ModifiedUnitedHealthcarePolicy 2026D0004AR

Infliximab products (IV) coverage

Criteria and medical necessity requirements for UnitedHealthcare coverage of intravenous infliximab products (including specific biosimilars) across multiple indications; affects providers seeking prior authorization for members covered under UnitedHealthcare plans.

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab products (IV) coverage

Policy CodePolicy 2026D0004AR

Change TypeMultiple operational and clinical revisions (removals, additions, and coding updates)

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, documentation of required prior therapy trials or intolerance, and physician attestation when requesting a non-preferred infliximab product.

SourceLink

POLICY UPDATE CHANGES

Removed coverage criteria for proven treatment of ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

Replaced references to 'targeted immunomodulator' with 'systemic targeted immunomodulator' in medical necessity criteria.

Updated lists of systemic targeted immunomodulators (added and removed specific agents) across multiple indications (ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, noninfectious uveitis).

Added criterion requiring diagnosis of an immune checkpoint inhibitor-related toxicity for that indication.

Removed HCPCS code Q5109.

Removed Documentation Requirements section.

Replaced 'Xeljanz (tofacitinib)' with 'Xeljanz/ Xeljanz XR (tofacitinib)' across several indications.

2preferred infliximab products named

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

4infliximab HCPCS codes listed

≤12 moinitial auth duration (many)

per indicationdosing caps noted

Coverage and Medical Necessity Criteria

Rheumatoid Arthritis (RA)

Infliximab is proven for the treatment of rheumatoid arthritis. Infliximab is medically necessary for the treatment of rheumatoid arthritis when ALL of the following criteria are met:

ALL of the following

For initial therapy, all of the following:
ALL of the following
- Diagnosis of moderately to severely active rheumatoid arthritis (RA);
- ANY of the following
  - History of failure or intolerance to a 3-month trial of one non-biologic disease modifying anti-rheumatic drug (DMARD) (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses within the last 6 months, unless contraindicated or clinically significant adverse effects are experienced;
  - Patient has been previously treated with a systemic targeted immunomodulator FDA-approved for the treatment of rheumatoid arthritis (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz/Xeljanz XR (tofacitinib));
  - Patient is currently on infliximab.
and
ALL of the following
- Infliximab is dosed according to U.S. FDA labeled dosing for rheumatoid arthritis;
- Patient is not receiving infliximab in combination with a systemic Targeted Immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz/Xeljanz XR (tofacitinib)) for treatment of the same indication;
- Prescribed by or in consultation with a rheumatologist;
- Initial authorization is for no more than 12 months.
For continuation of therapy, all of the following:
ALL of the following
- Documentation of positive clinical response to infliximab;
- Infliximab is dosed according to U.S. FDA labeled dosing for rheumatoid arthritis;
- Patient is not receiving infliximab in combination with a systemic Targeted Immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Xeljanz/Xeljanz XR (tofacitinib)) for treatment of the same indication;
- Reauthorization will be for no more than 12 months.

Initial Therapy Requirements

General initial therapy coverage criteria; diagnosis confirmation and prior trials/failures as applicable:

General initial therapy: Diagnosis appropriate for the specific indication; AND documentation of prior failure/intolerance of specified conventional therapies or prior use of targeted immunomodulators, or current infliximab use as listed by indication; AND infliximab dosed according to U.S. FDA labeled dosing for the indication; AND patient is not receiving infliximab in combination with another systemic targeted immunomodulator for the same indication; AND prescribed by or in consultation with the appropriate specialist (e.g., rheumatologist, gastroenterologist, dermatologist, ophthalmologist); AND initial authorization is for no more than 12 months (unless an acute indication specifies fewer doses).varies by indication

Some indications specify exact prior therapy requirements and dosing ceilings (e.g., uveitis <=5 mg/kg; sarcoidosis <=10 mg/kg).

Initial therapy requirements

Indication‑specific initial coverage criteria (summary):

Reauthorization and Continuation Rules

Continuation Therapy

Continuation (reauthorization) requirements across indications:

General continuation: Documentation of positive clinical response to infliximab; AND infliximab dosed according to U.S. FDA labeled dosing for the indication or within indication‑specific dosing limits; AND patient is not receiving infliximab in combination with another systemic targeted immunomodulator for the same indication; AND reauthorization is typically for no more than 12 months (acute indications may be limited to a specified number of doses).positive clinical response

Specific dosing frequency limits per indication apply (see dosing limits).

Continuation therapy rules

Continuation/reauthorization requirements vary by indication (summary):

General continuation: Documentation of positive clinical response to infliximab; maintenance dosing per U.S. FDA labeling or indication‑specific limits; patient not receiving infliximab in combination with another systemic targeted immunomodulator for the same indication; reauthorization periods as specified (commonly up to 12 months; acute indications up to 4 doses).

Prior Therapy and Step Requirements

Step	Requirement
1
Prior trial(s) of indicated conventional therapies (e.g., NSAIDs for ankylosing spondylitis; methotrexate or non‑biologic DMARDs for rheumatoid arthritis; topical/ systemic therapies for psoriasis) or prior treatment with another systemic targeted immunomodulator are required before initiating infliximab for many indications; documentation of prior trials, failure/intolerance, or prior targeted immunomodulator use must be provided.

Step

Requirement

Prior trial(s) of indicated conventional therapies (e.g., NSAIDs for ankylosing spondylitis; methotrexate or non‑biologic DMARDs for rheumatoid arthritis; topical/ systemic therapies for psoriasis) or prior treatment with another systemic targeted immunomodulator are required before initiating infliximab for many indications; documentation of prior trials, failure/intolerance, or prior targeted immunomodulator use must be provided.

Step	Requirement
1
For ulcerative colitis (UC), document prior conventional therapies or prior targeted immunomodulator use — include drug name, dates of therapy, and duration — or provide evidence of contraindication or intolerance before infliximab will be considered; provider should reference claims history or medical records as available.

Step	Note for Medicare Advantage members
1
Medicare Advantage members may be subject to Medicare Part B preferred therapy/step therapy programs; consult plan‑specific Part B step therapy requirements and applicable LCDs/LCAs when requesting prior authorization for infliximab.

Billing and Diagnosis Codes

HCPCS CodesHCPCS

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

Selected ICD-10 Codes for Covered Indications (partial list)ICD-10Covered

D86.0	Sarcoidosis of lung
D86.1	Sarcoidosis of lymph nodes
D86.2	Sarcoidosis of lung with sarcoidosis of lymph nodes
D86.3	Sarcoidosis of skin
D86.81	Sarcoid meningitis
D86.82	Multiple cranial nerve palsies in sarcoidosis
D86.83	Sarcoid iridocyclitis
D86.84	Sarcoid pyelonephritis
D86.85	Sarcoid myocarditis
D86.86	Sarcoid arthropathy

1–10 of 13

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Applicable ICD-10 Codes (selected excerpt)ICD-10

D89.810	Acute graft-versus-host disease
H20.041	Secondary noninfectious iridocyclitis, right eye
H20.042	Secondary noninfectious iridocyclitis, left eye
H20.043	Secondary noninfectious iridocyclitis, bilateral
H20.049	Secondary noninfectious iridocyclitis, unspecified eye
H20.10	Chronic iridocyclitis, unspecified eye
H20.11	Chronic iridocyclitis, right eye
H20.12	Chronic iridocyclitis, left eye
H20.13	Chronic iridocyclitis, bilateral
H30.001	Unspecified focal chorioretinal inflammation, right eye

1–10 of 13

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Applicable ICD-10 Codes (continued) — Rheumatoid and Related CodesICD-10

M05.A	Abnormal rheumatoid factor and anti-citrullinated protein antibody with rheumatoid arthritis
M05.00	Felty's syndrome, unspecified site
M05.011	Felty's syndrome, right shoulder
M05.012	Felty's syndrome, left shoulder
M05.019	Felty's syndrome, unspecified shoulder
M05.021	Felty's syndrome, right elbow
M05.022	Felty's syndrome, left elbow
M05.029	Felty's syndrome, unspecified elbow
M05.031	Felty's syndrome, right wrist
M05.032	Felty's syndrome, left wrist

1–10 of 20

1/2

Applicable ICD-10 Codes (Rheumatoid codes — required complete list) ICD-10

M05.251	Rheumatoid vasculitis with rheumatoid arthritis of right hip
M05.252	Rheumatoid vasculitis with rheumatoid arthritis of left hip
M05.259	Rheumatoid vasculitis with rheumatoid arthritis of unspecified hip
M05.261	Rheumatoid vasculitis with rheumatoid arthritis of right knee
M05.262	Rheumatoid vasculitis with rheumatoid arthritis of left knee
M05.269	Rheumatoid vasculitis with rheumatoid arthritis of unspecified knee
M05.271	Rheumatoid vasculitis with rheumatoid arthritis of right ankle and foot
M05.272	Rheumatoid vasculitis with rheumatoid arthritis of left ankle and foot
M05.279	Rheumatoid vasculitis with rheumatoid arthritis of unspecified ankle and foot
M05.29	Rheumatoid vasculitis with rheumatoid arthritis of multiple sites

1–10 of 33

1/4

Applicable ICD-10 Codes (Rheumatoid continuation 2)ICD-10

M05.40	Rheumatoid myopathy with rheumatoid arthritis of unspecified site
M05.411	Rheumatoid myopathy with rheumatoid arthritis of right shoulder
M05.412	Rheumatoid myopathy with rheumatoid arthritis of left shoulder
M05.419	Rheumatoid myopathy with rheumatoid arthritis of unspecified shoulder
M05.421	Rheumatoid myopathy with rheumatoid arthritis of right elbow
M05.422	Rheumatoid myopathy with rheumatoid arthritis of left elbow
M05.429	Rheumatoid myopathy with rheumatoid arthritis of unspecified elbow
M05.431	Rheumatoid myopathy with rheumatoid arthritis of right wrist
M05.432	Rheumatoid myopathy with rheumatoid arthritis of left wrist
M05.439	Rheumatoid myopathy with rheumatoid arthritis of unspecified wrist

1–10 of 16

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Applicable ICD-10 Codes (Rheumatoid — full series & related M06 codes)ICD-10

M05.461	Rheumatoid myopathy with rheumatoid arthritis of right knee
M05.462	Rheumatoid myopathy with rheumatoid arthritis of left knee
M05.469	Rheumatoid myopathy with rheumatoid arthritis of unspecified knee
M05.471	Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot
M05.472	Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot
M05.479	Rheumatoid myopathy with rheumatoid arthritis of unspecified ankle and foot
M05.49	Rheumatoid myopathy with rheumatoid arthritis of multiple sites
M05.50	Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified site
M05.511	Rheumatoid polyneuropathy with rheumatoid arthritis of right shoulder
M05.512	Rheumatoid polyneuropathy with rheumatoid arthritis of left shoulder

1–10 of 14

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Applicable ICD-10 Codes (Additional rheumatoid M05/M06 series)ICD-10

M05.531	Rheumatoid polyneuropathy with rheumatoid arthritis of right wrist
M05.532	Rheumatoid polyneuropathy with rheumatoid arthritis of left wrist
M05.539	Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified wrist
M05.541	Rheumatoid polyneuropathy with rheumatoid arthritis of right hand
M05.542	Rheumatoid polyneuropathy with rheumatoid arthritis of left hand
M05.549	Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hand
M05.551	Rheumatoid polyneuropathy with rheumatoid arthritis of right hip
M05.552	Rheumatoid polyneuropathy with rheumatoid arthritis of left hip
M05.559	Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hip
M05.561	Rheumatoid polyneuropathy with rheumatoid arthritis of right knee

1–10 of 15

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Applicable ICD-10 Codes (M05/M06/M08 etc. continued)ICD-10

M06.00	Rheumatoid arthritis without rheumatoid factor, unspecified site
M06.011	Rheumatoid arthritis without rheumatoid factor, right shoulder
M06.012	Rheumatoid arthritis without rheumatoid factor, left shoulder
M06.019	Rheumatoid arthritis without rheumatoid factor, unspecified shoulder
M06.021	Rheumatoid arthritis without rheumatoid factor, right elbow
M06.022	Rheumatoid arthritis without rheumatoid factor, left elbow
M06.029	Rheumatoid arthritis without rheumatoid factor, unspecified elbow
M06.031	Rheumatoid arthritis without rheumatoid factor, right wrist
M06.032	Rheumatoid arthritis without rheumatoid factor, left wrist
M06.039	Rheumatoid arthritis without rheumatoid factor, unspecified wrist

1–10 of 13

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Applicable ICD-10 Codes (M06 continuation)ICD-10

M06.051	Rheumatoid arthritis without rheumatoid factor, right hip
M06.052	Rheumatoid arthritis without rheumatoid factor, left hip
M06.059	Rheumatoid arthritis without rheumatoid factor, unspecified hip
M06.061	Rheumatoid arthritis without rheumatoid factor, right knee
M06.062	Rheumatoid arthritis without rheumatoid factor, left knee
M06.069	Rheumatoid arthritis without rheumatoid factor, unspecified knee
M06.071	Rheumatoid arthritis without rheumatoid factor, right ankle and foot
M06.072	Rheumatoid arthritis without rheumatoid factor, left ankle and foot
M06.079	Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot
M06.08	Rheumatoid arthritis without rheumatoid factor, vertebrae

1–10 of 11

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Applicable ICD-10 Codes (Remaining M06/M08/M45 etc.)ICD-10

M06.0A	Rheumatoid arthritis without rheumatoid factor, other specified site
M06.1	Adult-onset Still's disease
M06.20	Rheumatoid bursitis, unspecified site
M06.211	Rheumatoid bursitis, right shoulder
M06.212	Rheumatoid bursitis, left shoulder
M06.219	Rheumatoid bursitis, unspecified shoulder
M06.221	Rheumatoid bursitis, right elbow
M06.222	Rheumatoid bursitis, left elbow
M06.229	Rheumatoid bursitis, unspecified elbow
M06.231	Rheumatoid bursitis, right wrist

1–10 of 20

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Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization required for non‑preferred infliximab; initial auth duration

Prior authorization is required for non-preferred infliximab products; initial authorizations are generally limited to no more than 12 months (or per indication limits). For non-preferred infliximab (Remicade, Renflexis, other), include documentation of either: (A) a trial of at least 14 weeks of Inflectra or Avsola with minimal clinical response plus physician attestation that a non-preferred product would be expected to provide superior response; or (B) documentation of intolerance/contraindication/adverse event to Inflectra or Avsola plus physician attestation that the same would not be expected with the non-preferred product.

Initial authorization generally limited to no more than 12 months; some acute indications have shorter limits (e.g., up to 4 doses).

Prior Authorization

Prior authorization required — provide diagnosis and meet indication criteria

Prior authorization is required for all infliximab requests. Provide the member’s diagnosis and documentation that the indication‑specific coverage criteria are met (e.g., prior therapy trials, specialist prescribing/consultation, dosing per FDA label). Initial authorizations are typically limited to no more than 12 months unless an indication specifies a different initial limit.

Background and Policy Scope

This policy governs intravenous infliximab biologic products (the reference product and listed biosimilars) used for multiple inflammatory conditions. It treats biosimilars alongside the reference product for coverage purposes, identifies preferred biosimilars (e.g., Inflectra, Avsola), and establishes indication‑specific medical necessity criteria, dosing limits, and restrictions on combination therapy with other systemic targeted immunomodulators.

Definitions and Terms

Infliximab — collective reference

Collective term 'Infliximab''Infliximab' is used to refer collectively to all infliximab products, including listed biosimilars and Remicade

Examples of referenced productsPolicy lists Avsola (infliximab-axxq), Inflectra (infliximab-dyyb), Remicade (infliximab), Renflexis (infliximab-abda)

Benefit/administration noteIntravenous infliximab products are medical benefit administered (IV); self-administered subcutaneous infliximab is under pharmacy benefit unless specified

Positive clinical response (definition)

Definition of positive clinical responseClinical documentation demonstrating improvement on infliximab sufficient to support continuation or reauthorization

Required for continuation

Administration and Site-of-Care Guidance

Billing Rule

Infliximab IV — medical benefit; SC formulations under pharmacy benefit unless specified

Intravenous infliximab products are administered under the medical benefit (IV infusion); self‑administered subcutaneous infliximab formulations are obtained under the pharmacy benefit unless the member’s plan specifies otherwise.

Exception: certain UnitedHealthcare of California delegated reviews may allow self‑administered infliximab under the medical benefit per plan documents.

Billing Rule

Medicare Part B coverage and site‑of‑care considerations

Medicare Part B may cover outpatient/administered infliximab furnished 'incident to' a physician's service when the drug is not usually self‑administered; site‑specific coverage and step therapy for Medicare Advantage members may vary — consult Medicare guidance and plan rules.

Refer to the Medicare Benefit Policy Manual, Chapter 15 §50 and applicable LCDs/LCAs for Part B coverage rules.

Preferred Products and Biosimilar Notes

Billing Rule

Inflectra is a preferred infliximab product — coverage per diagnosis criteria

Inflectra (infliximab‑dyyb) is a preferred infliximab product; coverage for Inflectra is contingent on meeting the diagnosis‑specific criteria in this policy.

Preferred product coverage is subject to the Diagnosis‑Specific Criteria section.

Billing Rule

Avsola is a preferred infliximab product — coverage per diagnosis criteria

Avsola (infliximab‑axxq) is a preferred infliximab product; coverage for Avsola is contingent on meeting the diagnosis‑specific criteria in this policy.

Preferred product coverage is subject to the Diagnosis‑Specific Criteria section.

Billing Rule

Biosimilars listed with HCPCS codes — use appropriate code for claims

Biosimilar infliximab products are listed alongside the reference infliximab with HCPCS codes (e.g., J1745, Q5103, Q5104, Q5121); submit claims using the appropriate HCPCS code for the product administered.

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab products (IV) coverage

Policy CodePolicy 2026D0004AR

Change TypeMultiple operational and clinical revisions (removals, additions, and coding updates)

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, documentation of required prior therapy trials or intolerance, and physician attestation when requesting a non-preferred infliximab product.

SourceLink

On This Page

Dosed per U.S. FDA RA labeling; not in combination with another systemic targeted immunomodulator for same indication; prescribed by or in consultation with a rheumatologist; initial authorization up to 12 months; prior failure/intolerance to a non‑biologic DMARD or prior targeted immunomodulator as detailed in the RA criteria may be required.

Initial sarcoidosis: Diagnosis; prior failure/intolerance to corticosteroids and one immunosuppressant; dose <=10 mg/kg with schedule week 0, 2 then q4‑6w; not in combination with another systemic targeted immunomodulator; initial auth up to 12 months.<=10 mg/kg

Initial UC: Moderately to severely active UC plus either failure/intolerance to conventional therapy OR prior targeted immunomodulator OR currently on infliximab; dosed per FDA UC label; not in combination with another systemic targeted immunomodulator; prescribed by or in consultation with a gastroenterologist; initial auth up to 12 months.

Initial acute GVHD: Steroid‑refractory acute GVHD; receiving infliximab with systemic corticosteroids or intolerant to corticosteroids; initial authorization limited to no more than 4 doses.<=4 doses

Initial ICI‑toxicities: Recent checkpoint inhibitor therapy; diagnosis of immune checkpoint inhibitor‑related toxicity; inadequate improvement despite systemic corticosteroid therapy of adequate dose and duration for the specific severity and diagnosis; receiving infliximab with systemic corticosteroids or intolerant to corticosteroids; initial authorization limited to no more than 4 doses.<=4 doses

Immune checkpoint inhibitor-related toxicity criterion

Added criterion requiring diagnosis of an immune checkpoint inhibitor‑related toxicity:

ICI‑related toxicity requirement: Coverage for immune checkpoint inhibitor‑related toxicities requires a documented 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 (refined steroid‑failure language).

This replaced prior symptom‑specific initial therapy criteria with a diagnosis requirement.

Prescriber specialty/consultation must be documented (e.g., rheumatologist, gastroenterologist, dermatologist, ophthalmologist) as required by indication.
Dosing must follow U.S. FDA labeled dosing for the specified indication.

Documentation Required

Include applicable ICD‑10 diagnosis code on request/claim

Reference one of the ICD‑10 diagnosis codes listed in the policy’s coding sections that corresponds to the member’s condition when submitting prior authorization requests and claims.

Use the policy’s applicable ICD‑10 codes (see coding lists) to support medical necessity.

Note

Medicare/MA: check Part B step therapy and LCD/LCA guidance

For Medicare Advantage members, preferred therapy criteria and Medicare Part B step therapy programs may apply; consult plan‑specific guidance and applicable LCDs/LCAs for Part B billing and coverage details.

Refer to Local Coverage Determinations (LCDs/LCAs) for Medicare members and Medicare Part B billing guidance.
Medicare Advantage preferred therapy criteria may follow Medicare Part B Step Therapy Programs.

Billing Rule

Prior authorization applies per policy; HCPCS Q5109 removed

Prior authorization requirements follow this Medical Benefit Drug Policy. Note that HCPCS code Q5109 was removed from the policy’s coding list; submit claims using the remaining listed HCPCS codes (e.g., J1745, Q5103, Q5104, Q5121) as appropriate.

Do not use HCPCS Q5109 — it was removed from the policy.
Use the listed infliximab HCPCS codes found in the Applicable Codes section.

Step Therapy

Expect documented prior therapy failures per indication

Many indications require documented prior failure of specified conventional therapies (or prior targeted immunomodulator use) before infliximab is considered medically necessary; confirm and document required prior therapies per the diagnosis‑specific criteria.

Examples: NSAID trials for ankylosing spondylitis; methotrexate trials for psoriasis/psoriatic arthritis; non‑biologic DMARDs for rheumatoid arthritis; conventional UC therapies or prior targeted immunomodulator for ulcerative colitis.

Step Therapy

UC: document failure/intolerance to ≥1 conventional therapy or prior targeted immunomodulator

For ulcerative colitis, document history of failure, contraindication, or intolerance to at least one conventional therapy (e.g., 6‑mercaptopurine, azathioprine, aminosalicylates, corticosteroids) OR prior treatment with a systemic targeted immunomodulator; include drug name, dates, and duration.

Provide claims history or medical records documenting prior therapy (drug, date, duration) or evidence of contraindication/intolerance.

Documentation Required

Document prior trials/intolerance and include physician attestation for non‑preferred requests

When requesting a non‑preferred infliximab product, document trials, intolerance, contraindications, or adverse events to the preferred products (Inflectra, Avsola), and include a physician attestation when required.

Physician attestation is required when asserting that a non‑preferred product would be clinically superior or that intolerance to preferred products would not occur with the non‑preferred product.

Documentation Required

Include details of prior targeted immunomodulator use (drug, date, duration)

Provide supporting documentation of prior targeted immunomodulator use when required — specify the agent, dates of therapy, and duration — or provide evidence of failure, contraindication, or intolerance to conventional therapies as applicable.

Claims history or submitted medical records should document prior targeted immunomodulator therapy (drug, date, duration) when cited in the indication‑specific criteria.

Billing Rule

Use the policy’s listed ICD‑10 codes on requests and claims

Use an ICD‑10 diagnosis code from the policy’s listed applicable codes when requesting coverage or submitting claims for infliximab‑related treatments; omission of a listed code may jeopardize claim approval.

The policy includes extensive ICD‑10 lists; select the code that corresponds to the member’s documented condition.

Documentation Required

Documentation Requirements section removed — follow benefit plan and applicable mandates

The policy’s separate Documentation Requirements section was removed; follow the member‑specific benefit plan document and applicable state or federal mandates when submitting documentation for prior authorization or claims.

Benefit plan documents and applicable laws (including state mandates for off‑label coverage) govern final coverage decisions.

Denial Risk

Non‑preferred product requests risk denial without ≥14‑week preferred trial or attestation

Failure to document a trial of Inflectra or Avsola of at least 14 weeks, or failure to provide the required physician attestation for non‑preferred product justification, may prevent coverage of non‑preferred infliximab products.

The preferred product criteria require either a ≥14‑week trial with minimal response plus physician attestation of expected superiority with non‑preferred product, or documentation of intolerance/contraindication plus attestation that the same would not occur with the non‑preferred product.

Denial Risk

Potential denial triggers: missing diagnosis/prior‑therapy/dosing/combination issues

Requests may be denied if documentation is missing for diagnosis, required prior therapy failure/intolerance, dosing outside specified indication limits, concurrent use with another systemic targeted immunomodulator for the same indication, or missing required specialty prescriber/consultation.

Examples of dosing limits: uveitis ≤5 mg/kg induction at weeks 0,2,6 then q8w; sarcoidosis ≤10 mg/kg at weeks 0,2 then q4‑6w.
Combination therapy with another systemic targeted immunomodulator for the same indication is not permitted.

Denial Risk

Diagnosis code mismatch may lead to denial

Claims or prior authorization requests that do not include an ICD‑10 diagnosis code listed in the policy’s applicable codes for the requested service may be at risk for denial if the diagnosis does not support the requested treatment.

Ensure the claimed diagnosis maps to one of the codes in the policy’s Applicable Codes sections to support medical necessity.

Note

Consult member‑specific benefit plan; state mandates may supersede policy

Coverage determinations must be made in consultation with the member‑specific benefit plan document; where state mandates require off‑label coverage, those mandates supersede this policy language.

Consult the member’s Certificate of Coverage or plan documents when making coverage decisions.

Denial Risk

Removed covered indications — requests for these conditions may be denied

Requests for indications that were removed from the policy’s proven coverage rationale (ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis) may be subject to denial based on the updated coverage rationale; verify current policy status and benefit documents.

Check the Policy History/Revision Information and the member’s benefit plan for how removed indications are handled.

Documentation of positive clinical response is required for reauthorization across indications (typically up to 12 months; some acute indications limited to 4 doses)

Examples of supporting evidenceProvider documentation (clinical notes, objective measures) showing improvement in signs/symptoms consistent with the treated indication

Biosimilar definition

Biosimilar definition (FDA basis)A biosimilar is approved based on data demonstrating high similarity to an FDA‑approved reference product with no clinically meaningful differences

Regulatory implicationBiosimilars share the reference product's indications when approved by the FDA; prescribing information and equivalence studies support use

Examples referencedFDA definition and biosimilar concept described in policy references and prescribing information

Biosimilars — policy inclusion and equivalence

Biosimilar infliximab products includedPolicy includes biosimilars such as CT‑P13 (SB2), Inflectra (infliximab‑dyyb), Renflexis (infliximab‑abda), Avsola (infliximab‑axxq) and notes equivalence to Remicade

HCPCS and coding inclusionBiosimilars are listed alongside the reference infliximab with HCPCS codes in the coding section

Supporting evidenceRandomized equivalence and cohort studies cited in references support biosimilar efficacy and antibody reactivity equivalence

Billing Rule

Medicare Part B: outpatient drugs 'incident to' physician service — consult guidance

Medicare Part B generally covers outpatient drugs furnished 'incident to' a physician's service when not usually self‑administered; check Medicare guidance and LCDs/LCAs for site‑specific coverage decisions.

Consult the Medicare Benefit Policy Manual and relevant local coverage articles for detailed Part B billing rules.

The Applicable Codes section provides HCPCS and ICD‑10 codes for reference; inclusion in the policy does not guarantee payment — follow benefit plan rules.

Note

Reference infliximab and biosimilars share labeled indications — document rationale

Remicade and listed biosimilars are noted as biosimilar agents sharing many labeled indications; policy references equivalence and prescribing information for these agents when assessing coverage.

Refer to prescribing information and referenced equivalence studies when documenting clinical rationale for product selection.

Note

Policy treats biosimilars and reference infliximab as clinically comparable; cite evidence when needed

Biosimilars and the reference infliximab product are discussed interchangeably in the policy with supporting equivalence studies and prescribing information cited; providers should document clinical rationale when requesting non‑preferred products.

Supporting clinical evidence and prescribing information are listed in the References section to inform interchangeability and clinical decision making.