Golimumab (Simponi®, Simponi Aria®) is a tumor necrosis factor (TNF) blocker. Golimumab (Simponi, Simponi Aria) is efficacious for a variety of inflammatory conditions. Golimumab (Simponi, Simponi Aria) 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.

Golimumab (Simponi) for Subcutaneous (SC) Use

Golimumab (Simponi) subcutaneous injection (SC) may be considered medically necessary when an individual meets the criteria for ANY ONE of the following indications:

• Ankylosing Spondylitis (AS):
  • The individual is 18 years of age or older with AS; and
  • Treatment with at least one (1) nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated; and
  • Treatment with two (2) preferred biologic products (etanercept [Enbrel®], adalimumab [Humira®], or secukinumab [Cosentyx®]) was ineffective or not tolerated; or
• Psoriatic Arthritis (PsA):
  • Spinal or Axial PsA
    • The individual is 18 years of age or older with predominant spinal or axial PsA; and
    • Treatment with at least one (1) non-steroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated or all NSAIDs are contraindicated; and
    • Treatment with at least two (2) preferred biologic products (etanercept [Enbrel], adalimumab [Humira], secukinumab [Cosentyx], apremilast [Otezla®], ustekinumab [Stelara®] SC or tofacitinib [Xeljanz®, Xeljanz XR]) was ineffective or not tolerated; or
  • PsA without Spinal or Axial Disease
    • The individual is 18 years of age or older with active PsA; and
    • Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated; and
    • Treatment with two (2) preferred biologic products (etanercept [Enbrel], adalimumab [Humira], secukinumab [Cosentyx], apremilast [Otezla], ustekinumab [Stelara] SC or tofacitinib [Xeljanz, Xeljanz XR]) was ineffective or not tolerated; or
  • Enthesitis and/or Dactylitis associated PsA
    • The individual is 18 years of age or older with active enthesitis and/or dactylitis associated with PsA; and
    • Treatment with at least one (1) non-steroidal anti-inflammatory drug (NSAID) or local glucocorticoid injection was ineffective or not tolerated or all NSAIDs and all local glucocorticoid injections are contraindicated; and
    • Treatment with at least two (2) preferred biologic products (etanercept [Enbrel], adalimumab [Humira], apremilast [Otezla], secukinumab [Cosentyx], ustekinumab [Stelara] SC or tofacitinib [Xeljanz, Xeljanz XR]) was ineffective or not tolerated; or
• Rheumatoid Arthritis (RA):
  • The individual is 18 years of age or older with moderately to severely active RA; and
  • Treatment with at least one (1) nonbiologic disease modifying anti-rheumatic drug (DMARD) (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated; and
  • Treatment with at least two (2) preferred biologic products (tocilizumab [Actemra®] SC, etanercept [Enbrel], adalimumab [Humira], upadacitinib [Rinvoq™], or tofacitinib [Xeljanz or Xeljanz XR]) was ineffective or not tolerated; or
• Ulcerative Colitis (UC):
  • The individual is 18 years of age or older with moderately to severely active UC; and
  • Treatment with at least one (1) preferred biologic product (adalimumab [Humira®]) was ineffective or not tolerated.

The use of golimumab (Simponi) for any other indication is considered experimental/investigational and, therefore, non-covered. Scientific evidence has not established the effectiveness for any other indication.

Golimumab (Simponi Aria) for Intravenous (IV) Use

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

• Ankylosing Spondylitis (AS):
  • The individual is 18 years of age or older; and
  • Treatment with at least 1 NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated; or
• Polyarticular Juvenile Idiopathic Arthritis (PJIA):
  • The individual is 2 years of age and older; or
• Psoriatic Arthritis (PsA):
  • Spinal or Axial PsA:
    • The individual is 2 years of age or older with predominant spinal or axial PsA; and
    • Treatment with at least 1 NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated; or
  • PsA without Spinal or Axial Disease:
    • The individual is 2 years of age or older with active PsA; and
    • Treatment with at least 1 non-biologic DMARD was in effective or not tolerated, or all non-biologic DMARDS are contraindicated; or
  • Enthesitis and/or Dactylitis associated Psoriatic Arthritis
    • The individual is 2 years of age or older with active enthesitis and/or dactylitis associated with PsA; and
    • Treatment with at least 1 NSAID or local glucocorticoid injection was ineffective or not tolerated or all NSAIDs and all local glucocorticoid injections are contraindicated; or
• Rheumatoid Arthritis (RA):
  • The individual is 18 years of age or older with moderately to severely active RA in combination with methotrexate, or another DMARD if contraindication to methotrexate; and
  • Treatment with at least 1 non-biologic DMARD was ineffective or not tolerated, or all non-biologic DMARDS are contraindicated.

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.

Reauthorization Criteria

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

·         The individual has one of the above diagnoses; and

·         Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy; and

·         Reauthorization valid for 12 months.

Golimumab (Simponi, 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.

Golimumab (Simponi Aria) may be considered medically necessary for individuals 18 years of age and older when applicable clinical criteria for individual medication policies are met and when administered in a physician’s office not affiliated with a hospital, specialized infusion centers not affiliated with a hospital or in the home. 

Outpatient facility (Outpatient Hospital IV Infusion Department or Hospital-based Outpatient Clinical Level of Care) administration may be considered medically necessary if ANY of the following criteria are present to indicate the member is medically unstable for infusions in other than an outpatient facility setting:

• Member’s home is considered unsuitable for care by the home infusion provider; or
• Individual’s medical status requires enhanced monitoring beyond that which would routinely be needed for infusion therapy; or
• Previous severe adverse reaction (including but not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) during or following administration of prescribed medication despite standard pre-medication; or
• Individual is receiving other medications that require close monitoring with a higher level of care (e.g., cytotoxic chemotherapy or blood products); or
• Individual is at high risk for complications due to medication administration (e.g., at risk for post-transplant complications, increased risk of infusion reactions due to presence of circulating antibodies, unstable vascular access, cardiopulmonary condition at risk for severe adverse reactions, unstable renal function with inability to safely tolerate IV volume loads, etc.); or 
• Individual is initiating therapy or re-initiating therapy after a period of at least 6 months with no therapy; or
• Physically and/or cognitively impaired AND a home caregiver is not available to comply with the required treatment regimen and schedule.

Home health services may be considered medically necessary when utilized for the administration of home infusion therapy and when provided by licensed eligible provider. Each case will be addressed on an individual basis.

The medications identified in this policy will be considered not medically necessary if administered in an unapproved hospital outpatient setting when an approved site of care is a viable option for treatment.

Note: If an individual has already had a trial of at least one biologic agent, they are not required to “step back” and try a non-biologic agent.

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. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Golimumab (Simponi, Simponi Aria) is not to be used in combination with any other TNF blocker. 

The administration of Golimumab (Simponi or Simponi Aria) 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.

Evidence-based guidelines support the administration of injectable medications in alternative sites of care such as the non-hospital physician’s office, non-hospital infusion center or in the home.  Administration of the injectable medications subject to this policy at alternate sites of care is based upon the professional judgment of the provider, and takes into account the clinical appropriateness for each individual member. Requests for administration of any dose of the drugs listed in this policy received from a hospital-based facility, physician’s office or specialized infusion center will be assessed for meeting the policy exception criteria based on the clinical documentation provided by the requesting practitioner.