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, ankylosing spondylitis is covered under the medical benefits; 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 criteria ALL of the following:

1. ONE of the following:

Ankylosing Spondylitis (AS)

• The individual is 18 years of age or older with active AS; and
• ONE of the following:
  • 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 or AHFS for the treatment of AS; and
• Previous medication history indicates separate trials and failure of two preferred agents, Cosentyx (secukinumab), Humira (adalimumab), or Enbrel (etanercept); or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to all the preferred agents; and
• Previous medication history indicates a trial and failure of certolizumab pegol (Cimzia); or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to certolizumab pegol (Cimzia) or

Psoriatic Arthritis (PsA)

• The individual is 18 years of age or older with PsA; and
• ONE of the following:
  • 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 or AHFS for the treatment of PsA; and
• Previous medication history indicates separate trials and failure of two preferred agents, Cosentyx (secukinumab), Humira (adalimumab), Enbrel (etanercept), or Stelara (ustekinumab); or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to all the preferred agents; and
• Previous medication history indicates a trial and failure of certolizumab pegol (Cimzia); or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to certolizumab pegol (Cimzia) or

Rheumatoid Arthritis (RA)

• The individual is 18 years of age or older with moderately to severely active rheumatoid arthritis;and
• ONE of the following:
  • 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 or AHFS for the treatment of RA; and
• Previous medication history indicates separate trials and failure of two preferred agents, Humira (adalimumab), Enbrel (etanercept), or Rinvoq (upadacitinib); or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to all the preferred agents; and
• Previous medication history indicates a trial and failure of certolizumab pegol (Cimzia) or tocilizumab (Actemra); or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to certolizumab pegol (Cimzia) or tocilizumab (Actemra) or
  

  Information has been provided that indicated the individual is currently being treated with golimumab (Simponi Aria) (starting on samples is not approvable); or

  The prescriber states the individual is currently being treated with golimumab (Simponi Aria) (starting on samples is not approvable) andis at risk if therapy is changed and

2. The prescriber is a specialist in the area of the patient’s diagnosisor the prescriber has consulted with a specialist inthe area of the patient’s diagnosis; and

3. One of the following:

• The individual is NOTcurrently being treated with another biologic immunomodulator agent or Otezla; or
• The individual is currently being treated with another biologic immunomodulator agent or Otezla AND will discontinue prior to starting golimumab (Simponi Aria).
  
  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 provider has provided documentation that the individual has demonstrated disease stability or beneficial response to therapy
  
  Reauthorization valid for 12 months.

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

NA