CurrentCignaPolicy IP0660

Infliximab Intravenous Products Prior Authorization Policy

Defines medical necessity criteria, dosing, durations, prescribing specialist requirements, and not-covered uses for infliximab intravenous products across multiple indications (indeterminate colitis, juvenile idiopathic arthritis, pyoderma gangrenosum, sarcoidosis, scleritis/sterile corneal ulceration, spondyloarthritis other subtypes, Still's disease, uveitis, etc.). Also lists HCPCS/HCPCS-like codes for infliximab and biosimilars and appendix of biologics.

Policy Summary

PayerCigna

PolicyInfliximab Intravenous Products Prior Authorization Policy

Policy CodePolicy IP0660

Change TypeNew policy (11/01/2024) with subsequent annual and selected revisions

Effective Date09/01/2025

Next Review Date

Key ActionProviders must document prior trials of specified medications, patient age, specialty prescribing/consultation, and objective measures or symptom improvement when requesting continuation.

POLICY UPDATE CHANGES

New policy created with Date = 11/01/2024.

Annual Revision 02/15/2025: Immunotherapy-Related Toxicities examples updated (myalgia and myositis removed).

Selected Revision 09/01/2025: Ulcerative Colitis initial therapy options removed (specific options listed).

9Indications with explicit criteria in this part

4Typical initial approval durations (months)

12Maximum continuation approval (months) listed as 12

Coverage policy number

Coverage Summary

Infliximab intravenous products (Remicade and biosimilars): Coverage Policy IP0660 — CURRENT. Defines medical necessity criteria, dosing, approval durations, specialty prescribing or consultation requirements, and not-covered uses for infliximab intravenous products across multiple inflammatory indications. Policy effective/created 11/01/2024 with subsequent revisions (most recent listed 09/01/2025).

Key thresholds and counts

Established on therapy duration thresholdsVaries by indication: typically ≥3–6 months (examples: indeterminate colitis 6 months; JIA 6 months; pyoderma gangrenosum 4 months; sarcoidosis 3 months; scleritis 6 months; spondyloarthritis 6 months; Still's disease 6 months; uveitis 6 months)

Indications with explicit criteria in this part9

Typical initial approval duration (months)4

Maximum continuation approval (months)12

Objective sign for axial spondyloarthritisElevated CRP or sacroiliitis reported on MRI

Medical‑Necessity Criteria (by indication)

Indeterminate colitis

Approve for 6 months if the patient meets ALL of the following (i, ii, iii, iv, and v):

ALL of the following

Patient is ≥ 6 years of age.
Patient has tried one systemic corticosteroid.
Examples include prednisone and methylprednisolone.
Patient has tried mesalamine.
Patient has tried either azathioprine or 6-mercaptopurine.

Coding

Considered Medically Necessary HCPCS CodesHCPCSCovered

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.

Provider Actions & Billing Impact

Prior Authorization

Prior authorization required with indication-specific criteria

Approval durations and requirements are indication-specific; providers must document prior trials of specified medications, patient age, specialty prescribing/consultation, and objective measures or symptom improvement when requesting continuation.

J1745
Q5103
Q5104
Q5121

Documentation Required

Document objective response for continuation

For patients currently receiving infliximab, document objective measures or symptomatic improvement from baseline to qualify for 1-year approvals; examples listed per indication must be provided.

Background, Evidence & Definitions

Policy provides indication-specific medical necessity criteria and weight-based dosing for infliximab intravenous products and biosimilars. Indication-specific requirements include patient age thresholds, required prior therapies (for example, trials of corticosteroids, mesalamine, azathioprine/6-mercaptopurine for indeterminate colitis; conventional synthetic DMARDs or other systemic medications for rheumatologic and dermatologic conditions), and specialty prescribing or consultation (e.g., gastroenterologist, rheumatologist, dermatologist, ophthalmologist, pulmonologist, oncologist) for initial approvals. Continuation approvals require documentation of being established on therapy for the policy-specified minimum duration (typically 3–6 months depending on indication) and evidence of clinical benefit by at least one objective measure or symptomatic improvement. Receipt of sample product does not satisfy criteria for coverage.

Evidence and guidance cited include the primary manufacturer prescribing information (Infliximab prescribing information, Janssen Oct 2021; Inflectra 2021; Renflexis 2023) and multiple society clinical guidelines and reviews (e.g., ACR, AGA/ACG, AAD/NPF, ERS, NCCN, AAO) that inform use of TNF inhibitors across the listed indications.

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

Revision History

11/01/2024policy_added

New policy created (policy new as of 11/01/2024).

02/15/2025annual_revision_non-material

Annual revision: Immunotherapy-Related Toxicities examples updated — myalgia and myositis were removed from the examples of immunotherapy-related toxicities associated with checkpoint inhibitor therapy.

09/01/2025selected_revision_materialLatest

Selected revision: Ulcerative Colitis initial therapy options removed — for initial therapy, removed the options: (1) the patient has tried one systemic therapy; (2) the patient has pouchitis and tried an antibiotic, probiotic, corticosteroid enema, or mesalamine enema.

Policy Summary

PayerCigna

PolicyInfliximab Intravenous Products Prior Authorization Policy

Policy CodePolicy IP0660

Change TypeNew policy (11/01/2024) with subsequent annual and selected revisions

Effective Date09/01/2025

Next Review Date

Key ActionProviders must document prior trials of specified medications, patient age, specialty prescribing/consultation, and objective measures or symptom improvement when requesting continuation.

On This Page

The medication is prescribed by or in consultation with a gastroenterologist.

Indeterminate colitis — Patient Currently Receiving an Infliximab Product

Approve for 1 year if the patient meets BOTH of the following (i and ii):

ALL of the following

Patient has been established on therapy for at least 6 months.
A patient who has received < 6 months of therapy or who is restarting therapy with an infliximab product is reviewed under Initial Therapy.
at least ONE of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating an infliximab product).
  Examples: fecal markers (e.g., fecal calprotectin), serum markers (e.g., C-reactive protein), endoscopic assessment, and/or reduced dose of corticosteroids.
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or rectal bleeding).

Juvenile Idiopathic Arthritis (JIA) — Initial Therapy

Approve for 6 months if the patient meets ALL of the following (i, ii, and iii):

ALL of the following

Patient is > 6 years of age.
ONE of
- Patient has tried one other systemic medication for this condition.
  Examples: methotrexate, sulfasalazine, leflunomide, NSAIDs. A previous trial of one biologic other than the requested medication also counts; a biosimilar of the requested biologic does not count.
- Patient has aggressive disease, as determined by the prescriber.
The medication is prescribed by or in consultation with a rheumatologist.

JIA — Patient Currently Receiving an Infliximab Product

Approve for 1 year if the patient meets BOTH of the following (i and ii):

ALL of the following

Patient has been established on therapy for at least 6 months.
A patient who has received < 6 months of therapy or who is restarting therapy with an infliximab product is reviewed under Initial Therapy.
at least ONE of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating an infliximab product).
  Examples: Physician Global Assessment, Parent/Patient Global Assessment, JADAS, cJADAS, JSpADA, serum markers (CRP, ESR), and/or reduced dosage of corticosteroids.
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., improved limitation of motion, less joint pain or tenderness, decreased duration of morning stiffness or fatigue, or improved function/ADLs).

Pyoderma Gangrenosum — Initial Therapy

Approve for 4 months if the patient meets ALL of the following (i, ii, and iii):

ALL of the following

Patient is > 18 years of age.
ONE of
- Patient has tried one systemic corticosteroid.
  Examples include prednisone and methylprednisolone.
- Patient has tried one other immunosuppressant for at least 2 months or was intolerant to one of these medications.
  Examples include mycophenolate mofetil and cyclosporine.
The medication is prescribed by or in consultation with a dermatologist.

Pyoderma Gangrenosum — Patient Currently Receiving an Infliximab Product

Approve for 1 year if the patient meets ALL of the following (i, ii, and iii):

ALL of the following

Patient has been established on therapy for at least 4 months.
A patient who has received < 4 months of therapy or who is restarting therapy with an infliximab product is reviewed under Initial Therapy.
Patient experienced a beneficial clinical response, defined as improvement from baseline in at least one of: size, depth, and/or number of lesions.
Compared with baseline, patient experienced an improvement in at least one symptom, such as decreased pain and/or tenderness of affected lesions.

Sarcoidosis — Initial Therapy

Approve for 3 months if the patient meets ALL of the following (i, ii, iii, and iv):

ALL of the following

Patient is > 18 years of age.
Patient has tried at least one corticosteroid.
Examples include prednisone and methylprednisolone.
Patient has tried at least one immunosuppressive medication.
Examples include methotrexate, azathioprine, leflunomide, mycophenolate mofetil, hydroxychloroquine, or chloroquine.
The medication is prescribed by or in consultation with a pulmonologist, ophthalmologist, cardiologist, neurologist, or dermatologist.

Sarcoidosis — Patient Currently Receiving an Infliximab Product

Approve for 1 year if the patient meets ALL of the following (i, ii, and iii):

ALL of the following

Patient has been established on therapy for at least 3 months.
A patient who has received < 3 months of therapy or who is restarting therapy with an infliximab product is reviewed under Initial Therapy.
When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (organ-dependent).
Examples: lung function (predicted FVC, 6-minute walk distance), serum markers (CRP, liver enzymes, NT-proBNP), improvement in rash/skin, neurologic symptoms, rhythm control, or imaging (CXR, MRI, echocardiography).
Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased cough, fatigue, pain, palpitations, neurologic symptoms, and/or shortness of breath).

Scleritis or Sterile Corneal Ulceration — Initial Therapy

Approve for 6 months if the patient meets ALL of the following (i, ii, and iii):

ALL of the following

Patient is > 18 years of age.
Patient has tried one other therapy for this condition.
Examples include oral NSAIDs (indomethacin), oral/topical/IV corticosteroids, methotrexate, cyclosporine, or other immunosuppressants.
The medication is prescribed by or in consultation with an ophthalmologist.

Scleritis or Sterile Corneal Ulceration — Patient Currently Receiving an Infliximab Product

Approve for 1 year if the patient meets BOTH of the following (i and ii):

ALL of the following

Patient has been established on therapy for at least 6 months.
A patient who has received < 6 months of therapy or who is restarting therapy with an infliximab product is reviewed under Initial Therapy.
at least ONE of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline.
  Examples: serum markers (CRP, ESR).
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased eye pain, redness, light sensitivity, tearing, and/or improvement in visual acuity).

Spondyloarthritis, Other Subtypes — Initial Therapy

Approve for 6 months if the patient meets ALL of the following (i, ii, and iii):

ALL of the following

Patient is > 18 years of age.
ONE of
- Patient has arthritis primarily in the knees, ankles, elbows, wrists, hands, and/or feet AND has tried at least ONE conventional synthetic DMARD.
  Examples: methotrexate, leflunomide, sulfasalazine.
- Patient has axial spondyloarthritis with objective signs of inflammation, defined as at least one of: (1) elevated CRP; OR (2) sacroiliitis reported on MRI.
The medication is prescribed by or in consultation with a rheumatologist.

Spondyloarthritis — Patient Currently Receiving an Infliximab Product

Approve for 1 year if the patient meets BOTH of the following (i and ii):

ALL of the following

Patient has been established on therapy for at least 6 months.
A patient who has received < 6 months of therapy or who is restarting therapy with an infliximab product is reviewed under Initial Therapy.
at least ONE of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline.
  Examples: ASDAS and/or serum markers (CRP, ESR).
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, or improved function/ADLs).

Still's Disease — Initial Therapy

Approve for 6 months if the patient meets ALL of the following (i, ii, iii, and iv):

ALL of the following

Patient is > 18 years of age.
Patient has tried one corticosteroid.
Examples include prednisone and methylprednisolone.
Patient has tried one conventional synthetic DMARD given for at least 2 months or was intolerant.
Example: methotrexate. A previous trial of one biologic other than the requested drug also counts; a biosimilar of the requested biologic does not count.
The medication is prescribed by or in consultation with a rheumatologist.

Still's Disease — Patient Currently Receiving an Infliximab Product

Approve for 1 year if the patient meets BOTH of the following (i and ii):

ALL of the following

Patient has been established on this medication for at least 6 months.
A patient who has received < 6 months of therapy or who is restarting therapy with an infliximab product is reviewed under Initial Therapy.
at least ONE of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline.
  Examples: resolution of fever, improvement in rash, normalization of serum markers (CRP, ESR), and/or reduced corticosteroid dosage.
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., less joint pain/tenderness, stiffness, swelling; decreased fatigue; improved function/ADLs).

Uveitis — Initial Therapy

Approve for 6 months if the patient meets ALL of the following (i, ii, and iii):

ALL of the following

Patient is > 6 years of age.
Patient has tried one of the following therapies: periocular, intraocular, or systemic corticosteroids, or immunosuppressives.
Examples of corticosteroids: prednisolone, triamcinolone, betamethasone, methylprednisolone, prednisone. Examples of immunosuppressives: methotrexate, mycophenolate mofetil, cyclosporine. Exception: prior trial of etanercept or adalimumab for uveitis may allow exemption; a patient who has already tried one biologic other than the requested medication also counts. A biosimilar of the requested biologic does not count.
The medication is prescribed by or in consultation with an ophthalmologist.

Uveitis — Patient Currently Receiving an Infliximab Product

Approve for 1 year if the patient meets BOTH of the following (i and ii):

ALL of the following

Patient has been established on therapy for at least 6 months.
A patient who has received < 6 months of therapy or who is restarting therapy with an infliximab product is reviewed under Initial Therapy.
at least ONE of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline.
  Examples: best-corrected visual acuity, assessment of chorioretinal/inflammatory retinal vascular lesions, anterior chamber cell grade, vitreous haze grade.
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased eye pain, redness, light sensitivity, blurred vision; or improved visual acuity).

Indeterminate colitis: fecal calprotectin, CRP, endoscopic assessment, reduced corticosteroid dose
JIA: Physician Global Assessment, Parent/Patient Global Assessment, JADAS/cJADAS/JSpADA, CRP or ESR, reduced corticosteroid dose
Crohn's disease/Ulcerative colitis: fecal markers (fecal calprotectin), CRP, imaging (MRE/CTE), endoscopy
Organ-dependent examples: imaging (CXR, MRI, echocardiography), lung function, visual acuity, disease activity scores

Billing Rule

Dose and frequency limits

Initial dosing and maintenance frequency are specified by indication; examples include weight-based regimens with induction doses at baseline, 2 and 6 weeks, then maintenance at intervals not more frequent than every 6–8 weeks for many indications, and continuation maximum dosing rules allowing up to 10 mg/kg given no more frequently than every 4 weeks for patients currently receiving therapy; some indications allow higher initial or more frequent dosing (e.g., immunotherapy-related toxicities, uveitis, scleritis dosing options).

Typical induction: 5 mg/kg (or 6 mg/kg for certain indications) IV at 0, 2, and 6 weeks
Maintenance: usually every 6–8 weeks thereafter (varies by indication: some specify every 6 weeks, others every 8 weeks)
Established-on-therapy continuation maximum: up to 10 mg/kg IV no more frequently than once every 4 weeks
Immunotherapy-related toxicities and some ocular/ophthalmic indications may specify up to 10 mg/kg induction and maintenance no more frequently than every 4 weeks

Denial Risk

Not medically necessary for other uses and combination biologic therapy

Infliximab IV products are considered not medically necessary for any uses not listed in the policy and should not be administered in combination with another biologic or with a targeted synthetic oral small molecule drug for inflammatory conditions; such combinations may be denied. Receipt of sample product does not satisfy criteria requirements for coverage.

Concurrent use with another biologic or a targeted synthetic oral small molecule drug is not allowed and may lead to denial
Samples of infliximab do not satisfy prior authorization or coverage criteria