Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-35-013
Topic: Golimumab (Simponi, Simponi Aria)
Section: Injections
Effective Date: May 28, 2018
Issue Date: May 28, 2018
Last Reviewed: February 2018

Golimumab (Simponi®) subcutaneous injection is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult individuals with moderately-to-severely active rheumatoid arthritis (RA) in combination with methotrexate, adult individuals with active psoriatic arthritis alone or in combination with methotrexate, adult individuals with active ankylosing spondylitis, and adult individuals with ulcerative colitis.

Golimumab (Simponi Aria®) intravenous injection is indicated for the treatment of adult individuals with moderately-to-severely active RA in combination with methotrexate, adult individuals with active psoriatic arthritis alone or in combination with methotrexate, and adult individuals with active ankylosing spondylitis.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

Subcutaneous (SC) injection

Golimumab (Simponi) SQ may be considered medically necessary for the treatment of adults, greater than or equal to 18 years of age, with ANY ONE of the following conditions:

Rheumatoid Arthritis

Psoriatic Arthritis

Ankylosing Spondylitis 

Ulcerative Colitis

Golimumab (Simponi) is considered experimental/investigation and, therefore, non-covered when used in conjunction with another TNF blocker (e.g., Enbrel, Remicade, Humira, Kineret or Orencia.

The use of golimumab (Simponi) is considered experimental/investigational, and therefore, not covered for all other indications. Peer reviewed literature does not support the use of golimumab (Simponi) for any indications other than those listed on this medical policy.

Procedure Codes
J3590


Intravenous (IV) Injection

Golimumab (Simponi Aria) IV may be considered medically necessary for the treatment of adults, greater than or equal to 18 years of age, with ANY ONE of following conditions:

Rheumatoid Arthritis

Psoriatic Arthritis

Ankylosing Spondylitis

Golimumab (Simponi® Aria) IV is considered experimental/investigation and, therefore, non-covered when used in conjunction with another TNF blocker (e.g., Enbrel, Remicade, Humira, Kineret or Orencia).

The use of golimumab (Simponi® Aria) for all other indications is considered experimental/investigational and, therefore, not covered. Peer reviewed literature does not support the use of golimumab (Simponi Aria) for any indications other than those listed on this medical policy.

Procedure Codes
J1602


Refer to pharmacy policy J-558 Chronic Inflammatory Diseases for additional information.

NOTE: Dosage recommendations per the FDA label.



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of Golimumab is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

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If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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