ModifiedUnitedHealthcarePolicy IEXD0004.12

Infliximab (intravenous) coverage

Medical benefit coverage criteria for intravenous infliximab products and biosimilars, including preferred product rules and diagnosis‑specific medical necessity criteria for multiple inflammatory conditions for UnitedHealthcare Individual Exchange members.

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab (intravenous) coverage

Policy CodePolicy IEXD0004.12

Change TypePreferred product criteria revisedsarcoidosis continuation dosing updated

Effective DateJan 1, 2025

Next Review Date

Key ActionObtain prior authorization and document prior trials/failures of specified conventional therapies and the applicable ICD-10 diagnosis code when requesting infliximab.

SourceLink

POLICY UPDATE CHANGES

Revised preferred product criteria; removed criterion allowing coverage of non-preferred products without step therapy for pediatric patients aged 16 years or younger and for patients who are pregnant or breastfeeding.

Sarcoidosis continuation criteria revised: infliximab dosing frequency changed from every 8 weeks to every 4 to 6 weeks (max dose no higher than 10 mg/kg).

MultipleIncludes multiple indications

12 monthsTypical authorization length

220-450CDAI moderate-severe range

≤10 mg/kgSarcoidosis max dose

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5 mg/kgUveitis dose cap

boxedFDA TNFα boxed warning

Coverage Criteria and Indication-Specific Rules

Guideline-based uses (professional guideline recommendations)

Guideline-based uses and guideline-aligned coverage contexts — consolidated guidance and how clinical practice recommendations inform coverage decisions.

For conditions covered by this policy, UnitedHealthcare aligns coverage expectations with contemporary professional society guidance (e.g., ACR, ACG, AGA, American Uveitis Society) as summarized below. Guideline recommendations inform prior authorization requirements such as prior trials of conventional therapies, specialist prescribing, dosing, and monitoring; they do not replace individualized clinical judgment.

When guideline language recommends a treat-to-target strategy, use of combination DMARD + biologic when possible, measurement of drug levels for loss of response, or specialist management (e.g., gastroenterologist for IBD; rheumatologist for RA, JIA, sarcoidosis; dermatologist for plaque psoriasis; ophthalmologist for uveitis), those elements are incorporated into the Diagnosis-Specific Criteria in this policy and are expectations for medical necessity determinations.

Guideline-aligned coverage contexts

Coverage contexts aligned to guideline recommendations — summary of how guideline statements map to operational policy requirements.

Anti-TNF agents including infliximab are supported by guidelines for induction and maintenance therapy in moderate to severely active Crohn's disease and ulcerative colitis; when guidelines recommend specialist prescribing, the policy requires prescription by or consultation with the appropriate specialist (gastroenterologist for Crohn's/UC).

For rheumatoid arthritis, guidelines recommend a treat-to-target approach and initial methotrexate for most patients; escalation to biologic therapy (including TNFi) is appropriate for moderate-to-high disease activity despite DMARDs. The policy requires prior conventional DMARD trial(s) or intolerance as described in Diagnosis-Specific Criteria and specialist prescribing or consultation for RA.

For juvenile idiopathic arthritis (JIA), ACR guidance for oligoarticular and polyarticular disease, sacroiliitis, and enthesitis is reflected: TNFi initiation expectations (duration of prior methotrexate or sulfasalazine trials when applicable), combination with DMARDs for polyarthritis, and allowance to switch or escalate biologic therapy per guideline-specified timelines and activity thresholds (e.g., consider switching after ~4 months if inadequate response).

For non-infectious uveitis and Behçet's disease with vision-threatening disease, guidelines recommend early consideration of infliximab; policy requires failure/intolerance of or inadequate response to specified first-line topical/systemic corticosteroids and conventional immunosuppressants before infliximab for most uveitis indications, and specialist prescribing (rheumatologist or ophthalmologist).

When professional guidance recommends measurement of drug levels or antibodies to assess loss of response, clinicians are encouraged to obtain such testing; treatment modifications consistent with those findings are accepted for medical necessity determinations where documented.

When guidelines recommend combination therapy (e.g., infliximab + thiopurine for induction in UC per ACG), policy recognizes combination therapy as appropriate and may consider documentation of combination treatment when relevant.

Guideline recommendations regarding malignancy history (preference for DMARDs over biologics in certain prior skin cancers or lymphoproliferative disorders) are reflected in policy considerations and may influence product selection or prior authorization outcomes.

Crohn's disease — biologic therapy criteria

For initial therapy, ALL of the following must be met:

- Diagnosis of moderately to severely active Crohn's disease; and

- One of the following:

* History of failure, contraindication, or intolerance to corticosteroids, thiopurines, or methotrexate; or

* Patient has been previously treated with a targeted immunomodulator FDA-approved for Crohn's disease (e.g., adalimumab, certolizumab, ustekinumab, risankizumab, upadacitinib) as documented by medical records or claims; or

* Patient is currently on infliximab

Rheumatoid arthritis — therapy selection and escalation

Rheumatoid arthritis — therapy selection and escalation (policy-aligned summary)

For initial therapy, ALL of the following apply:

- Diagnosis of moderately to severely active rheumatoid arthritis (RA); and

- One of the following:

* History of failure or intolerance to a 3-month trial of at least one non-biologic 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; or

* Patient has been previously treated with a targeted immunomodulator FDA-approved for RA (e.g., adalimumab, etanercept, certolizumab, golimumab, abatacept, tofacitinib, baricitinib, upadacitinib); or

Juvenile idiopathic arthritis — TNF inhibitor initiation; Polyarticular JIA and switching; Subsequent therapy

Juvenile idiopathic arthritis — TNF inhibitor initiation and polyarticular JIA guidance

For oligoarticular JIA (≤4 joints):

- Initiation of a TNF inhibitor (including infliximab) is supported when the patient has received intraarticular glucocorticoid injections and at least 3 months of methotrexate at the maximum tolerated dose with moderate or high disease activity and features of poor prognosis; or after 6 months methotrexate for high disease activity without poor prognostic features. (ACR level C recommendations)

For polyarticular JIA (≥5 joints) — initiation and switching:

- Initiation of a TNF inhibitor is supported when the patient has received methotrexate or leflunomide for 3 months at the maximum tolerated dose and has moderate or high disease activity, irrespective of prognostic features (level B); or after 6 months of methotrexate/leflunomide for low disease activity (level B).

- Switching from one TNF inhibitor to another is an accepted approach after approximately 4 months of therapy with inadequate response (level C).

Sacroiliitis and enthesitis — guideline-aligned expectations

Sacroiliitis and enthesitis recommendations mapped to coverage expectations

For active sacroiliitis despite NSAID therapy: adding a TNFi (including infliximab) is strongly recommended over continued NSAID monotherapy. Policy requires documentation of inadequate response to NSAIDs and specialist (rheumatology) involvement for coverage.

For active enthesitis despite NSAIDs: use of a TNFi is conditionally recommended over methotrexate or sulfasalazine. Policy expects documentation of inadequate response to NSAIDs and consideration of guideline-preferred agents when authorizing infliximab.

Oligoarticular, TMJ, and Systemic JIA — guideline-aligned expectations

Oligoarticular JIA, TMJ arthritis, and Systemic JIA — guideline mapping to coverage

Oligoarticular JIA: biologic DMARDs (including TNFi) are strongly recommended if inadequate response to or intolerance of NSAIDs and/or intraarticular glucocorticoids and at least one conventional synthetic DMARD. Documentation of prior therapies and specialist recommendation expected.

TMJ arthritis: biologic DMARDs are conditionally recommended if inadequate response to NSAIDs/IAGCs and at least one conventional synthetic DMARD; policy requires documentation of prior therapy attempts and specialist evaluation.

Systemic JIA: IL-1 or IL-6 inhibitors are the preferred biologic options for initial monotherapy in many scenarios; TNF inhibitors such as infliximab are generally not first-line for systemic JIA without MAS. When infliximab is requested for systemic JIA, rationale and evidence of guideline-consistent treatment sequencing or contraindication/intolerance to recommended agents must be provided.

Covered indications — documentation requirements

Covered indications — documentation of inadequate response to conventional therapy (operationalized)

For all labeled and guideline-supported indications (e.g., Crohn's disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, pediatric Crohn's/UC, acute GVHD in steroid-refractory cases, non-infectious uveitis when vision-threatening and refractory), requests for infliximab should include documentation of:

- Diagnosis and severity (including relevant disease activity scores where available);

- Prior therapies tried, dates, doses, and reason for discontinuation (failure, intolerance, or contraindication);

- Relevant specialist consultation or that the prescriber is the appropriate specialist; and

- Proposed dosing consistent with U.S. FDA labeling (or guideline-supported off-label dosing when explicitly allowed by policy and supported by evidence).

Continuation therapy (sarcoidosis) — dosing/frequency update

Continuation therapy (sarcoidosis) — dosing and reauthorization criteria

For continuation of infliximab in sarcoidosis, ALL of the following must be met:

- Documentation of positive clinical response to infliximab; and

- Infliximab is dosed no higher than 10 mg/kg and administered every 4 to 6 weeks (policy update effective 01/01/2025); and

- Patient is not receiving infliximab in combination with another biologic DMARD or a JAK inhibitor; and

- Reauthorization will be for no more than 12 months.

Operational note: The change from an every-8-week continuation interval to every 4–6 weeks reflects clinical trial dosing and policy revision (see Policy History). Requests for dosing above labeled ranges should include supporting clinical rationale and evidence.

Applicable Billing and Diagnosis Codes

Applicable ICD-10 CodesICD-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

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Prior Authorization, Documentation, and Step-Therapy Actions

Prior Authorization

Prior authorization for non-preferred infliximab

Prior authorization is required to initiate or continue a non-preferred infliximab product (Remicade, Renflexis, or other non-preferred infliximab). Approval is contingent on meeting the preferred product exception criteria: either (1) documentation of a ≥14-week trial of Inflectra or Avsola with minimal clinical response plus physician attestation that the non-preferred product would be superior, or (2) 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. Also, the patient must not have had loss of a favorable response after established maintenance with a preferred biosimilar.

Document a ≥14-week trial of Inflectra or Avsola with minimal response and physician attestation of expected superiority for the non-preferred product; OR
Document intolerance/contraindication/adverse event to Inflectra or Avsola plus physician attestation that it would not occur with the non-preferred product; AND
Confirm no loss of favorable response after established maintenance with a preferred biosimilar.

Prior Authorization

Prior authorization required (initial and continuation therapy per indication-specific criteria)

Background and Clinical Context

Background: Infliximab is a chimeric monoclonal antibody targeting tumor necrosis factor‑alpha (TNF‑α) used intravenously for multiple immune‑mediated inflammatory diseases. This policy addresses coverage for intravenous infliximab products and biosimilars, identifies preferred products (Inflectra, Avsola), specifies diagnosis‑specific medical necessity criteria, dosing limits, step‑therapy expectations, and prior authorization requirements, and clarifies that self‑administered subcutaneous infliximab formulations are managed under the pharmacy benefit.

Definitions and Clinical Terms

inv-98: Ankylosing spondylitis definition/context

DefinitionAnkylosing spondylitis (AS): inflammatory spondyloarthropathy for which infliximab is medically necessary when diagnostic and prior therapy criteria are met

Prior therapy requirementFailure to two NSAIDs each for ≥4 weeks at maximally indicated doses, unless contraindicated; OR prior targeted immunomodulator; OR currently on infliximab

PrescriberPrescribed by or in consultation with a rheumatologist

inv-99: Crohn's disease definition/context

DefinitionModerately to severely active Crohn's disease: clinical state often corresponding to CDAI 220–450

Prior therapy/contextInfliximab indicated when high-risk features or prior targeted immunomodulator therapy documented, and prescribed by/with gastroenterologist

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab (intravenous) coverage

Policy CodePolicy IEXD0004.12

Change TypePreferred product criteria revisedsarcoidosis continuation dosing updated

Effective DateJan 1, 2025

Next Review Date

Key ActionObtain prior authorization and document prior trials/failures of specified conventional therapies and the applicable ICD-10 diagnosis code when requesting infliximab.

SourceLink

On This Page

- Infliximab is dosed according to U.S. FDA labeled dosing for Crohn's disease; and

- Patient is not receiving infliximab in combination with another biologic DMARD or a JAK inhibitor (examples listed in policy); and

- Prescribed by or in consultation with a gastroenterologist; and

- Initial authorization is for no more than 12 months.

For continuation of therapy, ALL of the following must be met:

- Documentation of positive clinical response to infliximab; and

- Infliximab is dosed according to U.S. FDA labeled dosing for Crohn's disease; and

- Patient is not receiving infliximab in combination with another biologic DMARD or a JAK inhibitor; and

- Reauthorization will be for no more than 12 months.

* Patient is currently on infliximab.

- Infliximab is dosed according to U.S. FDA labeled dosing for RA; and

- Patient is not receiving infliximab in combination with another biologic DMARD or a JAK inhibitor; and

- Prescribed by or in consultation with a rheumatologist; and

- Initial authorization is for no more than 12 months.

For continuation of therapy, ALL of the following apply:

- Documentation of positive clinical response to infliximab; and

- Infliximab is dosed according to U.S. FDA labeled dosing for RA; and

- Patient is not receiving infliximab in combination with another biologic DMARD or a JAK inhibitor; and

- Reauthorization will be for no more than 12 months.

- Policy reflects guideline preference for treat-to-target and use of methotrexate as initial DMARD when tolerated; biologic therapy is appropriate for patients with inadequate response to DMARDs. Combination therapy with methotrexate when possible is encouraged per guideline evidence of superior efficacy; documentation of prior DMARD trials or rationale for monotherapy should be provided.

- When escalating therapy for persistent disease, options include optimizing DMARD dose, intraarticular glucocorticoid injection(s), adding or changing biologic therapy per guideline-directed timelines and severity thresholds (cJADAS10 thresholds referenced in guidelines).

For polyarthritis subsequent therapy and biologic choice:

- For children initiating a biologic for polyarthritis, combination therapy with a DMARD is conditionally recommended over biologic monotherapy; combination therapy with a DMARD is strongly recommended for infliximab.

- If inadequate response to a first TNFi, switching to a non-TNFi biologic (e.g., abatacept, tocilizumab) is conditionally recommended over switching to a second TNFi in some scenarios; however switching between TNFi agents is an acceptable option per guideline statements.

- Documentation of prior DMARD trials, duration, doses, and disease activity assessments (e.g., cJADAS10) should be included in requests for initiation or switching of TNF inhibitors in JIA. Specialist (pediatric rheumatologist) involvement is expected.

Exceptions: members currently established on non-preferred infliximab products may continue without switching only when they meet the Preferred Product Criteria exceptions in this policy (e.g., documented intolerance or a 14-week trial with minimal response to preferred products plus physician attestation of expected superior response to the non-preferred product).

Prior authorization is required for both initial and continuation infliximab therapy and must meet the indication-specific criteria (diagnosis, prior therapy failure/intolerance/contraindication, dosing per U.S. FDA or policy limits, prescriber specialty when specified, and stated authorization durations).

Initial authorizations generally limited to ≤12 months (some indications have specific shorter limits, e.g., GVHD and ICI toxicities limited to ≤4 doses).
Continuation requests require documentation of positive clinical response and adherence to dosing and combination-therapy exclusions.

Billing Rule

Use of applicable ICD-10 codes for prior auth and claims

Include one or more of the applicable ICD-10 diagnosis codes from the policy's listed codes on prior authorization requests and claims to reflect the member's condition.

Use the exact code(s) that match clinical documentation from the Applicable Codes section (e.g., H30.x series for uveitis, K50/K51 series for IBD).

Documentation Required

Diagnosis code required on prior authorization request

Prior authorization requests must reference the member's specific ICD-10 diagnosis code from the policy's applicable codes list to support medical necessity.

Provide the precise ICD-10 code(s) that correspond to the documented diagnosis when submitting the prior authorization.

Prior Authorization

Guideline-based prior authorization (UC, ASUC contexts)

Prior authorization should align with professional guideline-based indications — for example, infliximab for moderate-to-severe ulcerative colitis (induction/maintenance) including ASUC rescue contexts, and for moderate-to-severe Crohn's disease per guideline recommendations.

For hospitalized ASUC refractory to IV corticosteroids, document the need for medical rescue therapy with infliximab per guideline recommendations.

Prior Authorization

Prior authorization — confirm prior therapy and disease activity

Prior authorization must confirm documented prior adequate trials of first-line therapies and disease activity before approving biologic therapy (e.g., corticosteroids, thiopurines, methotrexate for Crohn's and RA) and include disease activity evidence where required.

For Crohn's disease, document prior corticosteroid, thiopurine, or methotrexate therapy or high-risk features as indicated.
For RA/JIA, document prior non-biologic DMARD trials (e.g., methotrexate) of specified duration per indication.

Prior Authorization

Guideline-based prior authorization requirements for JIA (IAGCs, trial durations)

For JIA-related prior authorization, document intraarticular glucocorticoid (IAGC) injections and methotrexate (or leflunomide) trial durations per ACR guidance (e.g., ≥3 months methotrexate at maximum tolerated dose for oligoarticular JIA; 3 months for polyarticular JIA) before initiating a TNF inhibitor.

Oligoarticular JIA (≤4 joints): document IAGCs and ≥3 months methotrexate (or 6 months in certain scenarios).
Polyarticular JIA (≥5 joints): document ≥3 months methotrexate or leflunomide at max tolerated dose (6 months for low disease activity scenarios).

Prior Authorization

Prior authorization and product preference (policy revision implications)

Prior authorization is required for infliximab and biosimilars; policy revisions affect preferred product handling and step therapy — members on non-preferred products will generally be required to switch to preferred biosimilars unless exception criteria are met.

Inflectra and Avsola are preferred; coverage of non-preferred products contingent on meeting the preferred product exception criteria.
Policy revisions removed prior exceptions for some subgroups (see step therapy change).

Step Therapy

Step therapy requirements by diagnosis

Step therapy is required and implemented as prior trials or failures of specified conventional or targeted therapies before initiating infliximab for diagnosis-specific indications.

Examples: PsA requires a 3‑month methotrexate trial unless contraindicated; UC requires failure/intolerance to ≥1 conventional therapy or prior targeted agent; RA requires a 3‑month trial of a non-biologic DMARD within the last 6 months unless contraindicated.

Step Therapy

Step therapy / prior therapy requirements (failure/intolerance/contraindication)

Many indications require documentation of failure, intolerance, or contraindication to specified conventional therapies or immunosuppressants (e.g., sarcoidosis: corticosteroid plus one immunosuppressant; RA: non-biologic DMARD trial).

Sarcoidosis initial therapy requires prior corticosteroid failure/intolerance and failure/intolerance to one immunosuppressant.
Ulcerative colitis initial therapy requires failure/intolerance to at least one conventional therapy or prior targeted immunomodulator.

Documentation Required

Provider actions — clinical evidence and guideline citation requirements

Include clinical evidence in prior authorization documentation when applicable and cite guideline-based rationale (e.g., sarcoidosis trial entry required prednisone ≥10 mg/day or ≥3 months immunosuppressant; JIA trial requirements), especially when relying on trial-derived criteria or guideline recommendations.

For sarcoidosis, document prior prednisone ≥10 mg/day or one or more immunosuppressants for ≥3 months if relying on trial evidence.
For JIA, document prior methotrexate duration and response per ACR guidance.

Note

Sequencing/step therapy considerations (guideline notes)

Consider sequencing and step therapy guidance from specialty guidelines when documenting prior therapy history (e.g., for biologic‑naïve UC patients, infliximab or vedolizumab may be preferred over adalimumab; prior infliximab exposure guides subsequent agent choice).

Document prior biologic exposure and rationale for agent choice or sequencing when relevant to the request.

Step Therapy

Step therapy preference for conventional agents first

Step therapy expectations prioritize conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide) before initiating biologic or targeted therapies except where guidelines recommend earlier biologic use for severe disease or specific JIA scenarios.

For RA and many JIA phenotypes, document trials of methotrexate (typically 3 months at max tolerated dose) before TNF inhibitor initiation where indicated.

Step Therapy

Step therapy: conventional DMARDs before biologics

Across many indications, initial use of conventional synthetic DMARDs (methotrexate, leflunomide, sulfasalazine) is expected prior to biologic initiation; for infliximab, combination with a DMARD is recommended in pediatric polyarthritis and often preferred in RA.

Document duration and dose of prior DMARD therapy (e.g., 3–6 months at maximum tolerated dose) when required by indication-specific criteria.

Step Therapy

Step therapy preference change (policy revision removing pediatric/pregnancy exception)

Policy revision removed prior exception allowing non-preferred product coverage without step therapy for pediatric patients ≤16 years and for patients who are pregnant or breastfeeding; providers must follow step therapy and preferred product requirements for these groups going forward.

Do not rely on the removed exception — document required preferred product trials or exception criteria for these populations.

Documentation Required

Required clinical documentation (document trials/failures)

Provide clinical documentation of prior therapy trials/failures, dates, doses, durations, prescriber specialty, and objective response measures to support initial and continuation requests.

Document drug name, start/stop dates, dose, reason for discontinuation, and measurable clinical response.
Include specialist consultation notes when prescriber specialty is required.

Documentation Required

Required clinical information for biosimilar switch

For requests involving switching from Inflectra or Avsola to Remicade/Renflexis/Ixifi (J1745, Q5104), include medical notes documenting either: (1) a ≥14-week trial of Inflectra/Avsola with minimal response plus physician attestation that the proposed product would be superior; OR (2) documentation of intolerance/contraindication/adverse event to Inflectra/Avsola plus physician attestation that it would not occur with the proposed product.

Specify the biosimilar used, trial duration (≥14 weeks), objective measures of minimal response, and the physician's attestation.

Documentation Required

General documentation note (benefit determination caveat)

Documentation submitted for prior authorization is used to assess clinical criteria but does not guarantee coverage; benefit determination depends on the member-specific plan and applicable laws.

Ensure complete clinical records are submitted since documentation is the basis for assessing medical necessity.

Documentation Required

Diagnosis coding documentation requirement

Providers must document and submit the appropriate ICD-10 diagnosis code(s) from the applicable codes list that support medical necessity for the service rendered.

Select codes from the policy's Applicable Codes section that best match the clinical diagnosis (e.g., K50.x for Crohn's, K51.x for UC, H30/H44 series for uveitis).

Documentation Required

Clinical trial protocol prior therapy documentation

When coverage is based on clinical trial protocols (e.g., sarcoidosis RCT inclusion), prior therapies and measured outcomes required by the trial should be documented (e.g., prednisone ≥10 mg/day or immunosuppressant ≥3 months before screening).

Include trial-specific baseline measures (e.g., FVC change for sarcoidosis) when relying on trial evidence to support coverage.

Documentation Required

ASUC rescue therapy documentation

For hospitalized patients with acute severe ulcerative colitis refractory to IV corticosteroids, document the indication for rescue therapy with infliximab or cyclosporine and clinical response assessments when used for induction and maintenance.

Document failure to respond to IV corticosteroids (3–5 days) and subsequent response to rescue therapy.

Documentation Required

Required clinical documentation — disease activity measures and prior meds

Clinical documentation for prior authorization should include disease activity measures (e.g., Crohn's Disease Activity Index components or summary score), prior medication trials and durations, and evidence of moderate-to-high disease activity or poor prognosis features when initiating biologic therapy.

For Crohn's disease, provide CDAI score or component data when available (CDAI 220–450 indicates moderate–severe disease).
For RA/JIA, include disease activity assessments and prior DMARD trial details.

Documentation Required

Required clinical documentation — treatment durations and prior intraarticular therapies

Document prior treatments and durations relevant to the indication (e.g., 3–6 months of methotrexate or leflunomide at maximum tolerated dose, prior intraarticular glucocorticoids) to support initiation or switching of TNF or other biologic agents.

Specify dosing, duration, response, and reasons for discontinuation for each prior therapy listed.

Documentation Required

Clinical justification and safety monitoring (infection, malignancy vigilance)

Provide clinical justification for infliximab use and document vigilance for safety monitoring, including screening for infections and malignancy surveillance per FDA/class warnings when treating pediatric, adolescent, and young adult patients.

Document infection history and counseling; be aware of boxed warning updates regarding Legionella and Listeria and FDA pediatric malignancy surveillance.

Prior Authorization

Non-preferred product approval triggers (trial of preferred product required)

Coverage for non-preferred infliximab products will be provided only if the patient meets required exception criteria — typically a trial of the preferred product with inadequate response or documented intolerance/contraindication plus physician attestation — otherwise coverage is for preferred biosimilars.

Confirm documentation of preferred product trial durations or intolerance and include the required physician attestation with the request.

Denial Risk

Combination therapy exclusion (denial risk if used with another biologic/JAK/PDE4)

Requests may be denied if infliximab is prescribed in combination with another biologic DMARD, a JAK inhibitor, or a PDE4 inhibitor (for psoriatic arthritis) as these combinations are excluded by the policy.

Do not document concomitant use of excluded agents on prior authorization; if combination use is clinically justified, provide explicit rationale and supporting evidence.

Denial Risk

Coding-related denial risk (missing applicable ICD-10 may cause denial/miscoding)

Prior authorization requests or claims that do not include an applicable ICD-10 diagnosis code from the policy's list may be denied or miscoded; ensure the diagnosis code(s) submitted align with the clinical documentation.

Verify code selection against the Applicable Codes section (e.g., K50.x for Crohn's, K51.x for UC, H30/H44 series for uveitis) before submission.

Prior Authorization

Sarcoidosis trial prior therapy requirement (prednisone ≥10 mg/day or immunosuppressants ≥3 months)

For sarcoidosis, document prior therapy consistent with the trial evidence: prednisone ≥10 mg/day (or equivalent) or one or more immunosuppressants for ≥3 months before screening to align with study‑supported inclusion.

Include dates, doses, and response to prior corticosteroid and immunosuppressant therapy when submitting prior authorization.

Denial Risk

Limited evidence for miscellaneous indications — caution for prior auth

Use of infliximab for miscellaneous indications supported only by small open-label studies or case reports (e.g., adult-onset Still's disease, Sjögren's syndrome, hidradenitis suppurativa) carries a coverage risk; such uses lack large controlled-trial evidence and may be considered investigational or denied.

If requesting coverage for these indications, include robust supporting rationale and available evidence; be prepared for potential denial due to limited evidence.

Prior Authorization

Therapies for Crohn's disease — support for moderate-severe disease refractory to prior treatments

For Crohn's disease, prior authorization requires documentation that the patient has moderate-to-severe disease and is refractory to corticosteroids, thiopurines, or methotrexate; provide CDAI data or prior therapy history to support use.

Document CDAI score (220–450 indicates moderate–severe disease) or clinical features and prior medication trials to demonstrate refractory disease.

Step Therapy

Prior conventional therapy required before TNF initiation (IAGCs, csDMARDs)

Initiation of TNF inhibitors (including infliximab) generally requires prior trials of indicated conventional therapies (e.g., intraarticular glucocorticoids for oligoarticular JIA, and 3–6 months of methotrexate or leflunomide for polyarticular JIA or RA) unless contraindicated.

Document specific DMARD trials, doses, durations, and reasons for failure or intolerance as applicable.

Denial Risk

Safety-related denial risk (serious infection, malignancy surveillance)

Safety concerns (boxed warning and guidance) for TNFα blockers require providers to be vigilant for serious infections (including Legionella and Listeria) and malignancy surveillance, particularly in pediatric, adolescent, and young adult patients; such safety issues may influence approval and monitoring requirements.

Document infection history and counseling; include malignancy surveillance considerations where applicable.

Authorization lengthInitial authorization for no more than 12 months; reauthorization requires documentation of positive clinical response

inv-100: Biosimilar switching clinical documentation definition

DefinitionRequired clinical documentation when switching biosimilars: either a ≥14-week trial of Inflectra/Avsola with minimal response plus physician attestation of expected superiority of proposed product, OR documentation of intolerance/contraindication/adverse event to Inflectra/Avsola plus physician attestation that it would not occur with proposed product

Applicable codesApplies to requests involving J1745 and Q5104 (Remicade/Renflexis/Ixifi) per documentation section

PurposeTo justify exception to preferred-product switching requirements

inv-101: Applicable Codes (definition)

DefinitionApplicable Codes: ICD-10 diagnosis codes that must be provided on prior authorization and claims to support medical necessity

Provider actionSubmit one or more exact ICD-10 codes from the policy's applicable codes list that match clinical documentation

ExamplesEye/uveitis, sarcoidosis, IBD, rheumatologic codes are listed in the Applicable Codes section

inv-102: Infliximab — drug description

Drug class/descriptionInfliximab is a genetically engineered chimeric human/mouse monoclonal antibody against tumor necrosis factor-alpha (TNF-α) that neutralizes TNF-α activity by binding soluble and transmembrane forms

MechanismBlocks TNF-α binding to receptors, inhibiting interleukin induction, leukocyte migration, and adhesion molecule expression

Indications contextUsed for multiple immune-mediated inflammatory diseases including Crohn's disease, ulcerative colitis, RA, AS, PsA, and plaque psoriasis

inv-103: Crohn's Disease Activity Index (CDAI) definition

DefinitionCrohn's Disease Activity Index (CDAI): composite index summing weighted clinical and laboratory variables; CDAI 220–450 indicates moderate–severe disease

ComponentsIncludes stool frequency, abdominal pain, general well-being, complications, abdominal mass, hematocrit deviation, and percent weight deviation

UseUsed to document disease activity for biologic therapy decisions in Crohn's disease

inv-104: Acute Severe Ulcerative Colitis (ASUC) definition

DefinitionAcute Severe Ulcerative Colitis (ASUC): hospitalized severe UC refractory to IV corticosteroids where infliximab or cyclosporine is suggested as medical rescue therapy

Clinical roleInfliximab may be used as rescue therapy for steroid-refractory hospitalized ASUC

DocumentationDocumentation should support inadequate response to IV corticosteroids when used as rescue therapy

inv-105: Crohn's Disease Activity Index (CDAI) duplicate definition segment

DefinitionCDAI: composite score calculated from 8 weighted clinical and laboratory variables including stool frequency, abdominal pain, general well-being, complications, medications for diarrhea, abdominal mass, hematocrit deviation, and percent deviation from standard body weight

Moderate-severe range220–450

PurposeProvides objective measure to support Crohn's disease treatment decisions

inv-106: Treat-to-target definition

DefinitionTreat-to-target: management strategy setting a goal (low disease activity or remission) and adjusting therapy proactively to achieve that target

RA recommendationTreat-to-target strategy strongly recommended over non-targeted approach for RA

UseGuides escalation and monitoring decisions in RA and other inflammatory diseases

inv-107: Polyarthritis definition/context

DefinitionPolyarthritis: JIA phenotype involving multiple (≥5) joints where combination biologic plus DMARD is preferred over biologic monotherapy

DMARD combinationCombination therapy with a DMARD is strongly recommended for infliximab in polyarthritis

Escalation guidancecJADAS-10 thresholds inform escalation decisions in polyarticular JIA

inv-108: Sacroiliitis / Enthesitis definition/context

DefinitionSacroiliitis/Enthesitis: axial or enthesial involvement in JIA where TNF inhibitors are recommended when NSAIDs are insufficient

Prior therapyTNFi indicated after inadequate response to NSAIDs; enthesitis-related arthritis may require prior sulfasalazine trial

Recommendation strengthStrong recommendation for sacroiliitis; conditional for enthesitis

inv-109: Systemic JIA and TMJ/Oligoarticular disease context

ContextSystemic JIA and TMJ/oligoarticular disease guidance recommends biologic DMARDs after inadequate response to NSAIDs/IAGCs and at least one conventional DMARD

Systemic JIA preferenceSystemic JIA may favor IL-1 or IL-6 inhibitors rather than TNF inhibitors

Oligoarticular/TMJBiologic DMARDs recommended if inadequate response to NSAIDs and/or intraarticular glucocorticoids and ≥1 conventional DMARD

inv-110: Biosimilar definition

DefinitionBiosimilar: a biologic product approved based on data demonstrating high similarity to an FDA-approved reference product with no clinically meaningful differences

Reference productsPolicy references Remicade as the reference product and lists Avsola, Inflectra, Ixifi, Renflexis as biosimilars

ImplicationBiosimilar status informs preferred product and switching documentation requirements