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    v1.0.28
    OpenPayerPolicy UpdatesImmunology/Rheumatologyquartz infliximab coverage & prior auth | OpenPaye…
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    CurrentquartzPolicy N/A

    Infliximab Products Clinical Resource — Coverage and Medical Necessity

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    Defines coverage stance, medical necessity criteria, and supported/unsupported indications for branded and biosimilar infliximab products for Quartz members and providers.

    Policy Summary
    Payerquartz
    PolicyInfliximab Products Clinical Resource — Coverage and Medical Necessity
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJul 1, 2024
    Last ReviewJul 1, 2024
    Next Review DateJul 1, 2024
    Key ActionObtain medical necessity documentation for branded Remicade, Zymfentra, Renflexis, and unbranded infliximab prior to coverage.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    5FDA approved indications listed
    13Other uses with supportive evidence
    7Conditions lacking evidence
    6Named agents

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Coverage and Medical Necessity Criteria

    FDA-approved indications — covered with criteria

    Covered when the specific indication dosing and patient selection criteria are met

    Indication and dosing: Patient has one of the FDA-approved indications: ankylosing spondylitis; Crohn's disease; plaque psoriasis; psoriatic arthritis; rheumatoid arthritis; or ulcerative colitis, AND dosing follows the indication-specific regimens (examples: ankylosing spondylitis and psoriasis — 5 mg/kg at 0, 2, and 6 weeks then maintenance dosing; Crohn's disease and ulcerative colitis — 5 mg/kg induction at 0, 2, and 6 weeks with maintenance every 8 weeks starting at week 14; rheumatoid arthritis — 3 mg/kg induction at 0, 2, and 6 weeks with 3 mg/kg maintenance every 8 weeks; dose escalation up to 10 mg/kg or shortened interval may be considered for loss of response).see dosing per indication

    Dose escalation or interval shortening permitted for loss of response but consider increased infection risk

    Selection criteria for Crohn's disease or ulcerative colitis: Either A) high-risk disease features (examples: younger age at diagnosis, extensive anatomic involvement, deep ulcers, fistulizing or penetrating disease, prior surgical resection, perianal disease, extraintestinal manifestations, high inflammatory markers, steroid-requiring disease or hospitalization) OR B) low-risk patient who has failed conventional therapy (eg, azathioprine, mercaptopurine, mesalamine, methotrexate, sulfasalazine) or is steroid dependent or not a candidate for conventional therapy.

    If no response by week 14, consider discontinuing therapy

    Plaque psoriasis: Moderate to severe plaque psoriasis demonstrated by significant functional disability, BSA ≥ 3%, debilitating palm/plantar disease or involvement of difficult areas (nails, scalp, genitals, intertriginous), AND trial of prior topical therapy; some patients may require 10 mg/kg or more frequent maintenance dosing.BSA ≥ 3%
    Psoriatic arthritis: Presence of at least ONE of: actively inflamed peripheral joints, axial disease, active skin/nail/scalp psoriasis, dactylitis, or enthesitis.

    May be used with or without methotrexate

    Rheumatoid arthritis: Use in combination with methotrexate after prior trial of non-biologic DMARDs (eg, methotrexate, leflunomide, hydroxychloroquine, sulfasalazine); initiation at 3 mg/kg induction and maintenance every 8 weeks with dose adjustment for incomplete response.

    Higher doses and more frequent administration increase risk of serious infections

    Other uses with supportive evidence — conditional coverage

    These uses have supportive evidence and may be considered when standard therapy has failed or is not appropriate

    Supported other uses: Use may be considered for listed conditions when conventional therapy is ineffective, contraindicated, or patient is refractory; supported uses include: adult-onset Still's disease; Behcet's syndrome; immune checkpoint inhibitor–induced colitis (grade 2–4 with high‑risk endoscopic features or persistent symptoms despite 3 days of corticosteroids; dosing typically 5 mg/kg at week 0 with possible repeat doses at 2 and 6 weeks and concurrent corticosteroid); hospitalized COVID‑19 patients requiring oxygen with systemic inflammation who cannot use preferred agents (single 5 mg/kg dose); graft-versus-host disease; severe refractory hidradenitis suppurativa; severe refractory juvenile idiopathic arthritis; Kawasaki disease; multisystem inflammatory syndrome in children (refractory); polyarteritis nodosa; pustular psoriasis (5 mg/kg at 0,2,6 then every 8 weeks up to 46 weeks); acute refractory intestinal transplant rejection; rheumatoid arthritis monotherapy (dosing 1–10 mg/kg); SAPHO syndrome (severe refractory); refractory sarcoidosis (adjunctive therapy; initial 3–5 mg/kg then maintenance 3–5 mg/kg every 4–8 weeks); scleritis (noninfectious, refractory); synovitis; Takayasu's disease; uveitis (3–5 mg/kg at 0,2,6 then every 4–8 weeks).

    Dosing and regimen vary by condition; individualize therapy and consult specialist

    Conditions lacking supportive evidence — not recommended

    Use is not recommended for these conditions due to lack of conclusive evidence

    Not recommended conditions: Infliximab is considered not recommended (coverage not supported) for: congestive heart failure; celiac disease; necrobiosis lipoidica diabeticorum; polymyalgia rheumatica; pyoderma gangrenosum; subcorneal pustular dermatosis; and temporal arteritis.

    Use for these conditions may be denied as not medically necessary

    Coverage of infliximab products is not recommended for conditions where there is insufficient or inconclusive evidence to support benefit. The policy specifically lists congestive heart failure; celiac disease; necrobiosis lipoidica diabeticorum; polymyalgia rheumatica; pyoderma gangrenosum; subcorneal pustular dermatosis; and temporal arteritis as conditions lacking supportive evidence. Requests for these indications should be considered not recommended and may be subject to denial under medical necessity review.

    Use of infliximab for indications listed under Conditions lacking supportive evidence is considered not recommended and may be denied as not medically necessary. When these diagnoses are cited as the primary rationale for therapy, prior authorization and medical necessity reviewers should apply the policy exclusion and document denial rationale accordingly.

    Clinical Thresholds and Evaluation Timepoints

    inv-06: Psoriasis body surface area — BSA ≥ 3%
    ThresholdBody surface area (BSA) involvement ≥ 3%
    Clinical demonstrationSignificant functional disability, debilitating palmar/plantar psoriasis, or involvement of vulnerable areas (nails, scalp, genitals, intertriginous)
    Prior therapy requirementTrial of prior topical therapy is expected before infliximab for psoriasis
    inv-07: Response evaluation timepoint for Crohn's/UC — If no response by week 14, consider discontinuing therapy
    Primary timepointIf no clinical response by week 14, consider discontinuing therapy
    Induction schedule referencedInduction dosing commonly 5 mg/kg at weeks 0, 2, and 6 (varies by indication)
    Maintenance initiationMaintenance dosing typically begins at week 14 (eg, 5 mg/kg every 8 weeks for IBD)

    Prior Auth, Documentation, and Step Therapy

    Prior Authorization

    Prior authorization requirement

    Select infliximab biosimilars do not require prior authorization; branded Remicade, Zymfentra, Renflexis, and unbranded infliximab require an evaluation of medical necessity prior to coverage.

    Step Therapy

    Step therapy and prior trial expectations

    Prior trials of conventional or non-biologic therapies are expected for many indications before initiating infliximab unless the patient meets high‑risk criteria that justify earlier biologic therapy.

    • Ankylosing spondylitis: trial of NSAIDs prior to infliximab (chunk 5).
    • Rheumatoid arthritis: prior trial of non-biologic DMARDs (eg, methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) required (chunk 9).
    • Inflammatory bowel disease: low‑risk patients should fail conventional therapy (eg, azathioprine, mercaptopurine, mesalamine, methotrexate) or be steroid dependent before infliximab; high‑risk features allow earlier use (chunk 5, 10).
    • Psoriasis: trial of prior topical therapy expected for moderate–severe disease (chunk 7).
    Documentation Required

    Required clinical documentation

    Submit indication‑specific clinical documentation to support medical necessity, including prior therapy history, disease severity measures, dosing regimen, and objective high‑risk features where applicable.

    • Documentation of prior therapies attempted (eg, NSAIDs, topical agents, non‑biologic DMARDs, immunomodulators, corticosteroids) (chunks 5, 7, 9).
    • Disease severity measures: BSA ≥ 3% or functional disability for psoriasis; objective high‑risk features for Crohn's/UC (eg, deep ulcers, extensive colitis, age <40, high CRP/ESR, steroid‑requiring disease) (chunks 7, 10).
    • Dosing and treatment plan (induction and maintenance schedule; any planned dose escalation or interval changes) and response assessment timing (eg, reassess Crohn's/UC by week 14) (chunks 5, 9).
    Denial Risk

    Medical necessity evaluation required for certain products

    Use of branded Remicade, Zymfentra, Renflexis, and unbranded infliximab will require a medical necessity evaluation; absence of required documentation may result in denial of coverage.

    • Select infliximab biosimilars do not require prior authorization, but the branded and unbranded infliximab products explicitly require medical necessity review (chunk 3).

    Background

    Infliximab is a recombinant chimeric monoclonal antibody that targets tumor necrosis factor-alpha (TNFα) and is used across multiple immune-mediated inflammatory diseases. While this policy details supported and unsupported indications, the list of conditions lacking supportive evidence highlights areas where infliximab use is not recommended because conclusive benefit has not been demonstrated, for example congestive heart failure and other specified diagnoses.

    Definitions and High-Risk Features

    inv-13: Infliximab — definition of the agent
    Agent classInfliximab is a recombinant chimeric monoclonal antibody that binds to and inhibits tumor necrosis factor-alpha (TNFα)
    Clinical roleUsed to treat multiple immune-mediated inflammatory diseases including ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis
    Regulatory/coverage noteSelect biosimilar infliximab products do not require prior authorization; branded Remicade, Zymfentra, Renflexis, and unbranded infliximab require medical necessity evaluation
    inv-14: High-risk Crohn's/UC features — characteristics constituting high-risk disease
    High-risk features (Crohn's)Age <30 at diagnosis; extensive anatomic involvement; perianal and/or severe rectal disease; deep ulcers; prior surgical resection and/or penetrating behavior; fistulizing disease; extraintestinal manifestations of inflammation
    High-risk features (Ulcerative Colitis)Extensive colitis; deep ulcers; age <40 at diagnosis; markedly elevated CRP/ESR; steroid‑requiring disease; history of hospitalization for UC; history of C. difficile or CMV infection
    Implication for therapyPresence of these features may justify earlier initiation of biologic therapy rather than waiting for failure of conventional therapy
    Policy Summary
    Payerquartz
    PolicyInfliximab Products Clinical Resource — Coverage and Medical Necessity
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJul 1, 2024
    Last ReviewJul 1, 2024
    Next Review DateJul 1, 2024
    Key ActionObtain medical necessity documentation for branded Remicade, Zymfentra, Renflexis, and unbranded infliximab prior to coverage.
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaClinical Thresholds and Evaluation TimepointsPrior Auth, Documentation, and Step TherapyBackgroundDefinitions and High-Risk Features