ModifiedUnitedHealthcarePolicy 2025D0004AP

Infliximab (IV products) coverage

UnitedHealthcare policy governing medical benefit coverage criteria for intravenous infliximab products (Avsola, Inflectra, Remicade, Renflexis and FDA‑approved biosimilars) including diagnosis‑specific requirements and preferred product rules; affects providers prescribing/administering infliximab for covered members.

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab (IV products) coverage

Policy CodePolicy 2025D0004AP

Change TypePreferred product designation addednon‑preferred products require criteria

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document trial or intolerance of preferred biosimilars (Inflectra or Avsola) when requesting coverage for non‑preferred infliximab.

SourceLink

POLICY UPDATE CHANGES

Preferred product designation: Inflectra and Avsola are preferred; non‑preferred products (Remicade, Renflexis, others) require additional criteria to be medically necessary.

Any FDA‑approved and launched infliximab biosimilar not listed will be considered non‑preferred until reviewed by UnitedHealthcare.

2Preferred products named

12 moInitial/reauthorization period

4 dosesInitial limit (GVHD/ICI)

≤10 mg/kgSarcoidosis max dose

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YesUnproven indications listed

Coverage Criteria and Indication-Specific Requirements

Rheumatoid Arthritis, Special Populations, sJIA with MAS, Noninfectious Uveitis Anti‑TNF Recommendations, and FDA‑Approved Indications

Infliximab is proven and medically necessary for rheumatoid arthritis (RA) and specific populations when the criteria below are met. Guideline-based recommendations for management and special populations (hepatitis B/C, malignancy, serious infections, heart failure) and recommendations for systemic JIA with macrophage activation syndrome (MAS) and noninfectious uveitis anti‑TNF guidance are summarized for clinical context. FDA‑approved indications for infliximab and its biosimilars are listed for informational purposes.

For initial therapy, all of the following:; o Diagnosis of moderately to severely active rheumatoid arthritis (RA); and; o One of the following:; - Patient is receiving concurrent therapy with methotrexate; - History of contraindication or intolerance to methotrexate; and; o Infliximab is dosed according to U.S. FDA labeled dosing for rheumatoid arthritis; and; o Patient is not receiving infliximab in combination with a Targeted Immunomodulator (e.g., Enbrel, Cimzia, Simponi, Orencia, adalimumab, Xeljanz, Olumiant, Rinvoq); and; o Initial authorization is for no more than 12 months

For continuation of therapy, all of the following:; o Documentation of positive clinical response to infliximab; and; o Infliximab is dosed according to U.S. FDA labeled dosing for rheumatoid arthritis; and; o Patient is not receiving infliximab in combination with a Targeted Immunomodulator; and; o Reauthorization will be for no more than 12 months

Clinical practice guideline considerations (ACR and related guidance):; o Treat-to-target strategy is recommended for early and established RA aiming for low disease activity or remission.; o For DMARD‑naïve early RA, methotrexate is preferred initial therapy; biologics (including TNFi such as infliximab) are indicated for moderate‑to‑high disease activity not controlled with DMARDs.; o In established RA with moderate/high disease activity despite DMARDs, a TNFi or non‑TNF biologic (with or without methotrexate) is recommended rather than continuing DMARD monotherapy alone.; o When possible, biologic therapy should be used in combination with methotrexate rather than biologic monotherapy due to superior efficacy.

Special populations and management principles:; o Hepatitis B: patients with active hepatitis B receiving effective antiviral treatment may be treated similarly to those without infection; untreated chronic HBV should be referred for antiviral therapy prior to immunosuppression and viral load monitoring is required.; o Hepatitis C: patients with chronic HCV who are receiving effective antiviral treatment may be treated similarly to those without HCV; coordinate care with hepatology/gastroenterology. If antiviral therapy is not being given, consider DMARD therapy rather than TNFi.; o Malignancy: prior melanoma or non‑melanoma skin cancer—prefer DMARD therapy over biologics or tofacitinib; prior lymphoproliferative disorder—prefer rituximab over TNFi; prior solid organ cancer—can be treated as RA patients without history of solid organ cancer, with individualized assessment.; o Serious infections: assess infection risk before initiating biologics; consider methotrexate monotherapy over bDMARD/tsDMARD monotherapy in DMARD‑naïve moderate‑to‑high disease activity; monitor and manage infections per guidelines.; o Heart failure: for patients with NYHA class III/IV heart failure, consider non‑TNF biologics over TNFi; switching from TNFi to a non‑TNF agent is preferred if heart failure develops or worsens.

Systemic juvenile idiopathic arthritis (sJIA) with macrophage activation syndrome (MAS):; o IL‑1 and IL‑6 inhibitors are conditionally recommended over calcineurin inhibitors alone to achieve inactive disease and resolution of MAS.; o For residual arthritis or incomplete response to IL‑1/IL‑6 inhibitors, biologic DMARDs or conventional synthetic DMARDs are strongly recommended over long‑term glucocorticoids.; o TNF inhibitors (including infliximab) are not preferred first‑line agents for sJIA with MAS; use of infliximab should follow specialty guidance and be reserved for scenarios supported by clinical judgment and subspecialty consultation.

Noninfectious uveitis — Anti‑TNF recommendations (American Uveitis Society):; o Strong recommendation: consider anti‑TNF therapy with infliximab (good‑quality evidence) or adalimumab (moderate‑ to good‑quality evidence) early in management of vision‑threatening ocular manifestations of Behçet's disease.; o Strong recommendation: consider infliximab or adalimumab as second‑line immunomodulatory therapy for children with vision‑threatening uveitis secondary to JIA when methotrexate is insufficient or not tolerated; methotrexate may be combined with infliximab if tolerated.; o Strong recommendation: consider infliximab or adalimumab as second‑line therapy for vision‑threatening chronic uveitis from seronegative spondyloarthropathy.; o Discretionary: infliximab or adalimumab may be considered for sarcoidosis, scleritis, panuveitis that are vision‑threatening and corticosteroid‑dependent after failure of antimetabolites or calcineurin inhibitors.; o Strong recommendation: prefer infliximab or adalimumab over etanercept for ocular inflammatory disease (etanercept is less effective and associated with new/worsening uveitis in some settings).

FDA‑approved indications (informational only):; o Remicade (infliximab) — adults: rheumatoid arthritis (with methotrexate) for moderately to severely active RA; plaque psoriasis (chronic severe) for adults who are candidates for systemic therapy; psoriatic arthritis (reduce signs/symptoms, inhibit structural progression); ankylosing spondylitis (reduce signs/symptoms); Crohn's disease (reduce signs/symptoms, induce/maintain remission; fistulizing disease); ulcerative colitis (reduce signs/symptoms, induce/maintain remission, mucosal healing, reduce corticosteroid use).; o Remicade pediatric indications: pediatric Crohn's disease (≥6 years) and pediatric ulcerative colitis (≥6 years) for moderately to severely active disease with inadequate response to conventional therapy.; o Biosimilars (Avsola, Inflectra, Renflexis) are approved as biosimilar to Remicade and share the same labeled indications (Crohn's disease, pediatric Crohn's disease, ulcerative colitis, pediatric ulcerative colitis, rheumatoid arthritis with methotrexate, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis) per their FDA‑cleared labels.; Note: FDA approvals are informational and not determinative for coverage; see policy clinical criteria for coverage decisions.

Provider Requirements, Prior Authorization, and Operational Guidance

Prior Authorization

Prior authorization required — follow indication‑specific criteria

Prior authorization is required for infliximab; submit indication-specific documentation showing the confirmed diagnosis, dosing per U.S. FDA–labeled dosing for the indication, that the patient is not receiving infliximab in combination with a targeted immunomodulator, and prescriber specialty when specified.

Initial requests: include diagnosis and evidence that indication-specific entry criteria are met (e.g., prior therapy failure or high‑risk disease where required).
Dosing must follow U.S. FDA–labeled dosing for the requested indication.
Do not request coverage for infliximab combined with a targeted immunomodulator.

Prior Authorization

Prior authorization and authorization length — indication‑specific periods (typically ≤12 months)

Authorize only when the indication‑specific prior authorization criteria are met; initial and reauthorization periods are generally limited to no more than 12 months for most indications.

Applicable Codes and Limits

Background, Evidence, and Definitions

Infliximab is an anti‑TNF monoclonal antibody available as multiple intravenous branded and biosimilar products that are used to treat immune‑mediated conditions such as ankylosing spondylitis, Crohn's disease, noninfectious uveitis, and plaque psoriasis. The policy defines infliximab to include Avsola, Inflectra, Remicade, Renflexis and other FDA‑approved infliximab biosimilars, and outlines preferred‑product rules, diagnosis‑specific medical necessity criteria, dosing expectations, authorization limits, and requirements for prior trials or documentation.

Infliximab definition — scope of product names included

Scope of term 'Infliximab''Infliximab' refers to all infliximab products including Avsola (infliximab‑axxq), Inflectra (infliximab‑dyyb), Remicade (infliximab), Renflexis (infliximab‑abda), and other FDA‑approved infliximab biosimilars

Self‑administered product noteInfliximab for self‑administered subcutaneous injection (e.g., Zymfentra/infliximab‑dyyb) is managed under the pharmacy benefit

Non‑listed biosimilarsAny FDA‑approved and launched infliximab biosimilar not listed will be considered non‑preferred until reviewed by UnitedHealthcare

Policy Summary

PayerUnitedHealthcare

PolicyInfliximab (IV products) coverage

Policy CodePolicy 2025D0004AP

Change TypePreferred product designation addednon‑preferred products require criteria

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document trial or intolerance of preferred biosimilars (Inflectra or Avsola) when requesting coverage for non‑preferred infliximab.

SourceLink

On This Page

Ensure documentation supports any prior‑therapy requirements (e.g., NSAID or DMARD trials) specified for the indication.

Reauthorizations require documentation of continued benefit and will be limited to ≤12 months per policy for most covered indications.

Prior Authorization

Authorization limits and continuation — initial limit 4 doses; continuation needs documented response

Initial authorization for certain acute indications is limited to no more than 4 doses; continuation/reauthorization requires documentation of a positive clinical response to support ongoing therapy.

Initial authorization for steroid‑refractory acute GVHD and many ICI‑related toxicities: initial authorization ≤4 doses.
Reauthorization for these indications requires documentation of positive clinical response and, where applicable, continued need due to ongoing toxicity or concomitant corticosteroid use.

Note

Benefit‑conditional prior authorization — consult member benefit

Coverage determinations are contingent on the member's specific benefit plan; consult the member’s Certificate of Coverage to determine whether prior authorization or coverage for off‑label/experimental uses applies.

Some Certificates of Coverage may allow experimental/investigational or off‑label uses for life‑threatening illnesses when conditions are met.
State mandates for off‑label coverage may supersede the benefit document.

Prior Authorization

Prior authorization determined by benefit document — consult plan/state mandates

Determine prior authorization requirements and allowable uses by consulting the member‑specific benefit plan and any applicable state mandates; plan or state rules may supersede policy language.

Member benefit documents govern whether off‑label or investigational indications are covered.
State mandates may require coverage even if policy would otherwise restrict an indication.

Note

Preference for TNF inhibitors in PsA — guideline preference for TNFi as initial biologic

Clinical guidelines preferentially recommend TNF inhibitors (including infliximab) as initial biologic therapy for many patients with active psoriatic arthritis; follow guideline‑recommended sequencing when documenting medical necessity.

Treating clinicians should document rationale if deviating from TNFi preference (e.g., contraindications such as CHF, prior serious infections, demyelinating disease).
When prior oral small‑molecule therapy failed, documentation supporting switch to TNFi is expected.

Note

Agent preference in malignancy and uveitis — rituximab preferred for prior lymphoproliferative disease; infliximab favored in uveitis

For patients with prior lymphoproliferative disorders, rituximab is strongly preferred over TNF inhibitors; for vision‑threatening uveitis, anti‑TNF agents such as infliximab are recommended—document agent selection accordingly.

If prior lymphoproliferative disorder present, document rationale for not using rituximab if requesting a TNFi.
For vision‑threatening uveitis, document specialty consultation and indication for infliximab per uveitis guidance.

Note

LCD/Step therapy applicability — check local Medicare coverage and Part B step therapy

Refer to local LCDs/LCAs and Medicare Part B Step Therapy Programs for Medicare members; local coverage determinations may govern label and off‑label uses and Part B step therapy may specify preferred therapies for Medicare Advantage members.

Medicare Advantage providers must check applicable LCDs/LCAs for Part B coverage rules.
Preferred therapy criteria for Medicare Advantage may be defined by Part B step therapy programs.

Step Therapy

Preferred product step therapy — Inflectra and Avsola preferred; non‑preferred requires criteria

Inflectra and Avsola are designated as preferred infliximab products; members on non‑preferred products (Remicade, Renflexis, others) will be required to switch to a preferred product unless they meet the policy’s criteria for medical necessity for a non‑preferred product.

Coverage for non‑preferred infliximab requires either: (1) ≥14 weeks trial of Inflectra/Avsola with minimal response plus physician attestation that response would be superior on the non‑preferred product, or (2) documented intolerance/contraindication to Inflectra/Avsola with physician attestation that same would not occur with the non‑preferred product.
Members already on non‑preferred products will be required to change to Inflectra or Avsola unless criteria are met for continuation.

Step Therapy

Step therapy / prior treatment requirements — prior conventional/DMARD trials often required

Many indications require documented prior failure of conventional or topical therapies or a trial of methotrexate/non‑biologic DMARDs (commonly a 3‑month trial at maximally indicated dose) unless contraindicated or intolerant; prior targeted immunomodulator use or current infliximab may alternatively satisfy step requirements.

Examples: Crohn's — failure of at least one conventional therapy or high‑risk disease qualifies; PsA and RA — trial of methotrexate or other non‑biologic DMARD for 3 months at maximally indicated dose is commonly required unless contraindicated.
Document drug, dates, and duration when prior targeted immunomodulator therapy is cited.

Step Therapy

Biosimilar trial/attestation requirements — document trial/intolerance to Inflectra/Avsola or provide attestation

When seeking coverage for a non‑preferred infliximab product, provide documentation of a trial of Inflectra or Avsola (e.g., at least 14 weeks) demonstrating minimal clinical response, or document intolerance/contraindication to those biosimilars; where applicable include a physician attestation that clinical response would be superior with the requested non‑preferred product.

Required clinical information for specific HCPCS codes may include proof of a ≥14‑week trial of Inflectra/Avsola with minimal response or documentation of intolerance/contraindication.
If using physician attestation, include a clear clinical rationale linking expected superior response to the non‑preferred agent.

Note

Guideline‑driven therapy sequencing — use professional guidance for induction and sequencing

Follow specialty guideline recommendations for induction and sequencing: infliximab (or another TNFi) is often preferred for induction in UC, for PsA initial TNFi is preferred, and in axSpA start with TNFi then switch classes per response—document guideline‑based rationale.

When deviating from guideline sequences, document contraindications or patient factors supporting alternative choices.
Use guideline timelines for response assessment when supporting continuation requests.

Step Therapy

Preferred biologic sequence in axSpA/AS — start with TNFi; if fails switch to another TNFi or different class

For axial spondyloarthritis/ankylosing spondylitis, initiate therapy with a TNFi (such as infliximab); if the first TNFi fails, document switching to another TNFi or to an IL‑17 inhibitor as recommended by guidance.

Document initial response assessment at 3–6 months and rationale for switching if inadequate response.
Include extra‑articular features and comorbidities when justifying agent selection after TNFi failure.

Step Therapy

JIA step therapy expectations — trial conventional DMARDs/other measures before biologic

For juvenile idiopathic arthritis, expect documentation of prior trials of conventional DMARDs (e.g., methotrexate, sulfasalazine), NSAIDs, and intra‑articular glucocorticoids before initiating biologics; when infliximab is requested, document why standard JIA guidance supports biologic use.

Combination therapy with a DMARD is strongly recommended with infliximab in polyarthritis.
If biologic is used as initial therapy in high‑risk JIA cases, document risk factors and rationale per pediatric guidance.

Note

Medicare Part B step therapy note — check local program/LCD requirements

Medicare Part B Step Therapy Programs and local coverage rules may define preferred therapies for Medicare Advantage members; check local program and LCD/LCA requirements when submitting requests for Medicare beneficiaries.

Medicare may limit outpatient Part B drug coverage to drugs furnished "incident to" a physician’s service and local coverage determinations may govern label and off‑label uses.
Preferred therapy criteria for Medicare Advantage members may follow Part B step therapy program rules.

Documentation Required

Required documentation — prior trial history (e.g., 14‑week Inflectra/Avsola) when seeking non‑preferred coverage

When requesting non‑preferred product coverage, include prior trial history details (e.g., at least a 14‑week trial of Inflectra or Avsola with minimal response) and documentation of intolerance/contraindication when applicable; dosing per FDA label and prescriber specialty should also be provided.

For continuation requests, provide documentation of positive clinical response to support reauthorization.
For uveitis, include dosing evidence that does not exceed 5 mg/kg schedule where applicable.

Documentation Required

Required clinical documentation — list of prior therapies, dosing, prescriber specialty, and response

Include the following clinical information in initial and continuation requests: diagnosis, prior therapies (drug names, dates, durations), reason for switching (intolerance/loss of response), current infliximab dosing and schedule, prescriber specialty, and documentation of positive clinical response for reauthorization.

Document prior targeted immunomodulator therapy with drug/date/duration when applicable.
For current infliximab users, document ongoing benefit and dosing per label for continuation requests.

Documentation Required

Required clinical information — product/code‑specific documentation (Remicade, Renflexis, etc.)

For specific infliximab products and HCPCS codes, medical notes must include required clinical information per code (e.g., attestations of prior Inflectra/Avsola trial or intolerance when requesting Remicade, Renflexis, or Ixifi) to support initial and continuation requests.

Follow code‑specific required clinical information described in the policy when submitting claims.
Include physician attestation where policy requires clinician opinion about expected superior response or intolerance non‑occurrence.

Documentation Required

Steroid‑refractory toxicity documentation — show inadequate improvement with adequate systemic corticosteroids

For immune checkpoint inhibitor–related toxicities, document inadequate improvement despite adequate systemic corticosteroid therapy (dose and duration) to establish steroid‑refractory status before infliximab is authorized.

Document dates, dose, and duration of systemic corticosteroid therapy and clinical course demonstrating inadequate improvement.
If intolerant to corticosteroids, include documentation of intolerance.

Documentation Required

Member benefit consultation — verify member plan and state mandates

Consult the member‑specific benefit plan document to determine coverage applicability; state mandates for off‑label coverage may supersede this policy and should be followed where applicable.

Do not assume policy coverage applies—confirm via the member’s Certificate of Coverage.
When state mandates require coverage for certain off‑label uses, follow the mandate.

Documentation Required

Member benefit document required — check Certificate of Coverage and state mandates

The member specific benefit plan document must be consulted to determine whether the requested service is covered; state mandates may supersede policy language and should be followed.

Coverage determinations for experimental/investigational uses depend on plan language and mandated state requirements.
When plan allows investigational coverage for life‑threatening illness, include required plan‑level documentation.

Documentation Required

Response assessment timeline — assess at 3–6 months; reassess every 6 months

Assess initial efficacy response to anti‑TNF therapy after 3–6 months of treatment and reassess responders every 6 months; lack of response by 6 months or failure to maintain response at two consecutive assessments should prompt consideration of withdrawal.

Document objective and clinical measures used to assess response at 3–6 months.
For discontinuation decisions, document two consecutive failed assessments or lack of initial response at 6 months.

Documentation Required

Hepatitis C documentation — document antiviral status and specialist collaboration for RA patients

For RA patients with chronic hepatitis C, document antiviral treatment status and collaboration with gastroenterology/hepatology; if not receiving antiviral therapy, prefer DMARDs over TNFi per guideline recommendations.

Document whether the patient has received effective antiviral therapy for HCV.
Include notes of specialist (gastroenterologist/hepatologist) involvement when TNFi is considered.

Documentation Required

Biosimilar documentation — document biosimilar status and FDA labeling

Document biosimilar status and relevant FDA labeling when prescribing Avsola, Inflectra, Renflexis, or other biosimilars; include biosimilar product name and relation to reference product where applicable.

When requesting non‑preferred product, include biosimilar trial details or intolerance documentation per policy.
Include HCPCS code and product name in the clinical documentation.

Denial Risk

Non‑preferred product coverage triggers — trial/intolerance of preferred biosimilars required

Coverage for Remicade, Renflexis, and other non‑preferred infliximab products requires meeting the preferred product criteria—either a documented trial of Inflectra/Avsola with minimal response or documented intolerance/contraindication plus physician attestation; failure to meet these triggers denial risk.

If preferred product criteria are not met, non‑preferred products may be considered not medically necessary.
Provide full prior‑treatment and attestation documentation when requesting non‑preferred product coverage.

Denial Risk

Combination therapy exclusion — risk of denial if combined with targeted immunomodulator

Requests may be denied if infliximab is prescribed in combination with another targeted immunomodulator; ensure documentation shows patient is not on concomitant targeted therapies.

Policy explicitly excludes combination use with targeted immunomodulators for covered indications.
If combination therapy is clinically justified, provide clear rationale and supporting documentation.

Denial Risk

Dose limit — exceeding initial/reauthorization dose limits may lead to denial

Requests that exceed the policy’s initial or reauthorization limits (for example, initial and reauthorization limits of no more than 4 doses for certain acute indications) may be denied.

Initial authorization limits for steroid‑refractory acute GVHD and many ICI‑related toxicities: ≤4 doses.
For other indications, adhere to indicated dosing schedules and authorization length (commonly ≤12 months).

Denial Risk

Unproven indications — risk of denial for listed unproven conditions

Requests for infliximab for indications listed as unproven or not medically necessary (e.g., hidradenitis suppurativa, juvenile idiopathic arthritis, myelodysplastic syndromes, Reiter's syndrome) risk denial unless the member’s benefit specifically allows such coverage.

If requesting treatment for an unproven indication, include plan‑level justification or evidence of plan allowance for investigational/off‑label coverage.
Absent plan allowance, these indications are considered unproven and not medically necessary per policy.

Denial Risk

Benefit determination dependencies — coverage depends on member benefit plan

Coverage decisions depend on the member's specific benefit plan; experimental/investigational/unproven treatments may be covered only when the plan allows (e.g., for life‑threatening illnesses) or when state mandates apply—confirm and document plan allowances.

Consult the member’s Certificate of Coverage for allowances related to investigational or off‑label uses.
When plan allows coverage for life‑threatening investigational uses, document required plan‑level approvals.

Denial Risk

Benefit considerations may trigger denial without plan/state exceptions — check Certificate of Coverage

If the member’s Certificate of Coverage does not allow coverage for experimental/investigational or off‑label uses and no state mandate applies, the request may be denied even if clinical rationale is provided.

Always verify plan exclusions and state mandates prior to submitting requests for unproven indications.
Document any plan‑level exception requests and approvals when pursuing coverage outside policy.

Denial Risk

Withdrawal for lack of response — discontinue if no response by 6 months or failure to maintain response

If there is no initial clinical response by 6 months, or the patient fails to maintain response on two consecutive assessments, consider discontinuing the anti‑TNF agent; lack of documented response may lead to denial of continued coverage.

Document objective measures of response at the 3–6 month assessment and at subsequent 6‑month reassessments.
Reauthorization requires documentation of sustained clinical benefit.

Note

Methotrexate preferred initial therapy — document reasons if bypassing MTX

For DMARD‑naive patients with moderate‑to‑high rheumatoid arthritis disease activity, methotrexate monotherapy is the preferred initial therapy; deviation from this sequencing should be documented and may affect coverage decisions.

If requesting infliximab for DMARD‑naive RA, document rationale for not using methotrexate (contraindication, intolerance, or high‑risk features).
Policy expects methotrexate trial in many RA pathways unless contraindicated.

Note

Medicare coverage and LCD guidance — consult LCDs/LCAs and Part B step therapy programs

Medicare may restrict outpatient (Part B) drug coverage and local coverage determinations (LCDs/LCAs) may govern label and off‑label uses; consult LCDs/LCAs and Medicare Part B Step Therapy Programs for Medicare beneficiaries.

Check local LCDs/LCAs for specific Part B coverage rules and permitted off‑label uses.
Medicare Advantage members may be subject to Part B step therapy program rules defining preferred therapies.

Chronic severe plaque psoriasis definition — criteria and thresholds

Definition criteriaChronic severe plaque psoriasis defined as extensive and/or disabling plaque psoriasis

BSA/site thresholdsIncludes ≥3% body surface area involvement or involvement of palmoplantar, facial, genital areas, or severe scalp psoriasis

Prior therapy requirementRequires history of failure to at least one topical therapy unless contraindicated or intolerant

Steroid‑refractory acute GVHD definition — relation to initial authorization

Steroid‑refractory acute GVHD definitionAcute graft‑versus‑host disease that is steroid‑refractory (does not respond to systemic corticosteroids); infliximab use may be for patients receiving infliximab with systemic corticosteroids or intolerant to corticosteroids

Authorization contextInitial authorization for steroid‑refractory acute GVHD is limited to no more than 4 doses

Steroid‑refractory definition — inadequate improvement despite corticosteroids

Steroid‑refractory (general)Inadequate improvement in toxicities or symptoms despite systemic corticosteroid therapy of adequate dose and duration for the diagnosis

Documentation requirementDocumentation must show inadequate improvement after adequate corticosteroid therapy when used for ICI‑related toxicities

Chronic pulmonary sarcoidosis (trial population) — trial inclusion summary

Trial population criteriaChronic pulmonary sarcoidosis trial enrolled patients treated with ≥10 mg/day prednisone (or equivalent) or one or more immunosuppressants for ≥3 months prior to screening

Infliximab dosing in trialPatients received infliximab 3 mg/kg or 5 mg/kg at weeks 0, 2, 6, 12, 18, and 24 with follow‑up to 52 weeks

Primary endpoint/resultMean increase in percent predicted FVC at week 24 of 2.5% for infliximab versus no change with placebo (p=0.038)

Refractory noninfectious uveitis definition — chronic recalcitrant disease description

Refractory noninfectious uveitis definitionChronic, recalcitrant uveitis not responding to conventional therapies (topical/systemic corticosteroids and immunosuppressants); often vision‑threatening and may require infliximab

Evidence of efficacyRetrospective cohort (n=88) showed 81.8% achieved clinical remission; higher remission associated with starting dose ≥5 mg/kg

Concomitant therapy noteMany remitters required additional immunomodulatory medications; patient must not be receiving infliximab with a targeted immunomodulator per criteria

Crohn's Disease Activity Index (CDAI) — definition and score context

CDAI definitionCrohn's Disease Activity Index (CDAI) is a composite score calculated from stool frequency, abdominal pain, well‑being, complications, medication use, abdominal mass, hematocrit deviation, and weight deviation

Score contextModerate‑severe disease usually corresponds to CDAI 220–450

Use in policyCDAI range used to identify candidates for anti‑TNF therapy including infliximab

NYHA class III or IV heart failure — definition and clinical implication

NYHA class III–IV definitionNew York Heart Association class III or IV heart failure denotes advanced heart failure where non‑TNF biologics or tsDMARDs are preferred over TNF inhibitors

Treatment implicationFor patients with NYHA class III or IV and inadequate response to csDMARDs, addition or switching to a non‑TNF biologic or tsDMARD is conditionally recommended over a TNF inhibitor

Biosimilar definition — regulatory definition and interchangeability context

Regulatory definitionA biosimilar is a biological product approved based on data demonstrating it is highly similar to an FDA‑approved reference product with no clinically meaningful differences

ExamplesAvsola (infliximab‑axxq), Inflectra (infliximab‑dyyb), and Renflexis (infliximab‑abda) are biosimilars to Remicade

Coverage noteBiosimilar approval does not by itself determine coverage; policy may designate preferred biosimilars and require trials/attestations for non‑preferred products