CurrentViva HealthPolicy IC-0176

Simponi ARIA (golimumab) (Intravenous)

Medical policy governing coverage, dosing, and renewal criteria for intravenous golimumab (Simponi ARIA) for specified rheumatologic indications and immune checkpoint inhibitor-related toxicities for Viva Health members.

Policy Summary

PayerViva Health

PolicySimponi ARIA (golimumab) (Intravenous)

Policy CodePolicy IC-0176

Change TypeNon‑material revision

Effective Date

Next Review DateMar 4, 2025

Key ActionObtain prior authorization for J1602 (golimumab IV) with documentation of age, HBV and TB screening, and indication-specific prior therapy trials.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization length

250Per-dose units (mg)

J1602HCPCS code

ICD-10Diagnosis system

multipleAppendix codes

Coverage Criteria for Simponi ARIA (golimumab) IV

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Initial Therapy

Covered when ALL of the following universal criteria AND the indication-specific criteria are met

Universal prerequisites: Patient meets age requirement; screened for hepatitis B virus (HBV) prior to initiation; evaluated and screened for latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing TB monitoring during therapy; no active infection (including clinically important localized infections); will not receive live vaccines while on therapy; not on concurrent biologic or targeted synthetic therapy.

From Universal Criteria and Initial Approval sections (chunks 3-4)

Rheumatoid Arthritis (RA): Physician has assessed baseline disease severity using an objective measure/tool; documented moderate to severe active disease; patient has had at least a 3-month trial and failed ONE csDMARD (e.g., methotrexate, azathioprine, hydroxychloroquine, sulfasalazine, leflunomide, etc.) OR is already established on biologic or targeted synthetic therapy; prescribed in combination with methotrexate unless contraindicated or intolerant.

Chunk 5

Psoriatic Arthritis (PsA): Patient is at least 2 years of age; physician has assessed baseline disease severity using an objective measure/tool; documented moderate to severe active disease; for predominantly axial disease or enthesitis: failure of at least a 4-week trial of ONE NSAID (unless contraindicated); OR for peripheral arthritis or dactylitis: failure of at least a 3-month trial of ONE csDMARD; OR patient is already established on biologic or targeted synthetic therapy.

Chunk 6

Ankylosing Spondylitis (AS): Physician has assessed baseline disease severity using an objective measure/tool; documented active disease; patient had an adequate trial and failure of at least TWO NSAIDs over 4 weeks (total), unless contraindicated; OR patient is already established on biologic or targeted synthetic therapy.

Chunk 7

Polyarticular Juvenile Idiopathic Arthritis (pJIA): Patient is at least 2 years of age; physician has assessed baseline disease severity using an objective measure/tool; documented moderate to severe active polyarticular disease; patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of either oral NSAIDs OR a csDMARD (e.g., methotrexate, leflunomide, sulfasalazine) OR is already established on biologic or targeted synthetic therapy; may be used as single agent or in combination with methotrexate.

Chunk 8

Immune Checkpoint Inhibitor-Related Toxicities: Patient has been receiving an immune checkpoint inhibitor; has moderate or severe immunotherapy-related inflammatory arthritis; and is unable to taper corticosteroids after one week.

Chunk 9

Renewal Criteria

Covered for renewal when ALL of the following are met

General renewal prerequisites: Patient continues to meet universal and relevant indication-specific criteria (including concomitant therapy requirements where applicable); duration of authorization has not been exceeded; and there is absence of unacceptable toxicity from the drug (examples include serious infections, congestive heart failure, malignancy, demyelinating disorders, lupus-like syndrome, severe hypersensitivity including anaphylaxis, and severe hematologic cytopenias).

Chunk 10

Rheumatoid Arthritis (RA) renewal response: Demonstrated disease response vs baseline such as improvement in tender and swollen joint counts, reduction in C-reactive protein, improvement in patient global assessment, and/or improvement on a disease activity scoring tool (e.g., DAS28 improvement ≥1.2 points or ≥20% improvement by ACR20, or improvement on RAPID3).

Chunk 11

Psoriatic Arthritis (PsA) renewal response: Demonstrated disease response vs baseline such as improvement in tender and swollen joint counts, reduction in C-reactive protein, improvement in patient global assessment, improvement on imaging (X-ray, ultrasound, or MRI), and/or improvement on a disease activity scoring tool.

Per the policy universal criteria, patients must not receive live vaccines while on therapy. Ensure vaccination status is reviewed and any necessary live vaccines are administered prior to initiation of golimumab IV; live vaccines are contraindicated during treatment and while the patient remains immunosuppressed.

The policy’s covered diagnoses are those listed in Appendix 1. Diagnoses not included in Appendix 1 are not represented in this excerpt as covered; absence from the appendix may indicate noncoverage or the need for a separate review or prior authorization rationale tied to a listed ICD-10 code.

Treatment with golimumab IV is inappropriate and may be denied when the patient has an active infection, when required pre-treatment screening (e.g., latent TB or HBV screening) has not been completed, or when the patient is receiving concurrent biologic or targeted synthetic therapy. Coverage may also be withheld or renewal denied for unacceptable toxicity such as serious infections, congestive heart failure, malignancy, demyelinating disorders, severe hypersensitivity, or severe hematologic cytopenias.

Coding: HCPCS, NDC, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J1602

Injection, golimumab, 1 mg, for intravenous use

NDCNDC

57894-0350-xx

Simponi ARIA 50 mg/4 mL injection, single-dose vial

Covered ICD-10 Diagnosis Codes (Appendix 1)ICD-10Covered

L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis
L40.59	Other psoriatic arthropathy
M05.10	Rheumatoid lung disease with rheumatoid arthritis of unspecified site
M05.111	Rheumatoid lung disease with rheumatoid arthritis of right shoulder
M05.112	Rheumatoid lung disease with rheumatoid arthritis of left shoulder
M05.119	Rheumatoid lung disease with rheumatoid arthritis of unspecified shoulder
M05.121	Rheumatoid lung disease with rheumatoid arthritis of right elbow

1–10 of 165

1/17

Per-dose billable units — inv-09: 250 billable units per dose

Per-dose billable units250 billable units per dose for most indications (loading and maintenance dosing as specified); for immune checkpoint inhibitor‑related toxicities: 250 billable units x 1 dose

Loading dose (other indications)250 billable units on weeks 0 and 4

Maintenance dose (other indications)250 billable units every 8 weeks

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial therapy. Initial approval is provided for 6 months. Requests must document that the patient meets age and screening requirements and all indication-specific criteria.

Initial approval duration: 6 months
Patient age and HBV screening documented prior to initiation
Refer to indication-specific criteria for step/therapy requirements and baseline severity measures

Denial Risk

Prior Authorization Requires a Listed Diagnosis

Prior authorization requests must reference a covered ICD-10 diagnosis code from Appendix 1. Claims without a listed Appendix 1 diagnosis code may be at risk for denial; link clinical documentation to the submitted ICD-10 code.

Include one of the ICD-10 codes listed in Appendix 1 on the prior authorization and claim
Diagnosis-code mismatch between request and Appendix 1 may trigger denial

Documentation Required

Baseline Assessment and Prior Therapy Documentation

Documentation must include baseline assessment of disease severity using an objective measure and detailed records of prior therapy trials (duration, agent, and outcome). For example, RA requires documentation of a baseline disease activity measure and a ≥3-month trial of a csDMARD unless the patient is already established on biologic/targeted synthetic therapy or has a contraindication.

Document objective baseline disease severity (e.g., DAS28, BASDAI, JIA disease activity scores)
Record prior therapy trials with dates, duration, and reason for discontinuation (failure, intolerance, contraindication)
Confirm HBV and TB screening documented prior to initiation

Billing Rule

Billing Documentation

Billing must use HCPCS J1602 for golimumab IV; 1 billable unit = 1 mg. Include the NDC for Simponi ARIA single-dose vial when applicable.

HCPCS: J1602 - Injection, golimumab, 1 mg, for intravenous use
1 billable unit = 1 mg
NDC: Simponi ARIA 50 mg/4 mL injection, single-dose vial: 57894-0350-xx

Documentation Required

Link Claims to Appendix 1 Diagnosis Codes

Ensure claims are linked to an Appendix 1 diagnosis code and that submitted clinical documentation supports that ICD-10 code. Failure to align the claim diagnosis with Appendix 1 may result in claim denial.

Attach clinical notes that substantiate the selected Appendix 1 ICD-10 code
Verify the ICD-10 code on the claim matches the code used on the prior authorization request

OpenPayer

Simponi ARIA (golimumab) (Intravenous)

Coverage Criteria for Simponi ARIA (golimumab) IV

Coding: HCPCS, NDC, and Diagnosis Codes

Provider Actions, Documentation, and Prior Authorization

Definitions and Terminology

Background