Colorado Rocky Mountain Health Plans Simponi Aria Coverage

Coverage Criteria for Simponi Aria (golimumab) IV

Ankylosing spondylitis

Covered when ALL of the following are met

Ankylosing spondylitis - initial therapy: Diagnosis of active ankylosing spondylitis (AS); and one of: history of failure to two NSAIDs (each used ≥4 weeks at maximally indicated doses) unless contraindicated; OR prior treatment with an FDA‑approved systemic targeted immunomodulator for AS; OR patient is currently on Simponi Aria; and Simponi Aria is initiated and titrated according to FDA labeled dosing for ankylosing spondylitis; and patient is not receiving Simponi Aria in combination with another systemic targeted immunomodulator for the same indication; and prescribed by or in consultation with a rheumatologist; and initial authorization is for no more than 12 months.

Ankylosing spondylitis - continuation therapy: Patient has previously received Simponi Aria IV; and documentation of positive clinical response to Simponi Aria; and Simponi Aria dosing for ankylosing spondylitis is in accordance with FDA labeled dosing; and patient is not receiving Simponi Aria in combination with another systemic targeted immunomodulator for the same indication; and reauthorization is for no more than 12 months.

Psoriatic arthritis

Covered when ALL of the following are met

Psoriatic arthritis - initial therapy: Diagnosis of active psoriatic arthritis (PsA); and one of: history of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated; OR prior treatment with an FDA‑approved systemic targeted immunomodulator for PsA; OR patient is currently on Simponi Aria; and Simponi Aria is initiated and titrated according to FDA labeled dosing for psoriatic arthritis; and patient is not receiving Simponi Aria in combination with another systemic targeted immunomodulator for the same indication; and prescribed by or in consultation with a rheumatologist or dermatologist; and authorization is for no more than 12 months.

Psoriatic arthritis - continuation therapy: Patient has previously received Simponi Aria IV; and documentation of positive clinical response to Simponi Aria; and Simponi Aria dosing for psoriatic arthritis is in accordance with FDA labeled dosing; and patient is not receiving Simponi Aria in combination with another systemic targeted immunomodulator for the same indication; and reauthorization is for no more than 12 months.

Rheumatoid arthritis

Covered when ALL of the following are met

Rheumatoid arthritis - initial therapy: Diagnosis of moderately to severely active rheumatoid arthritis (RA); and one of: history of failure or intolerance to a 3‑month trial of one non‑biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses unless contraindicated; OR prior treatment with an FDA‑approved systemic targeted immunomodulator for RA; OR patient is currently on Simponi Aria; and Simponi Aria is initiated and titrated according to FDA labeled dosing for rheumatoid arthritis; and patient is not receiving Simponi Aria in combination with another systemic targeted immunomodulator for the same indication; and prescribed by or in consultation with a rheumatologist; and initial authorization is for no more than 12 months.

Rheumatoid arthritis - continuation therapy: Patient has previously received Simponi Aria IV; and documentation of positive clinical response to Simponi Aria; and Simponi Aria dosing for rheumatoid arthritis is in accordance with FDA labeled dosing; and patient is not receiving Simponi Aria in combination with another systemic targeted immunomodulator for the same indication; and reauthorization is for no more than 12 months.

Polyarticular juvenile idiopathic arthritis (PJIA)

Covered when ALL of the following are met

PJIA - initial therapy: Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA); and Simponi Aria is initiated and titrated according to FDA labeled dosing for PJIA; and patient is not receiving Simponi Aria in combination with another systemic targeted immunomodulator for the same indication; and prescribed by or in consultation with a rheumatologist; and initial authorization is for no more than 12 months.

Pediatric‑specific FDA dosing requirements apply

PJIA - continuation therapy: Patient has previously received Simponi Aria IV; and documentation of positive clinical response; and Simponi Aria is dosed according to FDA labeled dosing for PJIA; and patient is not receiving Simponi Aria in combination with another systemic targeted immunomodulator for the same indication; and reauthorization is for no more than 12 months.

Ankylosing Spondylitis (trial-based coverage context)

Covered when ALL of the following trial-based criteria are met (evidence supports efficacy in this population):

AS diagnosis: Definite ankylosing spondylitis per modified New York criteria

as used in pivotal trial

Active disease measures: BASDAI ≥ 4 AND VAS total back pain ≥ 4 (0–10) AND hsCRP ≥ 0.3 mg/dL (3 mg/L)BASDAI >=4; VAS >=4; hsCRP >=0.3 mg/dL

trial inclusion thresholds

Prior therapy: Inadequate response or intolerance to NSAIDs prior to initiating golimumab

patients in trial had NSAID failure

Concomitant medications:

Evidence summaries

Clinical trial evidence summaries (no explicit coverage criteria present in this excerpt).

Ankylosing Spondylitis trial evidence: Adults with definite AS (modified New York criteria) and active disease (BASDAI ≥4, VAS back pain ≥4, hsCRP ≥0.3 mg/dL) randomized to IV golimumab showed significantly higher ASAS20 at week 16 versus placebo; stable MTX/SSZ/HCQ/low‑dose steroids/NSAIDs permitted; other DMARDs/biologics prohibited.as specified

Source: randomized trial

Psoriatic Arthritis trial evidence: Adults with active PsA (≥5 swollen and ≥5 tender joints, CRP ≥0.6 mg/dL) randomized to IV golimumab showed significantly higher ACR20 at week 14 versus placebo; concomitant MTX allowed; prior biologic therapy not allowed.as specified

Includes improvements in enthesitis, dactylitis, HAQ‑DI, SF‑36

Rheumatoid Arthritis trial evidence: In GO‑FURTHER, IV golimumab 2 mg/kg plus MTX demonstrated sustained ACR responses and reduced radiographic progression through 100 weeks with safety follow‑up to 112 weeks (592 randomized patients).

This policy applies specifically to the intravenous formulation of Simponi Aria (golimumab) injection for intravenous infusion. The self‑administered subcutaneous formulation of Simponi is managed under the pharmacy benefit and is not covered under this medical benefit drug policy.

The pivotal clinical trials that support efficacy for indications such as ankylosing spondylitis and psoriatic arthritis did not permit use of other biologic agents or cytotoxic DMARDs during the randomized treatment periods. As a result, evidence cited in this policy pertains to patients who were not receiving concurrent biologic or cytotoxic DMARD therapy while on IV golimumab.

Across the randomized trials summarized in this policy, concurrent use of other DMARDs including cytotoxic agents or other biologics was explicitly prohibited during the study treatment periods. Where allowed, trials permitted only stable doses of certain non‑biologic concomitant medications (for example, methotrexate, sulfasalazine, hydroxychloroquine, low‑dose corticosteroids, and/or NSAIDs).

Requests for coverage must not be for combination therapy of Simponi Aria with another systemic targeted immunomodulator for the same indication. The policy requires that the patient is not receiving Simponi Aria in combination with a systemic targeted immunomodulator (examples listed in the policy) for treatment of the same condition; such combination use does not meet coverage criteria.

FDA approval of Simponi Aria provides regulatory context but does not by itself guarantee coverage. Coverage decisions are governed by the member's benefit plan and this medical benefit policy is intended to assist interpretation of those contractual, state, or federal requirements. FDA approval alone is not a basis for coverage.

Coding and Diagnosis Codes

Covered HCPCS Codes (reference)HCPCS

J1602

Injection, golimumab, 1 mg, for intravenous use

Diagnosis codes (psoriatic disease examples)ICD-10

L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis

Diagnosis codes (rheumatoid arthritis/Felty's syndrome examples)ICD-10

M05.00	Felty's syndrome, unspecified site
M05.011	Felty's syndrome, right shoulder
M05.20	Rheumatoid vasculitis with rheumatoid arthritis of unspecified site
M05.211	Rheumatoid vasculitis with rheumatoid arthritis of right shoulder

Applicable ICD-10 Codes (partial list)ICD-10

M05.471	Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot.
M05.472	Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot.
M05.479	Rheumatoid myopathy with rheumatoid arthritis of unspecified ankle and foot.
M05.49	Rheumatoid myopathy with rheumatoid arthritis of multiple sites.
M05.50	Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified site.

Applicable ICD-10 Codes (continued)ICD-10

M05.79	Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement.
M05.9	Rheumatoid arthritis with rheumatoid factor, unspecified.
M05.A	Abnormal rheumatoid factor and anti-citrullinated protein antibody with rheumatoid arthritis.
M06.00	Rheumatoid arthritis without rheumatoid factor, unspecified site.

Applicable ICD-10 Codes (continued)ICD-10

M06.071	Rheumatoid arthritis without rheumatoid factor, right ankle and foot.
M06.30	Rheumatoid nodule, unspecified site.
M06.311	Rheumatoid nodule, right shoulder.
M06.321	Rheumatoid nodule, right elbow.

Applicable ICD-10 Codes (continued)ICD-10

M06.80	Other specified rheumatoid arthritis, unspecified site.
M06.9	Rheumatoid arthritis, unspecified.
M08.00	Unspecified juvenile rheumatoid arthritis of unspecified site.
M08.011	Unspecified juvenile rheumatoid arthritis, right shoulder.

Applicable ICD-10 Codes (continued)ICD-10

M08.971	Juvenile arthritis, unspecified, right ankle and foot.
M08.99	Juvenile arthritis, unspecified, multiple sites.
M45.0	Ankylosing spondylitis of multiple sites in spine.
M45.9	Ankylosing spondylitis of unspecified sites in spine.

Duration of prior trials — required durations for step therapy

NSAID trial durationFailure of two NSAIDs, each used for at least 4 weeks at maximally indicated doses (unless contraindicated)

Methotrexate/DMARD trial duration (PsA)3-month trial of methotrexate at maximally indicated dose (unless contraindicated)

Non-biologic DMARD trial duration (RA)3-month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses (unless contraindicated)

BASDAI numeric threshold

BASDAI threshold

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for all listed indications (e.g., ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis). Initial and reauthorization approvals are limited to no more than 12 months. Ensure the submitted diagnosis code matches the applicable ICD-10 code and include supporting clinical documentation.

Prior authorization required for listed diagnoses — include ICD-10 code that matches the requested indication and supportive clinical notes.
Initial and reauthorization approvals limited to ≤ 12 months.

Note

Coverage Decision Guidance

This policy is provided to assist interpretation of coverage criteria but is not a substitute for the benefit plan. When deciding coverage, reference applicable federal, state, or contractual benefit plan requirements first; those requirements govern in the event of a conflict.

Policy assists interpretation but may be superseded by federal/state/contractual requirements.

Background and Scope

Simponi Aria is an intravenous formulation of golimumab, a human anti‑tumor necrosis factor (TNF) monoclonal antibody that targets soluble and transmembrane TNF‑alpha. Simponi Aria (IV) is indicated for inflammatory rheumatologic conditions addressed in this policy, including ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and polyarticular juvenile idiopathic arthritis. The IV product is administered in an infusion setting per FDA‑labeled dosing; the subcutaneous Simponi formulation is managed separately under the pharmacy benefit.

Definitions and Trial Measures

Simponi Aria — IV golimumab defined as medical benefit product

Product definitionSimponi Aria = golimumab injection for intravenous infusion (medical benefit) distinct from subcutaneous Simponi (pharmacy benefit)

Benefit distinctionIV formulation (Simponi Aria) is managed under the medical benefit; subcutaneous Simponi is obtained under the pharmacy benefit

Indications notedPolicy refers to IV golimumab for ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis

Golimumab — mechanism of action

Mechanism of actionHuman anti-tumor necrosis factor (TNF) monoclonal antibody targeting soluble and transmembrane TNF-alpha

TargetTNF-alpha — key proinflammatory cytokine involved in chronic inflammatory diseases

OpenPayer

Simponi Aria (Golimumab) IV infusion — Medical Benefit Drug Policy

Coverage Criteria for Simponi Aria (golimumab) IV

Coding and Diagnosis Codes

Provider Actions, Prior Authorization, and Documentation

Background and Scope

Definitions and Trial Measures