ModifiedCignaPolicy IP0668

Simponi Aria Prior Authorization Policy

Defines Cigna prior authorization, coverage criteria, dosing, and exclusions for Simponi Aria (intravenous golimumab) for inflammatory rheumatologic indications; affects providers prescribing/administering Simponi Aria to Cigna members.

Policy Summary

PayerCigna

PolicySimponi Aria Prior Authorization Policy

Policy CodePolicy IP0668

Change TypeMaterial: Appendix updatedpolicy created

Effective Date03/01/2026

Next Review DateN/A

Key ActionPrior authorization is required for Simponi Aria (golimumab IV); approvals granted when the patient meets the policy's coverage criteria and dosing.

SourceLink

POLICY UPDATE CHANGES

New policy was created with an initial date of 11/01/2024.

Otezla XR (apremilast extended-release tablets) was added in the Appendix under Oral Therapies/Targeted Synthetic Oral Small Molecular Drugs.

New policy created 11/01/2024 and subsequently revised annually with no criteria changes; Otezla XR was added to Appendix under Oral Therapies/Targeted Synthetic Oral Small Molecular Drugs.

4FDA-approved indications listed

1 yrApproval duration for established patients

6 moInitial approval duration

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Coverage Criteria for Simponi Aria (golimumab IV)

Ankylosing Spondylitis

Ankylosing Spondylitis — Approve when ONE of the following is met

A or B: A) Initial Therapy: Approve for 6 months if BOTH: i) patient is > 18 years of age; AND ii) medication is prescribed by or in consultation with a rheumatologist; OR B) Patient is Currently Receiving Simponi Aria or Subcutaneous: Approve for 1 year if BOTH: i) patient has been established on therapy for at least 6 months; AND ii) patient meets at least ONE of: a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, and/or serum markers such as CRP or ESR); OR b) compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, or improvement in function or activities of daily living).

A patient who has received < 6 months of therapy or who is restarting therapy with Simponi Aria or subcutaneous is reviewed under Initial Therapy (A).

Juvenile Idiopathic Arthritis (JIA)

Juvenile Idiopathic Arthritis — Approve when ONE of the following is met

A or B: A) Initial Therapy: Approve for 6 months if ALL: i) patient is > 2 years of age; AND ii) patient meets ONE of: a) patient has tried one other medication for this condition (examples: methotrexate, sulfasalazine, leflunomide, or an NSAID) — a prior trial of a biologic other than the requested medication also counts; OR b) patient has aggressive disease as determined by the prescriber; AND iii) medication is prescribed by or in consultation with a rheumatologist; OR B) Patient is Currently Receiving Simponi Aria or Subcutaneous: Approve for 1 year if BOTH: i) patient has been established on therapy for at least 6 months; AND ii) patient meets at least ONE of: a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR b) compared with baseline, patient experienced improvement in at least one symptom.

Pediatric dosing: up to 80 mg/m2 IV at Weeks 0 and 4, then not more frequently than once every 8 weeks.

Psoriatic Arthritis

Psoriatic Arthritis — Approve when ONE of the following is met

A or B: A) Initial Therapy: Approve for 6 months if BOTH: i) patient is > 2 years of age; AND ii) medication is prescribed by or in consultation with a rheumatologist or dermatologist; OR B) Patient is Currently Receiving Simponi Aria or Subcutaneous: Approve for 1 year if BOTH: i) patient has been established on therapy for at least 6 months; AND ii) patient meets at least ONE of: a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID-12, and/or serum markers such as CRP or ESR); OR b) compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue, improved function, or decreased soft tissue swelling).

Dosing: adults approve up to 2 mg/kg IV at Weeks 0 and 4, then not more frequently than once every 8 weeks; pediatric <18 years up to 80 mg/m2 IV per dosing schedule.

Rheumatoid Arthritis

Rheumatoid Arthritis — Approve when ONE of the following is met

A or B: A) Initial Therapy: Approve for 6 months if ALL: i) patient is > 18 years of age; AND ii) patient has tried ONE conventional synthetic DMARD for at least 3 months (examples include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) unless exception applies for prior biologic use (a prior 3-month trial of a biologic other than the requested medication satisfies this requirement); AND iii) medication is prescribed by or in consultation with a rheumatologist; OR B) Patient is Currently Receiving Simponi Aria or Subcutaneous: Approve for 1 year if BOTH: i) patient has been established on therapy for at least 6 months; AND ii) patient meets at least ONE of: a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include CDAI, DAS28-ESR/CRP, PAS-II, RAPID3, SDAI); OR b) compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue, improved function, or decreased soft tissue swelling).

Dosing: approve up to 2 mg/kg IV at Weeks 0 and 4, then not more frequently than once every 8 weeks thereafter.

Simponi Aria (intravenous golimumab) must not be used concurrently with another biologic or a targeted synthetic oral small molecule drug for an inflammatory condition. The policy states that combination therapy is not recommended because of a potentially higher rate of adverse events and lack of controlled clinical data demonstrating additive efficacy. Operationally, note that use of conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) in combination with Simponi Aria is not excluded by this rule.

The appendix and revision sections in this document do not specify additional clinical exclusions beyond those in the main policy language. Revision details indicate administrative updates and appendix additions rather than changes to clinical criteria.

Use of Simponi Aria for any indication not listed among the FDA-approved indications in this policy is considered not medically necessary. The policy explicitly lists concurrent use with another biologic or targeted synthetic oral small molecule drug, and IV golimumab for ulcerative colitis, as examples of indications or uses that are not medically necessary.

No additional 'not medically necessary' statements are present within the appendix or revision text; the revision history documents administrative updates and an appendix medication addition without altering clinical coverage statements.

Coding and Identifiers

Considered Medically Necessary HCPCSHCPCSCovered

J1602

Injection, golimumab, 1 mg, for intravenous use

Policy Identifiermixed

IP0668

Coverage Policy Number referenced on appendix pages

Provider Actions and Prior Authorization

Note

Coverage policy reference

Coverage Policy Number: IP0668 — This section is associated with Coverage Policy Number IP0668; prior authorization requirements and coverage criteria in this document apply to benefit plans administered by Cigna Companies and determinations should reference the applicable plan document.

Claims submitted without covered diagnosis/procedure codes or using deleted/ineffective codes may be denied. Use the most appropriate codes effective on the date of service.
This section does not specify additional provider action items beyond referencing the policy and authorization requirements; refer to other sections for documentation and submission instructions.

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required for Simponi Aria. Initial approvals require the medication to be prescribed by or in consultation with a specialist (rheumatologist for relevant indications). All approvals are provided for the duration listed in the policy (e.g., 6 months for initial therapy in many indications; 1 year for patients currently receiving therapy who meet continuation criteria). Requests for doses outside the established dosing in this policy will be reviewed case-by-case by a clinician (Medical Director or Pharmacist).

Background

Simponi Aria is an intravenous tumor necrosis factor (TNF) inhibitor with approved indications that include ankylosing spondylitis, juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), and rheumatoid arthritis (RA). The drug is administered by IV infusion according to the dosing guidance in the policy (adult dosing generally up to 2 mg/kg IV at Weeks 0 and 4, then every 8 weeks; pediatric dosing for JIA and pediatric PsA up to 80 mg/m2 IV at Weeks 0 and 4, then every 8 weeks).

Dosing and Definitions

Dosing regimens — adult and pediatric

Adult dosing (standard)Up to 2 mg/kg IV administered at Weeks 0 and 4, then not more frequently than every 8 weeks.

Pediatric dosing (JIA and pediatric PsA)For patients <18 years, approve up to 80 mg/m2 IV at Weeks 0 and 4, then not more frequently than every 8 weeks.

Dosing frequency noteAfter the Week 4 dose, subsequent infusions should be given no more frequently than once every 8 weeks.

Administration routeSimponi Aria is administered by intravenous infusion by a healthcare professional.

Switching formulationsEfficacy has not been established for patients switching between Simponi Aria (IV) and Simponi subcutaneous.

Revision History and Appendix Changes

2026-03-01Annual revisionLatest

Annual revision noted; no changes to clinical coverage criteria; Appendix includes Otezla XR addition recorded previously.

2025-03-01Annual revision

Annual revision noted with no changes to clinical coverage criteria.

2024-11-01New policy

Policy created (new policy effective date recorded).