CurrentBlue Cross Blue Shield - IowaPolicy N/A

Infliximab

Defines prior authorization criteria, preferred products, clinical indications (FDA and compendial), documentation and prescriber specialty requirements, quantity limits for Zymfentra, and billing codes for infliximab products for Wellmark Blue Cross and Blue Shield - Iowa. Part 1 covers indications, required documentation, prescriber specialties, preferred drug plan design, initial/continuation authorization criteria, TB screening, non-formulary exception criteria, dosing/quantity limits (Zymfentra), appendices and applicable HCPCS/CPT/J-codes/Q-codes.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyInfliximab

Policy CodePolicy N/A

Change TypeRevised

Effective DateJanuary 1, 2026

Next Review DateN/A

Key ActionProviders must submit chart notes, medical records, or claims history documenting prior medication trials, responses, biomarker testing (when applicable), and other indication-specific documentation to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

Policy revised in October 2025.

12 monthsTypical authorization duration

2Preferred IV infliximab products

1-2Required preferred product trials for Zymfentra

2Zymfentra quantity limit (pens per 28 days)

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multipleReferenced Indications/Guidelines

Coverage Summary

Coverage stance: covered_with_criteria for infliximab products and biosimilars. For this program Avsola (infliximab-axxq) and Inflectra (infliximab-dyyb) are the preferred products. Zymfentra is a subcutaneous infliximab-dyyb product and is covered with quantity limits. Non-preferred products Remicade (infliximab) and Renflexis (infliximab-abda) require documentation of an intolerable adverse event to all preferred products or other documented exception criteria for coverage.

Key thresholds & quick facts

Typical authorization duration12 months

Preferred IV infliximab productsAvsola and Inflectra (2 preferred products)

Zymfentra quantity limitStandard limit = 2 pens/syringes per 28 days

TB screening windowDocumented negative TST or IGRA within 12 months prior to initiation

Plaque psoriasis BSA thresholdAt least 10% BSA (or ≥3% BSA with additional criteria)

Methotrexate adequate dosing thresholdAt least 15 mg/week for ≥3 months (adequate trial)

Covered Indications and Exceptions

Covered Indications (General summary)

Coverage is provided when ALL applicable indication-specific criteria below are met; Avsola and Inflectra are preferred. Non-preferred Remicade and Renflexis require documented clinical exception.

FDA-approved indications covered (examples listed)

Adult patients with moderately to severely active Crohn's disease (CD) and fistulizing CD with inadequate response to conventional therapy
Pediatric (>=6 years) moderately to severely active CD with inadequate response to conventional therapy
Moderately to severely active ulcerative colitis (UC) in patients >=6 years with inadequate response to conventional therapy
Adult moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate

Provider Actions & Prior Authorization Requirements

Prior Authorization

Submit required documentation for prior authorization

Providers must submit chart notes, medical records, or claims history documenting prior medication trials, responses, biomarker testing (when applicable), and other indication-specific documentation to initiate prior authorization review. Required items include chart notes/medical records and claims history showing prior medication trials and responses, relevant biomarker testing results (e.g., RF, anti-CCP, CRP/ESR when applicable), and any other indication-specific documentation as listed in the policy.

Chart notes, medical records, or claims history documenting prior medication trials and responses
Biomarker testing results when applicable (e.g., RF, anti-CCP, CRP and/or ESR)
Indication-specific documentation (e.g., prior medication history per CD/UC/RA/etc.)

Documentation Required

Continuation documentation

For continuation requests, submit chart notes or medical record documentation supporting positive clinical response or remission. Examples include symptom improvement, disease activity scores, laboratory improvements, and endoscopy findings as applicable to the indication.

Applicable Codes

IV infliximab J-code (Remicade)HCPCSCovered

J1745

Injection infliximab, 10 mg (applies to Remicade product only; not biosimilars)

Zymfentra J-codeHCPCSCovered

J1748

Injection, infliximab-dyyb (zymfentra), 10 mg (effective 7/1/2024)

Infliximab biosimilar Q-/HCPCS codesHCPCSCovered

Q5102	Injection infliximab, biosimilar - 10mg (cancelled 4/1/2018)
Q5103	Injection infliximab, biosimilar - Inflectra, 10mg (new code effective 4/1/2018)
Q5104	Injection infliximab, biosimilar - Renflexis, 10mg (new code effective 4/1/2018)
Q5109	Injection, infliximab, biosimilar - Ixifi, 10 mg (new code effective 1/1/2019)
Q5121	Injection, infliximab-axxq, biosimilar (Avsola), 10 mg (new code effective 7/1/20)

Clinical Evidence & Guidelines

Key evidence and guideline alignment: policy references major guidelines including the AAD‑NPF psoriasis guidance (2020/2021 references), ACG Ulcerative Colitis guidance (2019), ACR rheumatoid arthritis guidance (2021), AGA Crohn's disease guidance (2021), hidradenitis suppurativa guidelines (2019/2021), and juvenile idiopathic arthritis guidance (2021/2022). The program is implemented to align with product labeling, current guidelines, and relevant studies cited in the policy references. The formulary preference for Avsola and Inflectra is based on the program's background preference rationale rather than listing specific trial data in this summary.

Background & Definitions

Program scope: payer = Wellmark Blue Cross and Blue Shield - Iowa. Covered products include Remicade, Inflectra, Renflexis, Avsola, and Zymfentra. The plan design specifies Avsola and Inflectra as preferred IV infliximab products; Remicade and Renflexis are non-preferred and require documentation of intolerable adverse events to preferred products or other exception justification. Zymfentra is a subcutaneous infliximab‑dyyb product subject to quantity limits (standard limit = 2 pens/syringes per 28 days) and has indication-specific preferred-product prerequisites for initial approval.

Definitions: Preferred products = Avsola (infliximab-axxq) and Inflectra (infliximab-dyyb). Non-preferred products = Remicade (infliximab) and Renflexis (infliximab-abda) unless exception criteria are met (documented intolerable adverse event to all preferred products or other clinical circumstances).

Revision History

October 2025revised

Policy revised in October 2025. (Per document: Revised: October 2025.)

January 1, 2026effectiveLatest

Current Effective Date January 1, 2026.

April 2026reviewed

Policy reviewed in April 2026. (Per document: Reviewed: April 2026.)

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyInfliximab

Policy CodePolicy N/A

Change TypeRevised

Effective DateJanuary 1, 2026

Next Review DateN/A

SourceLink

On This Page

Adult active ankylosing spondylitis (AS)

Adult active psoriatic arthritis (PsA)

Adult chronic severe plaque psoriasis (PsO) who are candidates for systemic therapy when other systemic therapies are medically less appropriate

Zymfentra-specific (subcutaneous) covered uses

Maintenance treatment of moderately to severely active ulcerative colitis in adults following treatment with an infliximab product administered intravenously
Maintenance treatment of moderately to severely active Crohn's disease in adults following treatment with an infliximab product administered intravenously

Compendial uses (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Non-radiographic axial spondyloarthritis
Behçet's syndrome
Granulomatosis with polyangiitis (Wegener's)
Hidradenitis suppurativa
Juvenile idiopathic arthritis
Pyoderma gangrenosum
Sarcoidosis
Takayasu's arteritis
Uveitis
Reactive arthritis
Immune checkpoint inhibitor-related toxicity
Acute graft versus host disease
Moderate to severe plaque psoriasis

Preferred Drug Plan Design / Non-preferred coverage rules

Member must meet BOTH Preferred Drug Plan Design and indication-specific criteria when applicable.

ALL of the following

Preferred products for IV infliximab: Avsola (infliximab-axxq) and Inflectra (infliximab-dyyb).
Coverage for non-preferred products (Remicade, Renflexis) is provided when member has documented intolerable adverse event to all preferred products and the adverse event was not an expected adverse event attributable to the active ingredient as described in prescribing information; or other clinical circumstances justify exception.
For Zymfentra and certain self-administered indications, additional preferred self-administered products (e.g., Adalimumab-aacf, Enbrel, Entyvio, Cosentyx, Otezla, Otulfi, Rinvoq, Simponi, Skyrizi, Tremfya, Velsipity, Xeljanz/Xeljanz XR) apply and require use of two preferred products before non-preferred unless exceptions apply.

Initial Approval Criteria (by indication)

Authorization durations and specific prerequisite therapy/testing per indication.

A) Crohn's disease (CD)

Avsola, Inflectra, infliximab, Remicade, Renflexis: Authorization of 12 months may be granted for treatment of moderately to severely active CD.
Zymfentra: Authorization of 12 months may be granted for adult members for treatment of moderately to severely active CD.

B) Ulcerative colitis (UC)

Avsola, Inflectra, infliximab, Remicade, Renflexis: Authorization of 12 months may be granted for treatment of moderately to severely active UC.
Zymfentra: Authorization of 12 months may be granted for adult members for treatment of moderately to severely active UC.

C) Rheumatoid arthritis (RA) (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Authorization of 12 months may be granted for adults who have previously received a biologic or targeted synthetic drug indicated for RA; medication must be prescribed in combination with methotrexate or leflunomide unless clinical reason not to use (see Appendix A).
biomarker criteria
- alternative biomarker set: Member tested for RF OR anti-CCP
- Member tested for RF
- Member tested for anti-CCP
- Member tested for CRP and/or ESR
Member prescribed medication in combination with methotrexate or leflunomide or has a clinical reason not to use them (Appendix A).

D) AS and nr-axSpA (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Authorization of 12 months may be granted for adults who have previously received a biologic or targeted synthetic drug indicated for AS or nr-axSpA.
Inadequate response to at least two NSAIDs.
Intolerance or contraindication to two or more NSAIDs.

F) Plaque psoriasis (PsO) (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Authorization of 12 months may be granted for adults who have previously received a biologic or targeted synthetic drug indicated for moderate to severe plaque psoriasis.
ANY of the following
- Crucial body areas affected (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas).
- At least 10% body surface area (BSA) affected.
- At least 3% BSA affected AND any of: inadequate response or intolerance to phototherapy or pharmacologic treatment with methotrexate, cyclosporine or acitretin; OR clinical reason to avoid those pharmacologic treatments (Appendix A).

G) Behçet's disease (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Authorization of 12 months may be granted for members who have previously received Otezla or a biologic indicated for Behçet's disease.
Authorization of 12 months may be granted when inadequate response to at least one non-biologic medication (e.g., azathioprine, colchicine, cyclosporine, systemic corticosteroids).

H) Granulomatosis with polyangiitis (Wegener's) (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Inadequate response to corticosteroids or immunosuppressive therapy (e.g., cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil).
Intolerance or contraindication to corticosteroids and immunosuppressive therapy.

I) Hidradenitis suppurativa (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Authorization of 12 months may be granted for members who have previously received a biologic indicated for severe, refractory hidradenitis suppurativa.
Inadequate response to an oral antibiotic used for hidradenitis suppurativa for at least 90 days; OR intolerance/contraindication to oral antibiotics.

J) Juvenile idiopathic arthritis (JIA) (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Authorization of 12 months may be granted for members who have previously received a biologic or targeted synthetic drug indicated for JIA.
Inadequate response to methotrexate or another conventional synthetic drug administered at adequate dose and duration; OR inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids AND presence of specific risk factors for poor outcome.

K) Pyoderma gangrenosum (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Authorization of 12 months may be granted for members who have previously received a biologic indicated for pyoderma gangrenosum.
Inadequate response to corticosteroids or immunosuppressive therapy; OR intolerance/contraindication to such therapy.

L) Sarcoidosis (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Inadequate response to corticosteroids or immunosuppressive therapy.
Intolerance or contraindication to corticosteroids and immunosuppressive therapy.

M) Takayasu's arteritis (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Inadequate response to corticosteroids or immunosuppressive therapy (e.g., methotrexate, azathioprine, mycophenolate mofetil).
Intolerance or contraindication to corticosteroids and immunosuppressive therapy.

N) Uveitis (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Previously received a biologic indicated for uveitis.
Inadequate response to corticosteroids or immunosuppressive therapy; OR intolerance/contraindication to such therapy.

O) Reactive arthritis (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Previously received a biologic indicated for reactive arthritis.
Inadequate response to at least a 3-month trial of sulfasalazine (titrated to 1000 mg twice daily) or methotrexate (titrated to at least 15 mg/week); OR intolerance/contraindication to methotrexate and sulfasalazine.

P) Immune checkpoint inhibitor-related toxicity (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Authorization of 6 months may be granted when inadequate response, intolerance or contraindication to corticosteroids.
Authorization of 12 months may be granted when moderate or severe inflammatory arthritis and inadequate response, intolerance or contraindication to corticosteroids.

Q) Acute graft versus host disease (Avsola, Inflectra, infliximab, Remicade, Renflexis only)

Inadequate response to systemic corticosteroids; OR intolerance or contraindication to corticosteroids.

Continuation / Renewal Criteria

All members requesting continuation must meet initial authorization criteria and provide documentation of positive clinical response.

Continuation requests require chart notes or medical record documentation supporting positive clinical response or remission (specifically called out for CD, UC, RA, and other indications).

For CD and UC: evidence of improvement in disease-specific measures (listed in indication sections) from baseline.

For RA: disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.

Other universal requirements and exclusions

Applies to all indications

Documented negative tuberculosis (TB) test (TST or IGRA) within 12 months of initiating therapy for persons naive to biologic or targeted synthetic drugs; if TB test positive, further testing to exclude active disease; do not administer if active TB; treat latent TB prior to initiation.

Member cannot use requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Zymfentra, Remicade, Inflectra, Renflexis and Avsola are considered not medically necessary for members who do not meet the criteria set forth.

Members receiving Zymfentra as samples or via manufacturer's patient assistance program must meet initial approval criteria.

Symptom improvement (e.g., abdominal pain, stool frequency, rectal bleeding)
Disease activity scores (e.g., CDAI, UCEIS, Mayo, tender/swollen joint counts with ≥20% improvement)
Laboratory improvement (e.g., CRP, fecal calprotectin, hematocrit)
Endoscopy or imaging findings showing improved mucosa

Prior Authorization

Non-preferred product exception

For Remicade or Renflexis (non-preferred products), submit documentation demonstrating intolerable adverse events to all preferred products (Avsola and Inflectra) or other clinical circumstances that justify an exception to preferred-product use. Documentation should show the adverse events were not expected adverse events attributable to the active ingredient per prescribing information.

Documentation of intolerable adverse events to all preferred products (Avsola, Inflectra)
Clinical rationale or other circumstances justifying an exception
Medical records showing severity and relationship of adverse events (not expected active-ingredient reactions)

Prior Authorization

Zymfentra preferred-product prerequisite

For Zymfentra initial approval, provide documentation of inadequate response or intolerable adverse events to at least TWO preferred products. The specific preferred-product lists differ by indication: for ulcerative colitis the list includes Adalimumab-aacf, Entyvio, Otulfi (ustekinumab-aauz), Rinvoq, Simponi, Skyrizi, Tremfya, Velsipity and Xeljanz/Xeljanz XR; for Crohn's disease the list includes Adalimumab-aacf, Entyvio, Otulfi (ustekinumab-aauz), Rinvoq, Skyrizi, and Tremfya.

Documentation of inadequate response or intolerable adverse events to ≥2 preferred products
For UC: trials of two from Adalimumab-aacf, Entyvio, Otulfi, Rinvoq, Simponi, Skyrizi, Tremfya, Velsipity, Xeljanz/XR
For CD: trials of two from Adalimumab-aacf, Entyvio, Otulfi, Rinvoq, Skyrizi, Tremfya

Documentation Required

TB testing requirement

Provide documented negative tuberculosis testing (TST or IGRA) within 12 months of initiating therapy for patients who are naïve to biologic or targeted synthetic drugs. If the TB screening test is positive, further evaluation to exclude active disease (e.g., chest x-ray) is required; do not administer therapy if active TB is present and treat latent TB prior to initiation.

Billing Rule

Use appropriate HCPCS/CPT/Q-codes

Report provider services using the listed J- and Q-codes for infliximab products. Note: J1745 applies to Remicade only and J1748 applies to infliximab-dyyb (Zymfentra) effective 7/1/2024.

J1745
J1748
Q5103
Q5104
Q5109
Q5121
Q5102

Billing Rule

Zymfentra quantity limit

Zymfentra (infliximab-dyyb) standard quantity limit is 2 pens/syringes per 28 days. FDA recommended dosing: inject 120 mg subcutaneously once every two weeks.

Step Therapy

Preferred product use required

Members generally must trial two of the plan's preferred products before coverage of certain non-preferred agents. Exceptions are allowed for documented clinical reasons that preclude use of preferred products or if the patient is currently receiving and benefiting from non-preferred therapy.

prior methotrexate response

Inadequate response to at least a 3-month trial of methotrexate despite adequate dosing (i.e., titrated to at least 15 mg/week).
Intolerance or contraindication to methotrexate.