CurrentUnitedHealthcarePolicy CS2026D0004AZ

Infliximab – Community Plan Medical Benefit Drug Policyopen_in_new

UnitedHealthcare Community Plan medical benefit drug policy governing intravenous infliximab products (Remicade and biosimilars Avsola, Inflectra, Renflexis and other FDA-approved infliximab biosimilars) including preferred product rules, diagnosis-specific medical necessity criteria, exclusions of unproven indications, and applicable procedure and diagnosis codes. Part 1 of 3 contains application, preferred product criteria, coverage rationale, diagnosis-specific criteria for multiple indications, unproven indications, and lists of J-codes/Q-codes and ICD-10 codes.

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab – Community Plan Medical Benefit Drug Policyopen_in_new

Policy CodePolicy CS2026D0004AZ

Change TypeTemplate Update (no clinical changes)

Effective DateApr 1, 2026

Next Review Date

Key ActionProviders must obtain authorization and document diagnosis, prior therapy trials (including drug, duration, and reason for failure/intolerance), dosing per FDA-labeled regimen, prescriber specialty (where required), and clinical response for continuation.

SourceLink

POLICY UPDATE CHANGES

Template Update removed content/language pertaining to the state of Louisiana and archived previous policy version CS2026D0004AY.

11Named proven indications listed

8Unproven indications listed

4Limited-dose authorizations (GVHD/ICI)

NCCN contexts (selected)

Coverage Summary

This policy (Policy Number CS2026D0004AZ, effective April 1, 2026) is the UnitedHealthcare Community Plan medical benefit drug policy governing intravenous infliximab products — including the reference product Remicade and the biosimilars Avsola, Inflectra, Renflexis and any other FDA‑approved infliximab biosimilars. The policy applies to IV administration only; self‑administered subcutaneous infliximab (for example, Zymfentra) is managed under the pharmacy benefit and is not covered by this medical benefit policy. Any U.S. FDA‑approved and launched infliximab biosimilar product not listed by name in this policy will be considered non‑preferred until reviewed by UnitedHealthcare.

Policy metadata & thresholds

Policy NumberCS2026D0004AZ

Effective DateApril 1, 2026

StatusCURRENT

Scope summaryUnitedHealthcare Community Plan medical benefit policy governing intravenous infliximab products (Remicade and biosimilars Avsola, Inflectra, Renflexis and other FDA‑approved infliximab biosimilars); self‑administered subcutaneous infliximab is managed under pharmacy benefit.

Preferred biosimilars (examples)Avsola, Inflectra, Renflexis (preferred) — Remicade and other infliximab biosimilars are non‑preferred unless criteria met.

Trial duration for preferred biosimilar before non‑preferred approval>= 14 weeks (documentation of trial of at least 14 weeks of Avsola, Inflectra, or Renflexis with minimal clinical response required)

Common numeric authorization limitsInitial/continuation authorizations generally ≤ 12 months for most indications; certain indications (GVHD, ICI toxicities) initial/reauthorization limited to no more than 4 doses)

Preferred Product Criteria (Switching / Non-preferred Requests)

Treatment with Remicade®, or other non-preferred infliximab biosimilar products, is medically necessary when the following nested criteria are met:

ALL of the following

ONE of
- Both of the following
  - Documentation of a trial of at least 14 weeks of Avsola®, Inflectra®, or Renflexis® resulting in minimal clinical response to therapy and residual disease activity.
  - Physician attests that, in their clinical opinion, the clinical response would be expected to be superior with Remicade® or other infliximab biosimilar product than experienced with Avsola®, Inflectra®, and Renflexis®.
- Both of the following

Initial Therapy Criteria (by Indication)

Ankylosing Spondylitis — Initial Therapy

Infliximab is proven and medically necessary for initial therapy when ALL of the following are met:

ALL of the following

Diagnosis of ankylosing spondylitis (AS)
ONE of
- History of failure to two NSAIDs at the maximally indicated doses, each used for at least 4 weeks, unless contraindicated or clinically significant adverse effects are experiencedeach NSAID >= 4 weeks
- Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for AS (examples listed in policy)

Continuation / Reauthorization Criteria (by Indication)

Ankylosing Spondylitis — Continuation Therapy

For reauthorization/continuation of ankylosing spondylitis, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response to infliximab
Infliximab is dosed according to FDA-labeled dosing for ankylosing spondylitis
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication
Reauthorization is for no more than 12 months<= 12 months

Unproven / Not Medically Necessary Indications

Proven Indications / Clinical Uses & Evidence Summary

+2.5%Mean increase in predicted FVC at week 24 vs placebo (sarcoidosis study)

~55%Proportion of eyes with improved BCVA in Behçet's uveitis cohort

59.1%Uveitis relapse rate after infliximab treatment (Behçet's study)

63.8%Week-14 response rate in JRA 3 mg/kg group (not statistically significant vs placebo)

Infliximab has been reported in small trials, open‑label studies, and case reports for a number of conditions but lacks large randomized controlled‑trial evidence; examples include limited randomized/small data in chronic pulmonary sarcoidosis, observational and retrospective series in refractory noninfectious uveitis (including Behçet's), pediatric juvenile idiopathic arthritis (mixed and limited trial results), and miscellaneous small open‑label studies/case reports for adult‑onset Still’s disease, Sjögren's syndrome, myelodysplastic syndromes, undifferentiated spondyloarthropathy, Reiter’s syndrome, hidradenitis suppurativa, and Wegener’s granulomatosis.

NCCN Recommendations & Safety / Warnings

Documentation Required

Monitor for infections and malignancy; consider FDA boxed warnings and safety surveillance

Be vigilant and document monitoring for serious infections (including Legionella and Listeria per FDA boxed warning) and malignancy surveillance in younger patients (FDA ongoing review for patients ≤30 years). Include clinical monitoring and documentation of any suspected infections or malignancy during therapy.

Applicable Codes

Provider Actions & Documentation Requirements

Prior Authorization

Authorization required with indication-specific documentation

Authorization requires indication-specific documentation. Provide: diagnosis; documentation of prior therapy trials (drug name, duration, and reason for failure or intolerance); dosing consistent with FDA-labeled regimen; prescriber specialty where required (e.g., rheumatologist, gastroenterologist, dermatologist, ophthalmologist); and documentation of clinical response for continuation. Note initial authorizations are limited per indication (commonly up to 12 months; select indications up to 4 doses).

Diagnosis
Prior therapy trials: drug name, dates/duration, reason for failure or intolerance
Dosing per FDA-labeled regimen
Prescriber specialty or consultation where required (e.g., rheumatology, gastroenterology, dermatology, ophthalmology)
Documentation of positive clinical response for continuation
Initial authorization limits (commonly ≤12 months; GVHD/ICI toxicities limited to ≤4 doses)

Background & Definitions

Background: Infliximab is a chimeric anti‑TNF monoclonal antibody indicated for multiple inflammatory conditions and is the reference biologic for several biosimilars. UnitedHealthcare manages IV infliximab products under the medical benefit and employs a preferred product approach: Avsola, Inflectra, and Renflexis are designated as preferred products with coverage contingent on diagnosis‑specific criteria, while Remicade and any other non‑preferred infliximab products require meeting the Preferred Product Criteria for coverage. Self‑administered subcutaneous infliximab (e.g., Zymfentra/infliximab‑dyyb) is obtained under the pharmacy benefit and is not covered by this medical benefit policy.

Term	Definition
Infliximab
Refers to all infliximab products (Remicade and biosimilars Avsola, Inflectra, Renflexis, and other FDA-approved biosimilars).
Biosimilar
A biological product approved based on data demonstrating high similarity to an FDA-approved reference biological product with no clinically meaningful differences.

Revision History

04/01/2026revisedLatest

Template Update; no clinical policy statement changes indicated; previous version archived

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab – Community Plan Medical Benefit Drug Policyopen_in_new

Policy CodePolicy CS2026D0004AZ

Change TypeTemplate Update (no clinical changes)

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Documentation of intolerance, contraindication, or adverse event to Avsola®, Inflectra®, or Renflexis®.

Physician attests that, in their clinical opinion, the same intolerance, contraindication, or adverse event would not be expected to occur with Remicade® or other infliximab biosimilar product.

Patient has not had a loss of a favorable response after established maintenance therapy with Avsola®, Inflectra®, or Renflexis®, or other infliximab biosimilar product.

Prior Authorization

Preferred product switching requirement

Members currently receiving Remicade® or another non-preferred infliximab product will be required to switch to a preferred biosimilar (Avsola®, Inflectra®, or Renflexis®) unless they meet the Preferred Product Criteria above. Exceptions documented per the criteria (e.g., documented intolerance or physician attestation of superior expected response) may allow continued coverage of non-preferred products.

Prior authorization is required for non-preferred infliximab products when not meeting the Preferred Product Criteria.
Document trial duration, adverse events/intolerances, and physician attestation in the medical record.

Documentation Required

Consider FDA boxed warnings and safety surveillance

Consider FDA boxed warnings and safety surveillance. Providers must be aware of the FDA boxed warnings for infliximab products (including risks of serious infections, malignancy, and infusion reactions) and should ensure appropriate screening (e.g., tuberculosis, hepatitis B) and monitoring per product labeling and local standards of care.

Verify TB and hepatitis B screening prior to initiating therapy.
Monitor for signs of serious infection and infusion-related reactions during and after administration.
Document counseling and safety monitoring in the medical record.

Patient is currently on infliximab

Infliximab is dosed according to FDA-labeled dosing for ankylosing spondylitis

Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for treatment of the same indication

Prescribed by or in consultation with a rheumatologist

Initial authorization is for no more than 12 months<= 12 months

Crohn's Disease — Initial Therapy

Infliximab is proven and medically necessary for initial therapy when ALL of the following are met:

ALL of the following

Diagnosis of moderately to severely active Crohn's disease
ONE of
- Disease is considered high risk (e.g., fistulizing, structuring, luminal, perianal, extensive disease, growth delay)
- Failure of conventional therapies: History of failure to one of the following conventional therapies at up to maximally indicated doses within the last 3 months, unless contraindicated or clinically significant adverse effects are experienced: corticosteroids; 6-mercaptopurine; azathioprine; or methotrexatewithin last 3 months
- Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for Crohn's disease (examples listed)
- Patient is currently on infliximab
Infliximab is dosed according to FDA-labeled dosing for Crohn's disease
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for treatment of the same
Prescribed by or in consultation with a gastroenterologist
Initial authorization is for no more than 12 months<= 12 months

Noninfectious Uveitis — Initial Therapy

Infliximab is proven and medically necessary for initial therapy when ALL of the following are met:

ALL of the following

Diagnosis of refractory noninfectious uveitis that is causing or threatening vision loss (e.g., associated with Behçet's or Reiter's syndromes)
History of failure, contraindication, or intolerance to topical corticosteroids
History of failure, contraindication, or intolerance to systemic corticosteroids
History of failure, contraindication, or intolerance to immunosuppressive drugs (e.g., azathioprine, cyclosporine, methotrexate)
Infliximab is dosed no higher than 5 mg/kg, administered at week 0, 2, 6, and every 8 weeks thereafter<= 5 mg/kg; weeks 0,2,6 then q8w
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same condition
Prescriber
- Prescribed by or in consultation with a rheumatologist
- Prescribed by or in consultation with an ophthalmologist
Initial authorization is for no more than 12 months<= 12 months

Plaque Psoriasis — Initial Therapy

Infliximab is proven and medically necessary for initial therapy when ALL of the following are met:

ALL of the following

Diagnosis of chronic severe plaque psoriasis (extensive and/or disabling)
ONE of
- Topical criteria: Greater than or equal to 3% body surface area involvement, palmoplantar, facial, genital involvement, or severe scalp psoriasis; and history of failure to one topical therapy unless contraindicated>= 3% BSA
- Methotrexate trial: History of failure to a 3 month trial of methotrexate at the maximally indicated dose, unless contraindicated3 months
- Systemic targeted prior: Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for plaque psoriasis (documented)
- Current infliximab: Patient is currently on infliximab
Infliximab is dosed according to FDA-labeled dosing for plaque psoriasis
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for treatment of the same indication
Prescribed by or in consultation with a dermatologist
Initial authorization is for no more than 12 months<= 12 months

Psoriatic Arthritis — Initial Therapy

Infliximab is proven and medically necessary for initial therapy when ALL of the following are met:

ALL of the following

Diagnosis of psoriatic arthritis (PsA)
ONE of
- Methotrexate trial: History of failure to a 3 month trial of methotrexate at the maximally indicated dose unless contraindicated3 months
- Systemic targeted prior: Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for PsA (examples listed)
- Current infliximab: Patient is currently on infliximab
Infliximab is dosed according to FDA-labeled dosing for psoriatic arthritis
Prescriber
- Prescribed by or in consultation with a rheumatologist
- Prescribed by or in consultation with a dermatologist
Initial authorization is for no more than 12 months<= 12 months

Rheumatoid Arthritis — Initial Therapy

Infliximab is proven and medically necessary for initial therapy when ALL of the following are met:

ALL of the following

Diagnosis of moderately to severely active rheumatoid arthritis (RA)
ONE of
- DMARD failure: History of failure or intolerance to a 3 month trial of one non-biologic DMARD at maximally indicated doses within the last 6 months unless contraindicated3 months within last 6 months
- Systemic targeted prior: Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for RA (examples listed)
- Current infliximab: Patient is currently on infliximab
Infliximab is dosed according to FDA-labeled dosing for RA
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication
Prescribed by or in consultation with a rheumatologist
Initial authorization is for no more than 12 months<= 12 months

Sarcoidosis — Initial Therapy

Infliximab is proven and medically necessary for initial therapy when ALL of the following are met:

ALL of the following

Diagnosis of sarcoidosis
History of failure, contraindication, or intolerance to corticosteroids (e.g., prednisone, methylprednisolone)
History of failure, contraindication, or intolerance to one immunosuppressant (e.g., methotrexate, cyclophosphamide, azathioprine)
Infliximab is dosed no higher than 10 mg/kg, administered at week 0, 2, then once every 4 to 6 weeks thereafter<= 10 mg/kg; weeks 0,2 then q4-6w
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication
Initial authorization is for no more than 12 months<= 12 months

Ulcerative Colitis — Initial Therapy

Infliximab is proven and medically necessary for initial therapy when ALL of the following are met:

ALL of the following

Diagnosis of moderately to severely active ulcerative colitis (UC)
ONE of
- History of failure, contraindication, or intolerance to at least one conventional therapy (e.g., 6-mercaptopurine, aminosalicylate, azathioprine, corticosteroids)
- Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for UC (documented)
- Patient is currently on infliximab
Infliximab is dosed according to FDA-labeled dosing for UC
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication
Prescribed by or in consultation with a gastroenterologist
Initial authorization is for no more than 12 months<= 12 months

Acute Graft-Versus-Host Disease (GVHD) — Initial Therapy

Infliximab is proven and medically necessary for initial therapy when ALL of the following are met:

ALL of the following

Diagnosis of steroid-refractory acute graft-versus-host disease (GVHD)
ONE of
- Patient is receiving infliximab in combination with systemic corticosteroids
- Patient is intolerant to systemic corticosteroid therapy
Initial authorization is for no more than 4 doses<= 4 doses

Immune Checkpoint Inhibitor-Related Toxicities — Initial Therapy

Infliximab is proven and medically necessary for initial therapy when ALL of the following are met:

ALL of the following

Patient has recently received checkpoint inhibitor therapy (examples listed)
Diagnosis of an immune checkpoint inhibitor-related toxicity
Patient has had inadequate improvement despite systemic corticosteroid therapy of adequate dose and duration for the diagnosis
ONE of
- Patient is receiving infliximab in combination with systemic corticosteroids
- Patient is intolerant to systemic corticosteroid therapy
Initial authorization is for no more than 4 doses<= 4 doses

Crohn's Disease — Continuation Therapy

For reauthorization/continuation of Crohn's disease, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response to infliximab
Infliximab is dosed according to FDA-labeled dosing for Crohn's disease
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication
Reauthorization is for no more than 12 months<= 12 months

Noninfectious Uveitis — Continuation Therapy

For reauthorization/continuation of noninfectious uveitis, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response to infliximab
Infliximab is dosed no higher than 5 mg/kg, administered every 8 weeks<= 5 mg/kg; q8w
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same condition
Reauthorization is for no more than 12 months<= 12 months

Plaque Psoriasis — Continuation Therapy

For reauthorization/continuation of plaque psoriasis, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response to infliximab
Infliximab is dosed according to FDA-labeled dosing for plaque psoriasis
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication
Reauthorization is for no more than 12 months<= 12 months

Psoriatic Arthritis — Continuation Therapy

For reauthorization/continuation of psoriatic arthritis, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response to infliximab
Infliximab is dosed according to FDA-labeled dosing for psoriatic arthritis
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication
Reauthorization is for no more than 12 months<= 12 months

Rheumatoid Arthritis — Continuation Therapy

For reauthorization/continuation of rheumatoid arthritis, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response to infliximab
Infliximab is dosed according to FDA-labeled dosing for RA
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication
Reauthorization is for no more than 12 months<= 12 months

Sarcoidosis — Continuation Therapy

For reauthorization/continuation of sarcoidosis, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response to infliximab
Infliximab is dosed no higher than 10 mg/kg, administered every 4 to 6 weeks<= 10 mg/kg; q4-6w
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication
Reauthorization is for no more than 12 months<= 12 months

Ulcerative Colitis — Continuation Therapy

For reauthorization/continuation of ulcerative colitis, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response to infliximab
Infliximab is dosed according to FDA-labeled dosing for UC
Patient is not receiving infliximab in combination with a systemic targeted immunomodulator for the same indication
Reauthorization is for no more than 12 months<= 12 months

Acute GVHD — Continuation Therapy

For reauthorization/continuation of acute GVHD, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response
Patient continues to experience acute GVHD
ONE of
- Patient is receiving infliximab in combination with systemic corticosteroids
- Patient is intolerant to systemic corticosteroid therapy
Reauthorization is for no more than 4 doses<= 4 doses

Immune Checkpoint Inhibitor-Related Toxicities — Continuation Therapy

For reauthorization/continuation of immune checkpoint inhibitor-related toxicities, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response
Patient continues to experience toxicities from checkpoint inhibitor therapy
ONE of
- Patient is receiving infliximab in combination with systemic corticosteroids
- Patient is intolerant to systemic corticosteroid therapy
Reauthorization is for no more than 4 doses<= 4 doses

Documentation Required

Document prior targeted immunomodulator or conventional therapy trials

Document prior use of targeted immunomodulators or conventional therapies by drug name, dates, and duration (or document that the patient is currently on infliximab). This documentation is required for several indications to meet initial therapy criteria.

List drug name(s) of prior therapies or current infliximab use
Provide dates and duration of each prior therapy trial

Documentation Required

Document indication and prior treatment failure

Document the specific indication and prior treatment failure or contraindication as applicable (e.g., failure of conventional therapies for Crohn's/UC, methotrexate trial for psoriasis/PsA, NSAID trials for ankylosing spondylitis). Reference NCCN-recommended contexts where infliximab is considered (e.g., steroid-refractory GVHD, certain immune checkpoint inhibitor–related toxicities) when applicable.

Specify indication
Detail prior inadequate response, intolerance, or contraindication to listed conventional or targeted therapies per indication
If claiming NCCN context, cite relevant scenario (e.g., steroid-refractory GVHD, ICI-related myocarditis/colitis)

Note

Reference prescribing information

Consult the current prescribing information for Remicade and the biosimilars for full indication, dosing, and safety details. Reference document dates: Remicade PI Feb 2025; Inflectra PI Sep 2025; Renflexis PI Dec 2023; Avsola PI Sep 2025.

Remicade PI: Feb 2025
Inflectra PI: Sep 2025
Renflexis PI: Dec 2023
Avsola PI: Sep 2025