Simponi Aria (Golimumab)

Simponi Aria (golimumab) Simponi Aria is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with: ● Moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate ● Active Psoriatic Arthritis (PsA) ● Active Ankylosing Spondylitis (AS) Simponi Aria will be considered for coverage when ALL of the criteria below are met and confirmed with supporting medical documentation. I. Criteria for Initial Approval Rheumatoid Arthritis (RA) ● Patient is 18 years old or older. ● Must be prescribed by, or in consultation with, a specialist in rheumatology. ● Documentation of moderate to severe active disease; AND ○ Patient has failed previous therapy with a oral disease modifying antirheumatic agent (DMARD) such as methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, or leflunomide. ● Documentation that pretreatment screening has occurred; ○ Documentation that the patient has been evaluated and screened for the presence of hepatitis B virus (HBV) prior to initiating treatment, AND ○ Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment, AND ○ Patient does not have any evidence of active infection, including clinically important localized infections. ● Prescribed in combination with methotrexate, unless contraindicated. ● Must not be administered concurrently with live vaccines. 1 ● Patient is not on concurrent treatment with another TNF inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib). Psoriatic Arthritis (PsA) ● Patient is 18 years or older. ● Must be prescribed by, or in consultation with, a specialist in dermatology or rheumatology. ● Documentation of moderate to severe active disease; AND ○ For patients with predominantly axial disease OR active enthesitis and/or dactylitis, an adequate trial and failure of a non-steroidal anti-inflammatory agents (NSAIDs), unless use is contraindicated; OR ○ For patients with peripheral arthritis, a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, or hydroxychloroquine. ● Documentation that pretreatment screening has occurred; ○ Documentation that the patient has been evaluated and screened for the presence of hepatitis B virus (HBV) prior to initiating treatment, AND ○ Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment, AND ○ Patient does not have any evidence of active infection, including clinically important localized infections. ● Prescribed in combination with methotrexate, unless contraindicated. ● Must not be administered concurrently with live vaccines. ● Patient is not on concurrent treatment with another TNF inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib). Ankylosing Spondylitis (AS) ● Patient is 18 years or older. ● Must be prescribed by, or in consultation with, a specialist in rheumatology. ● Documentation of moderate to severe active disease; AND ○ Patient had an adequate trial and failure of a non-steroidal antiinflammatory agents (NSAIDs), unless use is contraindicated ● Documentation that pretreatment screening has occurred; 2 ○ Documentation that the patient has been evaluated and screened for the presence of hepatitis B virus (HBV) prior to initiating treatment, AND ○ Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment, AND ○ Patient does not have any evidence of active infection, including clinically important localized infections. ● Prescribed in combination with methotrexate, unless contraindicated. ● Must not be administered concurrently with live vaccines. ● Patient is not on concurrent treatment with another TNF inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib). II. Criteria for Continuation of Therapy All of the criteria for initial therapy (in Section I.) must be met; AND ● The provider attests to a positive clinical response. ● Absence of unacceptable toxicity from the drug. ● Patient is receiving ongoing monitoring for presence of TB or other active infections. III. Dosing/Administration Simponi Aria must be administered according to the current FDA labeling guidelines for dosage and timing. The recommended dosing is as follows: ● 2 mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks. IV. Length of Authorization For Initial Therapy Simponi Aria will be authorized for 6 months when criteria for initial approval are met. ● Continuing therapy with Simponi will be authorized for 12 months. V. Billing Code/Information HCPCS Code: J1602 - Injection, golimumab, 1 mg, for intravenous use; 1mg = 1 billable unit. 3 Prior authorization of benefits is not the practice of medicine nor the substitute for the independent medical judgment of a treating medical provider. The materials provided are a component used to assist in making coverage decisions and administering benefits. Prior authorization does not constitute a contract or guarantee regarding member eligibility or payment. Prior authorization criteria are established based on a collaborative effort using input from the current medical literature and based on evidence available at the time. Approved by MDH Clinical Criteria Committee: 9/23/2020 Last Reviewed Date:9/23/2020 4 .

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