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. ​ ​

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● 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;

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○ 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.

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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

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