05.571  M05.572  M05.579 
M05.59  M05.60  M05.611  M05.612  M05.619  M05.621  M05.622 
M05.629  M05.631  M05.632  M05.639  M05.641  M05.642  M05.649 
M05.651  M05.652  M05.659  M05.661  M05.662  M05.669  M05.671 
M05.672  M05.679  M05.69  M05.70  M05.711  M05.712  M05.719 
M05.721  M05.722  M05.729  M05.731  M05.732  M05.739  M05.741 
M05.742  M05.749  M05.751  M05.752  M05.759  M05.761  M05.762 
M05.769  M05.771  M05.772  M05.779  M05.79  M05.80  M05.811 
M05.812  M05.819  M05.821  M05.822  M05.829  M05.831  M05.832 
M05.839  M05.841  M05.842  M05.849  M05.851  M05.852  M05.859 
M05.861  M05.862  M05.869  M05.871  M05.872  M05.879  M05.89 
M05.9  M06.00  M06.011  M06.012  M06.019  M06.021  M06.022 
M06.029  M06.031  M06.032  M06.039  M06.041  M06.042  M06.049 
M06.051  M06.052  M06.059  M06.061  M06.062  M06.069  M06.071 
M06.072  M06.079  M06.08  M06.09  M06.1  M06.20  M06.211 
M06.212  M06.219  M06.221  M06.222  M06.229  M06.231  M06.232 
M06.239  M06.241  M06.242  M06.249  M06.251  M06.252  M06.259 
M06.261  M06.262  M06.269  M06.271  M06.272  M06.279  M06.28 
M06.29  M06.30  M06.311  M06.312  M06.319  M06.321  M06.322 
M06.329  M06.331  M06.332  M06.339  M06.341  M06.342  M06.349 
M06.351  M06.352  M06.359  M06.361  M06.362  M06.369  M06.371 
M06.372  M06.379  M06.38  M06.39  M06.80  M06.811  M06.812 
M06.819  M06.821  M06.822  M06.829  M06.831  M06.832  M06.839 
M06.841  M06.842  M06.849  M06.851  M06.852  M06.859  M06.861 
M06.862  M06.869  M06.871  M06.872  M06.879  M06.88  M06.89 
M06.9  M08.00  M08.011  M08.012  M08.019  M08.021  M08.022 
M08.029  M08.031  M08.032  M08.039  M08.041  M08.042  M08.049 
M08.051  M08.052  M08.059  M08.061  M08.062  M08.069  M08.071 
M08.072  M08.079  M08.08  M08.09  M08.20  M08.211  M08.212 
M08.219  M08.221  M08.222  M08.229  M08.231  M08.232  M08.239 
M08.241  M08.242  M08.249  M08.251  M08.252  M08.259  M08.261 
M08.262  M08.269  M08.271  M08.272  M08.279  M08.28  M08.29 
M08.3  M08.40  M08.411  M08.412  M08.419  M08.421  M08.422 
M08.429  M08.431  M08.432  M08.439  M08.441  M08.442  M08.449 
M08.451  M08.452  M08.459  M08.461  M08.462  M08.469  M08.471 
M08.472  M08.479  M08.48  M08.80  M08.811  M08.812  M08.819 
M08.821  M08.822  M08.829  M08.831  M08.832  M08.839  M08.841 
M08.842  M08.849  M08.851  M08.852  M08.859  M08.861  M08.862 
M08.869  M08.871  M08.872  M08.879  M08.88  M08.89  M08.90 
M08.911  M08.912  M08.919  M08.921  M08.922  M08.929  M08.931 
M08.932  M08.939  M08.941  M08.942  M08.949  M08.951  M08.952 
M08.959  M08.961  M08.962  M08.969  M08.971  M08.972  M08.979

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.