Description

Golimumab is a tumor necrosis factor (TNF) blocker. Golimumab is efficacious for a variety of inflammatory conditions. Golimumab neutralizes the biological activity of TNF-alpha by binding to it and blocking its interaction with cell surface TNF receptors. TNF-alpha is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.

The intravenous formulation which is FDA-approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis 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.

Golimumab (Simponi Aria) for Intravenous (IV) Use

Golimumab (Simponi Aria) intravenous injection (IV) may be considered medically necessary when an individual meets the following criteria:

Ankylosing Spondylitis (AS)

• The individual is 18 years of age or older with active AS; 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 two different NSAIDs used in the treatment of AS for at least a 4-week total trial; or
  • The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL NSAIDs used in the treatment of AS; 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 AS; 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 golimumab (Simponi Aria) 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 (e.g., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months; or
  • The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents 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 PsO (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 OR Otezla 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 golimumab (Simponi Aria)with another biologic immunomodulator or apremilast (Otezla).

Rheumatoid Arthritis (RA)

• The individual is 18 years of age or older with moderately to severely active rheumatoid arthritis;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 a documented 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 golimumab (Simponi Aria) with another biologic immunomodulator.

The use of golimumab (Simponi Aria) 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

Reauthorization Criteria

Continuation of therapy with golimumab (Simponi Aria) may be considered medically necessary when the following criteria are met:

• The individual has previously been approved for golimumab (Simponi Aria) 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).
  
  

Golimumab (Simponi Aria) 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

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

Covered Diagnosis Codes for J1602 (Simponi Aria)

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Original Effective Date: July 1, 2018

Internal Medical Policy Committee 3-16-2020 Simponi non-preferred as of 1/1/2020, updated policy to reflect this change, added reauthorization criteria, added diagnosis codes

Internal Medical Policy Committee 5-19-2020 Removed preferred product language, updated criteria language 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.