Cigna prior authorization coverage policy for infliximab intravenous products (Remicade and listed biosimilars) across FDA-approved indications and selected other supported uses, defining initial and continuation criteria, dosing limits, required prescriber specialties, and approval durations. Applies to health benefit plans administered by Cigna Companies with exceptions per specific client plan language.
Change TypeSelected Revision; Annual Revision; New policy
Effective Date03/15/2026
Next Review Date
Key ActionPrior Authorization is required for benefit coverage of infliximab products; approvals granted only when indication-specific criteria and dosing are met.
Selected Revision: Crohn's Disease - removed several initial therapy approval options and other specific criteria changes.
Annual Revision: No criteria changes noted for one review; other prior revisions adjusted examples and specialists and removed specific toxicity examples.
New policy created on 11/01/2024.
11Indications included in part 1
5FDA-approved indications detailed in part 1
6
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.
Other supported uses described (partial list)
9Indications with explicit criteria in this part
1Code group for infliximab/biosimilars
variesApproval durations (months)
Coverage Summary & Scope
Cigna prior authorization coverage policy for infliximab intravenous products including Remicade and listed biosimilars (Avsola, Inflectra, Renflexis), applicable to health benefit plans administered by Cigna Companies. Coverage stance: covered_with_criteria requiring prior authorization with indication-specific initial and continuation criteria, prescriber specialty requirements, and dosing limits. Applies to Cigna plans unless a specific client plan language or exclusion supersedes. Policy metadata: Cigna | Drug Coverage Policy | IP0660 | Effective 2026-03-15.
Initial and Continuation Therapy Criteria (by indication)
General Policy Statement
Prior Authorization is required; approvals provided when Criteria and Dosing are met; initial prescriber specialty requirement applies.
Prior Authorization required for benefit coverage of infliximab products.
Reference: approvals provided when Criteria and Dosing are met; see dosing and specialist requirements in policy.
Initial approval requires prescription by or in consultation with a physician who specializes in the condition being treated.
Requests for doses outside established dosing will be considered case-by-case by a clinician.
Medical Director or Pharmacist review per policy.
Extended approvals allowed if patient continues to meet Criteria and Dosing.
All approvals provided for the duration noted in the policy.
FDA-Approved Indications
Approve when the listed indication-specific criteria and dosing are met.
1. Ankylosing Spondylitis - Initial Therapy: Patient is > 18 years of age; medication is prescribed by or in consultation with a rheumatologist.Approve 6 months
See dosing: initial up to 5 mg/kg at 0,2,6 weeks then no more frequently than every 6 weeks.
1. Ankylosing Spondylitis - Currently Receiving
Response evidence: 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); OR compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function/ADLs).
Examples listed in policy.
2. Crohn's Disease - Initial Therapy:
Other Uses with Supportive Evidence
Selected non-FDA but supported uses with indication-specific criteria and dosing.
7. Behcet's Disease - Initial Therapy: Patient is > 6 years of age; patient has tried at least ONE conventional therapy (examples: systemic corticosteroids, azathioprine, methotrexate, mycophenolate, cyclosporine, tacrolimus, chlorambucil, cyclophosphamide, interferon alfa) OR patient has ophthalmic manifestations of Behcet's disease; medication is prescribed by or in consultation with a rheumatologist, dermatologist, ophthalmologist, gastroenterologist, or neurologist.Approve 3 months
A prior trial of at least one TNFi counts as exception to conventional therapy requirement; biosimilar of requested biologic does not count.
7. Behcet's Disease - Currently Receiving: 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 (organ-dependent measures; examples: best-corrected visual acuity, CRP/ESR, ulcer depth/number/size); AND compared with baseline patient experienced improvement in at least one symptom (e.g., decreased pain or improved visual acuity).Approve 1 year
Patients with <3 months or restarting reviewed under Initial Therapy.
Remaining Indication-Specific Criteria
Render remaining indication-specific sections preserving Initial Therapy and Currently Receiving logic, approval durations, and objective measure examples.
Crohn's disease - A) Initial Therapy: Patient is ≥ 6 years of age; medication is prescribed by or in consultation with a gastroenterologist.Approve 6 months
Initial dosing up to 5 mg/kg at 0,2,6 weeks then maintenance no more frequently than every 8 weeks.
Crohn's disease - B) Currently Receiving: Patient has been established on therapy for at least 6 months; AND patient meets at least ONE of: objective measure response (fecal markers, serum markers, imaging MRE/CTE, endoscopy, reduced corticosteroid dose) OR symptom improvement (decreased pain, fatigue, stool frequency, blood in stool).Approve 1 year
Patients with <6 months or restarting reviewed under Initial Therapy.
Juvenile Idiopathic Arthritis (JIA) - A) Initial Therapy:
Not Medically Necessary / Exclusions
Exclusions / Not Medically Necessary Uses
Exclusions / Not Medically Necessary
Exclusion - Not Medically Necessary: Infliximab IV products are considered not medically necessary for any other uses not meeting the listed policy criteria, including concurrent use with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition.
Requests meeting this exclusion are subject to denial per policy.
Applicable Codes
Infliximab products named in policymixedCovered
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
infliximab intravenous infusion - Janssen/Johnson & Johnson
Renflexis
infliximab-abda intravenous infusion - Samsung Bioepis/Organon (biosimilar to Remicade)
Considered Medically Necessary codes (administration/drug)HCPCSCovered
Prior Authorization is required for benefit coverage of infliximab products. Approvals are granted only when the indication-specific criteria and dosing are met.
Documentation Required
Prescriber specialty requirement
Initial approval requires the infliximab product to be prescribed by or in consultation with a physician who specializes in the condition being treated. Examples of specialists referenced by indication include rheumatologist, gastroenterologist, dermatologist, ophthalmologist, oncologist/hematologist/transplant physician, and neurologist.
Evidence summary: Avsola, Inflectra, and Renflexis were approved as biosimilars to Remicade demonstrating no clinically meaningful differences in safety and effectiveness; only biosimilarity has been demonstrated (not interchangeability). Prescribing information cited includes Janssen infliximab PI (October 2021) and biosimilar PIs dated 2025. Multiple specialty society and clinical practice guidelines are referenced supporting TNFi use across indications, including ACG and AGA (Crohn's/UC), ACR (rheumatology), AAD/NPF and EuroGuiDerm (psoriasis), NCCN (GVHD, immune checkpoint toxicities), ERS (sarcoidosis), and others.
Background & Definitions
Background: Infliximab products are tumor necrosis factor inhibitors (TNFis) approved for multiple inflammatory conditions (e.g., ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis). Several biosimilars to Remicade are available. Specialty society guidelines endorse TNFi use across many of the listed conditions with indication‑specific placement and recommended monitoring; dosing and adjustment guidance is provided per indication.
Key definitions
Key definitions
Established on therapy: Duration thresholds vary by indication (e.g., ≥3 months or ≥6 months) as specified under each indication; patients with less than the threshold or who are restarting are reviewed under Initial Therapy criteria.
See indication-specific sections for exact durations.
Objective measures: Indication-specific validated disease activity scores, laboratory markers (CRP, ESR), fecal markers, imaging, endoscopy, or other measures as exemplified within each indication section.
Multiple prior revisions between 11/01/2024 and 03/01/2026: annual and selected revisions adjusted examples and specialists, removed certain examples of immunotherapy-related toxicities, and noted an annual review with no criteria changes for one review.
03/15/2026revisedLatest
Selected Revision: Crohn's Disease - removed several initial therapy approval options and other specific criteria changes affecting initial therapy criteria.
Change TypeSelected Revision; Annual Revision; New policy
Effective Date03/15/2026
Next Review Date
Key ActionPrior Authorization is required for benefit coverage of infliximab products; approvals granted only when indication-specific criteria and dosing are met.
Patient is ≥ 6 years of age; medication is prescribed by or in consultation with a gastroenterologist.
Approve 6 months
Initial dosing up to 5 mg/kg at 0,2,6 weeks then no more frequently than every 8 weeks.
2. Crohn's Disease - Currently Receiving
Response evidence: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, blood in stool).
Examples listed in policy.
3. Plaque Psoriasis - Initial Therapy: Patient is ≥ 18 years of age; medication is prescribed by or in consultation with a dermatologist; AND patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant, OR according to the prescriber the patient has a contraindication to methotrexate.Approve 3 months
A biosimilar of the requested biologic does not count as prior therapy.
3. Plaque Psoriasis - Currently Receiving: Patient has been established on therapy for at least 3 months; patient experienced a beneficial clinical response defined as improvement in at least one: estimated BSA affected, erythema, induration/thickness, and/or scale; AND compared with baseline patient experienced improvement in at least one symptom (e.g., decreased pain, itching, burning).Approve 1 year
Patients with <3 months or restarting reviewed under Initial Therapy.
4. Psoriatic Arthritis - Initial Therapy: Patient is > 18 years of age; medication is prescribed by or in consultation with a rheumatologist or a dermatologist.Approve 6 months
Initial dosing up to 5 mg/kg at 0,2,6 weeks then maintenance as indicated.
4. Psoriatic Arthritis - Currently Receiving
Response evidence: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR compared with baseline, patient experienced improvement in at least one symptom.
Examples listed in policy.
5. Rheumatoid Arthritis - Initial Therapy: Patient is > 18 years of age; patient has tried ONE conventional synthetic DMARD for at least 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) unless exception applies; medication is prescribed by or in consultation with a rheumatologist.Approve 6 months
Exception if prior 3-month trial of at least one biologic other than requested drug; biosimilar does not count.
5. Rheumatoid Arthritis - Currently Receiving: Patient has been established on therapy for at least 6 months; AND patient experienced a beneficial clinical response when assessed by at least one objective measure (examples: CDAI, DAS28-ESR/CRP, PAS-II, RAPID-3, SDAI) OR improvement in symptoms (decreased joint pain, morning stiffness, fatigue, improved ADLs).Approve 1 year
Patients with <6 months or restarting reviewed under Initial Therapy.
6. Ulcerative Colitis - Initial Therapy: Patient is ≥ 6 years of age; medication is prescribed by or in consultation with a gastroenterologist.Approve 6 months
Initial dosing up to 5 mg/kg at 0,2,6 weeks then maintenance no more frequently than every 8 weeks.
6. Ulcerative Colitis - Currently Receiving: Patient has been established on therapy for at least 6 months; AND patient meets at least ONE of the Response evidence criteria (objective measures or symptom improvement).Approve 1 year
8. Graft-Versus-Host Disease (acute) - Initial Therapy: 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, ruxolitinib, basiliximab, etanercept product, sirolimus, pentostatin, tocilizumab, vedolizumab); medication is prescribed by or in consultation with an oncologist, hematologist, or a physician affiliated with a transplant center.Approve 1 month
Initial approval duration shorter (1 month) per policy.
8. Graft-Versus-Host Disease - Currently Receiving: Patient has been established on an infliximab product for at least 1 month; AND patient meets at least ONE of the Response evidence criteria (e.g., normalization of LFTs, RBC count, platelets, resolution of fever or rash, or symptom improvement in skin/oral/ocular/GI symptoms).Approve 3 months
Patients with <1 month or restarting reviewed under Initial Therapy.
9. Hidradenitis Suppurativa - Initial Therapy: Patient is > 18 years of age; patient has tried one other therapy (examples: intralesional/oral corticosteroids, systemic antibiotics, isotretinoin); medication is prescribed by or in consultation with a dermatologist.Approve 3 months
Initial dosing up to 5 mg/kg at 0,2,6 weeks then maintenance.
9. Hidradenitis Suppurativa - Currently Receiving: 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 (examples: Hurley staging, Sartorius score, PGA, Hidradenitis Suppurativa Severity Index); AND compared with baseline patient experienced improvement in at least one symptom (e.g., decreased pain or drainage).Approve 1 year
Patients with <3 months or restarting reviewed under Initial Therapy.
10. Immunotherapy-Related Toxicities - Initial Therapy: Patient is > 18 years of age; prescriber states patient developed an immunotherapy-related toxicity other than hepatitis while receiving a checkpoint inhibitor; 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.Approve 6 months
Policy excludes use for immune-related hepatotoxicity per guidelines; examples of checkpoint inhibitors listed.
10. Immunotherapy-Related Toxicities - Currently Receiving: Patient has been established on therapy for at least 6 months; AND patient meets at least ONE of the Response evidence criteria (examples: clinically significant improvement or normalization of serum markers, fecal markers, reduced corticosteroid dose; or symptom improvement relevant to organ involved).Approve 1 year
Patients with <6 months or restarting reviewed under Initial Therapy.
11. Indeterminate Colitis - Initial Therapy: 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.Approve 6 months
Initial dosing up to 5 mg/kg at 0,2,6 weeks then maintenance.
11. Indeterminate Colitis - Currently Receiving: Patient has been established on therapy for at least 6 months; AND when assessed by at least one objective measure patient experienced a beneficial clinical response (examples: fecal markers, serum markers, endoscopic assessment, reduced corticosteroid dose); AND compared with baseline patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, rectal bleeding).Approve 1 year
Patients with <6 months or restarting reviewed under Initial Therapy.
Patient is > 6 years of age; patient has tried one other systemic medication for this condition (examples: methotrexate, sulfasalazine, leflunomide, NSAID) OR patient has aggressive disease as determined by prescriber; medication is prescribed by or in consultation with a rheumatologist.
Approve 6 months
A prior biologic other than requested medication counts as trial; biosimilar does not count.
Juvenile Idiopathic Arthritis (JIA) - B) Currently Receiving: Patient has been established on therapy for at least 6 months; AND patient meets at least ONE of: objective measure response (Physician/Parent Global Assessment, JDAS, cJDAS, JSpADA, serum markers, reduced corticosteroids) OR symptom improvement (improved motion, less joint pain/tenderness, decreased morning stiffness/fatigue, improved ADLs).Approve 1 year
Patients with <6 months or restarting reviewed under Initial Therapy.
Immunotherapy-Related Toxicities - Response criteria: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples across contexts: fecal markers, serum markers, endoscopy, imaging, disease-specific scores); OR compared with baseline patient experienced improvement in at least one symptom relevant to organ involved (e.g., decreased pain, improved GI symptoms, improved ADLs).Used for continuation approvals per indication-specific duration
Applies across multiple sections for continuation assessment.
Pyoderma Gangrenosum - A) Initial Therapy: 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 (examples: mycophenolate mofetil, cyclosporine); medication is prescribed by or in consultation with a dermatologist.Approve 4 months
Initial dosing up to 5 mg/kg at 0,2,6 weeks then maintenance.
Pyoderma Gangrenosum - B) Currently Receiving: 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; AND compared with baseline patient experienced improvement in at least one symptom (e.g., decreased pain/tenderness).Approve 1 year
Patients with <4 months or restarting reviewed under Initial Therapy.
Sarcoidosis - A) Initial Therapy: 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); medication is prescribed by or in consultation with a pulmonologist, ophthalmologist, cardiologist, neurologist, or dermatologist.Approve 3 months
Initial dosing up to 5 mg/kg at 0,2,6 weeks then maintenance no more frequently than every 6 weeks.
Sarcoidosis - B) Currently Receiving: 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 (examples: lung function, serum markers, improvement in rash/neurologic symptoms, imaging); AND compared with baseline patient experienced improvement in at least one symptom (e.g., decreased cough, fatigue, pain, palpitations).Approve 1 year
Patients with <3 months or restarting reviewed under Initial Therapy.
Scleritis or Sterile Corneal Ulceration - A) Initial Therapy: Patient is > 18 years of age; patient has tried one other therapy for this condition (examples: oral NSAIDs, oral/topical/IV corticosteroids, methotrexate, cyclosporine, other immunosuppressants); medication is prescribed by or in consultation with an ophthalmologist.Approve 6 months
Initial dosing per policy; see continuation criteria for objective measures.
Scleritis or Sterile Corneal Ulceration - B) Currently Receiving: Patient has been established on therapy for at least 6 months; AND patient meets at least ONE of the objective response criteria (examples: serum markers such as CRP/ESR) OR symptom improvement (decreased eye pain, redness, light sensitivity, tearing, improved visual acuity).Approve 1 year
Patients with <6 months or restarting reviewed under Initial Therapy.
Spondyloarthritis Other Subtypes - A) Initial Therapy: Patient is > 18 years of age; AND patient has arthritis primarily in peripheral joints and has tried at least ONE conventional synthetic DMARD (examples: methotrexate, leflunomide, sulfasalazine) OR patient has axial spondyloarthritis with objective signs of inflammation (CRP elevated or sacroiliitis on MRI); medication is prescribed by or in consultation with a rheumatologist.Approve 6 months
Initial dosing up to 5 mg/kg at 0,2,6 weeks then maintenance no more frequently than every 6 weeks.
Spondyloarthritis Other Subtypes - B) Currently Receiving: Patient has been established on therapy for at least 6 months; AND patient meets at least ONE of: objective measure response (e.g., ASDAS, CRP/ESR) OR symptom improvement (decreased pain/stiffness, improved function/ADLs).Approve 1 year
Patients with <6 months or restarting reviewed under Initial Therapy.
Uveitis - A) Initial Therapy: Patient is > 6 years of age; patient has tried one of: periocular, intraocular, or systemic corticosteroids, or immunosuppressives (examples: prednisolone, triamcinolone, betamethasone, methylprednisolone, prednisone, or immunosuppressives such as methotrexate, mycophenolate mofetil, cyclosporine); medication is prescribed by or in consultation with an ophthalmologist. Exceptions apply if prior trial of etanercept or adalimumab or prior biologic other than requested medication exists.Approve 6 months
Initial dosing up to 10 mg/kg with schedule per policy for uveitis.
Uveitis - B) Currently Receiving: Patient has been established on therapy for at least 6 months; AND patient meets at least ONE of: objective measure response (best-corrected visual acuity, assessment of chorioretinal/inflammatory retinal vascular lesions, anterior chamber cell grade, vitreous haze grade) OR symptom improvement (decreased eye pain, redness, light sensitivity, blurred vision, or improved visual acuity).Approve 1 year
Patients with <6 months or restarting reviewed under Initial Therapy.
For initial therapy, document prior therapy exposures where required (for example: conventional systemic agents, corticosteroids, DMARDs, or antibiotics as specified per indication). For continuation approvals, document objective measures or symptomatic improvement from baseline (examples provided per indication such as fecal markers, serum markers, imaging, endoscopy, disease activity scores, or symptom improvement).
Billing Rule
Dosing limits
Adhere to indication-specific dosing regimens and maximums. Initial regimens commonly approve up to 5 mg/kg IV (given at 0, 2, and 6 weeks) with maintenance intervals as specified by indication; for continuation, the maximum dose is up to 10 mg/kg IV no more frequently than once every 4 weeks. Note that dosing and intervals vary by indication (some indications specify different initial or maximum dosing).
Prior Authorization
Case-by-case dose exceptions
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).
Prior Authorization
Prior authorization required per criteria
Coverage requires documentation that the patient meets the indication-specific initial or continuation criteria (age, required prior medication trials, specialist prescribing/consultation, response measures, and established-on-therapy durations) and that dosing follows the policy.
J1745
Q5103
Q5104
Q5121
Documentation Required
Document objective response for continuation approvals
For continuation approvals, providers must document objective measures or symptom improvement from baseline as specified per indication (examples provided per condition such as disease activity scores, fecal or serum markers, imaging, endoscopic assessment, and/or reduced corticosteroid dose).
Billing Rule
Dose/frequency limits
Initial therapy dosing commonly approves up to 5 mg/kg IV (with additional doses at 2 and 6 weeks and maintenance intervals per indication) and continuation dosing allows up to a maximum of 10 mg/kg IV no more frequently than once every 4 weeks. Dosing and frequency requirements vary by indication and specific regimens are detailed in the policy.
J1745
Q5103
Q5104
Q5121
Denial Risk
Not medically necessary uses
Infliximab IV products are considered not medically necessary for uses not meeting the listed policy criteria, including concurrent use with another biologic or a targeted synthetic oral small molecule drug for inflammatory conditions.
Established on therapy duration: Duration on therapy specified per indication (e.g., ≥3, 4, or 6 months) required to be eligible for continuation approval; less than that is reviewed as initial therapy.
Specific durations: GVHD ≥1 month; pyoderma gangrenosum ≥4 months; sarcoidosis ≥3 months; psoriasis/HS ≥3 months; most others ≥6 months as noted in policy.
Policy dates and revision note: Effective date 2026-03-15, last review 2026-03-01. The policy has a material change flag set to true; the 03/15/2026 (Selected Revision) update was material and removed several prior options permitting approval for initial therapy in Crohn's disease, altering Crohn's disease initial therapy criteria.