CurrentCignaPolicy IP0668

Simponi Aria Prior Authorization Policy

Cigna pharmacy & specialty drug coverage and prior authorization criteria for Simponi Aria (golimumab intravenous infusion) for FDA‑approved inflammatory indications; applies to health benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicySimponi Aria Prior Authorization Policy

Policy CodePolicy IP0668

Change TypeNew policy (11/01/2024)Annual revision 03/01/2025 — no criteria changes

Effective DateMar 1, 2025

Next Review Date

Key ActionProviders must obtain prior authorization and ensure the medication is prescribed by or in consultation with an appropriate specialist; document objective clinical response for continuation.

SourceLink

POLICY UPDATE CHANGES

New policy created (Summary of Changes = New policy).

4FDA‑approved indications covered

6typical initial approval duration

1typical renewal duration for established patients

J1602HCPCS code for golimumab IV

Simponi Aria (golimumab IV) Coverage Criteria

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Simponi Aria (intravenous golimumab) is a tumor necrosis factor inhibitor indicated for ankylosing spondylitis, polyarticular juvenile idiopathic arthritis (patients ≥ 2 years), psoriatic arthritis (patients ≥ 2 years), and rheumatoid arthritis. It is administered as an intravenous (IV) infusion by a healthcare professional. Efficacy has not been established for switching between IV Simponi Aria and subcutaneous golimumab, and therefore interchangeability between the IV and SC formulations is not assumed.

General Prior Authorization / Prescriber Requirement

Prior authorization is required. Initial approval requires prescription by or in consultation with a specialist in the treated condition.

ALL of the following

Prior Authorization requested
Medication prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., rheumatologist, dermatologist as specified per indication)

Ankylosing Spondylitis — FDA‑Approved Indication

Approve if ONE of the following applies:

ANY of the following

A) Initial Therapy
- Patient is > 18 years of age
- Medication prescribed by or in consultation with a rheumatologist
B) Currently receiving Simponi Aria or Simponi subcutaneous
- Patient has been established on therapy for at least 6 months
- ANY of the following
  - When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: ASDAS, BASDAI, BASFI, BAS‑G, BASMI, DFI, HAQ‑S, CRP, ESR)

Dosing

Up to 2 mg/kg IV at Weeks 0 and 4, then not more frequently than once every 8 weeks thereafter

Juvenile Idiopathic Arthritis (JIA) — FDA‑Approved Indication

Approve if ONE of the following applies (includes PJIA and juvenile spondyloarthropathy/active sacroiliac arthritis):

ANY of the following

A) Initial Therapy
- Patient is > 2 years of age
- ANY of the following
  - Patient has tried one other medication for this condition (examples: methotrexate, sulfasalazine, leflunomide, NSAID); a prior trial of a biologic other than requested medication also counts; biosimilar of requested biologic does not count
  - Patient has aggressive disease, as determined by the prescriber
- Medication prescribed by or in consultation with a rheumatologist

Psoriatic Arthritis — FDA‑Approved Indication

Approve if ONE of the following applies:

ANY of the following

A) Initial Therapy
- Patient is > 2 years of age
- Medication prescribed by or in consultation with a rheumatologist or dermatologist
B) Currently receiving Simponi Aria or subcutaneous
- Patient has been established on therapy for at least 6 months
- ANY of the following

Rheumatoid Arthritis — FDA‑Approved Indication

Approve if ONE of the following applies:

ANY of the following

A) Initial Therapy
- Patient is > 18 years of age
- Patient has tried ONE conventional synthetic DMARD for at least 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). Exception: if patient already had a 3‑month trial of at least one biologic other than the requested medication, the DMARD trial may be waived. Biosimilars of the requested biologic do not count.
- Medication prescribed by or in consultation with a rheumatologist
B) Currently receiving Simponi Aria or subcutaneous

Not Medically Necessary / Exclusions

Simponi Aria use not covered when criteria below are met:

ANY of the following

Use of Simponi Aria in combination with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition (combination therapy) — not covered
Use of Simponi Aria for ulcerative colitis — not covered (subcutaneous golimumab is indicated for UC; IV dosing/efficacy unclear)
Any other uses not listed as covered indications are considered not medically necessary

Key Thresholds / Durations

Established on therapy>= 6 months

Initial approval duration6 months

Renewal approval duration (established patients)1 year

Billing Codes

HCPCS - Covered when criteria metHCPCSCovered

J1602

Injection, golimumab, 1 mg, for intravenous use

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for coverage of Simponi Aria; initial approvals are granted for 6 months and renewals for established patients are granted for 1 year per the policy.

J1602

Documentation Required

Document objective clinical response for continuation

For continuation/renewal, providers must document that the patient experienced benefit from therapy using at least one objective measure from baseline or documented improvement in symptoms compared with baseline; examples of objective measures are listed in the criteria (e.g., ASDAS, BASDAI, BASFI, MD global, JADAS, DAPSA, CDAI, DAS28, CRP, ESR).

Note

Specialist prescription or consultation required for initial approval

Initial approval requires the medication to be prescribed by or in consultation with a specialist appropriate to the indication (e.g., rheumatologist or dermatologist as specified in the indication criteria).

Billing Rule

Dosing outside policy reviewed case‑by‑case

Requests for dosing outside the established dosing regimens in the policy will be reviewed on a case‑by‑case basis by a clinician (Medical Director or Pharmacist); dosing per indication is specified in the Coverage Criteria.

Refer to indication-specific dosing in policy (e.g., up to 2 mg/kg IV at Weeks 0 and 4, then not more frequently than every 8 weeks; or up to 80 mg/m2 IV for pediatric dosing)

Defined Terms

Established on therapyPatient has received the therapy for at least 6 months.

Conventional synthetic DMARD — examplesMethotrexate (oral or injectable); leflunomide; hydroxychloroquine; sulfasalazine.

Conventional synthetic DMARD — trial requirementFor rheumatoid arthritis initial therapy, patient must have tried one conventional synthetic DMARD for at least 3 months (exceptions apply if prior biologic trial).

Clinical Background

Simponi Aria is an IV formulation of golimumab indicated across multiple inflammatory conditions, including adult ankylosing spondylitis, polyarticular juvenile idiopathic arthritis (≥ 2 years), psoriatic arthritis (≥ 2 years), and rheumatoid arthritis (used in combination with methotrexate for adults). Administration is by intravenous infusion in a clinical setting following the dosing regimens specified per indication. The policy notes that efficacy has not been established for patients switching between the IV infusion (Simponi Aria) and subcutaneous golimumab, and also specifies that Simponi Aria is not covered for certain uses such as ulcerative colitis where IV dosing/efficacy is unclear; combination use with another biologic or a targeted synthetic oral small molecule for inflammatory conditions is also considered not medically necessary.

Policy Changes

2024-11-01New policy

Policy created (Summary of Changes = New policy); this is a new policy effective 11/01/2024 (is_material: false).

2025-03-01Annual revisionLatest

Annual Revision dated 03/01/2025 — no criteria changes (administrative annual review; is_material: false).

Policy Summary

PayerCigna

PolicySimponi Aria Prior Authorization Policy

Policy CodePolicy IP0668

Change TypeNew policy (11/01/2024)Annual revision 03/01/2025 — no criteria changes

Effective DateMar 1, 2025

Next Review Date

SourceLink

On This Page

Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function/ADLs)

B) Currently receiving Simponi Aria or subcutaneous

Patient has been established on therapy for at least 6 months
ANY of the following
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: MD global, PGA, PDA, JADAS, cJADAS, JSpADA, CRP, ESR, reduced corticosteroid dose)
- Compared with baseline, patient experienced improvement in at least one symptom (e.g., improved ROM, less joint pain/tenderness, decreased morning stiffness/fatigue, improved function/ADLs)

Dosing

Up to 80 mg/m2 IV at Weeks 0 and 4, then not more frequently than once every 8 weeks thereafter

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID‑12, CRP, ESR)

Compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue, improved function/ADLs, decreased soft tissue swelling)

Dosing (age‑based options)

Patient ≥ 18 years: up to 2 mg/kg IV at Weeks 0 and 4, then not more frequently than once every 8 weeks
Patient < 18 years: up to 80 mg/m2 IV at Weeks 0 and 4, then not more frequently than once every 8 weeks

Patient has been established on therapy for at least 6 months

ANY of the following

Patient experienced a beneficial clinical response by at least one objective measure (examples: CDAI, DAS28‑ESR/CRP, PAS‑II, RAPID‑3, SDAI)
Patient experienced improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue; improved function/ADLs; decreased soft tissue swelling)

Dosing

Up to 2 mg/kg IV at Weeks 0 and 4, then not more frequently than once every 8 weeks thereafter