Golimumab (Simponi Aria)

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

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

J1602

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

J1602

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)

L40.50 L40.51 L40.52 L40.53 L40.59 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 M06.4 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 M45.0 M45.1 M45.2 M45.3 M45.4
M45.5 M45.6 M45.7 M45.8 M45.9 M48.8X1 M48.8X2
M48.8X3 M48.8X4 M48.8X5 M48.8X6 M48.8X7 M48.8X8 M48.8X9

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

Links

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.