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 

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

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

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 

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

Links

References (PDF)

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.