Abatacept (Orencia)

Section: Injections
Effective Date: June 01, 2020
Revised Date: May 13, 2020
Last Reviewed: May 19, 2020

Description

Abatacept (Orencia®) is a fully human recombinant fusion protein categorized as a costimulatory or second-signal blocker of T cell activation. Abatacept (Orencia) disrupts the activation pathway of T cells causing a disturbance in key mechanisms of inflammation and progression joint destruction in inflammatory diseases.

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.

Abatacept (Orencia) for Intravenous (IV) Use

Polyarticular Juvenile Idiopathic Arthritis (PJIA):

  • The individual is six (6) years of age or older with moderately to severely active PJIA; and
  • ONE of the following:
    • Information has been provided that indicates the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; or
    • The prescriber states the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
    • The individual has tried and had an inadequate response to ONE conventional agent (i.e., azathioprine, cyclosporine, intra-articular glucocorticoids, methotrexate, leflunomide, sulfasalazine, NSAIDs, COX-2 [celecoxib]) used in the treatment of PJIA for at least 3-months; or
    • The individual has an intolerance, FDA labeled contraindication or hypersensitivity to ALL of the following conventional agents (i.e., methotrexate, leflunomide) used in the treatment of PJIA; or
    • The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of PJIA; and
  • The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
  • The individual will NOT be using abatacept (Orencia) with another biologic immunomodulator.

Psoriatic Arthritis (PsA):

  • The individual is 18 years of age or older with active PsA; and
  • ONE of the following:
    • Information has been provided that indicates the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; or
    • The prescriber states the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
    • The individual has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, hydroxychloroquine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months; or
    • The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA; or
    • The individual has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive); or
    • The individual has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences); or
    • The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of PsA; and
  • The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
  • The individual will NOT be using abatacept (Orencia) with another biologic immunomodulator or apremilast (Otezla).

Rheumatoid Arthritis (RA):

  • The individual is 18 years of age or older with moderately to severely active RA; and
  • ONE of the following:
    • Information has been provided that indicates the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; or
    • The prescriber states the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
    • The individual has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) for at least 3-months; or
    • The individual has tried and had an inadequate response to another conventional agent (e.g., hydroxychloroquine, leflunomide, or sulfasalazine) used in the treatment of RA for at least 3-months; or
    • The individual has an intolerance, FDA labeled contraindication or hypersensitivity to ALL conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, and sulfasalazine) used in the treatment of RA; or
    • The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of RA; and
  • The prescriber is a specialist in the area of the individual’s diagnosis (e.g., rheumatologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
  • The individual will NOT be using abatacept (Orencia) with another biologic immunomodulator.

Procedure Codes 

J0129

Reauthorization Criteria

Continuation of therapy with abatacept (Orencia) may be considered medically necessary when the following criteria are met:

  • The individual has been previously approved for abatacept (Orencia) through Blue Cross Blue Shield of North Dakota's precertification process; and
  • The prescriber has provided documentation that the individual has demonstrated disease stability or beneficial response to therapy; and
  • The individual will NOT be using the requested agent with another biologic immunomodulator agent or apremilast (Otezla).

Abatacept (Orencia) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

Procedure Codes

J0129

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

  • 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 individual 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

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Original Effective Date July 1, 2018

Internal Medical Policy Committee 5-19-2020 Removed preferred product language, updated description, added additional criteria to match other biologic immunomodulator medical policies

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.