CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Simponi ARIA (golimumab) (Intravenous) Coverage Criteria

Medical benefit policy governing authorization, dosing, and renewal criteria for intravenous golimumab (Simponi ARIA) for Medicaid, Commercial, and Medicare-Medicaid members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySimponi ARIA (golimumab) (Intravenous) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date01/01/2020

Next Review DateN/A

Key ActionRequest prior authorization using HCPCS code J1602 and include a covered ICD-10 diagnosis from the provided list; initial approvals are for six months and may be renewed when renewal criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization length

J1602HCPCS code

50 mg/4 mLNDC presentation

250HCPCS units per dose

MultipleCovered ICD-10 codes

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Coverage Criteria for Simponi ARIA (golimumab) IV

Initial Therapy

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

Universal Requirements: Patient is at least 18 years of age (unless otherwise specified); patient has been evaluated and screened for hepatitis B virus (HBV) prior to initiating treatment; patient has been evaluated and screened for latent tuberculosis (TB) prior to initiating treatment and will receive ongoing monitoring for TB during treatment; patient does not have an active infection; patient will not receive live vaccines during therapy; patient is not on concurrent treatment with another injectable biologic response modifier (including TNF-inhibitors) or IL-inhibitor, or certain oral non-biologic agents; physician has assessed baseline disease severity using an objective measure/tool.

Members previously treated within 365 days are not subject to Step Therapy Requirements

Rheumatoid Arthritis (RA): Must be prescribed by, or in consultation with, a specialist in rheumatology; documented moderate to severe active disease; patient has had at least a 3-month trial and failure of ONE oral DMARD (e.g., methotrexate, azathioprine, hydroxychloroquine, sulfasalazine, leflunomide); prescribed in combination with methotrexate unless contraindicated; patient has had an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses.

FDA-approved indication

Psoriatic Arthritis (PsA): Patient is at least 2 years of age; must be prescribed by, or in consultation with, a specialist in dermatology or rheumatology; documented moderate to severe active disease; for predominantly axial disease or active enthesitis: trial and failure of at least 4 weeks of ONE NSAID unless contraindicated; for peripheral arthritis or dactylitis: trial and failure of at least 3 months of ONE oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine, hydroxychloroquine); may be used as single agent or in combination with methotrexate; patient has had an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab and at least a 6-month trial of ustekinumab at maximum tolerated doses.

Compendia recommended and FDA indications referenced

Ankylosing Spondylitis (AS): Must be prescribed by, or in consultation with, a specialist in rheumatology; documented active disease; patient had an adequate trial and failure of at least TWO NSAIDs over 4 weeks unless contraindicated; patient has had an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses.

FDA-approved indication

Polyarticular Juvenile Idiopathic Arthritis (pJIA): Patient is 2 years of age or older; documented moderate to severe active polyarticular disease; may be used alone or in combination with methotrexate; patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of either NSAID OR an oral DMARD (e.g., methotrexate, leflunomide, sulfasalazine); patient has had an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses.

Orphan drug/FDA indication

Renewal Therapy

Renewal permitted when ALL of the following are met:

General Renewal Requirements: Patient continues to meet the universal and indication-specific criteria; absence of unacceptable toxicity from the drug (examples include serious infections, cardiotoxicity/heart failure, malignancy, demyelinating disorders, lupus-like syndrome, severe hypersensitivity reactions, severe hematologic cytopenias); and documented disease response compared to baseline.

Examples of unacceptable toxicity listed in policy

RA Renewal Response: Improvement in signs and symptoms compared to baseline such as reduction in number of tender and swollen joint counts, reduction of C-reactive protein, improvement in patient global assessment, and/or improvement on a disease activity scoring tool (e.g., DAS28 improvement ≥1.2 or ≥20% improvement by ACR20).

PsA Renewal Response: Improvement in signs and symptoms compared to baseline such as reduction in tender and swollen joint counts and/or improvement on Psoriatic Arthritis Response Criteria (PsARC) defined as improvement in at least 2 of 4 criteria (one must be joint tenderness or swelling) with no worsening in any criterion.

Plan coverage approach

NHPRI adopted clinical coverage criteria aligning with FDA labeling and clinical literature; applies to members except where superseded by CMS policies:

Plan application: Use Simponi ARIA according to FDA‑approved labeling and/or relevant clinical literature; ensure a medically accepted indication and, when appropriate, attempt more cost‑effective options first; for Medicare‑Medicaid Plan (INTEGRITY) members these criteria apply only in the absence of applicable NCD/LCD criteria; Neighborhood may give individual consideration based on prescriber‑submitted information.

Detailed stepwise criteria not included in this excerpt

Concurrent use of Simponi ARIA (intravenous golimumab) with other injectable biologic response modifiers or certain oral targeted agents is not permitted. Specifically, patients must not be receiving concurrent injectable TNF-inhibitors (for example, adalimumab, etanercept, certolizumab, infliximab) or IL-inhibitors (for example, secukinumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, bimekizumab), nor other oral non-biologic agents such as apremilast, tofacitinib, baricitinib, or upadacitinib. This restriction is part of the Universal Criteria and is intended to reduce additive immunosuppression and infection risk.

The policy does not list broad, explicit diagnostic exclusions; instead coverage is tied to an appendix of covered ICD-10 diagnosis codes. If a patient’s diagnosis is not included in Appendix 1, coverage is not supported by this list and may be denied unless another policy or documented clinical rationale applies. Providers should submit a covered diagnosis from the Appendix when requesting authorization.

Where applicable, federal Medicare coverage guidance takes precedence. Providers must comply with any applicable NCDs, LCDs, or LCAs for Medicare Part B drug coverage; these CMS determinations supersede plan criteria when they exist and should be referenced in documentation and claims.

This policy references Medicare Part B coverage framework and CMS resources but does not list specific Medicare Part B diagnosis codes in this segment (noted as N/A for Medicare Part B Covered Diagnosis Codes). For Medicare patients, providers should consult applicable NCDs/LCDs/LCAs for any diagnosis-level Medicare coverage requirements before submission.

Coding, Dosing, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J1602

Injection, golimumab, 1 mg, for intravenous use; 1 mg = 1 billable unit

Covered HCPCS CodesHCPCSCovered

J1602

Injection, golimumab, 1mg, for intravenous use; 1mg = 1 billable unit

NDCNDCCovered

57894-0350-xx

Simponi ARIA 50 mg/4 mL injection, single-use vial (NDC)

Covered Diagnosis Codes (partial listing)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 15

1/2

Covered ICD-10 Diagnosis CodesICD-10Covered

M05.59	Rheumatoid polyneuropathy with rheumatoid arthritis of multiple sites.
M05.60	Rheumatoid arthritis of unspecified site with involvement of other organs and systems.
M05.611	Rheumatoid arthritis of right shoulder with involvement of other organs and systems.
M05.612	Rheumatoid arthritis of left shoulder with involvement of other organs and systems.
M05.619	Rheumatoid arthritis of unspecified shoulder with involvement of other organs and systems.
M05.621	Rheumatoid arthritis of right elbow with involvement of other organs and systems.
M05.622	Rheumatoid arthritis of left elbow with involvement of other organs and systems.
M05.629	Rheumatoid arthritis of unspecified elbow with involvement of other organs and systems.
M05.631	Rheumatoid arthritis of right wrist with involvement of other organs and systems.
M05.632	Rheumatoid arthritis of left wrist with involvement of other organs and systems.

1–10 of 146

1/15

Medicare Part B Covered Diagnosis Codesmixed

No codes listed

Medicare Part B Administrative Contractor (MAC) Jurisdictionsmixed

No codes listed

Dose per administration — loading and maintenance dosing summary

Loading dose (adult)2 mg/kg IV administered at weeks 0 and 4 (equates to 250 billable units per loading dose)

Maintenance dose (adult)2 mg/kg IV every 8 weeks (equates to 250 billable units per maintenance dose)

Pediatric dosing (pJIA, pediatric PsA)80 mg/m2 IV administered at weeks 0 and 4, then every 8 weeks thereafter

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals are provided for six months and may be renewed based on clinical documentation supporting ongoing medical necessity.

Prior authorization required
Initial authorizations: 6 months; renewals considered with documentation

Billing Rule

Prior Authorization using J1602

Submit prior authorization requests using HCPCS code J1602 (Injection, golimumab, 1 mg, for intravenous use). Include a covered ICD-10 diagnosis from the policy's Appendix 1 (supported diagnoses) and relevant clinical documentation.

Use HCPCS J1602 on request/claim
Include one covered ICD-10 diagnosis from Appendix 1

Note

Medicare Coverage and Plan Discretion

Medicare Part B coverage is governed by CMS manuals, NCDs, LCDs, and LCAs where applicable. The plan will comply with applicable Medicare coverage determinations and references the CMS Medicare Coverage Database. Neighborhood may cover additional indications at its discretion.

Comply with applicable NCDs/LCDs/LCAs
CMS coverage database: http://www.cms.gov/medicare-coverage-database/search/advancedsearch.aspx
Plan may cover additional indications at its discretion

Denial Risk

Triggers for Denial

Requests may be denied if required documentation is missing or contraindications are present. Common triggers for denial include: missing HBV or latent TB screening, active infection, concurrent use of another injectable biologic or disallowed concurrent therapies, failure to document prior therapy trials/failures, or coding/diagnosis mismatches.

Missing HBV screening prior to initiation
Missing latent TB screening prior to initiation
Active infection or clinically important localized infections
Concurrent treatment with another injectable biologic or specified oral agents
Failure to document required prior therapy trials/failures
Claims without HCPCS J1602 or without a covered ICD-10 diagnosis risk denial

Documentation Required

Dose and Product Documentation

Providers must document dosing and product information consistent with the labeled intravenous golimumab (Simponi ARIA) administration. Include dose (mg/kg or mg/m2 where applicable), infusion schedule, and the NDC when available.

Documented dosing regimen consistent with labeled IV golimumab (adult and pediatric dosing)
Include infusion schedule (weeks 0, 4, then every 8 weeks)
Include product NDC when available (e.g., 57894-0350-xx)

Documentation Required

Prescriber Documentation and Individual Consideration

Prescribers must submit medical necessity information and supporting clinical documentation. Neighborhood will give individual consideration to each request reviewed and may require specialist consultation notes, baseline disease severity assessments, and prior therapy trial documentation.

Specialist prescription or consultation notes (as applicable)
Baseline disease severity assessment using an objective measure/tool
Documentation of prior therapy trials and reasons for failure/intolerance/contraindication
Neighborhood provides individual consideration based on submitted information

Step Therapy

Step Therapy — None Specified in This Section

No additional explicit step therapy rules are specified in this section beyond the indication-specific prior therapy/trial requirements noted in the clinical criteria.

No standalone step therapy program detailed here; follow indication-specific trial/failure requirements

Definitions and Reference Terms

Simponi (golimumab) — brief summary

Drug classTumor necrosis factor (TNF) blocker evaluated in multicenter randomized trials for RA, PsA, AS, and UC

Indications (summary)Adult RA (with methotrexate), active PsA, ankylosing spondylitis, moderate to severe UC; pediatric pJIA indications noted

Common adverse eventsUpper respiratory tract infection, nasopharyngitis, injection site reactions

Evidence basisEfficacy demonstrated in multiple randomized controlled trials (RA-1/2/3, PsA, AS, UC trials)

Simponi ARIA (intravenous golimumab) — IV formulation and dosing context

FormulationSimponi ARIA is the intravenous formulation of golimumab administered by infusion

Adult IV dosing regimen2 mg/kg IV at weeks 0 and 4, then every 8 weeks thereafter

Pediatric IV dosing regimen80 mg/m2 IV at weeks 0 and 4, then every 8 weeks thereafter (used in pJIA and pediatric PsA)

Billing units referencePolicy references 250 billable HCPCS units per adult loading or maintenance dose (1 mg = 1 unit; see HCPCS coding)

CMS coverage policies referenced that may supersede plan criteria

CMS policy typesNational Coverage Determination (NCD), Local Coverage Determination (LCD), Local Coverage Article (LCA)

PrecedenceWhere applicable, NCDs/LCDs/LCAs take precedence and must be followed

Reference locationCMS coverage guidance available via the Medicare Coverage Database (http://www.cms.gov/medicare-coverage-database/search/advancedsearch.aspx)

Plan discretionAdditional indications may be covered at the discretion of the health plan when CMS policies do not apply

OpenPayer

Simponi ARIA (golimumab) (Intravenous) Coverage Criteria

Coverage Criteria for Simponi ARIA (golimumab) IV

Coding, Dosing, and Diagnosis Codes

Provider Actions, Authorization, and Documentation

Background and Context

Definitions and Reference Terms