ModifiedUnitedHealthcarePolicy IEXD0004.14

Infliximab (intravenous) products coverage

Medical benefit policy governing coverage criteria for intravenous infliximab products (Avsola, Inflectra, Remicade, Renflexis and other FDA-approved biosimilars) for UnitedHealthcare Individual Exchange plans; affects providers prescribing or requesting authorization for these agents. Excludes self-administered subcutaneous infliximab which is under the pharmacy benefit.

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab (intravenous) products coverage

Policy CodePolicy IEXD0004.14

Change TypeCriteria and terminology updatesPreferred Product rule clarified

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit prior authorization with indication-specific documentation and, for non-preferred infliximab, include physician attestation and evidence of trial or intolerance to preferred products.

SourceLink

POLICY UPDATE CHANGES

The Preferred Product section of the policy applies to medical necessity plans; for non-medical necessity plans, any infliximab product is to be approved contingent on the coverage criteria in the Diagnosis-Specific Criteria section.

Replaced references to 'Biologic disease-modifying antirheumatic drug (DMARD)/Janus kinase inhibitor/phosphodiesterase 4 (PDE4) inhibitor' with 'systemic targeted immunomodulator' and 'Targeted immunomodulator' with 'systemic targeted immunomodulator'.

Added conventional therapy failure criterion for Crohn's disease initial therapy allowing prior failure to corticosteroids, 6-mercaptopurine, azathioprine, or methotrexate.

Updated numerous lists of systemic targeted immunomodulators that must not be received in combination with infliximab for the same indication (adds and removes multiple agents across indications).

Removed HCPCS code Q5109 from the Applicable Codes section.

For immune checkpoint inhibitor-related toxicities, added requirement for a diagnosis of an immune checkpoint inhibitor-related toxicity and replaced previous specific-list requirement for initial therapy.

Removed Documentation Requirements section from the policy.

Inflectra/Avsola

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Coverage Criteria

Preferred Product Criteria

Treatment with Remicade, Renflexis, or other non-preferred infliximab is medically necessary when ALL of the following are met:

Non-preferred infliximab medical necessity: 1) One of the following: (A) BOTH: documentation of a trial of at least 14 weeks of Inflectra or Avsola resulting in minimal clinical response and residual disease activity; AND physician attests that clinical response would be expected to be superior with the non-preferred infliximab product than with Inflectra/Avsola; OR (B) BOTH: documentation of intolerance, contraindication, or adverse event to Inflectra or Avsola; AND physician attests the same intolerance/contraindication/adverse event would not be expected with the non-preferred infliximab product. 2) Patient has not had a loss of a favorable response after established maintenance therapy with Inflectra, Avsola, or other infliximab biosimilar product.14 weeks

Physician attestation required

Ankylosing Spondylitis

Covered when ALL of the following are met for ankylosing spondylitis:

Initial therapy for AS: Diagnosis of ankylosing spondylitis; AND one of: history of failure to two NSAIDs at maximally indicated doses each used for at least 4 weeks unless contraindicated or clinically significant adverse effects; OR prior treatment with a systemic targeted immunomodulator FDA-approved for ankylosing spondylitis; OR patient is currently on infliximab; AND infliximab dosed per U.S. FDA labeled dosing for ankylosing spondylitis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a rheumatologist; AND initial authorization is for no more than 12 months.NSAIDs: 2 x ≥4 weeks

Continuation therapy for AS: Documentation of positive clinical response to infliximab; AND infliximab dosed per U.S. FDA labeled dosing for ankylosing spondylitis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND reauthorization will be for no more than 12 months.

Crohn's Disease

Covered when ALL of the following are met for Crohn's disease:

Initial therapy for Crohn's disease: Diagnosis of moderately to severely active Crohn's disease; AND one of: disease is high risk (e.g., fistulizing, stricturing, luminal, perianal, extensive disease, growth delay); OR history of failure to one conventional therapy at up to maximally indicated doses (corticosteroids, 6-mercaptopurine, azathioprine, or methotrexate) unless contraindicated; OR prior treatment with an FDA-approved systemic targeted immunomodulator for Crohn's disease; OR patient is currently on infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for Crohn's disease; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a gastroenterologist; AND initial authorization is for no more than 12 months.

Document conventional therapy details when cited

Continuation therapy for Crohn's disease: Documentation of positive clinical response to infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for Crohn's disease; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND reauthorization will be for no more than 12 months.

Non-infectious Uveitis

Covered when ALL of the following are met for non-infectious uveitis:

Initial therapy for non-infectious uveitis: Diagnosis of refractory non-infectious uveitis causing or threatening vision loss (e.g., associated with Behçet's or Reiter's syndromes); AND history of failure, contraindication, or intolerance to topical corticosteroids, systemic corticosteroids, AND immunosuppressive drugs (e.g., azathioprine, cyclosporine, methotrexate); AND infliximab dosed no higher than 5 mg/kg administered at week 0, 2, 6 and every 8 weeks thereafter; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a rheumatologist or ophthalmologist; AND initial authorization is for no more than 12 months.max 5 mg/kg

Continuation therapy for non-infectious uveitis: Documentation of positive clinical response to infliximab; AND infliximab dosed no higher than 5 mg/kg administered every 8 weeks; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same condition; AND reauthorization will be for no more than 12 months.max 5 mg/kg

Plaque Psoriasis

Covered when ALL of the following are met for plaque psoriasis:

Initial therapy for plaque psoriasis: Diagnosis of chronic severe plaque psoriasis (extensive and/or disabling); AND one of: (A) ALL: ≥3% body surface area involvement or palmoplantar/facial/genital/severe scalp involvement; AND history of failure to one topical therapy (e.g., corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar); AND history of failure to a 3-month trial of methotrexate at the maximally indicated dose unless contraindicated; OR (B) prior treatment with a systemic targeted immunomodulator FDA-approved for plaque psoriasis documented by claims/medical records; OR patient is currently on infliximab; AND infliximab dosed per U.S. FDA labeled dosing for plaque psoriasis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a dermatologist; AND initial authorization is for no more than 12 months.methotrexate: 3 months

Document drug/date/duration if prior systemic therapy

Continuation therapy for plaque psoriasis: Documentation of positive clinical response to infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for plaque psoriasis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND reauthorization will be for no more than 12 months.

Psoriatic Arthritis

Covered when ALL of the following are met for psoriatic arthritis:

Initial therapy for PsA: Diagnosis of psoriatic arthritis; AND one of: history of failure to a 3-month trial of methotrexate at the maximally indicated dose unless contraindicated; OR prior treatment with a systemic targeted immunomodulator FDA-approved for psoriatic arthritis; OR patient is currently on infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for psoriatic arthritis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a rheumatologist or dermatologist; AND initial authorization is for no more than 12 months.methotrexate: 3 months

Continuation therapy for PsA: Documentation of positive clinical response to infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for psoriatic arthritis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND reauthorization will be for no more than 12 months.

Rheumatoid Arthritis

Covered when ALL of the following are met for rheumatoid arthritis:

Initial therapy for RA: Diagnosis of moderately to severely active rheumatoid arthritis; AND one of: history of failure or intolerance to a 3-month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses within the last 6 months unless contraindicated; OR prior treatment with a systemic targeted immunomodulator FDA-approved for rheumatoid arthritis; OR patient is currently on infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for rheumatoid arthritis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a rheumatologist; AND initial authorization is for no more than 12 months.DMARD: 3 months

Continuation therapy for RA: Documentation of positive clinical response to infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for rheumatoid arthritis; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND reauthorization will be for no more than 12 months.

Psoriatic Arthritis (initial and continuation)

Covered for psoriatic arthritis when ALL of the following are met

Psoriatic arthritis initial therapy: Diagnosis of psoriatic arthritis; infliximab dosed according to U.S. FDA labeled dosing for psoriatic arthritis; patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; prescribed by or in consultation with a rheumatologist or dermatologist; initial authorization is for no more than 12 months.

Psoriatic Arthritis (continuation)

Continuation therapy for psoriatic arthritis when ALL of the following are met

Psoriatic arthritis continuation: Documentation of positive clinical response to infliximab; infliximab dosed according to U.S. FDA labeled dosing for psoriatic arthritis; patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; reauthorization for no more than 12 months.

Rheumatoid Arthritis (initial and continuation)

Covered for rheumatoid arthritis when ALL of the following are met

RA initial therapy: Diagnosis of moderately to severely active rheumatoid arthritis; and one of: history of failure/intolerance to a 3-month trial of a non-biologic DMARD at maximally indicated doses within the last 6 months unless contraindicated; OR prior treatment with a systemic targeted immunomodulator FDA-approved for RA; OR patient is currently on infliximab. Additionally, infliximab dosed per U.S. FDA labeled dosing for RA; patient is not receiving infliximab in combination with another systemic targeted immunomodulator for the same indication; prescribed by or in consultation with a rheumatologist; initial authorization up to 12 months. Continuation requires documentation of positive clinical response and dosing per label; reauthorization up to 12 months.

Sarcoidosis (initial and continuation)

Covered for sarcoidosis when ALL of the following are met

Sarcoidosis initial therapy: Diagnosis of sarcoidosis; history of failure, contraindication, or intolerance to corticosteroids (e.g., prednisone, methylprednisolone); AND history of failure, contraindication, or intolerance to one immunosuppressant (e.g., methotrexate, cyclophosphamide, azathioprine); AND infliximab is dosed no higher than 10 mg/kg administered at week 0, 2, then once every 4 to 6 weeks thereafter; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND initial authorization is for no more than 12 months. Continuation requires documentation of positive clinical response and dosing ≤10 mg/kg every 4-6 weeks; reauthorization up to 12 months.<= 10 mg/kg

Ulcerative Colitis (initial and continuation)

Covered for ulcerative colitis when ALL of the following are met

Ulcerative colitis initial therapy: Diagnosis of moderately to severely active ulcerative colitis; AND one of: history of failure, contraindication, or intolerance to at least one conventional therapy (e.g., 6-mercaptopurine, aminosalicylate, azathioprine, corticosteroids); OR prior treatment with a systemic targeted immunomodulator FDA-approved for UC documented by claims/medical records; OR patient is currently on infliximab; AND infliximab is dosed according to U.S. FDA labeled dosing for UC; AND patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with a gastroenterologist; AND initial authorization is for no more than 12 months. Continuation requires documentation of positive clinical response and dosing per label; reauthorization up to 12 months.

Document prior systemic targeted therapy (drug, date, duration) if cited.

Acute Graft-versus-Host Disease

Covered for acute graft-versus-host disease when ALL of the following are met

Acute GVHD initial therapy: Diagnosis of steroid-refractory acute graft-versus-host disease (GVHD); AND one of: patient is receiving infliximab in combination with systemic corticosteroids; OR patient is intolerant to systemic corticosteroid therapy; AND initial authorization is for no more than 4 doses. For continuation: documentation of positive clinical response, ongoing acute GVHD, and either continued combination with systemic corticosteroids or intolerance to systemic corticosteroids; reauthorization for no more than 4 doses.<= 4 doses

NCCN supports use in steroid-refractory GVHD

Immune Checkpoint Inhibitor-Related Toxicities

Covered for immune checkpoint inhibitor-related toxicities when ALL of the following are met

Checkpoint inhibitor-related toxicity: Recent receipt of checkpoint inhibitor therapy (e.g., pembrolizumab, nivolumab); AND diagnosis of an immune checkpoint inhibitor-related toxicity; AND inadequate improvement despite systemic corticosteroid therapy of adequate dose and duration for the specific severity and diagnosis; AND one of: patient is receiving infliximab in combination with systemic corticosteroids; OR patient is intolerant to systemic corticosteroid therapy; AND initial authorization is for no more than 4 doses. Continuation requires documentation of positive clinical response and ongoing toxicity; reauthorization up to 4 doses.<= 4 doses

Examples of checkpoint inhibitors: pembrolizumab, nivolumab.

Unproven / Not Medically Necessary Indications

Not covered / unproven

Unproven indications: Use of infliximab is considered unproven and not medically necessary for: hidradenitis suppurativa; juvenile idiopathic arthritis (juvenile rheumatoid arthritis); myelodysplastic syndromes; Reiter's syndrome.

Randomized controlled trials are needed for these conditions.

Proven Indications

Covered when indications are met and conventional therapy has been inadequate

Covered Indications: Infliximab is proven and covered for treatment of: Crohn's disease (adult and pediatric ≥6 years) with inadequate response to conventional therapy; ulcerative colitis (adult and pediatric ≥6 years) with inadequate response to conventional therapy; rheumatoid arthritis in combination with methotrexate; plaque psoriasis (severe, candidates for systemic therapy); psoriatic arthritis; ankylosing spondylitis; and maintenance of fistula closure in fistulizing Crohn's disease.

See individual indication nodes for specifics

Indications and guideline recommendations

Uses and recommendations presented (FDA labeled and NCCN-guided) in the document:

FDA-indicated uses (Remicade): Includes Crohn's disease (adult and pediatric), ulcerative colitis (adult and pediatric), rheumatoid arthritis (with methotrexate), plaque psoriasis, psoriatic arthritis, ankylosing spondylitis; details on reducing signs/symptoms, inducing and maintaining remission, mucosal healing, and reducing fistulas are provided.

Source lists Remicade indications.

Biosimilars indicated similarly: Avsola, Inflectra, Renflexis are described as biosimilars to Remicade with the same spectrum of indications noted for the reference product.

Biosimilars listed as having similar indicated uses.

NCCN recommended uses: NCCN Drugs & Biologics Compendium recommends infliximab for steroid-refractory acute GVHD and for specified immune checkpoint inhibitor-related toxicities and other steroid-refractory conditions with suggested timing thresholds for lack of improvement.

NCCN recommendations (2A) summarized.

Refractory and investigational clinical evidence

Clinical studies and observational series reported for additional or refractory conditions:

Sarcoidosis: Randomized multicenter placebo-controlled study showed modest mean FVC % predicted increase (~2.5%) at 24 weeks for infliximab 3 or 5 mg/kg vs placebo; trials required prior prednisone ≥10 mg/day or immunosuppressant ≥3 months before screening.

Small trials and case series support use in treatment-resistant sarcoidosis.

Non-infectious uveitis (Behçet's and refractory uveitis): Retrospective multicenter and cohort studies report decreased ocular attack frequency and improved best-corrected visual acuity in many patients, with relapse common within 1 year but often controlled by dose escalation/interval shortening; adverse effects led to discontinuation in ~15-19% in some cohorts.

Study sizes and outcomes summarized.

Juvenile idiopathic arthritis (JIA): A randomized trial in children on methotrexate did not show statistically significant superiority for infliximab 3 mg/kg vs placebo at week 14; longer-term open-label data mixed and further trials required.

Safety and immunogenicity signals noted.

Summary of Revised Coverage Criteria

Policy criteria revised for initial therapy and combination therapy exclusions across indications; material changes summarized below.

General policy-level requirements: Preferred Product section applies to medical necessity plans; for non-medical necessity plans, approval of any infliximab product is contingent on meeting the Diagnosis-Specific Criteria.

See Policy History/Revision Information

Terminology updates: Replaced references to 'Biologic DMARD/JAK inhibitor/PDE4 inhibitor' and 'Targeted immunomodulator' with 'systemic targeted immunomodulator' across the policy.

Terminology updated in revisions

Crohn's disease initial therapy addition: Initial therapy coverage now allows prior failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated: corticosteroids, 6-mercaptopurine, azathioprine, or methotrexate.

Policy change effective 02/01/2026

Self-administered subcutaneous infliximab products (for example, Zymfentra) are processed under the member's pharmacy benefit and are not covered under this medical benefit infliximab policy. Intravenous infliximab products referenced in this policy (e.g., Remicade, Inflectra, Avsola, Renflexis and other FDA‑approved biosimilars) remain medical‑benefit therapies administered in infusion settings.

The policy designates certain uses of infliximab as unproven / not medically necessary. Examples explicitly listed include: hidradenitis suppurativa, juvenile idiopathic arthritis (juvenile rheumatoid arthritis), myelodysplastic syndromes, and Reiter's syndrome. The document notes that randomized controlled trials are needed to establish sufficient evidence of efficacy versus available treatments for these indications.

Coverage for experimental, investigational, or otherwise unproven uses of infliximab is dependent on the member-specific benefit plan and applicable state mandates. Some Certificates of Coverage or state requirements may allow off‑label or investigational coverage for life‑threatening or rare disease circumstances when defined conditions are met; providers must consult the member's Certificate of Coverage to determine applicability.

The policy summarizes additional conditions reported in the literature where infliximab has been used but lacks robust controlled-trial evidence; these are provided as examples of investigational/unsupported uses and include adult‑onset Still's disease, Sjögren's syndrome, undifferentiated spondyloarthropathy, Wegener's granulomatosis, and other small open‑label or case‑report indications.

For the sarcoidosis coverage criteria, the policy text was updated to remove the prior illustrative list of specific Biologic DMARD/JAK inhibitors that the patient must not be receiving in combination with infliximab for the same indication. The sarcoidosis criteria continue to require that infliximab not be used in combination with another systemic targeted immunomodulator for the same indication, but the example agent list was omitted.

The policy prohibits concurrent use of infliximab with another systemic targeted immunomodulator for the treatment of the same indication. For multiple indications (e.g., Crohn's disease, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis), the criteria specify that the patient must not be receiving infliximab in combination with agents such as other anti‑TNF agents, IL inhibitors, JAK inhibitors, or other named systemic targeted therapies for the same condition; requests that document concurrent therapy for the same indication are at risk for denial.

Reiterating the policy's unproven indication statement: use of infliximab is considered not medically necessary for hidradenitis suppurativa, juvenile idiopathic arthritis, myelodysplastic syndromes, and Reiter's syndrome. These conditions lack sufficiently powered randomized controlled trials to support routine coverage.

The prior version's more prescriptive initial‑therapy language for immune checkpoint inhibitor‑related toxicities was revised. The policy now requires a documented diagnosis of an immune checkpoint inhibitor‑related toxicity and clarifies that the patient must have had inadequate improvement despite systemic corticosteroid therapy of adequate dose and duration for the specific severity and diagnosis, rather than relying on a previous fixed list of specific clinical presentations.

Initial Therapy Criteria (by indication)

Initial Therapy (by indication)

Initial therapy criteria vary by indication and generally require diagnosis confirmation, prior therapy failure or high-risk disease, dosing per FDA label, prescriber specialty, and initial authorization up to 12 months.

Initial therapy general: Diagnosis confirmed for the indicated condition; prior failure/intolerance to specified conventional, topical, or systemic therapies unless contraindicated OR prior treatment with an FDA-approved systemic targeted immunomodulator OR current infliximab use; infliximab dosed per U.S. FDA labeling for the indication; patient not receiving infliximab in combination with another systemic targeted immunomodulator for the same indication; prescribed by an appropriate specialist for the indication; initial authorization for no more than 12 months (unless otherwise specified for acute indications).

Initial therapy specifics

Indication-specific initial therapy requirements

Rheumatoid arthritis initial: Diagnosis of moderately to severely active rheumatoid arthritis; AND prior failure/intolerance to a 3-month trial of a non-biologic DMARD at maximally indicated doses within the last 6 months unless contraindicated; OR prior treatment with an FDA-approved systemic targeted immunomodulator for RA; OR patient currently on infliximab; infliximab dosed per U.S. FDA labeled dosing for RA; patient not receiving combination systemic targeted immunomodulator for same indication; prescribed by/consultation with a rheumatologist; initial authorization up to 12 months.

Continuation and Maintenance Therapy

Continuation Therapy

Continuation coverage requires documentation of positive clinical response and adherence to FDA dosing; reauthorizations limited to no more than 12 months for listed indications.

General continuation: Documentation of positive clinical response to infliximab; infliximab dosed per U.S. FDA labeling for the indication; patient is not receiving infliximab in combination with another systemic targeted immunomodulator for the same indication; reauthorization will be for no more than 12 months (unless indication-specific shorter limits apply).

Continuation therapy

Continuation therapy requirements vary by indication

General continuation: Documentation of positive clinical response to infliximab; continued dosing per indication-specific labeling or dosing limits; patient not receiving infliximab in combination with another systemic targeted immunomodulator for the same indication; reauthorization durations per indication (commonly up to 12 months; up to 4 doses for certain acute uses).

Prescriber specialty and prior documentation requirements still apply.

Step Therapy and Sequencing Requirements

Step	Requirement	Exception criteria / notes
1	Members currently on non-preferred infliximab products (Remicade, Renflexis, or other non-preferred infliximab) are required to change therapy to a preferred infliximab product (Inflectra or Avsola).	Coverage for non-preferred product may be allowed only when Preferred Product Criteria are met: (A) documentation of ≥14 weeks trial of Inflectra or Avsola with minimal clinical response plus physician attestation that response would be expected to be superior with the non-preferred product; OR (B) documentation of intolerance/contraindication/adverse event to Inflectra or Avsola plus physician attestation that same would not be expected with the non-preferred product. Patient must not have lost a prior favorable response on a preferred infliximab biosimilar.

Step	Requirement before initiating infliximab	When requirement is waived
1	Indication-specific prior therapy requirements must be met before initiating infliximab — for example, rheumatoid arthritis requires history of failure or intolerance to a 3-month trial of a non-biologic DMARD at maximally indicated doses within the last 6 months (e.g., methotrexate) unless contraindicated; ulcerative colitis/sarcoidosis/Crohn's disease require prior failure/contraindication/intolerance to specified conventional therapies (e.g., corticosteroids, 6‑mercaptopurine, azathioprine).	Requirement is waived if the patient is currently on infliximab or if contraindications to the specified prior therapies are documented. Documentation of prior systemic targeted immunomodulator use may also meet initial-therapy criteria per indication. Providers should document drug, dates, and duration of prior therapies as applicable.

Step	Conventional therapy failure required for IBD indications	Examples of conventional therapies
1	For Crohn's disease and ulcerative colitis (adult and pediatric ≥6 years) infliximab coverage generally requires prior inadequate response to conventional therapy before initiation of infliximab. This is part of the Diagnosis-Specific Criteria for IBD indications.	Conventional therapies include corticosteroids (e.g., prednisone, methylprednisolone, budesonide), 6‑mercaptopurine (Purinethol), azathioprine (Imuran), and methotrexate. The policy update explicitly added failure to one of these conventional therapies as an acceptable prior therapy for Crohn's disease initial coverage when given at maximally indicated doses unless contraindicated.

Step	NCCN steroid-refractory recommendations	Timing thresholds / examples
1	NCCN recommends adding infliximab for steroid-refractory conditions as adjunct immunosuppression when patients do not respond to high‑dose corticosteroids for the timeframes specified for the toxicity or organ system. Examples include steroid‑refractory acute GVHD and immune checkpoint inhibitor-related toxicities.	Timing examples from NCCN: myocarditis — no improvement within 24–48 hours of high‑dose methylprednisolone; pneumonitis — no improvement after 48–72 hours of corticosteroids; moderate to severe GI toxicities — consider for persistent/progressive symptoms or significant ulceration on endoscopy; acute GVHD — used when no response to first‑line systemic corticosteroids (steroid‑refractory). Early introduction may be considered in severe colitis to reduce recurrence.

Step	Combination therapy exclusion	Notes / updated agent lists
1	Infliximab must not be administered in combination with another systemic targeted immunomodulator for treatment of the same indication; concurrent use with the listed systemic targeted immunomodulators is not permitted per the policy.	The policy was updated to revise and expand the lists of systemic targeted immunomodulators that must not be received in combination with infliximab for the same indication across multiple conditions. Examples of added agents include Orencia (abatacept) and Rinvoq (upadacitinib) for RA, and Omvoh (mirikizumab‑mrkz), Rinvoq (upadacitinib), Simponi (golimumab), Skyrizi (risankizumab), Tremfya (guselkumab), ustekinumab, and Zeposia (ozanimod) for ulcerative colitis; numerous other additions/removals are detailed per indication in the policy revisions. Providers should reference the indication‑specific lists when evaluating combination therapy exclusions.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for intravenous infliximab products administered as a medical benefit. Initial authorizations are generally limited to no more than 12 months for most FDA‑labeled indications (shorter initial authorization limits apply for certain indications, e.g., initial authorization for acute GVHD and immune checkpoint inhibitor–related toxicities is limited to up to 4 doses). Approval for any infliximab product for members in non-medical‑necessity plans is contingent on meeting the Diagnosis‑Specific Criteria in this policy.

Initial authorization typically ≤ 12 months (except where specified).
Intravenous infliximab is billed under the medical benefit; subcutaneous infliximab (self‑administered) is obtained under the pharmacy benefit.

Documentation Required

Use ICD‑10 Codes for Authorization

Use one of the applicable ICD‑10 diagnosis codes listed in the Applicable Codes section when requesting prior authorization or submitting claims. Claims or authorization requests that do not include an appropriate ICD‑10 code from the policy list may not meet coded diagnosis expectations.

Applicable Codes (HCPCS, CPT, ICD-10)

Biosimilar and Product Notes

Billing Rule

Preferred biosimilars: Inflectra and Avsola

Inflectra and Avsola are the preferred infliximab products for medical‑necessity plans; other FDA‑approved infliximab biosimilars are considered non‑preferred until reviewed and require meeting the Preferred Product Criteria for coverage.

Billing Rule

HCPCS coding: J1745 and biosimilar codes (Q5103/Q5104/Q5121)

Use HCPCS code J1745 for infliximab and the listed biosimilar HCPCS codes (Q5103, Q5104, Q5121) as provided in the Applicable Codes section; the policy treats infliximab and biosimilars interchangeably for coverage/coding reference.

Billing Rule

Biosimilars described as highly similar with supporting equivalence studies

Definitions and Terms

'Infliximab' — policy definition

Scope of term'Infliximab' in this policy refers to all intravenous infliximab products including Remicade (infliximab) and listed biosimilars (Inflectra, Renflexis, Avsola, and any FDA‑approved infliximab biosimilar not named).

Preferred vs non-preferredInflectra and Avsola are identified as preferred infliximab products; other FDA‑approved infliximab biosimilars are considered non‑preferred until reviewed.

Route/benefit noteSelf-administered subcutaneous infliximab (e.g., Zymfentra) is obtained under the pharmacy benefit and is not covered under this medical benefit policy.

Initial authorization — definition and duration

DefinitionInitial authorization = the first approval period for infliximab therapy for a given indication; duration limits are specified per indication.

Typical duration (chronic indications)

Background and Clinical Evidence

Infliximab is a genetically engineered chimeric human/mouse monoclonal antibody directed against tumor necrosis factor alpha (TNF‑alpha). It neutralizes TNF‑alpha activity and reduces inflammation and immune‑mediated tissue injury. The drug is used intravenously for multiple immune‑mediated inflammatory diseases, including Crohn's disease, ulcerative colitis, rheumatoid arthritis (in combination with methotrexate), plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and certain refractory inflammatory conditions referenced in guidelines.

Quick Reference Metrics

2preferred products (named)

14preferred trial duration (weeks) before exception

12typical auth duration (months)

<=10max sarcoidosis dose (mg/kg)

Revision History and Policy Changes

Policy updates include changes to prior‑therapy and preferred‑product requirements that may affect step and sequence for authorization. Notably, Preferred Product rules continue to require documentation for exceptions to remain on non‑preferred products (for example, a documented ≥14‑week trial of Inflectra or Avsola with minimal response or intolerance to preferred products with physician attestation). In addition, initial‑therapy listings were updated (for example Crohn's disease) to allow prior failure of specified conventional therapies; providers should review indication‑specific prior therapy lists when preparing prior authorization requests.

The policy's standalone Documentation Requirements section was removed in this revision. Despite that removal, providers must continue to supply medical records and other documentation as required by the member's benefit plan and the Diagnosis‑Specific Criteria (for example: prior therapies, dates and durations, physician attestations, and evidence of clinical response or failure). Consult the member‑specific Certificate of Coverage for exact documentation expectations.

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab (intravenous) products coverage

Policy CodePolicy IEXD0004.14

Change TypeCriteria and terminology updatesPreferred Product rule clarified

Effective DateFeb 1, 2026

Next Review Date

SourceLink

On This Page

Contexts used in initial therapy trials

Trial designs and starting contexts informing initial use:

JRA trial context: Randomized pediatric JRA trial required prior methotrexate ≥3 months before enrollment; infliximab dosing in trials included 3 mg/kg (with later escalation); primary endpoints assessed at week 14.

Suggests expected prior MTX in pediatric rheumatology use.

Sarcoidosis trial context: Sarcoidosis randomized trial required prior prednisone ≥10 mg/day or immunosuppressant ≥3 months before screening; infliximab doses 3 or 5 mg/kg at specified intervals with modest FVC improvement at 24 weeks.

Indicates background therapy requirement in the trial.

Prior Authorization

PA for FDA‑Indicated Uses

For FDA‑indicated uses (e.g., Crohn's disease, ulcerative colitis, rheumatoid arthritis with methotrexate, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, pediatric Crohn's and UC where indicated), prior authorization decisions are governed by the Diagnosis‑Specific Criteria. FDA approval alone is informational and not sufficient for coverage without meeting policy criteria and member benefit requirements.

FDA‑labeled dosing and prescriber specialty requirements must be followed per indication.
Continuation and reauthorization require documentation of positive clinical response and adherence to dosing limits in the Diagnosis‑Specific Criteria.

Step Therapy

Non‑Preferred Product Exception Requirements

Non‑preferred infliximab products (e.g., Remicade, Renflexis, or other non‑preferred biosimilars) require documentation to support a medical necessity exception. Members already on a non‑preferred product will generally be required to transition to a preferred product (Inflectra or Avsola) unless an exception is met.

Preferred products: Inflectra (infliximab‑dyyb) and Avsola (infliximab‑axxq).
Non‑preferred product coverage requires both: 1) documentation of ≥14 weeks trial of Inflectra or Avsola with minimal clinical response and physician attestation that non‑preferred product is expected to be superior; OR 2) documentation of intolerance/contraindication to Inflectra or Avsola and physician attestation that the same would not be expected with the non‑preferred product.
Patient must not have had loss of favorable response after established maintenance therapy with a preferred infliximab product.

Denial Risk

Potential Triggers for Denial

Potential triggers for denial include dosing inconsistent with U.S. FDA‑labeled dosing or dosing limits specified in the Diagnosis‑Specific Criteria, concomitant use of infliximab with another systemic targeted immunomodulator for the same indication, lack of required specialty prescriber or consultation, missing documentation of prior therapies or responses, and lack of an applicable ICD‑10 code on the request or claim.

Requests showing combination therapy with another systemic targeted immunomodulator for the same indication will be denied.
Dosing above the policy‑specified limits (e.g., higher than indicated mg/kg where capped) may be a basis for denial.
Missing documentation of prior treatment trials, dates, durations, or clinical response can lead to denial.

Note

Benefit‑Dependent Coverage Risk

Coverage is benefit‑dependent. Consult the member‑specific Certificate of Coverage or plan benefit document to determine whether the member's plan includes coverage for the requested indication, off‑label use, or experimental/investigational services. State mandates or plan exceptions may supersede policy language.

Some Certificates of Coverage allow coverage of unproven/experimental treatments for life‑threatening illnesses under specific conditions — see member benefit document.
Where state mandates apply, mandated coverage supersedes policy or benefit exclusion language.

Denial Risk

Infection and Malignancy Safety Considerations

Infliximab and its biosimilars carry boxed warnings and important safety considerations, including increased risk of serious infections (including Legionella and Listeria) and potential malignancy risk in younger patients. Healthcare professionals should screen for active infections prior to initiation, monitor during therapy, and be vigilant for malignancies per FDA guidance and product labeling.

Follow boxed warning and Warnings/Precautions in product labeling.
Be alert for infections, screen for latent tuberculosis and other risk factors before initiating therapy.
Monitor pediatric, adolescent, and young adult patients for malignancy as advised by current FDA surveillance recommendations.

Prior Authorization

Non‑Medical Necessity Approval Contingent on Criteria

For members under non‑medical‑necessity plans, approvals are contingent solely on meeting the Diagnosis‑Specific Criteria in this policy; the Preferred Product rules apply only to medical necessity plans. Any infliximab product requested for non‑medical‑necessity plans will be evaluated against the Diagnosis‑Specific Criteria.

Preferred Product section applies to medical necessity plans; for non‑medical‑necessity plans any product is approved only if Diagnosis‑Specific Criteria are met.

Documentation Required

Required Documentation for Non‑Preferred Infliximab

Required documentation to support requests for non‑preferred infliximab includes physician attestation and medical records or claims history documenting prior trials (drug name, dates, doses, duration), reason for switching (e.g., intolerance, inadequate response), and clinical rationale for expecting superior response with the non‑preferred product when applicable.

Submit medical records or claims history documenting prior therapies with dates, durations, and response.
Physician attestation must state clinical rationale for non‑preferred product when applicable.
Document trials of conventional therapies or systemic targeted immunomodulators where required by the Diagnosis‑Specific Criteria.

Documentation Required

Clinical Evidence and Prior Therapy Documentation

Clinical evidence and prior therapy documentation should include relevant trial and observational study details when supporting requests (e.g., duration and outcome of prior conventional therapy trials, methotrexate use in pediatric JIA trials where applicable). Maintain records showing dates, doses, clinical response, and any adverse events to support medical necessity determinations.

For Crohn's disease and ulcerative colitis, document inadequate response to conventional therapy when required (e.g., corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate).
For rheumatoid arthritis, document failure or intolerance to a 3‑month trial of a non‑biologic DMARD or prior use of an FDA‑approved systemic targeted immunomodulator, as specified.
Include clinical measures of positive response for continuation requests.

Step Therapy

Step Therapy / Prior Treatment Requirements

Step therapy/prior treatment requirements are applied per indication. Many indications require documented failure, intolerance, or contraindication to conventional therapies or prior systemic targeted immunomodulators before infliximab is approved. Members already receiving infliximab may continue therapy if criteria for continuation are met.

Rheumatoid arthritis: failure/intolerance to a 3‑month trial of a non‑biologic DMARD or prior systemic targeted immunomodulator treatment documented.
Crohn's disease and ulcerative colitis: inadequate response to conventional therapies is typically required (document drug, date, duration).
Members currently on infliximab may be eligible for continuation with documentation of positive clinical response.