CurrentBlue Cross Blue Shield - IowaPolicy N/A

Simponi Aria (golimumab) — Coverage and Medical Necessity Criteria

Coverage and medical necessity criteria for Simponi Aria (golimumab) for indicated rheumatologic conditions for Wellmark Blue Cross and Blue Shield members; affects prescribers, providers, and pharmacy/medical benefit administrators.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySimponi Aria (golimumab) — Coverage and Medical Necessity Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJune 6, 2025

Next Review DateApril 2026

Key ActionObtain prior authorization (12-month approvals) when specific clinical criteria for the indicated condition are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization period for approvals

>=2 yrsMinimum age for PsA and pJIA indications

2 NSAIDsRequired inadequate response for AS

TB testPre-initiation screening

J1602HCPCS/J-code listed

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Jun 6, 2025Current effective date

Coverage and Medical Necessity Criteria

Initial Therapy — Rheumatoid arthritis

Authorization of 12 months may be granted for adult members for treatment of moderately to severely active RA when ALL of the following are met:

RA initial criteria: Member has been tested for rheumatoid biomarkers and at least one test (rheumatoid factor [RF] or anti-cyclic citrullinated peptide [anti-CCP]) was positive/elevated; C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR) results are documented when available.

Biomarker testing required per policy

RA initial criteria: Member is prescribed the requested medication in combination with methotrexate or leflunomide, or there is a documented clinical reason not to use methotrexate or leflunomide (see Appendix A).see Appendix A for clinical reasons to avoid methotrexate/leflunomide

Combination therapy expected unless contraindicated

RA initial criteria: Member has experienced an inadequate response to at least a 3-month trial of methotrexate at adequate dosing (e.g., titrated to at least 15 mg/week), or has documented intolerance or contraindication to methotrexate.>= 3 months methotrexate trial at adequate dosing

Intolerance/contraindication documented per Appendix A

Initial Therapy — Psoriatic arthritis

Authorization of 12 months may be granted for members 2 years and older for treatment of active PsA when EITHER of the following is met:

PsA initial criteria: Member has mild to moderate disease and has had an inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD (e.g., sulfasalazine) administered at an adequate dose and duration, or has intolerance/contraindication to these agents; OR member has enthesitis or predominantly axial disease.age >=2 years

Prior biologic/targeted synthetic use also qualifies per policy

PsA initial criteria: Member has severe psoriatic arthritis.age >=2 years

Prior biologic/targeted synthetic use qualifies as an alternative pathway

Initial Therapy — Ankylosing spondylitis / nr-axSpA

Authorization of 12 months may be granted for adult members for active AS or nr-axSpA when ANY of the following are met:

AS initial criteria: Member has experienced an inadequate response to at least two non-steroidal anti-inflammatory drugs (NSAIDs).failure of >= 2 NSAIDs

AS initial criteria: Member has an intolerance or contraindication to two or more NSAIDs.intolerance/contraindication to >= 2 NSAIDs

AS initial criteria: Member previously received a biologic or targeted synthetic drug indicated for active ankylosing spondylitis or non-radiographic axial spondyloarthritis.

Prior biologic/targeted synthetic use qualifies

Initial Therapy — Articular juvenile idiopathic arthritis

Authorization of 12 months may be granted for members 2 years and older for active articular JIA when ANY of the following are met:

JIA initial criteria: Member has had an inadequate response to methotrexate or another conventional synthetic DMARD (e.g., leflunomide, sulfasalazine, hydroxychloroquine) administered at an adequate dose and duration.age >=2 years

JIA initial criteria: Member has had an inadequate response to a trial of scheduled NSAID and/or intra-articular glucocorticoids and has one or more risk factors for poor outcome (e.g., erosive disease or enthesitis; involvement of ankle, wrist, hip, sacroiliac joint, or TMJ; delay in diagnosis; symmetric disease; elevated inflammatory markers).age >=2 years

Risk factors detailed in Appendix B

JIA initial criteria: Member previously received a biologic or targeted synthetic drug indicated for active articular juvenile idiopathic arthritis.

Continuation Therapy

Authorization of 12 months may be granted for continuation when members achieve or maintain a positive clinical response as evidenced by:

RA continuation: Disease activity improvement from baseline (member achieves or maintains a positive clinical response).improvement in disease activity from baseline

Authorization of 12 months may be granted if improvement documented

PsA continuation: Improvement in any of the following from baseline: number of swollen joints, number of tender joints, dactylitis, enthesitis, axial disease, skin or nail involvement, functional status, or C-reactive protein (CRP).improvement from baseline

12-month authorization may be granted if criteria met

AS/nr-axSpA continuation: Improvement in any of the following from baseline: functional status, total spinal pain, swollen joints, morning stiffness/inflammation, tender joints, or C-reactive protein (CRP).

Do not administer the requested medication to members with active tuberculosis infection. All members naive to biologic or targeted synthetic therapies must have a documented negative TB test (TST or IGRA) within 12 months before initiating therapy. If screening is positive, further evaluation (for example, chest X‑ray) is required to exclude active disease; if latent TB is identified, treatment must be started before beginning the requested medication. Additionally, the medication must not be used concomitantly with any other biologic or targeted synthetic drug for the same indication.

Appendix A lists clinical reasons that may justify avoiding methotrexate or leflunomide and thereby support use of alternative therapy. Examples include: drug interactions, risk of treatment‑related toxicity, pregnancy or planning pregnancy, significant comorbidity that prohibits systemic agents (for example, liver or kidney disease, blood dyscrasias, uncontrolled hypertension), breastfeeding, hypersensitivity, and a history of intolerance or adverse event to these drugs.

Simponi Aria (golimumab) is considered not medically necessary for members who do not meet the coverage criteria and documentation requirements set forth in this policy.

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization of up to 12 months may be granted when specific clinical criteria for the indicated condition are met.

Prior authorization required for Simponi Aria; approvals generally limited to 12 months when criteria are met.
Approvals may be subject to dosing limits consistent with FDA labeling, accepted compendia, and evidence-based guidelines.

Billing Rule

Prior authorization and billing for IV golimumab

Approvals may be subject to dosing limits per FDA labeling and clinical guidelines. When billing for intravenous golimumab, report HCPCS J1602.

Dosing limits may follow FDA-approved labeling and evidence-based practice guidelines.

Procedures and Billing Codes

Procedures and Billing CodesHCPCS

J1602

Injection, golimumab , mg; for intravenous use

Indications, Risk Factors, and Clinical Definitions

FDA-Approved Indications / Compendial Uses

FDA‑Approved indicationsActive psoriatic arthritis (PsA) in patients 2 years of age and older; Moderately to severely active rheumatoid arthritis (adults) in combination with methotrexate; Active ankylosing spondylitis (adults); Active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.

Compendial usesOligoarticular juvenile idiopathic arthritis; Non‑radiographic axial spondyloarthritis.

Minimum age thresholdsIndications for PsA and pJIA: ≥2 years of age.

Risk factors for Articular Juvenile Idiopathic Arthritis

Positive rheumatoid factor (RF)Presence of RF is a risk factor for articular JIA progression.

Positive anti‑CCP antibodies

Drug Background and Context

Simponi Aria (golimumab) is an anti‑tumor necrosis factor (anti‑TNF) biologic used to treat multiple inflammatory rheumatologic conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis/non‑radiographic axial spondyloarthritis, and polyarticular juvenile idiopathic arthritis. Use is aligned with FDA‑approved indications and compendial guidance and requires appropriate pre‑treatment evaluation (for example, TB screening) and adherence to prior‑therapy and documentation requirements described in this policy.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySimponi Aria (golimumab) — Coverage and Medical Necessity Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJune 6, 2025

Next Review DateApril 2026

Key ActionObtain prior authorization (12-month approvals) when specific clinical criteria for the indicated condition are met.

SourceLink

On This Page

improvement from baseline

12-month authorization may be granted if criteria met

JIA continuation: Improvement in number of joints with active arthritis (e.g., swelling, pain, limitation of motion) or number of joints with limitation of movement from baseline.improvement from baseline

12-month authorization may be granted if criteria met

Billing: HCPCS J1602 for golimumab, intravenous use.

Step Therapy

Step therapy requirements

Step therapy is required for many indications. Members must have an inadequate response to specified conventional therapies (or documented contraindication/intolerance) prior to approval.

Rheumatoid arthritis: Prior inadequate response to at least a 3-month trial of methotrexate (titrated to at least 15 mg/week) unless there is an intolerance or contraindication to methotrexate or leflunomide (see Appendix A).
Psoriatic arthritis: Prior inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD (e.g., sulfasalazine) administered at adequate dose and duration, or intolerance/contraindication to these agents; exceptions for severe disease or enthesitis/predominantly axial disease.
Ankylosing spondylitis / nr-axSpA: Prior inadequate response to at least two NSAIDs, or intolerance/contraindication to two or more NSAIDs.
Articular juvenile idiopathic arthritis: Prior inadequate response to methotrexate or another conventional synthetic agent (e.g., leflunomide, sulfasalazine, hydroxychloroquine) at adequate dose/duration, or inadequate response to scheduled NSAID/intra-articular glucocorticoids plus high-risk features.

Step Therapy

Step therapy considerations

Appendix A lists clinical reasons to avoid methotrexate or leflunomide that may support exceptions to step therapy requirements.

Examples include pregnancy or planning pregnancy, breastfeeding, significant comorbidity (e.g., liver or kidney disease, blood dyscrasias), drug interactions, risk of treatment-related toxicity, hypersensitivity, or history of intolerance/adverse event.

Documentation Required

Required documentation

Initial authorization requests must include documentation supporting prior medications tried (if applicable), responses to therapy, or clinical reasons to avoid required therapies.

Initial requests: chart notes, medical record documentation, or claims history showing prior medication trials with dates and doses, and laboratory results or biomarker testing when applicable (e.g., RF, anti-CCP, CRP, ESR).
Continuation requests: chart notes or medical record documentation supporting positive clinical response.
For all indications: documentation of recent (within 12 months) negative TB testing prior to initiation if biologic/targeted synthetic–naive; if latent TB is present, treatment must be started before initiation; do not administer if active TB.

Billing Rule

Billing documentation

Use appropriate CPT, HCPCS, Revenue, and ICD diagnostic codes when reporting provider services; include HCPCS J1602 for intravenous golimumab.

Report HCPCS J1602 (Injection, golimumab, mg; for intravenous use) when billing IV golimumab.

Denial Risk

Not medically necessary when criteria unmet

Simponi Aria is considered not medically necessary when the criteria in this policy are not met.

Requests that do not meet the clinical criteria, step therapy requirements, or required documentation are not medically necessary.

Prior Authorization

Dosing limits risk

Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and evidence-based practice guidelines.

Review dosing against FDA labeling and applicable practice guidelines when authorizing therapy.

Positive anti‑cyclic citrullinated peptide (anti‑CCP) antibodies indicate higher risk for poor outcomes.

Pre‑existing joint damageExisting erosive or structural joint damage is a risk factor for worse prognosis.

Clinical reasons to avoid methotrexate or leflunomide

Drug interactionsPotential for clinically significant drug interactions that contraindicate methotrexate or leflunomide use.

Risk of treatment‑related toxicityElevated risk of hepatotoxicity, myelosuppression, or other toxicities that preclude safe use.

Pregnancy or planning pregnancyPregnancy or current plans for pregnancy are listed as reasons to avoid methotrexate or leflunomide.

Significant comorbidityConditions such as liver or kidney disease, blood dyscrasias, or uncontrolled hypertension that prohibit systemic agents.

Breastfeeding / hypersensitivity / prior intoleranceBreastfeeding, hypersensitivity, or history of intolerance/adverse events are listed as examples to avoid these agents.