CurrentEmblemHealthPolicy MG.MM.PH.104

Simponi ARIA (golimumab)

Clinical policy governing medical-benefit coverage, dosing, initial approval and renewal criteria, eligible indications (RA, PsA, AS, pJIA), dosing limits, applicable procedure/NDC/ICD-10 codes, and length of authorization for Simponi ARIA (golimumab) intravenous formulation for EmblemHealth/ConnectiCare members.

Policy Summary

PayerEmblemHealth

PolicySimponi ARIA (golimumab)

Policy CodePolicy MG.MM.PH.104

Change TypeAnnual review (revisions to initial and renewal criteria)

Effective Date

Next Review Date

Key ActionTreating physician must submit documentation that member meets the clinical criteria (screening for latent TB and HBV, prior therapy trials, specialist consultation documentation, baseline disease severity assessment) for preauthorization or post-payment review

SourceLink

POLICY UPDATE CHANGES

Annual review updated Psoriatic Arthritis initial criteria to adjust trials for axial disease/enthesitis and peripheral disease/dactylitis and clarified age and specialist requirements

Ankylosing Spondylitis initial criteria clarified NSAID trial requirement

Polyarticular JIA initial and renewal criteria updated

Added coverage use for pediatric patients aged 2 years and older with active pJIA and added ICD-10 codes M08.09, M08.40

Removed phrase 'or active enthesitis' from earlier PsA axial disease statement and reinserted in later revision

4Covered Indications

Initial Authorization Length

J1602Primary Billing Code

57894-0350-XXRepresentative NDC

Coverage Summary

Scope: This clinical policy governs medical-benefit coverage, dosing, initial approval and renewal criteria, eligible indications (rheumatoid arthritis [RA], psoriatic arthritis [PsA], ankylosing spondylitis [AS], and polyarticular juvenile idiopathic arthritis [pJIA]), applicable procedure/NDC/ICD-10 codes, length of authorization, and utilization management for the intravenous formulation of Simponi ARIA (golimumab) for EmblemHealth/ConnectiCare members. Coverage stance: Covered with criteria for the listed indications (RA, PsA, AS, pJIA) subject to the specified initial and renewal requirements.

Quick Facts and Key Thresholds

Covered Indications4

Initial Authorization Length6 months

Primary Billing CodeJ1602

Representative NDC57894-0350-XX

General Pre-conditions

General Pre-conditions (applies to all indications)

Covered when ALL of the following are met:

ALL of the following

Patient has been evaluated and screened for the presence of latent TB infection prior to initiating treatment
Patient has been evaluated and screened for the presence of hepatitis B virus (HBV) prior to initiating treatment
Patient does not have an active infection, including clinically important localized infections
Must not be administered concurrently with live vaccines
Patient is not on concurrent treatment with another TNF inhibitor, biologic response modifier or other non-biologic agent (e.g., apremilast, tofacitinib, baricitinib, upadacitinib)

Initial Therapy Criteria — Rheumatoid Arthritis (RA)

Initial Approval Criteria — Rheumatoid Arthritis (RA)

Covered when ALL of the following are met:

ALL of the following

Age: Patient is 18 years or older
Specialist: Must be prescribed by, or in consultation with, a specialist in rheumatology
Disease severity: Documented moderate to severe active disease
Prior DMARD trial:

Initial Therapy Criteria — Psoriatic Arthritis (PsA)

Initial Approval Criteria — Psoriatic Arthritis (PsA)

Covered when ALL of the following are met (with branching depending on axial vs peripheral disease):

ALL of the following

Age: Patient is 2 years or older
Specialist: Must be prescribed by, or in consultation with, a specialist in dermatology or rheumatology
Disease severity: Documented moderate to severe active disease
ONE of

Initial Therapy Criteria — Ankylosing Spondylitis (AS)

Initial Approval Criteria — Ankylosing Spondylitis (AS)

Covered when ALL of the following are met:

ALL of the following

Age: Patient is 18 years or older
Specialist: Must be prescribed by, or in consultation with, a specialist in rheumatology
Disease activity: Documented active disease
NSAID trial:

Initial Therapy Criteria — Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Initial Approval Criteria — Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Covered when ALL of the following are met:

ALL of the following

Age (pediatric): Patient is 2 years of age or older
Specialist: Must be prescribed by, or in consultation with, a specialist in rheumatology
Disease severity: Documented moderate to severe active disease
Prior trial (NSAID or DMARD):

Continuation / Renewal Criteria

Renewal Criteria (applies to all indications)

Coverage may be renewed when ALL of the following are met:

ALL of the following

Continued initial criteria: Patient continues to meet initial criteria for the treated indication
Toxicity: Absence of unacceptable toxicity (examples: serious infections, cardiotoxicity/heart failure, malignancy, demyelinating disorders, lupus-like syndrome, severe hypersensitivity reactions, severe hematologic cytopenias)
Infection monitoring: Patient is receiving ongoing monitoring for presence of TB or other active infections
AND evidence of disease response as defined per indication

Unproven / Exclusions

Exclusionary rules and preconditions: Patients must be screened for latent tuberculosis and hepatitis B prior to initiation and have no active infection; therapy must not be administered concurrently with live vaccines; concurrent treatment with another TNF inhibitor, other biologic response modifiers, or specified non-biologic agents (e.g., apremilast, tofacitinib, baricitinib, upadacitinib) is not allowed. Renewal requires continued absence of unacceptable toxicity (examples: serious infections, cardiotoxicity/heart failure, malignancy, demyelinating disorders, lupus-like syndrome, severe hypersensitivity, severe hematologic cytopenias) and ongoing monitoring for TB or other active infections; continuation also requires objective evidence of disease response per indication.

Applicable Codes

Billing Rule

Dosing units and billing

Provider Actions & Requirements

Prior Authorization

Submit clinical evidence for medical necessity

Submit clinical evidence to support medical necessity for preauthorization (or for post‑payment review) including the items below. Include J1602 on claims as applicable.

Documentation of TB screening and evaluation prior to initiation
Documentation of hepatitis B virus (HBV) screening prior to initiation
Records of prior therapy trials and failures per indication (NSAID/DMARD trials as required)
Documentation of specialist consultation or that prescriber is a relevant specialist
Baseline disease severity assessment using an objective tool (see disease activity measures)

Documentation Required

Clinical Evidence

Evidence base: development of these criteria used the Simponi ARIA package insert (Janssen Biotech Inc., September 2020), the GO-FURTHER phase 3 trial demonstrating efficacy in RA (Weinblatt et al., Ann Rheum Dis. 2013), and guideline sources (e.g., ACR 2015, EULAR 2016, NICE reviews). These sources and the cited literature and guidelines were used to inform the labeling- and evidence-based criteria in this policy.

Background & Definitions

Background: Simponi ARIA (golimumab) is a human monoclonal antibody that targets tumor necrosis factor alfa (TNF-alpha) and is administered intravenously for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and polyarticular juvenile idiopathic arthritis (pJIA). EmblemHealth developed these utilization management and medical necessity criteria based on FDA labeling, the published literature, and relevant clinical guidelines.

Definitions: Simponi ARIA — A human monoclonal antibody that binds to tumor necrosis factor alfa (TNF alfa) inhibiting the binding of TNF alfa to its receptors.

Revision History

2025-02-18revisedLatest

Annual review updated Psoriatic Arthritis initial criteria to adjust trials for axial disease/enthesitis and peripheral disease/dactylitis and clarified age and specialist requirements (is_material: true). Detail: Removed earlier wording and reinserted 'or active enthesitis' into peripheral disease DMARD requirement and set patient age to 2 years or older; requires specialist in dermatology or rheumatology.

2024-01-08revised

Ankylosing Spondylitis initial criteria clarified NSAID trial requirement (is_material: true). Detail: Added 'over 4 weeks (in total)' language to the requirement that patient had an adequate trial and failure of at least two NSAIDs over 4 weeks in total unless contraindicated.

Policy Summary

PayerEmblemHealth

PolicySimponi ARIA (golimumab)

Policy CodePolicy MG.MM.PH.104

Change TypeAnnual review (revisions to initial and renewal criteria)

Effective Date

Next Review Date

SourceLink

On This Page

Physician has assessed baseline disease severity utilizing an objective measure/tool

Patient has had at least a 3 month trial and failed previous therapy with ONE oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, or leflunomide

Methotrexate combination: Prescribed in combination with methotrexate unless contraindicated

Documentation Required

Baseline and ongoing disease activity assessment

Physician should document baseline disease severity and ongoing assessments using validated objective tools relevant to rheumatoid arthritis (examples): DAS28, American College of Rheumatology (ACR) response criteria (e.g., ACR20), tender and swollen joint counts, C‑reactive protein, and patient global assessment. Document these measures at baseline prior to initiation and on follow-up to support initial approval and renewal.

Disease Activity Score-28 (DAS28)
American College of Rheumatology response criteria (ACR20/ACR measures)
Tender and swollen joint counts
C‑reactive protein (CRP)
Patient global assessment

Axial or enthesitis NSAID trial: For patients with predominantly axial disease OR active enthesitis: an adequate trial and failure of at least 4 weeks of ONE non-steroidal anti-inflammatory agent (NSAID), unless use is contraindicated>= 4 weeks (one NSAID)

Peripheral/dactylitis/enthesitis DMARD trial: For patients with peripheral arthritis, or dactylitis, OR active enthesitis: a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, or hydroxychloroquine>= 3 months

Documentation Required

Specialist involvement required

Prescriptions for psoriatic arthritis must be written by, or in consultation with, a specialist in dermatology or rheumatology. Document specialist involvement in the medical record and on the authorization request.

Patient had an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents (NSAIDs), over 4 weeks (in total), unless use is contraindicated

>= 4 weeks total across >= 2 NSAIDs

Patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of previous therapy with either oral non-steroidal anti-inflammatory drugs (NSAIDs) OR an oral disease-modifying anti-rheumatic agent (DMARD) (e.g., methotrexate, leflunomide, sulfasalazine)

Documentation Required

Age and specialist consultation for pJIA

For polyarticular juvenile idiopathic arthritis (pJIA) document the patient’s age (must be 2 years of age or older) and that treatment was prescribed by or in consultation with a pediatric or adult rheumatology specialist. Include documentation of moderate to severe active disease and prior trial (at least 1 month) of NSAID or DMARD when applicable.

Age documented (>= 2 years)
Specialist consultation/prescriber (rheumatology)
Documented moderate to severe active disease
Prior 1‑month trial and failure of NSAID OR oral DMARD

RA response examples: Rheumatoid Arthritis: improvement in signs and symptoms compared to baseline such as number of tender and swollen joints, reduction of C-reactive protein, improvement of patient global assessment, and/or improvement on a disease activity scoring tool (e.g., DAS28 improvement of 1.2 points or more or >=20% improvement on ACR20)
PsA response examples: Psoriatic Arthritis: improvement in signs and symptoms compared to baseline such as number of tender and swollen joint counts and/or improvement on a disease activity scoring tool (e.g., improvement in at least 2 of 4 PsARC criteria, one of which must be joint tenderness or swelling, with no worsening in any criterion)
AS response examples: Ankylosing Spondylitis: improvement in signs and symptoms compared to baseline such as total back pain, physical function, morning stiffness, and/or improvement on a disease activity scoring tool (e.g., >=1.1 improvement on ASDAS or >=2 improvement on BASDAI)
pJIA response examples: pJIA: improvement in signs and symptoms compared to baseline and/or improvement on disease activity scoring tool (e.g., JADAS or ACR Pedi-30: at least 30% improvement from baseline in three of six variables)

Documentation Required

Baseline and ongoing disease activity assessment

Document objective measures of disease activity at baseline and on renewal using indicated tools. Acceptable assessments include DAS28, ACR response criteria, PsARC, ASDAS, BASDAI, JADAS, and ACR Pedi (e.g., ACR‑Pedi 30) as applicable to the treated indication and patient population.

DAS28
ACR response criteria (e.g., ACR20/ACR measures)
Psoriatic Arthritis Response Criteria (PsARC)
ASDAS (Ankylosing Spondylitis Disease Activity Score)
BASDAI
Juvenile Arthritis Disease Activity Score (JADAS)
ACR Pediatric (ACR‑Pedi, e.g., ACR‑Pedi 30)

Infection monitoring

Document screening for latent tuberculosis (TB) and hepatitis B virus (HBV) prior to initiating golimumab IV and record ongoing monitoring for TB or other active infections while on therapy. Include results in the medical record and authorization materials.

Pre‑initiation TB screening documented
Pre‑initiation HBV screening documented
Ongoing infection monitoring during therapy (TB/other active infections)

Documentation Required

Specialist involvement required

Specialist prescribing requirements vary by indication: for rheumatoid arthritis, ankylosing spondylitis, and polyarticular JIA the drug must be prescribed by or in consultation with a rheumatologist; for psoriatic arthritis it must be prescribed by or in consultation with a dermatologist or rheumatologist. Document specialty involvement on the request.

RA/AS/pJIA: rheumatology prescriber or documented rheumatology consultation
PsA: dermatology or rheumatology prescriber or documented consultation

Polyarticular JIA initial and renewal criteria updated (is_material: true). Detail: Added 'moderate to severe' for documented disease activity; replaced prior DMARD-only failure requirement with a 1-month trial of NSAID OR DMARD; renewal criteria clarified to require objective measures such as JADAS or ACR-Pedi 30 for evidence of response.

2020-10-08added

Added coverage use for pediatric patients aged 2 years and older with active pJIA and added ICD-10 codes M08.09, M08.40 (is_material: true). Detail: Originated policy and transferred pediatric indication into template.

revised

Multiple revisions adjusted wording around enthesitis and dactylitis inclusion in PsA criteria (is_material: false). Detail: Phrase 'or active enthesitis' was removed from an earlier PsA axial disease statement and later reinserted.