Simponi Aria (golimumab) for Intravenous Use
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This policy governs medical-benefit coverage and prior-authorization criteria for intravenous golimumab (Simponi Aria) for specified inflammatory indications; it affects providers administering IV golimumab and members whose benefit plans follow Blue Cross of Idaho policies.
No material clinical or coverage changes in this revision.
Coverage Criteria for Intravenous Golimumab (Simponi Aria)
Initial Therapy
Covered when ALL of the following are met for initial therapy
If switching from another targeted immune modulator with no new risk factors, TB screening is not necessary; see Appendices for concomitant therapy lists.
Each bulleted indication has its own age and prior-therapy requirements as cited.
Continuation Therapy
Continuation Therapy — covered when ALL criteria are met
Requests may be considered not medically necessary if the individual has active or untreated latent tuberculosis, hepatitis B, or other active serious infections, or a history of recurrent infections.
Covered Indications (summary)
Simponi Aria (golimumab) IV may be considered medically necessary for the following when criteria are met:
Policy history and codes list these diagnoses as covered when criteria are met (see ICD-10 groups).
Subcutaneous golimumab (the SC formulation) is not covered under this medical-benefit policy and is handled through the pharmacy benefit. Coverage, utilization management, and any prior authorization requirements for the SC product are governed by the member’s pharmacy benefit plan and associated formulary rules; therefore subcutaneous golimumab is outside the scope of this medical policy.
If an individual develops a serious infection or sepsis while receiving a TNF inhibitor (including golimumab), the TNF inhibitor should be discontinued. This action is consistent with the agents’ Black Box Warning and the directive to weigh risks and benefits in patients with serious or recurrent infections.
Requests for intravenous golimumab may be considered not medically necessary when the documented continuation or initiation criteria are not met, and for all other indications not specified by this policy. Additionally, treatment is not medically necessary for individuals with active or untreated latent tuberculosis, active hepatitis B, other active serious infections, or a history of recurrent infections.
No additional explicit "not medically necessary" statements beyond those already cited are provided in the referenced portions of the policy; the policy instead details contraindications, safety testing, and circumstances (for example active or untreated latent TB or development of serious infection) under which use would be inappropriate or discontinued.
Initial Therapy Criteria
Initial Therapy
If switching from another targeted immune modulator with no new risk factors, TB screening is not necessary; see Appendices for concomitant therapy lists.
Initial therapy safety
Safety and mechanism considerations for initiating therapy
Monitor for infections and malignancy risk; document TB testing prior to and during therapy as indicated.
Continuation Criteria
Continuation
Requests may be considered not medically necessary if the individual has active or untreated latent tuberculosis, hepatitis B, or other active serious infections, or a history of recurrent infections.
Provider Actions and Documentation Requirements
Prior authorization required; 1‑year initial approval and FDA/compendia dosing
Prior authorization is required for intravenous golimumab (Simponi Aria). Initial approvals are limited to a duration of 1 year and dosing must be initiated in accordance with FDA‑approved labeling or accepted drug compendia.
- Prior‑approval duration: 1 year (see Prior‑Approval Limits)
- Dosing per FDA labeling or accepted compendia (adult and pediatric loading/maintenance dosing specified)
Medical-policy review required for IV golimumab; bill with specified codes
Intravenous golimumab (Simponi Aria) requires medical policy review for medical necessity when requested for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or polyarticular juvenile idiopathic arthritis; infusion billing should use the HCPCS, CPT and NDC codes listed in the policy.
- HCPCS J1602 (Injection, golimumab, 1 mg, IV) and NDC 57894-0350-01 apply for Simponi Aria
- Use appropriate CPT infusion codes (96365–96368) for infusion administration
Requirement: prior inadequate response/intolerance/contraindication to conventional therapies
For RA, AS, PsA, and pJIA, documentation must show prior inadequate response, intolerance, or contraindication to conventional therapies (for RA, methotrexate titrated to maximally tolerated dose unless contraindicated; for AS/PsA/pJIA, relevant conventional DMARDs/NSAIDs as noted).
- RA: inadequate response to methotrexate titrated to maximally tolerated dose, or intolerance/contraindication to methotrexate and other conventional therapies (sulfasalazine, leflunomide, hydroxychloroquine)
- AS: inadequate response/intolerance/contraindication to conventional therapy (e.g., NSAIDs or nonbiologic DMARDs)
- PsA and pJIA: inadequate response/intolerance/contraindication to conventional DMARDs (e.g., methotrexate, sulfasalazine, cyclosporine, leflunomide)
Refer to Appendix 1 DMARD lists when assessing prior therapies
Policy references Appendix 1 lists of conventional, biologic, and targeted synthetic DMARDs that must be considered when documenting prior treatment history and step‑therapy decisions.
- Appendix 1 includes conventional DMARDs (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine) and biologic DMARDs (e.g., abatacept, adalimumab, infliximab, golimumab) for reference
Document TB screening within 6 months prior to initiation
Document tuberculosis (TB) screening within 6 months prior to initiation showing no active tuberculosis; if switching from another targeted immune modulator with no new risk factors, prior TB screening may suffice.
- If latent TB is present, documentation must show treatment was started prior to golimumab use
- If switching from another targeted agent that required TB screening at initiation and there are no new risk factors, repeat TB screening is not necessary
Document latent TB testing before initiation and during therapy; record indication and infusion data
Document testing for latent tuberculosis before initiation and during therapy, and include the requested indication and relevant baseline/administration data (diagnosis and infusion details such as HCPCS/CPT/NDC).
- Record indication (e.g., RA, PsA, AS, pJIA) and infusion coding: HCPCS J1602, CPT 96365–96368, NDC 57894-0350-01
- Document baseline TB test results and any TB treatment started prior to initiation
Denial risk: active/untreated latent TB, hepatitis B, or other active serious infections
Requests may be considered not medically necessary if the individual has active or untreated latent tuberculosis, active hepatitis B, other active serious infections, or a history of recurrent infections.
- Policy states IV golimumab is NOT medically necessary when these infection risks are present
- Repeat TB testing not required for ongoing therapy, but active/untreated infections preclude approval
Denial risk/discontinuation if serious infection or lack of required TB testing
Use of TNF inhibitors should be discontinued and may be denied or discontinued if the individual develops a serious infection or sepsis; failure to test for latent TB prior to initiation could influence coverage decisions.
- TNFi (including golimumab) should be discontinued if a serious infection or sepsis develops
- Testing for latent TB before and during therapy is required; lack of testing/treatment for latent TB may affect medical‑necessity determinations
Billing and Coding
| No codes listed |
| J1602 | Injection, golimumab, 1 mg , for intravenous use only. |
| 96365 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug). |
| 96366 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug). |
| 96367 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug). |
| 96368 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug). |
| 57894-0350-01 | Simponi Aria 50 mg/4mL injection, single-dose vial. |
| M05.00-M06.9 | Rheumatoid Arthritis (RA). |
| M08.00-M08.99 | Juvenile Idiopathic Arthritis (pJIA). |
| L40.50-L40.59 | Psoriatic Arthritis (PsA). |
| M45.0-M45.9 | Ankylosing Spondylitis (AS). |
Step Therapy and Prior Treatment Requirements
| Requirement | Details |
|---|---|
| Prior failure, intolerance, or contraindication required | |
| Rheumatoid arthritis: inadequate response to methotrexate titrated to maximally tolerated dose, or intolerance/contraindication to methotrexate with inadequate response or intolerance to other conventional therapy (sulfasalazine, leflunomide, hydroxychloroquine) | |
| Ankylosing spondylitis: inadequate response to, intolerance of, or contraindication to conventional therapy (eg, NSAIDs or nonbiologic DMARDs such as sulfasalazine) | |
| Psoriatic arthritis: inadequate response to, intolerance of, or contraindication to conventional therapy (DMARDs such as methotrexate, sulfasalazine, cyclosporine, or leflunomide) | |
| Polyarticular juvenile idiopathic arthritis: inadequate response to, intolerance of, or contraindication to conventional therapy (DMARDs such as methotrexate, sulfasalazine, cyclosporine, or leflunomide); age ≥2 years |
| Policy reference | What to consider |
|---|---|
| Appendix 1 — Conventional DMARDs list | |
| Consider prior use, intolerance, or contraindication to conventional DMARDs listed in Appendix 1 (eg, methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, azathioprine, cyclosporine) | |
| Appendix 1 — Biological DMARDs list | |
| Policy also references biological DMARDs in Appendix 1 (eg, abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab) and targeted/other agents when assessing prior or concurrent therapy |
Quantity Limits and Dosing
Site of Care / Benefit Application
Infusion center: administer under the medical benefit in appropriate clinical infusion setting
Infusion of intravenous golimumab is covered under the medical benefit and must be administered in an appropriate clinical infusion setting in accordance with medical‑benefit rules.
- IV golimumab is a medical‑benefit drug (subcutaneous formulation is pharmacy benefit and outside this medical policy)
Outpatient/home infusion: permitted places of service and billing guidance
Infusions may be administered in outpatient physician office, infusion clinic, or home health settings per place‑of‑service guidance; bill using the applicable outpatient medical place of service codes.
- Place of service guidance lists outpatient settings: physician office, infusion clinic, or home health
- Use HCPCS/CPT/NDC codes as documented in the policy for billing (J1602, 96365–96368, NDC 57894-0350-01)
Definitions
Background
Golimumab is a human monoclonal antibody of the IgG1κ subclass that binds both soluble and transmembrane forms of tumor necrosis factor alpha (TNFα), inhibiting TNF-mediated inflammatory activity. It is used to treat several chronic inflammatory conditions and is classified as a TNF inhibitor (TNFi), a class with a Black Box Warning for serious infections and malignancy; prior authorization is used to ensure appropriate, safe, and cost-effective IV use.
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