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Golimumab and Related Biosimilars for Intravenous Infusion
MA08.070h

Policy

In the absence of coverage criteria from applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals, or other Medicare coverage documents, this policy uses internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, and/or regulatory status.

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

​Note: This policy only addresses Simponi Aria and Immgolis Intri™, the intravenous (IV) form of golimumab, which is covered under the medical benefits of the Company when the medical necessity criteria listed in this medical policy are met. This policy does not address Simponi®, the subcutaneous form of golimumab, which may be available under any applicable pharmacy benefit.

MEDICALLY NECESSARY

INITIAL THERAPY

Golimumab products for intravenous infusion (Simponi Aria and Immgolis Intri™) are considered medically necessary and, therefore, covered for the following indications when, for each individual indication, all of the associated criteria are met:

Ankylosing Spondylitis (AS)/Radiographic Axial Spondyloarthritis (r-axSpA) 


  • The individual is at least 18 years old.
  • Documentation of failure, contraindication, or intolerance to the following:
    • At least a 4-week trial of two nonsteroidal anti-inflammatory drugs (NSAIDs) at maximum recommended or tolerated anti-inflammatory dose
  • Active or latent tuberculosis (TB) has been ruled out.

Immune Checkpoint Inhibitor–Related Toxicities  


For the management of moderate or severe immunotherapy-related inflammatory arthritis when all of the following criteria are met:

  • If no improvement after holding immunotherapy and treating with oral corticosteroids, or if unable to taper corticosteroids, or no response to conventional synthetic disease-modifying antirheumatic drugs (DMARDs) (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine)
  • Active or latent TB has been ruled out.

Polyarticular Juvenile Idiopathic Arthritis (pJIA)  


  • The individual is at least 2 years old.
  • Documentation of failure, contraindication, or intolerance to at least 2 months of one DMARD (e.g., methotrexate)
  • Active or latent TB has been ruled out.

Psoriatic Arthritis (PsA) 


  • The individual is at least 2 years old.
  • Documentation of failure, contraindication, or intolerance to either of the following:
    • At least a 4-week trial of any NSAIDs at maximum recommended or tolerated anti-inflammatory dose
    • At least a 3-month trial of one DMARD (e.g., methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine)
  • Active or latent TB has been ruled out.

Rheumatoid Arthritis (RA) 

For the treatment of moderately to severely active RA in combination with methotrexate (MTX) (or a different DMARD when MTX is contraindicated or the individual is intolerant [e.g., sulfasalazine, hydroxychloroquine, and leflunomide]) when all of the following criteria are met:

  • The individual is at least 18 years old.
  • The individual has persistent disease despite at least 3 months of MTX.
    • In individuals in whom MTX is contraindicated or the individual is intolerant to MTX, a 3-month trial of a different DMARD (e.g., sulfasalazine, hydroxychloroquine, and leflunomide) is acceptable.
  • Active or latent TB has been ruled out.

CONTINUATION THERAPY    

Golimumab and Related Biosimilars (Simponi Aria and Immgolis Intri™) is considered medically necessary and, therefore, covered for the continuation therapy when the individual meets all of the following: 

  • Individual has met the medical necessity criteria for Initial Therapy    
  • There is documentation of positive clinical response or stabilization to therapy (e.g., improvement in total active [swollen and tender] joint count from baseline, or improvement in symptoms [e.g., pain, stiffness, inflammation] from baseline)
EXPERIMENTAL/INVESTIGATIONAL

All other uses for golimumab and related biosimilars (Simponi Aria and Immgolis Intri™​)​ are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

Guidelines

There is no Medicare coverage determination addressing this drug; therefore, the Company policy is applicable.

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, golimumab (Simponi Aria®) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

For Medicare Advantage members, certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when golimumab (Simponi Aria®) is covered under a member's medical benefit (Part B benefit). It does not address instances when golimumab (Simponi Aria®) is covered under a member’s pharmacy benefit (Part D benefit).​
US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Golimumab (Simponi Aria®​) was approved by the FDA on July 18, 2013, for the treatment of adult individuals with moderately to severely active rheumatoid arthritis, in combination with MTX. Supplemental approvals for golimumab (Simponi Aria®) have since been issued by the FDA.

Immgolis Intri™ (golimumab-sldi) was approved by the FDA on May 15, 2026.  It is the first interchangeable biosimilar to Simponi Aria (golimumab).​​
The safety and effectiveness of golimumab (Simponi Aria®) have been established in pediatric individuals 2 years of age and older with active polyarticular juvenile idiopathic arthritis and psoriatic arthritis. ​

Description

Tumor necrosis factor (TNF) is a naturally occurring cytokine that is involved in inflammatory and immune responses. Elevated TNF levels in the blood, synovium, and joints have been implicated in the pathophysiology of ankylosing spondylitis (AS), psoriatic arthritis (PsA), and rheumatoid arthritis (RA). TNF is an important mediator of the articular inflammation that is characteristic of these diseases. Golimumab (Simponi Aria®) modulated the in vitro biological effects mediated by TNF in several bioassays, including the expression of adhesion proteins responsible for leukocyte infiltration (E-selectin, intercellular adhesion molecule [ICAM]-1, and vascular cell adhesion molecule [VCAM]-1) and the secretion of proinflammatory cytokines (interleukin [IL]-6, IL-8, granulocyte colony-stimulating factor [G-CSF] and granulocyte-macrophage colony-stimulating factor [GM-CSF]). 

Golimumab (Simponi Aria®) is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human tumor necrosis factor-alpha (TNF-α). This interaction prevents the binding of TNF-α to its receptors, thereby inhibiting the biological activity of TNF, a cytokine protein.

Note: Golimumab (Simponi Aria®) is an intravenous formulation that was approved by the US Food and Drug Administration (FDA) on July 18, 2013. There is also a subcutaneous formulation that was approved by the FDA on April 24, 2009.

FDA approval of golimumab-sldi (Immgolis Intri) was based on analytical similarity, PK comparability, immunogenicity and safety assessments, and a Phase 3 clinical equivalence study demonstrating no clinically meaningful differences from the reference golimumab product.​

ANKYLOSING SPONDYLITIS (AS)

The spondyloarthritis (SpA) category of conditions are broken down into two major subtypes: ankylosing spondylitis (AS) and nonradiographic axial SpA (nr-axSpA). AS is a chronic inflammatory disease manifested by back pain and progressive spinal stiffness. AS characteristically affects young adults with a peak age of onset between 20 and 30 years. Although classically thought of as a spinal disease, transient acute arthritis of peripheral joints occurs in up to 50% of affected individuals. In addition, other organs such as the eyes, lungs, heart, and kidneys can be affected.

The FDA approved the intravenous (IV) form of golimumab (Simponi Aria®) on October 20, 2017, for the treatment of adults with active AS.

The safety and efficacy of golimumab (Simponi Aria®) was studied in a phase III, randomized, double-blind, placebo-controlled trial in 208 adults with active AS who had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs) (Deodhar et al., 2018). Participants were randomly assigned (1:1) to receive IV infusions of golimumab (Simponi Aria®) at weeks 0, 4, 12, and every 8 weeks, or placebo at weeks 0, 4, and 12, with crossover to golimumab (Simponi Aria®) at week 16. The primary outcome was the clinical response, measured using the American College of Rheumatology (ACR) response criteria. The results are reported as a percentage of study participants who achieve ACR20 (20% improvement in swollen joints) at week 16. The results showed a statistically significant improvement in the golimumab (Simponi Aria®) group (73% of participants) when compared with the placebo group (26% of participants) (P<0.001).

POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (pJIA) 

Polyarticular juvenile idiopathic arthritis (pJIA) is a subset of JIA and comprises 20% to 30% of all individuals with JIA. The diagnosis of pJIA is made when five or more joints are affected in the first 6 months after disease onset. Management of pJIA may include medications such as corticosteroids, NSAIDs, or disease-modifying antirheumatic drugs (DMARDs), including immunomodulators or biologic agents.

The FDA approved the IV form of golimumab (Simponi Aria®), on September 29, 2020, for the treatment of pediatric individuals 2 years of age and older for the treatment of active pJIA. ​

The efficacy of golimumab (Simponi Aria®) in pediatric individuals with pJIA was based on the pharmacokinetic exposure and extrapolation of the established efficacy of golimumab (Simponi Aria®) ​in individuals with RA. The efficacy was also assessed in a multicenter, open-label, single-arm study in 127 children (2 to <18 years of age) with JIA with active polyarthritis despite treatment with MTX for at least 2 months (Trial pJIA, NCT02277444). The pJIA subtypes included in the study were as follows: rheumatoid factor negative (43%), rheumatoid factor positive (35%), enthesitis­-related arthritis (9%), oligoarticular extended (6%), juvenile psoriatic arthritis (4%), and systemic JIA without systemic manifestations (3%). All individuals received golimumab (Simponi Aria®)​ 80 mg/m2 as an intravenous infusion at week 0, 4, and every 8 weeks through week 52. Participants continued stable doses of MTX weekly through week 28; after week 28, changes in MTX dose were permitted. Efficacy was assessed as supportive endpoints through Week 52. The efficacy was generally consistent with responses in individuals with RA.

PSORIATIC ARTHRITIS (PsA)

Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis. Similarly to rheumatoid arthritis, those with PsA present with pain and stiffness in the affected joints. Morning stiffness lasting more than 30 minutes occurs in one-half of patients. The stiffness is accentuated with prolonged immobility and is alleviated by physical activity. A history of psoriasis is present in about 70% of patients presenting with arthritis.

The FDA approved the IV form of golimumab (Simponi Aria®), on October 20, 2017, for the treatment of adults with active PsA.

The safety and efficacy of golimumab (Simponi Aria®) was studied in a phase III, randomized, double-blind, placebo-controlled trial in 480 adults with active PsA (Kavanaugh et al., 2017). Participants had previously received DMARD therapy (≥3 months) and/or NSAID therapy (≥4 weeks) or demonstrated intolerance to these agents. Participants were randomly assigned (1:1) to receive golimumab (Simponi Aria®) or placebo at weeks 0, 4, 12, and 20. The primary outcome of the study was the percentage of participants who met the ACR 20% improvement criteria (achieving an ACR20 response) at week 14. The results showed a statistically significant improvement in the golimumab (Simponi Aria®) group (75% of participants) when compared with the placebo group (22% of participants) (P<0.001).

The efficacy of golimumab (Simponi Aria®) in pediatric individuals with PsA was based on the pharmacokinetic exposure and extrapolation of the established efficacy of golimumab (Simponi Aria®) in adults with PsA.​
RHEUMATOID ARTHRITIS (RA)

Rheumatoid arthritis (RA) is an autoimmune disease that results in a chronic and systemic inflammatory disorder that affects tissues and organs. RA can cause pain, stiffness, swelling, and limited motion and function of many joints. In RA, the focus of the inflammation is in the synovium, the tissue that lines the joint. Immune cells release inflammation-causing chemicals. These chemicals can damage cartilage (the tissue that cushions between joints) and bone.

The FDA approved an IV form of golimumab (Simponi Aria®) on July 18, 2013, for the treatment of adult individuals with moderately to severely active RA, in combination with methotrexate (MTX).

The FDA's approval of golimumab (Simponi Aria®) is based on a double-blind, placebo-controlled clinical study involving 592 individuals. The study participants were 18 years and older, with moderately to severely active RA, who were simultaneously treated with MTX. The individuals in the study were diagnosed with RA according to the ACR classification criteria 3 months prior to the start of the study. All participants were required to have at least six swollen and six tender joints. These individuals were randomly assigned into either the treatment group (n=395) or the placebo group (n=197). Individuals in the treatment group received golimumab (Simponi Aria®) with MTX. The golimumab (Simponi Aria®) dose regimen administered was 2 mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks thereafter. The placebo group received a placebo with MTX up until week 24. After week 24, individuals in the placebo group, while still blinded, received golimumab (Simponi Aria®) and MTX through week 52.

All participants completed 52 weeks of treatment. Participants were able to continue stable doses of concurrent low-dose corticosteriods (≤10 mg of prednisone a day). The use of other DMARDS, including cytotoxic agents or other biologics, was prohibited.

The clinical response was measured using the ACR response criteria for RA. The ACR criteria are used, in most clinical trials, to assess efficacy of the treatment for RA. The results are reported as a percentage of study participants who achieve ACR20 (20% improvement in swollen joints), ACR50 (50% improvement), and ACR70 (70% improvement) in three of the five criteria:
  • Acute phase reactant (e.g., sedimentation rate)
  • Patient assessment
  • Physician assessment
  • Pain scale
  • Disability/functional questionnaire
Fifty-nine percent of participants in the golimumab (Simponi Aria®) and MTX group achieved an ACR20 at week 14, with 63% achieving ACR20 at week 24. Twenty-five percent of participants in the placebo group achieved an ACR20 at week 14, with 32% achieving ACR20 at week 24. A higher percentage of participants in the treatment group achieved ACR50 and ACR70 when compared with the placebo group at weeks 14 and 24.

The data revealed that treatment with golimumab (Simponi Aria®) plus MTX significantly improved signs and symptoms and physical function at week 24, and inhibited the progression of structural damage in individuals with moderate to severe RA at weeks 24 and 52. A greater percentage of individuals who received golimumab (Simponi Aria®) and MTX had improvements in their RA when compared with the placebo group.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569-2581.

American College of Rheumatology. ACR Preliminary Definition of Improvement in Rheumatoid Arthritis. Arthritis Rheum. 1995;38:727-735.

American College of Rheumatology; Spondylitis Association of America; Spondyloarthritis Research and Treatment Network. 2026 update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network recommendations for the treatment of axial spondyloarthritis in adults and children/adolescents. Published June 2026. Accessed July 24, 2026.

American Hospital Formulary Service (AHFS). Drug Information 2023. Golimumab (Simponi Aria®). [Lexicomp Online Web site]. 04/27/2022. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed July 24, 2026.​​

Beukelman T, Patkar NM, Saag KG.  2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res (Hoboken). 2011;63(4):465-482.

Bingham CO, Mendelsohn AM, Kim L, et al. Maintenance of clinical and radiographic benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: week-112 efficacy and safety results of the open-label long-term extension of a phase III, double-blind, randomized, placebo-controlled trial. Arthritis Care Res. 2015;67:1627-1636.

Bingham CO, Weinblatt M, Han C, et al. The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial. J Rhematol. 2014;41:1067-1076.

Cohen S, Cannella A. Treatment of rheumatoid arthritis in adults resistant to initial conventional synthetic (nonbiologic) DMARD therapy. 04/29/2023. UpToDate. [UpToDate Web site]. Available at: https://www.uptodate.com/contents/treatment-of-rheumatoid-arthritis-in-adults-resistant-to-initial-nonbiologic-dmard-therapy?source=search_result&search=rheumatoid arthritis treatment&selectedTitle=3~150 [via subscription only]. Accessed July 24, 2026.​

Deodhar A, Reveille JD, Harrison DD, et al. Safety and efficacy of golimumab administered intravenously in adults with ankylosing spondylitis: results through week 28 of the GO-ALIVE study. J Rheumatol. 2018;45(3):341-348.

Elsevier’s Clinical Pharmacology Compendium. Golimumab (Simponi Aria®). 01/09/2023. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed July 24, 2026.

Felson DT, Anderson JJ, Boers M, et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. Arthritis Rheum. 1993;36(6):729-740. 

Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021;73(7):924-939. 

Gladman DD, Ritchlin C. Clinical manifestations and diagnosis of psoriatic arthritis.04/12/2023. UpToDate. [UpToDate Web site]. Available at: https://www.uptodate.com/contents/clinical-manifestations-and-diagnosis-of-psoriatic-arthritis?search=PSORIATIC ARTHRITIS&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1 [via subscription only]. Accessed July 24, 2026.

Gladman DD, Ritchlin C. Treatment of psoriatic arthritis. 03/06/2023. UpToDate. [UpToDate Web site]. Available at: https://www.uptodate.com/contents/treatment-of-psoriatic-arthritis?search=PSORIATIC ARTHRITIS&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2#H133947860 [via subscription only]. Accessed July 24, 2026.​

Golimumab (Simponi Aria®). Janssen Biotech, Inc. Golimumab (Simponi Aria®) [Labeling]. 04/2025. Available at: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI+ARIA-pi.pdf. Accessed July 24, 2026.​

Jani M, Barton A, Warren RB, et al. The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory disease. Rheumatology. 2014;53:213-222.

Kavanaugh A, Husni ME, Harrison DD, et al. Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: results through week twenty-four of the GO-VIBRANT study. Arthritis Rheum. 2017;69(11):2151-2161. 

Kremer J, Ritchlin C, Mendelsohn A, et al. Golimumab, a new human anti-tumor necrosis factor alpha antibody, administered intravenously in patients with active rheumatoid arthritis: forty-eight-week efficacy and safety results of a phase III randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2010;62:917-928.

Lexi-Drugs Compendium. Golimumab (Simponi Aria®). 05/09/2023. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed July 24, 2026.

Moreland LW, Cannella A. General principles of management of rheumatoid arthritis in adults. 03/07/2023. UpToDate.[UpToDate Web site]. Available at: https://www.uptodate.com/contents/general-principles-of-management-of-rheumatoid-arthritis-in-adults?source=search_result&search=rheumatoid arthritis treatment&selectedTitle=1~150 [via subscription only]. Accessed July 24, 2026.​​

National Comprehensive Cancer Network (NCCN).  NCCN Clinical Practice Guidelines in Oncology - Management of Immunotherapy-Related Toxicities. V.1.2026. 10/23/2025. [NCCN Web site]. Available at: immunotherapy.pdf (nccn.org) [via free subscription]. Accessed July 24, 2026.​


National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Golimumab (Simponi Aria). [NCCN Web site]. 2026. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed July 24, 2026.​


Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care Res (Hoboken). 2019;71(6):717-734.

Singh JA, Furst DE, Bharat A, et al. 2012 update of the American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64:625-639.

Singh JA, Guyatt G, Ogdie A, et al. Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2019;71(1):2-29. ​​

Singh JA, Saag KG, Bridges SL, et al. 2015 American College of Rheumatology guidelines for the treatment of rheumatoid arthritis. Arthritis Care Res. 2016;68:1-26.

Song IH, Poddubnyy DA, Rudwaleit M, Sieper J. Benefits and risks of ankylosing spondylitis treatment with nonsteroidal antiinflammatory drugs. Arthritis Rheum. 2008;58(4):929-938.

Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73:492-509.

Truven Health Analytics. Micromedex® DrugDex® Compendium. Golimumab. 03/07/2023. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed July 24, 2026.​

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Golimumab (Simponi Aria) [prescribing information]. [FDA Web site]. Original 07/18/13. Updated 04/2025. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed July 24, 2026.

van der Heijde D, Ramiro S, Landewé R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76(6):978-991. 

van der Heijde D, Sieper J, Maksymowych WP, et al. 2010 Update of the international ASAS recommendations for the use of anti-TNF agents in patients with axial spondyloarthritis. Ann Rheum Dis.;70(6):905-908. 

Ward MM, Deodhar A, Akl EA, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2016;68(2):282-298. 

Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613. 

Weinblatt ME, Bingham CO, Mendelsohn AM, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis.2013;72:381-389.

Weinblatt ME, Westhovens R, Mendelsohn AM, et al. Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: results up to 1 year of the phase 3, randomised, multicentre, double blind, placebo controlled GO-FURTHER trial. Ann Rheum Dis. ​2014;73(12):2152-2159. 

Weiss PF. Polyarticular juvenile idiopathic arthritis: Treatment. UpToDate. 01/19/2022. Available at: https://www.uptodate.com/contents/polyarticular-juvenile-idiopathic-arthritis-treatment?search=polyarticular-juvenile-idiopathic-arthritis-treatmen&source=search_result&selectedTitle=2~19&usage_type=default&display_rank=2 [via subscription only]. Accessed July 24, 2026.

Yu DT, van Tubergren A. Treatment of axial spondyloarthritis (ankylosing spondylitis and nonradiographic axial spondyloarthritis) in adults. 05/01/2023. UpToDate. [UpToDate Web site]. Available at: https://www.uptodate.com/contents/treatment-of-axial-spondyloarthritis-ankylosing-spondylitis-and-nonradiographic-axial-spondyloarthritis-in-adults [via subscription only]. Accessed July 24, 2026.​

Coding

CPT Procedure Code Number(s)
N/A
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
See Attachment A.
HCPCS Level II Code Number(s)

J1602 Injection, golimumab, 1 mg, for intravenous use
THE FOLLOWING CODES ARE USED TO REPRESENT Immgolis Intri™​ (golimumab-sldi):
C9399        Unclassified drugs or biologicals
J3590    Unclassified biologics



Revenue Code Number(s)
N/A


Coding and Billing Requirements

Policy History

Revisions From MA08.070h:​
10/19/2026

This version of the policy will become effective 10/19/2026​.

Updated ankylosing spondylitis criteria by removing the disease-modifying antirheumatic drug (DMARD) prerequisite and aligning treatment requirements and references with the 2026 ACR/SAA/SPARTAN axial spondyloarthritis recommendations.

Added golimumab-sldi (Immgolis Intri™), the first biosimilar to Simponi Aria®, following US Food and Drug Administration (FDA) approval.​

The policy title was expanded to include related biosimilars.  

​The following NOC codes have been added to this policy to represent golimumab-sldi (Immgolis Intri™):
  • C9399 Unclassified drugs or biologics
  • J3590 Unclassified biologics​

Revisions From ​MA08.070g:
10/01/2025

This version of the policy will become effective 10/01/2025.

The following ICD-10 CM codes have been added to this policy: 

M05.A Abnormal rheumatoid factor and anti-citrullinated protein antibody with rheumatoid arthritis​​


Revisions From ​MA08.070f:
​08/06/2025
​The ​policy has been reviewed and reissued to communicate the Company's continuing position on golimumab (Simponi Aria) intravenous (IV) injection. ​
​07/10/2024
The ​policy has been reviewed and reissued to communicate the Company's continuing position on golimumab (Simponi Aria) intravenous (IV) injection. ​
​01/01/2024

​Effective 01/01​/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.​
10/30/2023

This version of the policy will become effective 10/30/2023.

This policy has been updated to communicate the Company's coverage position ​for Immune Checkpoint Inhibitor-Related Toxicities, in accordance with the National Comprehensive Cancer Network (NCCN). 

Additionally, Continuation Therapy was added as a policy criterion.


The following ICD-10 CM code has been added to this policy:
M06.4 Inflammatory polyarthropathy 


The following ICD-10 CM codes for Felty's syndrome and rheumatoid arthritis​ have been deleted from this policy, due to unspecified laterality:
M05.019, M05.029, M05.039, M05.049, M05.059, M05.069, M05.079, M05.119, M05.129, M05.139, M05.149, M05.159, M05.169, M05.179, M05.219, M05.229, M05.239, M05.249, M05.259, M05.269, M05.279, M05.319, M05.329, M05.339, M05.349, M05.359, M05.369, M05.379, M05.419, M05.429, M05.439, M05.449, M05.459, M05.469, M05.479, M05.519, M05.529, M05.539, M05.549, M05.559, M05.569, M05.579, M05.619, M05.629, M05.639, M05.649, M05.659, M05.669, M05.679, M05.719, M05.729, M05.739, M05.749, M05.759, M05.769, M05.779, M05.819, M05.829, M05.839, M05.849, M05.859, M05.869, M05.879, M06.019, M06.029, M06.039, M06.049, M06.059, M06.069, M06.079, M06.819, M06.829, M06.839, M06.849, M06.859, M06.869, M06.879.


Revisions From MA08.070e:
10/05/2022The policy has been reviewed and reissued to communicate the Company's continuing position on golimumab (Simponi Aria®) Intravenous (IV) Injection.
​09/08/2021
​This policy has been reissued in accordance with the Company's annual review process.
​12/21/2020
​This policy has been updated to communicate the Company's coverage position in accordance with the newly FDA-approved indication for active polyarticular juvenile idiopathic arthritis (pJIA) in individuals 2 years of age and older. Additionally, the FDA approved the expanded age for psoriatic arthritis (PsA) indication from 18 years and older to 2 years of age and older.​
​

​The following ICD-10 codes were added to Attachment A (Coding Table) of this policy:

​

L40.54 Psoriatic juvenile arthropathy

​​

M08.3 Juvenile rheumatoid polyarthritis (seronegative)


​Revisions From MA08.070d:
10/01/2020

This policy has been identified for the ICD-10 CM code update, effective 10/01/2020.

 

The following ICD-10 CM codes have been added to this policy:


M05.7A Rheumatoid arthritis with rheumatoid factor of other specified site without organ or systems involvement

M05.8A Other rheumatoid arthritis with rheumatoid factor of other specified site

M06.0A Rheumatoid arthritis without rheumatoid factor, other specified site

M06.8A Other specified rheumatoid arthritis, other specified site​​


Revisions From MA08.070c:
03/13/2019This policy has been reissued in accordance with the Company's annual review process.
03/07/2018This policy has undergone a routine review, and the medical necessity criteria have been revised as follows:

Two new FDA-approved indications, ankylosing spondylitis and psoriatic arthritis, have been added to this policy.

Revisions From MA08.070b:
07/12/2017This policy was updated to include Medically Necessary criteria to rule out tuberculosis prior to therapy.

Revisions From MA08.070a:
12/28/2016This version of the policy will become effective 12/28/2016.
  • The following policy requirements have been revised:
    FROM:

    Golimumab (Simponi® Aria™) (IV), in combination with methotrexate, is considered medically necessary and, therefore, covered for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults 18 years of age who have failed at least 3 months of methotrexate.

    TO:

    Golimumab (Simponi Aria®) is considered medically necessary and, therefore, covered for the treatment of moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX) (or a different DMARD when MTX is contraindicated or the individual is intolerant (e.g., sulfasalazine, hydroxychloroquine and leflunomide) when both of the following criteria are met:
    • The individual is at least 18 years old
    • The individual has persistent disease despite at least three months of MTX

    In individuals where MTX is contraindicated or the individual is intolerant to MTX a 3 month trial of a different disease modifying antirheumatic drugs (DMARDs) (e.g., sulfasalazine, hydroxychloroquine and leflunomide) is acceptable.
  • The following ICD-10 codes have been added to this policy:
    M05.019, M05.029, M05.039, M05.049, M05.059, M05.069, M05.079, M05.10, M05.111, M05.112, M05.119, M05.121, M05.122, M05.129, M05.131, M05.132, M05.139, M05.141, M05.142, M05.149, M05.151, M05.152, M05.159, M05.161, M05.162, M05.169, M05.171, M05.172, M05.179, M05.19, M05.219, M05.229, M05.239, M05.249, M05.259, M05.269, M05.279, M05.319, M05.329, M05.339, M05.349, M05.359, M05.369, M05.379, M05.40, M05.419, M05.429, M05.439, M05.449, M05.459, M05.469, M05.479, M05.519, M05.529, M05.539, M05.549, M05.559, M05.569, M05.579, M05.619, M05.629, M05.639, M05.649, M05.659, M05.679, M05.719, M05.729, M05.739, M05.749, M05.759, M05.769, M05.779, M05.819, M05.829, M05.839, M05.849, M05.859, M05.869, M05.879, M06.019, M06.029, M06.039, M06.049, M06.059, M06.069, M06.079, M06.819, M06.829, M06.839, M06.849, M06.859, M06.869, M06.879

Revisions From​ MA08.070:
05/27/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Golimumab (Simponi® Aria™) Intravenous (IV) Injection.
01/01/2015This is a new policy.

10/19/2026
10/19/2026
MA08.070
Medical Policy Bulletin
Medicare Advantage
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.