CurrentCignaPolicy IP0660

Infliximab Intravenous Products Prior Authorization Policy

Prior authorization policy for infliximab intravenous products (Remicade and biosimilars Avsola, Inflectra, Renflexis, and Janssen infliximab) covering FDA-approved indications and selected supportive-evidence uses with dosing and approval durations; applies to Cigna-administered health benefit plans and requires specialist prescribing/consultation for initiation.

Policy Summary

PayerCigna

PolicyInfliximab Intravenous Products Prior Authorization Policy

Policy CodePolicy IP0660

Change TypeRevisions and annual updates

Effective DateMar 15, 2026

Next Review Date

Key ActionPrior Authorization is required for benefit coverage of infliximab products; ensure requests document indication-specific criteria, specialist involvement, dosing, and duration to obtain approval.

SourceLink

POLICY UPDATE CHANGES

Selected Revision: Crohn's Disease initial therapy options were removed and other modifications noted; effective 03/15/2026.

Annual and selected revisions between 11/01/2024 and 03/01/2026 including updates to examples, specialists, and indication-specific language.

New policy created 11/01/2024.

11Indications listed (FDA-approved + supportive)

≥6Minimum age thresholds vary (years)

3–6

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Common initial approval months (typical)

10Maximum documented IV dose (mg/kg)

1Continuation approval duration (year)

Coverage Summary

Coverage stance: Policy status is covered_with_criteria and requires prior authorization with specialist prescribing/consultation for initiation. Scope: Applies to Remicade (Janssen) and biosimilars Avsola, Inflectra, and Renflexis across FDA-approved indications and selected supportive‑evidence uses for Cigna‑administered plans. Approval durations and dosing limits: Initial approvals are time‑limited (commonly 3–6 months depending on indication) while continuation approvals are typically 1 year; initial induction regimens generally allow 5 mg/kg IV (varies by indication) with a documented maximum maintenance dose of 10 mg/kg IV no more frequently than once every 4 weeks.

Key thresholds

Age thresholdsVaries by indication. Common thresholds: ≥6 years for pediatric GI and ophthalmic indications; >18 years for most adult indications.

Established-on-therapy duration (continuation)Varies by indication; commonly ≥6 months for many adult indications; some indications require ≥3 months, ≥4 months, or ≥1 month (GVHD).

Initial dosing (common induction schedule)Typically 5 mg/kg IV at baseline then at 2 and 6 weeks with maintenance interval per indication (eg, q8w, q6w, or q4w as specified). Some indications use different induction doses (JIA 6 mg/kg; certain ocular uses up to 10 mg/kg).

Maximum maintenance doseUp to 10 mg/kg IV no more frequently than once every 4 weeks for patients currently receiving therapy.

Prior Authorization & Provider Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for benefit coverage of infliximab intravenous products. Requests for doses outside the established dosing documented in the policy will be reviewed on a case-by-case basis by a clinician (Medical Director or Pharmacist). Approvals are provided for specified durations in the policy.

Documentation Required

Specialist prescribing/consultation required for initiation

Initial approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated. Examples of required specialists by indication include rheumatologist, gastroenterologist, dermatologist, oncologist/hematologist/physician affiliated with a transplant center, and ophthalmologist.

Rheumatologist

Initial Therapy Criteria (by indication)

Policy Statement - Prior Authorization Requirement

Prior authorization is required for all infliximab intravenous products. Requests must include documentation supporting the requested indication, prior therapies tried (when applicable), dosing plan including induction and maintenance regimen, and the treating specialist’s information. Approvals will be consistent with the criteria below.

ALL of the following

The requested agent is an infliximab intravenous product covered under this policy (e.g., Remicade, Inflectra, Renflexis, Avsola, other infliximab IV products).
A prior authorization request has been submitted and includes clinical documentation supporting the diagnosis and medical necessity (see overview and guidelines sections).
Documentation should include relevant prior treatment history, response/intolerance, and objective disease activity where applicable.
Specialist requirement

Continuation Therapy Criteria (Currently Receiving)

Continuation criteria for FDA-approved indications

Continuation criteria - Ankylosing Spondylitis

established duration: Patient has been established on therapy for at least 6 months
response requirement
- objective measure: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (eg ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, CRP, ESR)
- symptom improvement: Compared with baseline, patient experienced improvement in at least one symptom (eg decreased pain or stiffness, improved function/ADLs)

Exclusions / Not Medically Necessary

Explicit exclusions include concurrent use of infliximab with another biologic or with a targeted synthetic oral small molecule for the same inflammatory condition — such combination therapy is considered not medically necessary and may be denied. The policy notes that Avsola, Inflectra, and Renflexis are approved as biosimilars to Remicade but are not interchangeable; additionally, a preferred‑product step (PSM005) requires use of preferred infliximab products before approval of a requested non‑preferred product, which can restrict approvals of non‑preferred agents.

Applicable Codes

Infliximab products referencedmixed

Avsola	infliximab-axxq IV infusion (Amgen) - biosimilar to Remicade
Inflectra	infliximab-dyyb IV infusion (Hospira/Pfizer) - biosimilar to Remicade
Infliximab (Janssen)	infliximab IV infusion - Janssen/Johnson & Johnson
Remicade	infliximab IV infusion - Janssen/Johnson & Johnson
Renflexis	infliximab-abda IV infusion (Samsung Bioepis/Organon) - biosimilar to Remicade

Considered Medically Necessary HCPCSHCPCSCovered

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

Providers must document that patients meet the indication‑specific clinical criteria (age, prior therapy trials, specialist involvement, and duration on therapy for continuation) when billing the listed HCPCS codes. Dosing limits in the policy (induction schedules and the 10 mg/kg q4w maximum maintenance) affect billing and will be enforced per the dosing/billing rules. Note that some HCPCS codes explicitly distinguish biosimilars from the innovator product (for example, J1745 excludes biosimilars while Q5103/Q5104/Q5121 are biosimilar codes).

Clinical Evidence & References

Background: Infliximab products are tumor necrosis factor inhibitors approved for multiple inflammatory conditions. Biosimilars (Avsola, Inflectra, Renflexis) have regulatory approval as biosimilars to Remicade but are not interchangeable. Dosing is weight‑based and varies by indication; dose increases, interval shortening, or switching may be used for loss of response, and the policy documents weight‑based induction regimens with maintenance dosing limits (including adjustments up to a maximum of 10 mg/kg).

Background

Definitions

Indeterminate colitisDefined as colitis that cannot be classified with certainty as either ulcerative colitis or Crohn's disease.

Established on therapyDuration on infliximab therapy specified per indication (varies); commonly ≥6 months, with some indications requiring ≥3, ≥4, or ≥1 month before qualifying for continuation (1-year) criteria.

Objective measureDisease-specific laboratory, imaging, endoscopic assessments, or validated disease activity scores demonstrating clinical response from baseline (examples provided per indication, e.g., fecal calprotectin, CRP, imaging, ASDAS, BASDAI, CDAI, endoscopy, visual acuity).

Revision History

2026-03-15material revisionLatest

Selected Revision: Crohn's Disease initial therapy options were removed and other modifications noted; effective 03/15/2026.

2024-11-01 to 2026-03-01annual/selected revisions

Annual and selected revisions between 11/01/2024 and 03/01/2026 including updates to examples, specialists, and indication-specific language.

2024-11-01initial policy creation

New policy created 11/01/2024.

Policy Summary

PayerCigna

PolicyInfliximab Intravenous Products Prior Authorization Policy

Policy CodePolicy IP0660

Change TypeRevisions and annual updates

Effective DateMar 15, 2026

Next Review Date

SourceLink

On This Page

Oncologist / Hematologist / Transplant-affiliated physician

Documentation Required

Evidence of response for continuation approvals

For continuation (‘Currently Receiving’) approvals, providers must document that the patient has been established on therapy for the policy-specified duration and has either a beneficial clinical response on at least one objective measure or improvement in at least one symptom compared with baseline. Examples of objective measures and the established-on-therapy durations vary by indication (commonly ≥6 months; some indications require ≥3 or ≥4 months as specified).

Documentation of established on-therapy duration per indication (e.g., ≥6 months, ≥3 months, ≥4 months as specified)
Objective measure showing benefit (lab, imaging, validated disease score relevant to indication) OR symptom improvement vs baseline

Billing Rule

Dosing/billing limits

Dosing and billing approvals specify weight‑based mg/kg limits, induction schedules, and a maximum maintenance dose. Initial induction regimens and maintenance intervals are defined per indication (examples: many initial regimens use 5 mg/kg at baseline then at weeks 2 and 6; some indications use up to 10 mg/kg induction). For patients currently receiving therapy the policy limits dosing to a maximum of 10 mg/kg IV no more frequently than once every 4 weeks. Billers must adhere to the dosing intervals and use appropriate HCPCS codes for infliximab products.

mg/kg dosing limits and induction schedules defined per indication (e.g., 5 mg/kg at baseline, then 2 and 6 weeks for many indications)
Maximum maintenance dose: 10 mg/kg IV no more frequently than once every 4 weeks
Adhere to dosing intervals and associated HCPCS codes (e.g., J1745, Q5103, Q5104, Q5121)

Billing Rule

Preferred product step requirement

Use of preferred infliximab products is required before approval of a requested non‑preferred infliximab IV product per the Inflammatory Conditions - Infliximab Intravenous Products Preferred Specialty Management Policy (PSM005).

Prior Authorization

Prior authorization required per clinical criteria

To obtain prior authorization, providers must document indication‑specific clinical criteria including the patient’s age, prior medication trials or contraindications, specialist involvement or consultation, and duration established on therapy for continuation requests. Typical approval durations referenced in the policy include initial approvals commonly for 3–6 months (varies by indication) and continuation approvals for 1 year when continuation criteria are met.

Document indication and patient age per policy thresholds
Document prior medication trials or exceptions (examples provided per indication)
Document specialist prescribing/consultation
Document duration established on therapy for continuation requests

Denial Risk

Combination therapy exclusion

Concurrent administration of an infliximab product with another biologic or a targeted synthetic oral small molecule for an inflammatory condition is considered not medically necessary and may be denied. Concurrent use of conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) is allowed.

Concurrent biologic or targeted synthetic therapy: may be denied
Conventional synthetic DMARDs (e.g., methotrexate) may be continued with infliximab

Prescribing provider is a relevant specialist for the indication (e.g., rheumatologist for RA/AS/psoriatic arthritis/spondyloarthritis, gastroenterologist for Crohn’s disease/ulcerative colitis/indeterminate colitis, dermatologist for plaque psoriasis/hidradenitis suppurativa, ophthalmologist for uveitis/scleritis, transplant/hematology-oncology for GVHD).

If not prescribed by a specialist, documentation must show collaborative care with or referral to an appropriate specialist.

FDA-Approved Indications - Initial Therapy criteria per indication

Covered, medically necessary initial therapy criteria for FDA‑approved indications. For each indication the Initial Therapy branch lists required conditions, age thresholds, specialist requirement, and induction dosing options where applicable.

Ankylosing Spondylitis - Initial Therapy

Diagnosis of active ankylosing spondylitis confirmed by a specialist (rheumatologist or equivalent).
Patient has signs and symptoms appropriate for biologic therapy per guideline-based care; documentation of inadequate response, intolerance, or contraindication to conventional therapy when applicable.
Age and specialist
- Patient is an adult (≥ 18 years) or pediatric if supported by product labeling and specialist documentation.
- Prescribed by or in consultation with a rheumatologist.
Induction dosing options
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6 (standard induction).
- Higher induction dosing (e.g., 10 mg/kg) when supported by product labeling and documented clinical rationale and specialist recommendation.

Crohn's Disease - Initial Therapy

Diagnosis of moderately to severely active Crohn's disease confirmed by a gastroenterologist or pediatric gastroenterologist as applicable.
Age threshold
- Patient is ≥ 6 years of age for labeled pediatric use.
- If patient is < 6 years, coverage may be considered only with strong clinical justification and specialist documentation (off‑label).
Documentation of inadequate response to or intolerance of conventional therapies when indicated, unless guideline-supported upfront advanced therapy is used and documented.
Induction dosing options
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6 (standard induction).

Plaque Psoriasis - Initial Therapy

Diagnosis of chronic severe plaque psoriasis in an adult confirmed by a dermatologist; candidate for systemic therapy and other systemic agents are less appropriate or have failed/intolerant.
Prescribed by or in consultation with a dermatologist.
Induction dosing options
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6 (standard induction).
- Alternate induction dosing when supported by product labeling and dermatologist justification.

Psoriatic Arthritis - Initial Therapy

Diagnosis of active psoriatic arthritis confirmed by a rheumatologist or dermatologist experienced in psoriatic disease.
Patient has inadequate response or intolerance to conventional therapies when applicable, or biologic therapy is otherwise indicated per guidelines.
Prescribed by or in consultation with a rheumatologist or dermatologist with experience in psoriatic arthritis.
Induction dosing options
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6 (standard induction).
- Higher induction dosing when supported by labeling and documented specialist rationale.

Rheumatoid Arthritis - Initial Therapy

Diagnosis of moderately to severely active rheumatoid arthritis confirmed by a rheumatologist.
Infliximab is used in combination with methotrexate unless contraindicated; documentation required if methotrexate cannot be used.
Patient has had an inadequate response or intolerance to conventional DMARD therapy (e.g., methotrexate) unless guideline-supported exception documented.
Induction dosing options
- Infliximab 3 mg/kg IV at weeks 0, 2, and 6 (per labeled RA regimen).
- Dose escalation (e.g., 5 mg/kg or higher) or alternative induction schedule allowed if supported by labeling and specialist documentation of clinical need.

Ulcerative Colitis - Initial Therapy

Diagnosis of moderately to severely active ulcerative colitis confirmed by a gastroenterologist or pediatric gastroenterologist as applicable.
Age threshold
- Patient is an adult (≥ 18 years) for adult labeling.
- Patient ≥ 6 years of age for labeled pediatric use supported by specialist documentation.
Documentation of inadequate response to conventional therapy, unless induction strategy using an advanced agent is planned and documented per guideline recommendations.
Induction dosing options
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6 (standard induction for UC).

Supportive-Evidence Uses - Initial Therapy criteria per indication

Initial therapy criteria for other uses with supportive evidence. For each indication include age thresholds, specialist requirement, and dosing where applicable.

Behcet's Disease - Initial Therapy

Diagnosis of Behcet's disease with mucocutaneous, ocular, gastrointestinal, or other severe manifestations confirmed by an appropriate specialist (e.g., rheumatologist, ophthalmologist, gastroenterologist).
Patient has refractory disease or features (e.g., sight‑threatening uveitis or severe GI disease) warranting biologic therapy per guideline recommendations.
Prescribed by or in consultation with an appropriate specialist.
Dosing/Induction
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6 (typical induction).
- Alternate dosing per specialist justification and supporting evidence.

Graft‑Versus‑Host Disease (acute) - Initial Therapy

Diagnosis of acute steroid‑refractory graft‑versus‑host disease documented by a transplant specialist or hematologist/oncologist.
Prescribed by or in consultation with a transplant specialist or hematologist/oncologist experienced in GVHD management.
Use is consistent with guideline‑recommended salvage therapies for steroid‑refractory acute GVHD when other preferred agents are not appropriate or have failed.
Dosing/Induction
- Infliximab dosing as used in institutional protocols or published literature for acute GVHD with specialist documentation (commonly 5–10 mg/kg IV dosing; induction schedule per protocol).
- Higher or repeated dosing permitted with specialist justification and supporting documentation.

Hidradenitis Suppurativa - Initial Therapy

Diagnosis of moderate to severe hidradenitis suppurativa confirmed by a dermatologist; patient has inadequate response or intolerance to conventional systemic therapies when indicated.
Prescribed by or in consultation with a dermatologist experienced in HS management.
Dosing/Induction
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6 (commonly used induction schedule).
- Alternate induction dosing per dermatologist justification and supporting evidence.

Immunotherapy‑Related Toxicities - Initial Therapy

Severe or steroid‑refractory immune checkpoint inhibitor‑related toxicity (e.g., colitis/diarrhea, pneumonitis, inflammatory arthritis, uveitis) confirmed by the treating oncologist or relevant specialist.
Excludes immune‑related hepatotoxicity (infliximab not recommended for this toxicity).
Prescribed by or in consultation with the treating oncologist and relevant subspecialist.
Dosing/Induction
- Infliximab 5 mg/kg IV single dose is commonly used for steroid‑refractory colitis; additional doses per specialist guidance and clinical response.
- Dosing may vary by toxicity type and specialist protocol; document rationale for induction/maintenance when applicable.

Indeterminate Colitis - Initial Therapy

Diagnosis of indeterminate colitis confirmed by a gastroenterologist with documentation of disease severity and prior therapies.
Prescribed by or in consultation with a gastroenterologist; use considered for refractory disease or when Crohn’s vs UC distinctions preclude standard labeled pathways.
Dosing/Induction
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6 (typical induction).
- Alternate dosing per specialist rationale and supporting evidence.

Additional Indications - Initial Therapy criteria

Initial therapy criteria for additional indications supported by evidence or guideline recommendations. These criteria focus on specialist confirmation, age thresholds when applicable, and induction dosing options.

Crohn's Disease (Part 2) - Initial Therapy

For fistulizing Crohn's disease in adults: diagnosis confirmed by a gastroenterologist and documentation of draining enterocutaneous or rectovaginal fistulas when applicable.
Patient has failed or is intolerant to appropriate prior therapies for fistulizing disease or meets guideline criteria for biologic therapy.
Prescribed by or in consultation with a gastroenterologist; specialist must document intended induction and maintenance plan.
Induction dosing
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6; dose escalation per specialist rationale for fistulizing disease.

Juvenile Idiopathic Arthritis (JIA) - Initial Therapy

Diagnosis of JIA confirmed by a pediatric rheumatologist; use consistent with product labeling and pediatric guidance.
Patient meets age/weight criteria per labeling or has specialist justification for off‑label use.
Prescribed by or in consultation with a pediatric rheumatologist; induction dosing per labeling and pediatric protocols (documented).

Pyoderma Gangrenosum - Initial Therapy

Diagnosis of pyoderma gangrenosum confirmed by a dermatologist or dermatologic surgeon with documentation of severity and prior treatments.
Use considered for refractory or severe disease per specialist guidance.
Dosing/Induction
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6 (common induction).
- Alternate dosing per specialist rationale and evidence.

Sarcoidosis - Initial Therapy

Diagnosis of sarcoidosis with severe or refractory organ‑threatening manifestations confirmed by a pulmonologist, rheumatologist, or other appropriate specialist.
Prescribed by or in consultation with the relevant specialist; infliximab considered for refractory disease per specialist judgment and supporting evidence.
Dosing/Induction
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6; dosing adjustments per specialist discretion and evidence.

Scleritis / Sterile Corneal Ulceration - Initial Therapy

Diagnosis confirmed by an ophthalmologist; disease is severe, vision‑threatening, or refractory to first‑line therapies.
Prescribed by or in consultation with an ophthalmologist experienced in ocular inflammatory disease.
Dosing/Induction
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6 or alternative dosing per ophthalmologist protocol and justification.

Spondyloarthritis (other subtypes) - Initial Therapy

Diagnosis of non‑radiographic axial spondyloarthritis or other spondyloarthritis subtypes confirmed by a rheumatologist.
Patient has active disease appropriate for biologic therapy per guidelines; specialist documents prior therapies and rationale.
Dosing/Induction
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6; alternative induction (including dose escalation) allowed per specialist documentation.

Uveitis - Initial Therapy

Diagnosis of noninfectious uveitis or sight‑threatening ocular inflammation confirmed by an ophthalmologist.
Infliximab use is for severe, recurrent, or refractory uveitis when first‑line therapies are inadequate or contraindicated; prescribed by or in consultation with an ophthalmologist.
Dosing/Induction
- Infliximab 5 mg/kg IV at weeks 0, 2, and 6 is a commonly used induction regimen; higher or altered dosing permitted with ophthalmologist justification.

maintenance dosing: Approve up to a maximum dose of 10 mg/kg IV no more frequently than once every 4 weeks

Continuation criteria - Crohn's Disease

established duration: Patient has been established on therapy for at least 6 months
response requirement
- objective measure: Beneficial clinical response by at least one objective measure (eg fecal lactoferrin, fecal calprotectin, CRP, MRE/CTE, endoscopy, reduced corticosteroid dose)
- symptom improvement: Compared with baseline, improvement in at least one symptom (decreased pain, fatigue, stool frequency, blood in stool)
maintenance dosing: Approve up to a maximum dose of 10 mg/kg IV no more frequently than once every 4 weeks

Continuation criteria - Plaque Psoriasis

established duration: Patient has been established on therapy for at least 3 months
objective response: Patient experienced a beneficial clinical response (improvement in BSA, erythema, induration/thickness, and/or scale)
symptom improvement: Compared with baseline, patient experienced improvement in at least one symptom (decreased pain, itching, burning)
maintenance dosing: Approve up to a maximum dose of 10 mg/kg IV no more frequently than once every 4 weeks

Continuation criteria - Psoriatic Arthritis

established duration: Patient has been established on therapy for at least 6 months
response requirement
- objective measure: Beneficial clinical response by at least one objective measure (eg DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID-12, CRP, ESR)
- symptom improvement: Compared with baseline, improvement in at least one symptom (less joint pain, morning stiffness, fatigue, improved function, decreased swelling)
maintenance dosing: Approve up to a maximum dose of 10 mg/kg IV no more frequently than once every 4 weeks

Continuation criteria - Rheumatoid Arthritis

established duration: Patient has been established on therapy for at least 6 months
response requirement
- objective measure: Patient experienced a beneficial clinical response when assessed by at least one objective measure (eg CDAI, DAS28-ESR/CRP, PAS-II, RAPID-3, SDAI)
- symptom improvement: Patient experienced an improvement in at least one symptom (decreased joint pain, morning stiffness, fatigue, improved function, decreased swelling)
maintenance dosing: Approve up to a maximum dose of 10 mg/kg IV no more frequently than once every 4 weeks

Continuation criteria - Ulcerative Colitis

established duration: Patient has been established on therapy for at least 6 months
response requirement
- objective measure: Beneficial clinical response by at least one objective measure (eg fecal calprotectin, CRP, endoscopic assessment, reduced corticosteroid dose)
- symptom improvement: Compared with baseline, improvement in at least one symptom (decreased pain, fatigue, stool frequency, rectal bleeding)
maintenance dosing: Approve up to a maximum dose of 10 mg/kg IV no more frequently than once every 4 weeks

Continuation criteria for supportive-evidence indications

Continuation criteria - Behcet's Disease

established duration: Patient has been established on therapy for at least 3 months
objective response: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples depend on organ involvement: visual acuity, CRP, ESR, ulcer depth/number/size)
symptom improvement: Compared with baseline, patient experienced improvement in at least one symptom (eg decreased pain or improved visual acuity)
maintenance dosing: Approve up to a maximum dose of 10 mg/kg IV no more frequently than once every 4 weeks

Continuation criteria - Graft-Versus-Host Disease (acute)

established duration: Patient has been established on an infliximab product for at least 1 month
response requirement
- objective measure: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (eg normalization of LFTs, RBC count, platelet count, resolution of fever or rash)
- symptom improvement: Compared with baseline, patient experienced improvement in at least one symptom (eg improvement in skin, oral mucosal, ocular, or GI symptoms)
maintenance dosing: Dose up to 10 mg/kg IV; doses administered no more frequently than once weekly (as authorized)

Continuation criteria - Hidradenitis Suppurativa

established duration: Patient has been established on therapy for at least 3 months
objective response: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (eg Hurley staging, Sartorius score, PGA, HS Severity Index)
symptom improvement: Compared with baseline, patient experienced improvement in at least one symptom (eg decreased pain or drainage)
maintenance dosing: Approve up to a maximum dose of 10 mg/kg IV no more frequently than once every 4 weeks

Continuation criteria - Immunotherapy-Related Toxicities

established duration: Patient has been established on therapy for at least 6 months
response requirement
- objective measure: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (eg improvement/normalization of CRP, ESR, fecal markers, reduced corticosteroid dose)
- symptom improvement: Compared with baseline, patient experienced improvement in at least one symptom relevant to organ involved
maintenance dosing: Approve up to a maximum dose of 10 mg/kg IV no more frequently than once every 4 weeks

Continuation criteria - Indeterminate Colitis

established duration: Patient has been established on therapy for at least 6 months
response requirement
- objective measure: Beneficial clinical response by at least one objective measure (eg fecal markers, CRP, endoscopic assessment, reduced corticosteroid dose)
- symptom improvement: Compared with baseline, patient experienced improvement in at least one symptom (decreased pain, fatigue, stool frequency, rectal bleeding)
maintenance dosing: Approve up to a maximum dose of 10 mg/kg IV no more frequently than once every 4 weeks

Across indications the policy defines a 'beneficial clinical response' consistently as meeting BOTH: 1) objective improvement on at least one disease‑specific measure from baseline, and 2) improvement in at least one relevant symptom compared with baseline. Examples of objective measures by organ/system include: musculoskeletal — ASDAS, BASDAI, BASFI, DAPSA, CPDAI, DAS28, CDAI, RAPID‑3, SDAI; gastrointestinal — fecal lactoferrin, fecal calprotectin, CRP, MRE/CTE, endoscopic assessment; dermatologic — estimated body surface area, erythema/induration/scale, Hurley staging, Sartorius score, Physician Global Assessment; ocular/ophthalmic — best‑corrected visual acuity, anterior chamber cell grade, vitreous haze grade, chorioretinal/retinal lesion assessments; pulmonary/cardiac/neurologic/systems — lung function (predicted FVC, 6‑minute walk), serum markers (CRP, ESR, LFTs, NT‑proBNP), imaging (chest radiograph, MRI, echocardiography); hematologic/ GVHD examples — normalization of LFTs, RBC/platelet counts, resolution of fever or rash.

Higher induction dosing (e.g., 10 mg/kg) or alternative dosing schedules when supported by labeling, clinical trial evidence, or specialist rationale (documented).

Higher induction dosing (e.g., 10 mg/kg) or alternative schedules when supported by labeling and documented specialist rationale.