ModifiedCignaPolicy IP0660

Infliximab Intravenous Products Prior Authorization Policy

Prior authorization policy governing coverage and approval criteria for infliximab intravenous products (including biosimilars) for inflammatory conditions under Cigna-administered health benefit plans; applies to prescribers and payers administering these benefits.

Policy Summary

PayerCigna

PolicyInfliximab Intravenous Products Prior Authorization Policy

Policy CodePolicy IP0660

Change TypeSelected revision (material) + annual edits

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit prior authorization with indication-specific documentation (age, prescriber specialty/consultation, prior therapy history, and objective response for continuation).

SourceLink

POLICY UPDATE CHANGES

Selected Revision: Ulcerative Colitis: For initial therapy, removed options of approval including prior trial of one systemic therapy and certain pouchitis-related prior therapies.

Annual Revision: Immunotherapy-Related Toxicities Associated with Checkpoint Inhibitor Therapy: Myalgia and myositis were removed from the examples of immunotherapy-related toxicities.

New policy effective date recorded as 11/01/2024 and marked New policy.

PA requiredcoverage stance

5 mg/kgcommon initial dose

10 mg/kgmax continuing dose

5named products

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.

≥14indications listed

Coverage Criteria for Infliximab IV Products

Prior Authorization

Coverage Criteria for Infliximab IV Products

When coverage is available and medically necessary, prior authorization is required. Requests must include documentation supporting the diagnosis, prior therapy trials (when required), prescriber specialty or consultation notes, dosing history, and objective measures of response when applicable. Denials may be issued if submitted diagnoses are not covered by this policy, required prior trials or specialist consultation are not documented, the patient has concurrent biologic or targeted synthetic therapy, or the requested dosing/frequency exceeds policy limits.

Prior authorization is required for all infliximab IV product requests under this policy.
Include documentation: diagnosis, prior trial(s) of specified therapies, specialist prescription/consult note, dosing regimen, and objective response measures when continuation requested.
A biosimilar of the requested biologic does NOT count toward required prior biologic trials.
No step therapy requirements are specified beyond the indication-specific prior trial requirements.
Do not combine infliximab with another biologic or targeted synthetic oral small molecule — requests for combination therapy are excluded and may be denied.

Claims Coding and Age/Dosing Notes

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.

Age thresholds for pediatric indications

Crohn's disease age thresholdPatient is ≥ 6 years of age for initial therapy

Ankylosing spondylitis age threshold (initial)Patient is > 18 years of age for initial therapy

Plaque psoriasis age thresholdPatient is ≥ 18 years of age for initial therapy

Age or prior therapy thresholds — examples

Sarcoidosis - age/prior therapyInitial therapy requires patient > 18 years and prior trial of at least one corticosteroid and one immunosuppressive medication

Uveitis - age/prior therapyInitial therapy requires patient > 6 years and prior trial of periocular, intraocular, or systemic corticosteroids or immunosuppressives (exceptions noted)

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior authorization required for benefit coverage

Prior authorization is required for benefit coverage of infliximab products; approvals are provided for the durations noted in the criteria and may be extended if the patient continues to meet the Criteria and Dosing.

Requests for doses outside established dosing are reviewed case-by-case by a clinician.
All approvals are provided for the duration noted (months = 30 days).

Documentation Required

Document indication-specific criteria (age, prior trials, prescriber specialty)

Authorization requests must document indication-specific criteria such as age limits, required prior therapy trials or documented contraindications/intolerance, and prescriber specialty or consultation when specified by the indication.

Examples: age thresholds (e.g., Crohn's disease ≥6 years, plaque psoriasis ≥18 years, ankylosing spondylitis >18 years).
Document prior therapy trials or reason for exception (intolerance/contraindication) per the indication node.

Initial Therapy Approval Criteria

Initial therapy

Initial therapy approval criteria and dosing vary by indication

Ankylosing Spondylitis - Initial: Patient is > 18 years AND medication prescribed by or in consultation with a rheumatologistapprove 6 months

Dosing: up to 5 mg/kg IV at 0, 2, and 6 weeks then no more frequently than q6 weeks

Crohn's Disease - Initial: Patient is ≥ 6 years AND meets one of listed prior therapy or disease characteristics (corticosteroid trial/contraindication, trial of one conventional systemic therapy, fistulas, or ileocolonic resection) AND medication prescribed by or in consultation with a gastroenterologistapprove 6 months

Dosing: up to 5 mg/kg IV at 0, 2, and 6 weeks then maintenance q8 weeks

Criteria for Patients Currently Receiving Infliximab

Continuation therapy

Criteria for patients currently receiving an infliximab product

General continuation: Patient has been established on therapy for the specified minimum duration (e.g., ≥6 months for ankylosing spondylitis and Crohn's disease; ≥3 months for plaque psoriasis) AND patient experienced beneficial clinical response by objective measure or symptom improvement compared with baselineapprove for 1 year

Documentation must demonstrate objective measures or symptom improvement per indication

Continuation therapy

Continuation approval conditions generally require the patient to be established on therapy for an indication-specific minimum duration and to have experienced objective or symptomatic improvement compared with baseline.

General continuation node: Established on therapy for the indication-specific minimum duration (range 1–6 months) AND when assessed by at least one objective measure experienced a beneficial clinical response OR experienced improvement in at least one symptom compared with baseline.

Step Therapy and Prior Trial Requirements

Requirement	Policy detail
Preferred product requirement
Policy requires use of preferred infliximab products per the Inflammatory Conditions - Infliximab Intravenous Products Preferred Specialty Management Policy (PSM005) before approval of a requested non‑preferred infliximab intravenous product.

Prior therapy / duration	Indications / policy example
3 months — traditional systemic agent trial
Plaque psoriasis: patient must have tried at least one traditional systemic agent for ≥3 months unless intolerant; exception if prior biologic trial already completed (biosimilars do not count).
3 months — conventional synthetic DMARD
Rheumatoid arthritis: patient must have tried one conventional synthetic DMARD for ≥3 months before initial approval (exception if prior biologic trial completed; biosimilars do not count).
3 months — established on therapy for continuation
Plaque psoriasis continuation: established on infliximab ≥3 months and demonstrated clinical response; approve for 1 year.
6 months — induction/established duration for some indications
Ankylosing spondylitis, Crohn disease, Psoriatic arthritis, JIA initial approvals generally require age/prior therapy and are approved for 6 months; continuation requires established therapy ≥6 months with response (approval 1 year).
Condition‑specific shorter trials (examples)
Graft‑versus‑Host Disease initial approval may be for 1 month after trial of conventional systemic treatment; Behcet's initial approval often 3 months after trial of conventional therapy.

Indication	Prior trial(s) required before initial approval
Plaque psoriasis
At least one traditional systemic agent for ≥3 months (examples: methotrexate, cyclosporine, acitretin, PUVA counts); exception if prior biologic other than requested med already tried. A biosimilar of the requested biologic does not count.
Rheumatoid arthritis
Trial of one conventional synthetic DMARD for ≥3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine); exception if prior biologic trial completed. A biosimilar does not count.
Crohn's disease
One of: trial of corticosteroids (or contraindication to steroids), trial of another conventional systemic therapy, or presence of complicating features (e.g., fistula, ileocolonic resection); medication prescribed by/with gastroenterologist; initial approval 6 months.
Indeterminate colitis
Tried one systemic corticosteroid AND tried mesalamine AND tried azathioprine or 6‑mercaptopurine; prescribed by/with gastroenterologist; initial approval 6 months.
Juvenile idiopathic arthritis (JIA)
Tried one other systemic medication for JIA (examples: methotrexate, sulfasalazine, leflunomide, or prior biologic other than requested) OR has aggressive disease; prescribed by/with rheumatologist; initial approval 6 months.
Sarcoidosis
Tried at least one corticosteroid AND at least one immunosuppressive medication (examples: methotrexate, azathioprine, leflunomide, mycophenolate); prescribed by/with appropriate specialist; initial approval 3 months.
Scleritis / sterile corneal ulceration
Tried one other therapy for condition (examples: NSAIDs, topical/systemic corticosteroids, methotrexate, cyclosporine, other immunosuppressants); prescribed by/with ophthalmologist; initial approval 6 months.
Uveitis
Tried periocular, intraocular, or systemic corticosteroids or immunosuppressives (examples: prednisolone, triamcinolone, methotrexate, mycophenolate, cyclosporine); prescribed by/with ophthalmologist; initial approval 6 months. Exception if prior etanercept or adalimumab trial already completed. A biosimilar does not count.

Dose and Quantity Limits

Infliximab (IV) — dosing varies by indication and status

Standard initial dosing (many indications)Initial therapy: up to 5 mg/kg IV with additional doses at weeks 2 and 6, then maintenance generally every 6–8 weeks depending on indication

Continuation / maximum dosingPatients currently receiving an infliximab product: approve up to a maximum of 10 mg/kg IV no more frequently than once every 4 weeks

Crohn's specific dosingInitial regimen: up to 5 mg/kg IV at 0, 2, and 6 weeks then no more frequently than every 8 weeks thereafter

JIA specific dosingSome indications (e.g., JIA) may allow initial dosing up to 6 mg/kg IV with standard induction then maintenance every 8 weeks

Site of Care Considerations

Note

Ensure clinically appropriate site of care (infusion center, hospital outpatient, or office)

Site of care should be reasonable and clinically appropriate; dosage, frequency, duration, and site of care must be supported by evidence and adjusted based on severity and prior response.

Recommended settings include infusion center, hospital outpatient, or office when clinically appropriate.
Receipt of sample product does not satisfy coverage criteria.

Biosimilars and Reference Product Notes

Billing Rule

Remicade and biosimilars listed; prior authorization and PSM005 apply

Remicade and listed biosimilars (Inflectra, Renflexis, Avsola) are included in the policy; biosimilars were approved as biosimilar to Remicade but are not designated interchangeable. Prior authorization and reference to the preferred product policy are required.

Appendix lists Avsola, Inflectra, Renflexis as biosimilars to Remicade; interchangeability has not been demonstrated.
Policy requires prior authorization and refers to PSM005 for preferred product requirements.

Documentation Required

Biosimilars do not satisfy prior biologic trial requirement

A biosimilar of the requested biologic does not count toward the required prior biologic trial when documenting prior therapy trials for initial therapy.

Policy note: 'A biosimilar of the requested biologic does not count.'

Background

Infliximab products are tumor necrosis factor (TNF) inhibitors approved for multiple inflammatory conditions, including but not limited to ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

Definitions and Terms

Biosimilars to Remicade (examples)

AvsolaInfliximab-axxq (Avsola) is approved as a biosimilar to Remicade

InflectraInfliximab-dyyb (Inflectra) is approved as a biosimilar to Remicade

RenflexisInfliximab-abda (Renflexis) is approved as a biosimilar to Remicade

Indeterminate colitis

DefinitionColitis that cannot be classified with certainty as either ulcerative colitis or Crohn's disease

Initial therapy ageInitial therapy criteria reference patient age ≥ 6 years

Required specialist

Policy Summary

PayerCigna

PolicyInfliximab Intravenous Products Prior Authorization Policy

Policy CodePolicy IP0660

Change TypeSelected revision (material) + annual edits

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit prior authorization with indication-specific documentation (age, prescriber specialty/consultation, prior therapy history, and objective response for continuation).

SourceLink

On This Page

Indeterminate colitis - prior therapies

Initial therapy requires patient ≥ 6 years and prior trials of a systemic corticosteroid, mesalamine, and azathioprine or 6-mercaptopurine

Still's disease - prior therapy duration exampleInitial therapy requires prior trial of one conventional synthetic DMARD for ≥2 months (or intolerance) as specified

Prior Authorization

Prior authorization ties approval dosing/duration to specific HCPCS codes

Prior authorization is required per the policy criteria and approvals reference specific dosing regimens and durations for initial versus continuation therapy and should be billed using the listed HCPCS codes.

Initial dosing commonly approved up to 5 mg/kg with induction at 0, 2, and 6 weeks; continuation dosing up to 10 mg/kg no more frequently than q4 weeks for many indications.
Use HCPCS codes J1745, Q5103, Q5104, or Q5121 when submitting claims for covered infliximab products.

Note

Appendix is part of Coverage Policy IP0660

This appendix is part of Coverage Policy Number IP0660 and must be used alongside IP0660 when making authorization decisions for infliximab products.

Coverage Policy Number: IP0660 is referenced throughout the criteria and coding sections.
Appendix and policy text should be reviewed together for authorization determinations.

Step Therapy

Use preferred infliximab products before non-preferred approval (PSM005)

The policy requires use of preferred products before approval of a requested non-preferred infliximab IV product; refer to the Preferred Specialty Management Policy (PSM005) for preferred product criteria and exceptions.

The policy note: "This product also requires the use of preferred products before approval of a requested non-preferred infliximab intravenous product. Refer to ... PSM005."

Step Therapy

Initial indications often require specified prior therapy trials

For many initial indications, the request must document trials of specified prior therapies (for example, traditional systemic agents for plaque psoriasis or conventional synthetic DMARDs for rheumatoid arthritis) unless an exception (intolerance, contraindication, or prior biologic trial) applies.

Plaque psoriasis: trial of at least one traditional systemic agent for ≥3 months unless intolerant, or prior biologic trial may substitute (biosimilars do not count).
Rheumatoid arthritis: trial of one conventional synthetic DMARD for ≥3 months unless exception applies.

Step Therapy

Required prior trials (corticosteroids, immunosuppressives, DMARDs) for initial therapy

Initial therapy criteria frequently require prior trials of corticosteroids and/or conventional immunosuppressive agents or DMARDs as specified by indication (examples: indeterminate colitis, sarcoidosis, Still's disease).

Indeterminate colitis: tried one systemic corticosteroid, mesalamine, and azathioprine or 6‑MP.
Sarcoidosis: tried at least one corticosteroid and one immunosuppressive medication.

Note

No other step therapy requirements specified in appendix chunks

No additional step therapy requirements beyond those specified per indication and the preferred product requirement are listed in these appendix sections.

The appendix notes it is not an all-inclusive list and directs providers to prescribing information for full details.

Documentation Required

Prescriber specialty required; dosing exceptions reviewed case-by-case

Initial approval generally requires the medication be prescribed by or in consultation with a specialist appropriate for the condition (e.g., rheumatologist, gastroenterologist, dermatologist, ophthalmologist); dosing exceptions are considered case-by-case.

Policy: "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 established dosing are reviewed on a case-by-case basis by a clinician.

Documentation Required

Required documentation: age, specialist involvement, prior therapy history, clinical details

Documentation submitted for authorization must include patient age, prescriber specialty or documentation of specialist consultation when required, prior therapy history (including duration and reasons for failure/intolerance), and relevant clinical details supporting the indication.

Include prior therapy trials or contraindications/intolerance and objective measures where applicable (e.g., CRP, endoscopy, imaging, disease scores).
Specify duration of prior therapies and any exceptions relied upon.

Documentation Required

Documentation for continuation: established duration and objective/symptomatic response

For continuation approvals, documentation must show the patient was established on the infliximab product for the indication-specific minimum duration (e.g., ≥3 or ≥6 months) and demonstrate objective clinical response or symptom improvement from baseline.

Continuation approval commonly granted for 1 year when established on therapy for the required minimum duration and response is documented.
Objective measures vary by indication (examples listed per indication: disease activity scores, imaging, lab markers, visual acuity).

Note

Check prescribing information for FDA‑approved indications and details

Refer to the prescribing information for each agent for FDA‑approved indications and full prescribing details.

The appendix notes: 'Refer to the prescribing information for the respective agent for FDA‑approved indications.'

Billing Rule

Claims without covered HCPCS codes will be denied

Claims for services that are not submitted with HCPCS codes covered by this policy will be denied as not covered; providers must bill using the most appropriate covered codes.

Instruction: 'When billing, providers must use the most appropriate codes... Claims submitted for services that are not accompanied by covered code(s) ... will be denied as not covered.'

Denial Risk

Incomplete trials or documentation and unsupported dosing may trigger denial

Requests missing required prior trials, necessary documentation (age, specialist consultation, objective response), or that seek dosing outside stated limits may be denied.

Examples of triggers: absence of documented prior conventional/systemic therapies or biologic trials when required, lack of specialist consultation when indicated, or no objective/symptom improvement for continuation.

Denial Risk

Non‑listed indications or combination biologic/targeted therapy considered not medically necessary

Use of infliximab intravenous products for indications not listed in the policy or concurrent use with another biologic or targeted synthetic oral small molecule for an inflammatory condition is considered not medically necessary and may be denied.

Policy states combination biologic/targeted synthetic therapy is not allowed for coverage purposes; conventional synthetic DMARDs are not excluded from combination use.

Note

No other provider actions specified in appendix

No additional provider actions are specified in these appendix chunks beyond the requirements already stated in the policy.

The appendix notes it is not all-inclusive and refers providers to the main policy and prescribing information for further details.

Plaque Psoriasis - Initial:

Patient is ≥ 18 years AND tried at least one traditional systemic agent for ≥3 months (or intolerant/contraindicated) AND medication prescribed by or in consultation with a dermatologist

Dosing regimens in policy; exception if prior biologic trial present

Initial therapy

Initial therapy approvals are time-limited and require indication-specific age limits, prior therapy trials, and prescriber specialty or consultation.

Example initial node - standard indications: Typical initial approval: approve for 3–6 months (varies by indication) if patient meets age requirement, has tried required prior therapies (e.g., systemic agents, DMARDs, corticosteroids, mesalamine, azathioprine/6-MP), and medication is prescribed by or in consultation with the indicated specialist.

See individual indication nodes for exact prior therapy and duration requirements

Initial therapy criteria

Initial therapy approval is time-limited and requires prior trials and specialist involvement as specified per indication.

Initial therapy general: Initial approvals vary by indication (examples: sarcoidosis initial approval 3 months with prior steroid and immunosuppressive trials; scleritis initial approval 6 months with prior therapy; uveitis initial approval 6 months with prior corticosteroid or immunosuppressive trial).

Prescriber specialty or consultation required as indicated

Objective measures are listed per indication (e.g., CRP, fecal calprotectin, CDAI, DAPSA, imaging, endoscopy).

Continuation therapy criteria

Continuation (patient currently receiving an infliximab product)

Continuation approval general: Approvals generally for 1 year when patient has been established on therapy for the indication-specific minimum duration (commonly ≥3 or ≥6 months) and demonstrates objective clinical response and/or symptom improvement compared with baseline; documentation of objective measures or symptom improvement required.

Specialist consultation or prescribing may be required for certain indications (e.g., pulmonologist for sarcoidosis, ophthalmologist for uveitis).

Billing Rule

HCPCS Q5103 is covered when criteria met

HCPCS code Q5103 (infliximab-dyyb, Inflectra) is listed as considered medically necessary when policy criteria are met.

Q5103 — Injection, infliximab-dyyb (Inflectra), 10 mg

Billing Rule

HCPCS Q5104 is covered when criteria met

HCPCS code Q5104 (infliximab-abda, Renflexis) is listed as considered medically necessary when policy criteria are met.

Q5104 — Injection, infliximab-abda (Renflexis), 10 mg

Billing Rule

HCPCS Q5121 is covered when criteria met

HCPCS code Q5121 (infliximab-axxq, Avsola) is listed as considered medically necessary when policy criteria are met.

Q5121 — Injection, infliximab-axxq (Avsola), 10 mg

Note

Rituxan and biosimilars listed in appendix (no preference specified)

Rituximab products and their biosimilars are listed in the appendix alongside the reference product; no specific preference or requirement is specified in these appendix chunks.

Appendix entries show Rituxan IV products and biosimilars as examples of related biologic agents.

Note

Actemra and biosimilars listed in appendix (no preference specified)

Tocilizumab (Actemra) products and biosimilars are listed in the appendix alongside the reference product; no preference rule is specified in these appendix chunks.

Appendix lists Actemra IV and SC formulations and notes indications; no preference requirement provided here.

Medication must be prescribed by or in consultation with a gastroenterologist for initial therapy

Infliximab and biosimilars — products listed

Reference productRemicade (infliximab) is the reference infliximab IV product

Inflectra (infliximab-dyyb)Listed biosimilar to infliximab (Inflectra) in appendix and considered in coding

Renflexis (infliximab-abda)Listed biosimilar to infliximab (Renflexis) in appendix and considered in coding

Avsola (infliximab-axxq)Listed biosimilar to infliximab (Avsola) in appendix and considered in coding

SC — definition

AbbreviationSC = Subcutaneous

Usage noteUsed in appendix to denote route of administration for certain biologics (e.g., SC formulations listed)

IV — definition

AbbreviationIV = Intravenous

ContextInfliximab products are administered IV; dosing and frequency requirements in policy reference IV infusions

TNF — definition

TermTNF = Tumor necrosis factor

Class contextInfliximab and listed biosimilars act by inhibition of TNF as noted in the appendix