CurrentCignaPolicy IP0660

Infliximab Intravenous Products Prior Authorization Policy

Defines prior authorization requirements, clinical criteria, dosing, and approval durations for infliximab intravenous products (Remicade and biosimilars) for FDA-approved and other supported indications across Cigna-administered health plans. Applies to initial and continuation therapy with specialty prescriber/practice requirements and references preferred product management policy for product selection.

Policy Summary

PayerCigna

PolicyInfliximab Intravenous Products Prior Authorization Policy

Policy CodePolicy IP0660

Change TypeSelected & Annual Revisions (03/15/2026)

Effective Date03/15/2026

Next Review Date

Key ActionSubmit prior authorization for any infliximab intravenous product; approval contingent on meeting indication-specific criteria and dosing; initial approvals require specialist prescriber or consultation.

SourceLink

POLICY UPDATE CHANGES

Selected Revision: Crohn's Disease initial therapy options were narrowed by removing multiple prior-therapy options.

Annual Revision: Immunotherapy-Related Toxicities examples updated; myalgia and myositis removed previously; specialists list expanded/modified in subsequent selected revisions.

Policy originally created as new on 11/01/2024.

11Indications listed (FDA-approved and supportive evidence)

6Typical approval durations (months) for initial therapy

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Continuation approval duration (years)

10Dosing regimens described (mg/kg variations and intervals)

8Detailed covered indications described

Coverage Summary & Policy Statement

This prior authorization policy (effective 03/15/2026, last reviewed 03/01/2026) applies to Cigna-administered health plans and covers Remicade (infliximab) and specified biosimilars when the patient meets indication-specific clinical criteria, dosing, and documentation requirements. Prior authorization is required for all infliximab intravenous products; initial approvals must be prescribed by or in consultation with a specialist for the treated condition and continuation approvals generally require objective evidence of benefit or attainment of the condition-specific "established on therapy" duration. Use of preferred infliximab products is required before a non-preferred infliximab product will be approved (see referenced preferred product policy).

Policy Statement - Prior Authorization Requirement

Prior Authorization is required; initial approvals require specialist prescriber or consultation. Preferred product use and dose-exception handling are specified.

Prior Authorization required for benefit coverage of infliximab products.

Initial approval requires infliximab products to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Requests for doses outside of the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

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

FDA-Approved Indications — Initial and Continuation Criteria

FDA-Approved Indications

Approve for the duration noted if patient meets ONE of the following (A or B) per indication.

Ankylosing Spondylitis

A) Initial Therapy (Approve for 6 months)
- Patient is > 18 years of age
- Medication is prescribed by or in consultation with a rheumatologist
B) Currently Receiving an Infliximab Product (Approve for 1 year)
- Patient has been established on therapy for at least 6 months
  A patient who has received < 6 months or is restarting is reviewed under criterion A

Other Uses with Supportive Evidence — Criteria

Other Uses with Supportive Evidence

Approvals allowed for specified conditions with stated initial and continuation criteria and durations.

Behcet's Disease

A) Initial Therapy (Approve for 3 months)
- Patient is > 6 years of age
- Patient has tried at least ONE conventional therapy (examples: systemic corticosteroids, immunosuppressants such as azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, chlorambucil, cyclophosphamide, interferon alfa). Exception if patient already had trial of at least one TNF inhibitor OR patient has ophthalmic manifestations of Behcet's disease.
  A biosimilar of requested biologic does not count
- Medication is prescribed by or in consultation with a rheumatologist, dermatologist, ophthalmologist, gastroenterologist, or neurologist

Additional Indications (JIA, Pyoderma Gangrenosum, Sarcoidosis, Scleritis, Spondyloarthritis, Uveitis)

Crohn's disease; Juvenile Idiopathic Arthritis (JIA); Pyoderma Gangrenosum; Sarcoidosis; Scleritis or Sterile Corneal Ulceration; Spondyloarthritis, Other Subtypes; Uveitis; and Immunotherapy-Related Toxicities Summary

Approve when ONE of the following (A or B) is met:

Crohn's disease

A) Initial Therapy (approve 6 months)
- Patient is ≥ 6 years of age
- Patient has tried at least ONE conventional therapy (examples: systemic corticosteroids, immunosuppressants such as azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, chlorambucil, cyclophosphamide, interferon alfa). Exception if patient already had trial of at least one TNF inhibitor.
- Medication is prescribed by or in consultation with a gastroenterologist

Provider Actions & Required Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for all requests for any infliximab intravenous product (including branded and biosimilar agents). Submit a PA for the specific infliximab IV product being requested. A specialist prescriber is required for approval based on the indication (e.g., rheumatologist, gastroenterologist, dermatologist, or other appropriate specialist); consultation notes or documentation from the specialist must be included with the request.

Applies to all infliximab IV products (brand and biosimilar)
Include specialist prescriber name and specialty (e.g., rheumatology, gastroenterology, dermatology) or documentation of specialist consultation
Submit completed PA application and all supporting documentation prior to therapy initiation

Documentation Required

Objective Measures and Baseline Documentation

Applicable Codes

Considered Medically Necessary when criteria metHCPCSCovered

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.

Infliximab products referencedmixed

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

Infliximab products referencedmixed

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

Dosing Thresholds & Limits

Clinical Evidence & Regulatory Context

Infliximab products are tumor necrosis factor inhibitors (TNFis) approved across multiple inflammatory conditions and are included in specialty society treatment guidelines for many of those indications.

Biosimilars Avsola, Inflectra, and Renflexis have been approved as biosimilars to Remicade but are not designated as interchangeable with the reference product.

Clinical guideline recommendations reflect prominent roles for TNFis in conditions such as ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic disease, rheumatoid arthritis, and others; specialty societies recommend TNFi use in many of the listed conditions either as first-line advanced therapy or as subsequent therapy depending on disease and prior treatment.

Dosing is weight-based and may be adjusted (increased dose or shortened interval) for patients who initially respond and then lose response; dosing regimens and escalation options vary by indication.

Biosimilarity statement: Avsola, Inflectra, and Renflexis were approved as biosimilars to Remicade, demonstrating no clinically meaningful differences in safety and effectiveness but not demonstrating interchangeability.

Cited prescribing information: Remicade (Janssen) prescribing information dated October 2021; Inflectra prescribing information dated September 2025; Renflexis prescribing information dated October 2025.

Definitions

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

Established on therapy: Patient has been receiving the infliximab product for the minimum condition-specific duration listed (e.g., 3–6 months) prior to continuation review.

Objective measure: A quantifiable clinical test or assessment (e.g., lab markers, imaging, endoscopy, validated disease activity scores) demonstrating response compared with baseline.

Policy Revision History

2024-11-01added

Policy originally created as new on 11/01/2024.

2025-02-15revised

Annual Revision: Immunotherapy-Related Toxicities examples updated; myalgia and myositis removed from examples.

2025-09-01revised

Selected Revision: Ulcerative Colitis initial therapy approval options were narrowed by removing specified initial approval options.

Policy Summary

PayerCigna

PolicyInfliximab Intravenous Products Prior Authorization Policy

Policy CodePolicy IP0660

Change TypeSelected & Annual Revisions (03/15/2026)

Effective Date03/15/2026

Next Review Date

SourceLink

On This Page

Beneficial response measures: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, serum markers [CRP, ESR]) OR compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function/ADLs).

Crohn's Disease

A) Initial Therapy (Approve for 6 months)
- Patient is ≥ 6 years of age
- Medication is prescribed by or in consultation with a gastroenterologist
B) Currently Receiving an Infliximab Product (Approve for 1 year)
- Patient has been established on therapy for at least 6 months
  A patient who has received < 6 months or is restarting is reviewed under criterion A
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal markers [fecal lactoferrin, fecal calprotectin], serum markers [CRP], imaging [MRE, CTE], endoscopic assessment, and/or reduced dose of corticosteroids) OR compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool).

Plaque Psoriasis

A) Initial Therapy (Approve for 3 months)
- Patient is ≥ 18 years of age
- Prior therapy requirement: Patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant (examples: methotrexate, cyclosporine, acitretin; 3-month PUVA counts). A biosimilar of requested biologic does not count. Exception if patient already had 3-month trial or intolerance to at least one biologic other than requested medication, Otezla, or Sotyktu; OR according to the prescriber, the patient has a contraindication to methotrexate.
- Medication is prescribed by or in consultation with a dermatologist
B) Currently Receiving an Infliximab Product (Approve for 1 year)
- Patient has been established on therapy for at least 3 months
  A patient who has received < 3 months or is restarting is reviewed under criterion A
- Patient experienced a beneficial clinical response (improvement from baseline in at least one of: estimated body surface area affected, erythema, induration/thickness, and/or scale) and improvement in at least one symptom (e.g., decreased pain, itching, burning)

Psoriatic Arthritis

A) Initial Therapy (Approve for 6 months)
- Patient is > 18 years of age
- Medication is prescribed by or in consultation with a rheumatologist or a dermatologist
B) Currently Receiving an Infliximab Product (Approve for 1 year)
- Patient has been established on therapy for at least 6 months
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument Score, MDA, PsAID-12, serum markers [CRP, ESR]) OR compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue; improved function/ADLs)

Rheumatoid Arthritis

A) Initial Therapy (Approve for 6 months)
- Patient is > 18 years of age
- Patient has tried ONE conventional synthetic DMARD for at least 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). Exception if patient already had 3-month trial of at least one biologic other than requested medication.
- Medication is prescribed by or in consultation with a rheumatologist
B) Currently Receiving an Infliximab Product (Approve for 1 year)
- Patient has been established on therapy for at least 6 months
- Patient experienced a beneficial clinical response when assessed by at least one objective measure (examples: CDAI, DAS28 [ESR or CRP], PAS-II, RAPID-3, SDAI) OR patient experienced improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue; improved function/ADLs)

Ulcerative Colitis

A) Initial Therapy (Approve for 6 months)
- Patient is ≥ 6 years of age
- Medication is prescribed by or in consultation with a gastroenterologist
B) Currently Receiving an Infliximab Product (Approve for 1 year)
- Patient has been established on therapy for at least 6 months
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal markers [fecal calprotectin], serum markers [CRP], endoscopic assessment, and/or reduced dose of corticosteroids) OR compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or rectal bleeding).

B) Currently Receiving (Approve for 1 year)

Patient has been established on therapy for at least 3 months
When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples depend on organ involvement; e.g., best-corrected visual acuity, serum markers [CRP, ESR], ulcer depth/number/size)
Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or improved visual acuity if ophthalmic manifestations)

Graft-Versus-Host Disease (GVHD)

A) Initial Therapy (Approve for 1 month)
- Patient is > 6 years of age
- Patient has acute graft-versus-host disease
- Patient has tried at least one systemic medication for GVHD (examples: corticosteroids, antithymocyte globulin, cyclosporine, tacrolimus, mycophenolate mofetil, ruxolitinib, basiliximab, etanercept, sirolimus, pentostatin, tocilizumab, vedolizumab)
- Medication is prescribed by or in consultation with an oncologist, hematologist, or physician affiliated with a transplant center
B) Currently Receiving (Approve for 3 months)
- Patient has been established on an infliximab product for at least 1 month
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: normalization of LFTs, RBC count, platelet count, or resolution of fever or rash) OR compared with baseline, patient experienced improvement in at least one symptom (e.g., improvement in skin, oral mucosal, ocular, or GI symptoms)

Hidradenitis Suppurativa

A) Initial Therapy (Approve for 3 months)
- Patient is > 18 years of age
- Patient has tried one other therapy (examples: intralesional or oral corticosteroids, systemic antibiotics, isotretinoin)
- Medication is prescribed by or in consultation with a dermatologist
B) Currently Receiving (Approve for 1 year)
- Patient has been established on therapy for at least 3 months
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: Hurley staging, Sartorius score, Physician Global Assessment, Hidradenitis Suppurativa Severity Index)
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or drainage of lesions, nodules, or cysts)

Immunotherapy-Related Toxicities Associated with Checkpoint Inhibitor Therapy

A) Initial Therapy (Approve for 6 months)
- Patient is > 18 years of age
- According to the prescriber, patient developed an immunotherapy-related toxicity other than hepatitis while receiving a checkpoint inhibitor (examples: pembrolizumab, nivolumab, ipilimumab, atezolizumab, avelumab, durvalumab)
- Patient has tried one systemic corticosteroid (examples: methylprednisolone, prednisone)
- Medication is prescribed by or in consultation with an oncologist, cardiologist, gastroenterologist, hematologist, nephrologist, pulmonologist, rheumatologist, or ophthalmologist
B) Currently Receiving (Approve for 1 year)
- Patient has been established on therapy for at least 6 months
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples depend on organ involvement: clinically significant improvement/normalization of serum markers [CRP, ESR], fecal markers [fecal calprotectin], and/or reduced corticosteroid dose) OR compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain/tenderness, stiffness or swelling; stool frequency/rectal bleeding; improved function/ADLs)

Indeterminate Colitis

A) Initial Therapy (Approve for 6 months)
- Patient is ≥ 6 years of age
- Patient has tried one systemic corticosteroid (examples: prednisone, methylprednisolone)
- Patient has tried mesalamine
- Patient has tried either azathioprine or 6-mercaptopurine
- Medication is prescribed by or in consultation with a gastroenterologist
B) Currently Receiving an Infliximab Product (Approve for 1 year)
- Patient has been established on therapy for at least 6 months
  Patients with <6 months or restarting are reviewed under criterion A
- At least ONE of: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal markers [fecal calprotectin], serum markers [CRP], endoscopic assessment, and/or reduced corticosteroid dose) OR compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or rectal bleeding).

B) Patient is Currently Receiving an Infliximab Product (approve 1 year)

Patient has been established on therapy for at least 6 months
Patients with <6 months or restarting are reviewed under criterion A
At least ONE of: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include fecal markers, serum markers, imaging, endoscopy) OR compared with baseline, patient experienced improvement in at least one symptom such as decreased pain, fatigue, stool frequency, and/or rectal bleeding.

Juvenile Idiopathic Arthritis (JIA)

A) Initial Therapy (approve 6 months)
- Patient is > 6 years of age
- One of: Patient has tried one other systemic medication for this condition (examples: methotrexate, sulfasalazine, leflunomide, NSAIDs) OR patient has aggressive disease as determined by prescriber. A previous trial of one biologic other than requested medication counts; a biosimilar does not count.
- Medication is prescribed by or in consultation with a rheumatologist
B) Patient is Currently Receiving an Infliximab Product (approve 1 year)
- Patient has been established on therapy for at least 6 months
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: Physician Global Assessment, Parent/Patient Global Assessments, JDAS, cJDAS, JSpADA, serum markers [CRP, ESR], and/or reduced corticosteroid dose) OR compared with baseline, patient experienced improvement in at least one symptom (e.g., improved motion, less joint pain/tenderness, decreased morning stiffness or fatigue, improved function/ADLs).

Pyoderma Gangrenosum

A) Initial Therapy (approve 4 months)
- Patient is > 18 years of age
- Patient has tried one systemic corticosteroid (examples: prednisone, methylprednisolone) OR patient has tried one other immunosuppressant for at least 2 months or was intolerant (examples: mycophenolate mofetil, cyclosporine)
- Medication is prescribed by or in consultation with a dermatologist
B) Patient is Currently Receiving an Infliximab Product (approve 1 year)
- Patient has been established on therapy for at least 4 months
- 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

A) Initial Therapy (approve 3 months)
- Patient is > 18 years of age
- Patient has tried at least one corticosteroid (examples: prednisone, methylprednisolone)
- Patient has tried at least one immunosuppressive medication (examples: methotrexate, azathioprine, leflunomide, mycophenolate mofetil, hydroxychloroquine, or chloroquine)
- Medication is prescribed by or in consultation with a pulmonologist, ophthalmologist, cardiologist, neurologist, or dermatologist
B) Patient is Currently Receiving an Infliximab Product (approve 1 year)
- Patient has been established on therapy for at least 3 months
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples depend on organ involvement: lung function, serum markers, improvement in rash/neurologic symptoms, or imaging)
- Compared with baseline, patient experienced 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

A) Initial Therapy (approve 6 months)
- Patient is > 18 years of age
- Patient has tried one other therapy for this condition (examples: oral NSAIDs, oral/topical/IV corticosteroids, methotrexate, cyclosporine, or other immunosuppressants)
- Medication is prescribed by or in consultation with an ophthalmologist
B) Patient is Currently Receiving an Infliximab Product (approve 1 year)
- Patient has been established on therapy for at least 6 months
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: serum markers [CRP, ESR]) OR compared with baseline, patient experienced improvement in at least one symptom (decreased eye pain, redness, light sensitivity, tearing, and/or improved visual acuity)

Spondyloarthritis, Other Subtypes

A) Initial Therapy (approve 6 months)
- One of: Patient is > 18 years of age AND (patient has arthritis primarily in peripheral joints AND has tried at least ONE conventional synthetic DMARD OR patient has axial spondyloarthritis with objective signs of inflammation defined as elevated CRP OR sacroiliitis on MRI)
- Medication is prescribed by or in consultation with a rheumatologist
B) Patient is Currently Receiving an Infliximab Product (approve 1 year)
- Patient has been established on therapy for at least 6 months
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: ASDAS and/or serum markers [CRP, ESR]) OR compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function/ADLs)

Uveitis

A) Initial Therapy (approve 6 months)
- Patient is > 6 years of age
- Patient has tried periocular, intraocular, or systemic corticosteroids, or immunosuppressives (examples: prednisolone, triamcinolone, betamethasone, methylprednisolone, prednisone; methotrexate, mycophenolate mofetil, cyclosporine). Exception: prior trial of an etanercept or adalimumab product or one biologic other than requested medication counts; a biosimilar does not count.
- Medication is prescribed by or in consultation with an ophthalmologist
B) Patient is Currently Receiving an Infliximab Product (approve 1 year)
- Patient has been established on therapy for at least 6 months
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: best-corrected visual acuity, chorioretinal/inflammatory retinal lesion assessment, anterior chamber cell grade or vitreous haze) OR compared with baseline, patient experienced improvement in at least one symptom (decreased eye pain, redness, light sensitivity, blurred vision, or improved visual acuity)

Immunotherapy-Related summary: Established-on-therapy durations and approval lengths vary by condition (typically initial approvals 1-6 months per condition; continuation approvals generally 1 year) and require documentation of objective beneficial response or symptom improvement compared with baseline for continuation reviews.

See condition-specific established-on-therapy durations in policy (Crohn's: ≥6 months; JIA: ≥6 months; Pyoderma gangrenosum: ≥4 months; Sarcoidosis: ≥3 months; Scleritis: ≥6 months; Spondyloarthritis: ≥6 months; Uveitis: ≥6 months).

Document objective measures at baseline and provide comparisons for continuation approvals. Objective evidence should demonstrate disease activity, response to therapy, or treatment failure as applicable to the indication.

Examples for inflammatory bowel disease: baseline and follow-up clinical assessment (e.g., Harvey‑Bradshaw Index, partial Mayo score), endoscopic findings, fecal calprotectin, CRP, and steroid use or tapering
Examples for rheumatoid arthritis/psoriatic arthritis/ankylosing spondylitis: baseline and follow-up joint counts, validated disease activity scores (e.g., DAS28, CDAI, BASDAI), imaging when relevant, and functional assessments
Examples for plaque psoriasis: baseline and follow-up body surface area (BSA), Psoriasis Area and Severity Index (PASI) or Physician Global Assessment (PGA)
Examples for other indications (e.g., uveitis, hidradenitis suppurativa, GVHD): disease-specific objective measures, imaging, ophthalmology notes, or specialist assessments

Documentation Required

Document objective measures and baseline comparisons

For continuation of therapy, submit documentation of initial response compared to baseline objective measures and rationale for ongoing therapy (e.g., improvement in validated scores, decreased steroid dependence, healing on endoscopy).

State baseline measure(s) and most recent measure(s) with dates to allow comparison
Include information on prior therapies tried and reason for discontinuation or inadequate response
If dose escalation or interval shortening is requested, provide objective evidence supporting the need

Billing Rule

Dose Exceptions

Requests for doses or dosing schedules outside the established product-specific dosing in the prescribing information will be reviewed on a case-by-case basis by a Cigna clinician. Provide clinical justification and supporting objective data when requesting dose exceptions.

Dose exceptions are reviewed individually and require clear justification
Include prior dosing history, response, adverse events, and objective measures supporting the change

Prior Authorization

Preferred Product Requirement

Preferred infliximab products must be used per the PSM005 preferred product list where applicable before approval of a non-preferred infliximab product, unless there is a documented medical reason not to use the preferred product(s).

Refer to policy PSM005 for the current preferred infliximab products and step requirements
Document clinical rationale for requesting a non-preferred product (e.g., prior intolerance, formulation availability, or other medical necessity)

Billing Rule

Use appropriate HCPCS code for product administered

Use the appropriate HCPCS/ billing code for the specific infliximab product administered. Include the correct code on the claim to reflect the product actually given.

J1745 - Infliximab, 10 mg
Q5103 - Infliximab‑axxq (Avsola) biosimilar, specific billing guidance as applicable
Q5104 - Infliximab‑dyyb (Inflectra) biosimilar, specific billing guidance as applicable
Q5121 - Infliximab‑abda (Renflexis) biosimilar, specific billing guidance as applicable

Denial Risk

Not medically necessary for other uses

Requests for uses not listed in the coverage criteria, or requests for concurrent use of another biologic or targeted synthetic DMARD when not supported by the policy, are likely to be denied as not medically necessary.

Therapy for indications not meeting the listed criteria may be denied
Concurrent use of multiple biologic or targeted synthetic DMARD therapies is not supported unless explicitly allowed and justified

2025-10-15revised

Selected Revision: Graft-versus-Host Disease initial approval criteria modified to require acute GVHD and updated examples of prior systemic medications.

2026-01-01revised

Selected Revision(s) and Annual Revision: miscellaneous updates including specialist and example adjustments (01/01/2026 and 03/01/2026 noted as revision dates).

2026-03-15revisedLatest

Selected Revision dated 03/15/2026 removed several initial therapy approval options for Crohn's disease. (Material change)