CurrentUnitedHealthcarePolicy CS2025D0051W

Simponi Aria (golimumab) Injection for Intravenous Infusion

Medical benefit drug policy for Simponi Aria (golimumab) intravenous infusion covering indications ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and polyarticular juvenile idiopathic arthritis with initial and continuation criteria, applicable codes, and prescribing/provider requirements. Excludes subcutaneous Simponi which is pharmacy benefit.

Policy Summary

PayerUnitedHealthcare

PolicySimponi Aria (golimumab) Injection for Intravenous Infusion

Policy CodePolicy CS2025D0051W

Change TypeRevisions to prior-therapy and contraindicated combination lists

Effective DateMar 1, 2025

Next Review Date

Key ActionDocument prior NSAID/methotrexate/non-biologic DMARD trials or prior targeted immunomodulator use and submit prior authorization for up to 12 months when criteria are met.

POLICY UPDATE CHANGES

Enbrel (etanercept) added to list of targeted immunomodulators previously received for Ankylosing Spondylitis and other indications.

Humira (adalimumab) removed from some lists and replaced with generic 'adalimumab' wording.

Several agents added to Psoriatic Arthritis prior therapy list: Cosentyx (secukinumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Skyrizi (risankizumab), Taltz (ixekizumab).

Simponi (golimumab) added to the RA targeted immunomodulators list.

Simponi (golimumab) added to polyarticular juvenile idiopathic arthritis prior-therapy list.

Olumiant (baricitinib) added to list of agents not to be used in combination with Simponi Aria for Ankylosing Spondylitis.

Multiple agents added to list of agents not to be used in combination with Simponi Aria for Psoriatic Arthritis: Cosentyx, Olumiant, Skyrizi, Stelara, Taltz, Tremfya.

Replaced brand-name 'Humira (adalimumab)' references with 'adalimumab'.

4Covered Indications (AS, PsA, RA, PJIA)

12 monthsMax initial/reauthorization period

Coverage summary

This policy is a medical benefit drug policy for Simponi Aria (golimumab) intravenous infusion covering ankylosing spondylitis (AS), psoriatic arthritis (PsA), rheumatoid arthritis (RA), and polyarticular juvenile idiopathic arthritis (PJIA). The policy excludes the subcutaneous formulation Simponi (subcutaneous), which is obtained under the pharmacy benefit. Coverage is covered_with_criteria and initial and reauthorization approvals are limited to a maximum of 12 months per the policy.

Ankylosing spondylitis — Initial therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of active ankylosing spondylitis (AS).
ONE of
- History of failure to two NSAIDs (e.g., ibuprofen, naproxen) at the maximally indicated doses, each used for at least 4 weeks, unless contraindicated or clinically significant adverse effects are experienced.2 trials x >=4 weeks
  Each NSAID trial should be distinct agents; document dates, doses, and reason for discontinuation if applicable.
- Patient has been previously treated with a targeted immunomodulator FDA-approved for the treatment of ankylosing spondylitis (examples: certolizumab [Cimzia], adalimumab, upadacitinib [Rinvoq], tofacitinib [Xeljanz/Xeljanz XR]).
  Specify agent, dose, duration, and reason for discontinuation if applicable.
- Patient is currently receiving Simponi Aria (golimumab) intravenous infusion and continuation criteria are being sought.
Simponi Aria is initiated and titrated according to U.S. Food and Drug Administration (FDA) labeled dosing for ankylosing spondylitis.
Refer to FDA label for induction and maintenance infusion schedules and weight-based dosing if applicable.
Patient is not receiving Simponi Aria in combination with another targeted immunomodulator (examples: etanercept [Enbrel], certolizumab [Cimzia], abatacept [Orencia], adalimumab, tofacitinib [Xeljanz], baricitinib [Olumiant], upadacitinib [Rinvoq]).
Concurrent use with other biologic or targeted synthetic DMARDs is not permitted.
The medication is prescribed by, or in consultation with, a rheumatologist.
Documentation of consultation should be included in the medical record.
Initial authorization is for no more than 12 months.<= 12 months

Clinical trial entry / efficacy criteria (disease-specific)

Clinical trials for ankylosing spondylitis evaluating golimumab generally enrolled patients with active disease despite NSAID therapy; prior inadequate response to at least two NSAIDs is commonly used as an entry criterion.
Document baseline disease activity measures (e.g., BASDAI, spinal mobility, CRP) when available to support medical necessity.
Efficacy in trials was assessed by improvement in signs and symptoms and validated disease activity scores; continuation requests should include documentation of positive clinical response (improved BASDAI, functional status, or physician assessment).
Specify objective or clinician-documented improvement compared to baseline.

Ankylosing spondylitis — Continuation of therapy

Psoriatic arthritis — Initial therapy

Psoriatic arthritis — Continuation of therapy

Rheumatoid arthritis — Initial therapy

Rheumatoid arthritis — Continuation of therapy

Polyarticular juvenile idiopathic arthritis (PJIA) — Initial therapy

Polyarticular juvenile idiopathic arthritis (PJIA) — Continuation of therapy

Coverage rationale — prior targeted immunomodulator history

Medications not to be used in combination with Simponi Aria

FDA-approved indications (informational)

Informational — FDA-approved indications (for reference only): Simponi Aria (intravenous golimumab) is indicated for: moderately to severely active rheumatoid arthritis in adults in combination with methotrexate; active psoriatic arthritis in patients ≥2 years; active ankylosing spondylitis; and active polyarticular juvenile idiopathic arthritis in patients ≥2 years. Simponi (subcutaneous golimumab) is indicated in adults for RA (with MTX), PsA (alone or with MTX), AS, and moderately to severely active ulcerative colitis. FDA approvals are provided for informational purposes and do not by themselves determine coverage.

Clinical evidence cited

68.1%ACR20 at week 100 (GO-FURTHER long-term combined groups)

43.8%ACR50 at week 100 (GO-FURTHER long-term combined groups)

23.5%ACR70 at week 100 (GO-FURTHER long-term combined groups)

16.2%ASAS20 low disease activity at week 16 (AS trial: golimumab vs placebo)

127pJIA open‑label study sample size (children 2 to <18 yrs)

Clinical trial evidence and entry/efficacy criteria cited to support coverage decisions: AS trials enrolled adults with definite AS (≥3 months) and active disease meeting thresholds such as BASDAI ≥ 4, VAS back pain ≥ 4, and elevated inflammatory markers (hsCRP ≥ 0.3 mg/dL); the primary endpoint reported was ASAS20 at week 16. PsA trials enrolled adults with active disease despite NSAID/DMARD therapy with entry criteria including joint count and CRP thresholds (e.g., ≥5 swollen and ≥5 tender joints and CRP ≥ 0.6 mg/dL); the primary endpoint reported was ACR20 at week 14. The GO-FURTHER RA program evaluated IV golimumab 2 mg/kg plus methotrexate versus placebo + MTX with primary efficacy measures including ACR20/50/70 and radiographic progression assessed through long-term follow-up (up to week 100/112). A pediatric open-label pJIA study (children 2 to <18 yrs) evaluated IV golimumab dosing (80 mg/m2) through week 52 with efficacy supportive via pharmacokinetic exposure and extrapolation from RA.

Applicable codes

HCPCS (drug)HCPCSCovered

J1602

Injection, golimumab, 1 mg, for intravenous use

Diagnosis codes (ICD-10)ICD-10

L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis
L40.54	Psoriatic juvenile arthropathy
L40.59	Other psoriatic arthropathy
M05.00	Felty's syndrome, unspecified site
M05.011	Felty's syndrome, right shoulder
M05.012	Felty's syndrome, left shoulder
M05.019	Felty's syndrome, unspecified shoulder

1–10 of 100

1/10

Applicable ICD-10 Diagnosis CodesICD-10

M06.221	Rheumatoid arthritis without rheumatoid factor of right hand
M06.222	Rheumatoid arthritis without rheumatoid factor of left hand
M06.229	Rheumatoid arthritis without rheumatoid factor of unspecified hand
M06.231	Rheumatoid arthritis without rheumatoid factor of right hip
M06.232	Rheumatoid arthritis without rheumatoid factor of left hip
M06.239	Rheumatoid arthritis without rheumatoid factor of unspecified hip
M06.241	Rheumatoid arthritis without rheumatoid factor of right knee
M06.242	Rheumatoid arthritis without rheumatoid factor of left knee
M06.249	Rheumatoid arthritis without rheumatoid factor of unspecified knee
M06.251	Rheumatoid arthritis without rheumatoid factor of right ankle and foot

1–10 of 20

1/2

Provider actions and requirements

Prior Authorization

Initial authorization required

Initial authorization for Simponi Aria (IV golimumab) is required and limited to no more than 12 months. Use HCPCS code J1602 for billing/claims.

HCPCS: J1602
Initial authorization ≤ 12 months
Prior authorization required to confirm criteria are met

Documentation Required

Documentation of prior therapies

Document prior therapies per indication: prior trials of two NSAIDs for ankylosing spondylitis, a 3-month methotrexate trial for psoriatic arthritis, or a 3-month non-biologic DMARD trial for rheumatoid arthritis — and/or prior treatment with targeted immunomodulators or current use of Simponi Aria as applicable.

Thresholds and definitions

Surface thresholds

NSAID trial requirement (AS)Failure of two NSAIDs, each used for at least 4 weeks at maximally indicated doses

Methotrexate trial (PsA)Failure of a 3-month trial of methotrexate at the maximally indicated dose

Non-biologic DMARD trial (RA)Failure or intolerance to a 3-month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses

BASDAI (Ankylosing spondylitis)>= 4 (trial inclusion)

VAS for total back pain (Ankylosing spondylitis)>= 4 (0-10 cm scale) (trial inclusion)

hsCRP (Ankylosing spondylitis)>= 0.3 mg/dL (3 mg/L) (trial inclusion)

Background

Background: This medical benefit policy covers Simponi Aria (IV golimumab) infusion for autoimmune rheumatologic indications (AS, PsA, RA, PJIA). The subcutaneous product Simponi is addressed separately under the pharmacy benefit and is indicated for similar and additional conditions. Note: FDA approvals and labeled indications are cited for informational purposes and do not alone determine coverage.

Revision history

2025-03-01material_change_addedLatest

Revised lists of targeted immunomodulators: Enbrel (etanercept) added for ankylosing spondylitis; Cosentyx (secukinumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Skyrizi (risankizumab), and Taltz (ixekizumab) added to psoriatic arthritis prior-therapy list; Simponi (golimumab) added to rheumatoid arthritis prior-therapy list; Simponi (golimumab) added to polyarticular juvenile idiopathic arthritis prior-therapy list.

2025-03-01material_change_removedLatest

Humira (adalimumab) references replaced with the generic 'adalimumab' wording across prior-therapy and combination-exclusion lists.