CurrentCignaPolicy IP0660

Infliximab Intravenous Products Prior Authorization Policy

Cigna prior authorization policy for infliximab intravenous products (brand and biosimilars) covering FDA-approved indications and selected other uses with supportive evidence, with specific clinical criteria, prescribing specialist requirements, approval durations, and dosing regimens. Applies to health benefit plans administered by Cigna Companies; refers to preferred-product requirements in a separate policy.

Policy Summary

PayerCigna

PolicyInfliximab Intravenous Products Prior Authorization Policy

Policy CodePolicy IP0660

Change TypeSelected Revision (03/15/2026) and multiple prior revisions

Effective DateMar 15, 2026

Next Review Date

Key ActionSubmit prior authorization request; initial approval requires prescriber who specializes in the treated condition or consultation and adherence to indication-specific criteria and dosing.

SourceLink

POLICY UPDATE CHANGES

Selected Revision: Crohn's Disease initial therapy options were removed; other condition-specific criteria were modified across revisions ending 03/15/2026.

Immunotherapy-related toxicities examples and specialist requirements were updated in selected revisions.

Annual Revision 03/01/2026 indicates no criteria changes in that annual revision but Selected Revision 03/15/2026 made substantive criteria edits.

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Coverage Summary

This policy applies to Cigna Companies and requires prior authorization for infliximab intravenous products (brand and biosimilars) administered by Cigna Companies. Initial approval requires the infliximab product to be prescribed by or in consultation with a physician who specializes in the condition being treated, and requests for non-preferred infliximab IV products are subject to preferred-product requirements per PSM005. Prior Authorization is required for benefit coverage and approvals follow the indication-specific criteria and dosing outlined in the policy.

Key thresholds and quick facts

Typical initial approval durationMost initial approvals: 3–6 months depending on indication (e.g., 3 months for plaque psoriasis, hidradenitis suppurativa, Behcet's; 6 months for Crohn's, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, uveitis)

Established-on-therapy (continuation) minimumsContinuation approvals require patients to be established on therapy for indication-specific minimums (commonly 3 months for some conditions [eg, plaque psoriasis, HS, Behcet's, sarcoidosis], 4 months for pyoderma gangrenosum, 6 months for many GI and rheumatologic indications; 1 month minimum for acute GVHD)

Typical initial dosing regimensInduction commonly up to 5 mg/kg IV at 0, 2, and 6 weeks then maintenance every 6–8 weeks (varies by indication); some indications use 3 mg/kg initial (RA) or up to 6 mg/kg (JIA); uveitis and some severe indications allow higher initial dosing per policy

Maximum/ escalation dosing for ongoing useFor patients currently receiving infliximab, policy allows up to 10 mg/kg IV as a maximum dose with dosing no more frequently than once every 4 weeks (some indications permit up to 10 mg/kg initial/maintenance schedules)

Exclusion — concurrent therapiesInfliximab IV products should not be used in combination with another biologic or a targeted synthetic oral small molecule for inflammatory conditions (conventional synthetic DMARDs like methotrexate are allowed)

Prior Authorization and Provider Requirements

Prior Authorization

Prior authorization required

Submit a prior authorization (PA) request per policy IP0660. Initial approvals require the prescriber to be a specialist in the condition or include documentation of consultation with a specialist, and the request must meet the indication-specific criteria and dosing requirements described in this policy.

Prior Authorization

Preferred product requirement

Preferred infliximab products must be used first when available per Cigna Preferred Specialty Medication guidance (PSM005). If a non-preferred product is requested, provide documentation of medical necessity or justification for exception.

General Prior Authorization and Therapy Criteria

General Prior Authorization

Prior Authorization is required; initial approval requires specialist prescriber or consultation and preferred-product requirements apply.

ALL of the following

Prior Authorization required for benefit coverage of infliximab products.
Initial approval requires the infliximab product to be prescribed by or in consultation with a physician who specializes in the condition being treated.
Use of preferred products is required before approval of a requested non-preferred infliximab intravenous product; refer to the Inflammatory Conditions - Infliximab Intravenous Products Preferred Specialty Management Policy (PSM005) for details.
Requests for doses outside established dosing in this policy are considered case-by-case by a clinician (Medical Director or Pharmacist).

FDA-Approved Indications — Initial and Continuation Criteria

FDA-Approved Indications

Approve when patient meets the indication-specific Initial Therapy OR Currently Receiving criteria and dosing.

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Other Uses with Supportive Evidence

Approve for specified duration when initial or continuation criteria are met

Behcet's Disease

A) Initial Therapy
- Patient is > 6 years of age
- Prior therapy (one of)
  - Patient has tried at least ONE conventional therapy
  - Patient has ophthalmic manifestations of Behcet's disease

Additional Indications and Specified Approval Durations

Subsequent Indication-Specific Sections Consolidated

Approve for specified duration when initial or continuation criteria are met

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Subsequent Indication-Specific Sections Consolidated

Exclusions and Not Medically Necessary Use

Infliximab IV products are not medically necessary for uses not listed in this policy. These products must not be administered concurrently with another biologic or a targeted synthetic oral small molecule drug for an inflammatory condition; by contrast, concomitant use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) is allowed. Providers must submit a prior authorization request and meet the policy's indication-specific criteria, including specialist prescribing or consultation, to obtain approval.

Applicable Codes

Products referencedmixed

Avsola	infliximab-axxq intravenous infusion (Amgen) - biosimilar to Remicade
Inflectra	infliximab-dyyb intravenous infusion (Hospira/Pfizer) - biosimilar to Remicade
Renflexis	infliximab-abda intravenous infusion (Samsung Bioepis/Organon) - biosimilar to Remicade
Remicade	infliximab IV infusion (Janssen) - reference product
Infliximab	infliximab intravenous infusion - Janssen/Johnson & Johnson (generic descriptor)

Considered Medically Necessary when criteria are metHCPCSCovered

J1745	Injection, infliximab, excludes biosimilar, 10 mg
Q5103	Injection, infliximab-dyyb, biosimilar, (Inflectra), 10 mg
Q5104	Injection, infliximab-abda, biosimilar, (Renflexis), 10 mg
Q5121	Injection, infliximab-axxq, biosimilar, (Avsola), 10 mg

Definitions

Term	Definition
Indeterminate colitis	Colitis that cannot be classified with certainty as either ulcerative colitis or Crohn's disease.
Established on therapy	Patient has been receiving the infliximab product for at least the minimum duration specified for the indication (varies by indication).
Objective measure	A laboratory, imaging, endoscopic, or disease-specific validated score or marker demonstrating clinical response compared with baseline; examples vary by indication and are provided in the policy.

Background

Infliximab products are tumor necrosis factor inhibitors approved for multiple inflammatory conditions. Avsola, Inflectra, and Renflexis are biosimilars to Remicade. Recommended dosing is weight-based and varies by indication, and dose escalation or interval shortening may be used for patients who lose therapeutic response.

Evidence and references include prescribing information for Infliximab (Janssen Oct 2021), Inflectra (Sept 2025), Renflexis (Oct 2025), and Avsola (Aug 2025), and guideline sources such as the American College of Gastroenterology (ACG), American Gastroenterological Association (AGA), American College of Rheumatology (ACR), National Comprehensive Cancer Network (NCCN), and European Respiratory Society (ERS).

Revision History

2024-11-01new_policy

New policy created (Infliximab Intravenous Products Prior Authorization Policy).

2025-02-15revision

Annual revision: Immunotherapy-Related Toxicities — myalgia and myositis removed from examples of immunotherapy-related toxicities associated with checkpoint inhibitor therapy.

2025-09-01revision

Selected revision: Ulcerative Colitis initial therapy options removed (removed approval options related to prior systemic therapy, pouchitis treatments, and certain post-surgical scenarios).

Policy Summary

PayerCigna

PolicyInfliximab Intravenous Products Prior Authorization Policy

Policy CodePolicy IP0660

Change TypeSelected Revision (03/15/2026) and multiple prior revisions

Effective DateMar 15, 2026

Next Review Date

Key ActionSubmit prior authorization request; initial approval requires prescriber who specializes in the treated condition or consultation and adherence to indication-specific criteria and dosing.

SourceLink

On This Page

B) Patient is Currently Receiving an Infliximab Product

Patient has been established on therapy for at least 3 months
When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline
Examples depend on organ involvement (best-corrected visual acuity, serum markers, ulcer depth/number/size)
Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or improved visual acuity)

2026-03-15selected_revisionLatest

Selected Revision (material): Crohn's Disease initial therapy options were removed (removed prior corticosteroid/conventional systemic therapy and certain fistula and post-resection criteria) and other condition-specific criteria were modified across the policy ending 03/15/2026; examples of immunotherapy-related toxicities were removed and 'according to the prescriber' language was added; additional specialists (cardiologist, hematologist, nephrologist, pulmonologist) were added for immunotherapy-related toxicity criteria. Marked as a material policy change.