ModifiedBlue Cross Blue Shield - North CarolinaPolicy N/A

Infliximab (Remicade) and infliximab biosimilars notification policy

Defines medical necessity, site-of-care, dosing, and documentation requirements for infliximab (Remicade) and specified infliximab biosimilars for Blue Cross Blue Shield North Carolina members receiving intravenous infusions administered by a healthcare professional.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyInfliximab (Remicade) and infliximab biosimilars notification policy

Policy CodePolicy N/A

Change TypeCriteria revisions and allowances (July 2026Nov 2025 site-of-care update)

Effective DateJuly 2026

Next Review DateN/A

Key ActionSubmit prior authorization with supporting medical record documentation demonstrating indication-specific criteria or documentation of clinical benefit if continuing an established biologic.

SourceLink

POLICY UPDATE CHANGES

Added allowance for patients currently established on a biologic or systemic immunomodulator agent with demonstrated clinical benefit to continue for RA, PS, PsA, AS, CD, and UC.

For Crohn's disease, removed required trial and failure of conventional therapy and replaced with required demonstration of moderately to severely active disease by symptoms plus objective evidence of active inflammation or significant extent/upper GI involvement or corticosteroid-dependence/refractory status.

For ulcerative colitis, removed required trial and failure of conventional therapy and replaced with required demonstration of moderately to severely active disease by symptoms plus objective evidence of active inflammation or high-risk disease or corticosteroid-dependence/refractory status.

Updated site-of-care medical necessity criteria to add bypass for patients with history of severe adverse events or conditions increasing risk for severe adverse events to align with Place of Service for Medical Infusions policy.

Adjusted psoriasis phototherapy conventional agent option to include both PUVA and UVB examples.

For PsA and psoriasis, added examples defining long-term damage interfering with function associated with severe psoriatic arthritis.

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.

Coverage and Medical Necessity Criteria

Medical necessity criteria

Covered when ALL of the following general conditions and the indication-specific criteria are met

General prerequisites

Indication-specific prior therapy or criteria: For each covered indication, one of the listed prior-therapy conditions must be met (examples below).
See indicated children for each disease

Rheumatoid arthritis (RA): Patient >=18 years AND (inadequate response to maximally tolerated methotrexate titrated to ~25 mg weekly for >=3 months OR inadequate response to another conventional agent for >=3 months OR intolerance/hypersensitivity/contraindication to conventional agents OR currently established on an FDA-approved biologic/systemic immunomodulator with documented clinical benefit) AND will take the agent with methotrexate unless intolerant/contraindicated

RA detailed in chunk 4

Chronic severe plaque psoriasis (PS): Patient >=18 years AND (inadequate response to one conventional topical/systemic/phototherapy agent for >=3 months OR intolerance/contraindication OR severe chronic PS [>10% BSA or special locations or serious impact] OR concomitant severe PsA OR currently established on an FDA-approved biologic/systemic immunomodulator with documented clinical benefit)

PS detailed in chunks 5-6

Psoriatic arthritis (PsA): Patient >=18 years AND (inadequate response to one conventional agent for >=3 months OR intolerance/contraindication OR severe active PsA OR concomitant severe psoriasis OR currently established on an FDA-approved biologic/systemic immunomodulator with documented clinical benefit)

PsA detailed in chunks 6-7

Ankylosing spondylitis (AS): Patient >=18 years AND (inadequate response to two different NSAIDs for at least a 4-week total trial OR intolerance/contraindication to two NSAIDs OR FDA contraindication to all NSAIDs OR currently established on an FDA-approved biologic/systemic immunomodulator with documented clinical benefit)

AS detailed in chunks 7-8

Crohn's disease (CD): Patient >=6 years AND moderately to severely active disease evidenced by either: (i) symptoms of active CD AND objective evidence of active inflammation on imaging/intestine ultrasound/MRI OR (ii) significant extent/upper GI involvement on radiographic/endoscopic assessment OR (iii) corticosteroid-dependence or steroid-refractory) OR currently established on an FDA-approved biologic/systemic immunomodulator with documented clinical benefit

CD detailed in chunks 8-9

Ulcerative colitis (UC): Patient >=6 years AND moderately to severely active disease evidenced by either: (i) symptoms AND objective evidence of active inflammation on endoscopy (MES, UCEIS) OR intestinal ultrasound OR biomarkers OR poor prognostic factor OR (ii) corticosteroid-dependence or steroid-refractory) OR currently established on an FDA-approved biologic/systemic immunomodulator with documented clinical benefit

UC detailed in chunks 9-10

Refractory sarcoidosis: Tried and had inadequate response to glucocorticoids AND methotrexate OR intolerance/contraindication to both AND provider submitted supporting medical records

Chunk 11

Immune checkpoint inhibitor-related GI toxicity: Moderate to severe diarrhea/colitis from PD-1/PD-L1 therapy AND stool evaluation has ruled out infection AND symptoms not responsive to up to 3 days of corticosteroids; medical record documentation required

Chunk 11

Hidradenitis suppurativa (HS): Moderate-to-severe refractory HS with inadequate response to adalimumab OR secukinumab, or intolerance/contraindication to both; medical record documentation required

Chunk 12

Non-preferred product criteria: If request is for Remicade or a non-preferred infliximab biosimilar, patient must have tried and had inadequate response to BOTH preferred products Avsola (infliximab-axxq) and Inflectra (infliximab-dyyb) OR have intolerance/contraindication to ALL preferred products that is not expected with the requested agent

Chunk 12-13

Prescriber and combination therapy rules: Prescriber must be a relevant specialist or have consulted one AND infliximab must not be used in combination with another biologic immunomodulator, Otezla, or Zeposia

Chunk 11-12

Testing and dosing limits: Latent TB testing when required by prescribing information and start of therapy if positive AND requested dose must not exceed FDA labeled dosing or doses supported by DrugDex/AHFS/NCCN unless documentation justifies higher dose; quantity limit exception criteria apply (titration, strength availability, safety limits, or supporting documentation for higher dose)

Chunks 13, 15-16

Updated coverage criteria and exceptions

Coverage is provided when indication-specific medical necessity criteria are met; several indications had step or trial requirements updated as follows.

General: Medical record documentation required for all indications; dosing not to exceed FDA labeled or compendia-supported dosing; site-of-care and bypass allowances apply per policy; prior authorization required.

based on historical updates and policy text

Continuation on established biologic: For RA, PS, PsA, AS, CD, and UC: patients currently established on a biologic or systemic immunomodulator FDA-approved for the requested indication who have had positive clinical benefit may continue therapy.

July 2026 change

Crohn's disease (CD): Removed requirement for trial and failure of conventional therapy; coverage requires demonstration of moderately to severely active disease by documented symptoms + (objective evidence of active inflammation OR significant extent/upper GI involvement on radiographic or endoscopic assessment OR corticosteroid-dependence or refractory to oral corticosteroids).

aligns with updated clinical guidelines; July 2026

Infliximab (Remicade) and infliximab biosimilars must not be administered concurrently with another biologic immunomodulator agent, Otezla®, or Zeposia®. The prescriber must confirm in the medical record that the patient is not receiving any of these agents at the time of the requested infliximab infusion.

Certain specific agents and combinations are explicitly prohibited. The policy clarifies that Zeposia® is an agent that should not be used in combination with another biologic immunomodulator agent, and requests must document avoidance of such combinations. Providers should refer to the medical record to show that the requested infliximab product will not be given together with any disallowed agent.

Requests lacking the required medical record documentation or requesting doses that exceed FDA-labeled dosing or doses supported by recognized compendia may be considered not medically necessary. Medical records must support prior therapy trials, intolerances/contraindications, evidence of active disease when required, and justification for dosing above label or compendia limits.

Billing and Codes

Referenced HCPCS codesHCPCS

J1745	Infliximab (Remicade) HCPCS (listed for Remicade/Infliximab)
Q5104	infliximab-abda (Renflexis) HCPCS
Q5121	infliximab-axxq (Avsola) HCPCS
Q5103	infliximab-dyyb (Inflectra) HCPCS

Prior Authorization, Documentation, and Operational Steps

Prior Authorization

Prior Authorization Required

Prior authorization is required for infliximab (Remicade) and infliximab biosimilars. Providers must submit supporting medical record documentation showing required prior therapies, intolerance/contraindication documentation, and evidence of active disease or inflammation as specified for the requested indication. Applicable HCPCS/administration billing codes include: J1745, Q5104, Q5121, and Q5103.

Prior authorization required for infliximab (Remicade) and infliximab biosimilars
HCPCS codes: J1745, Q5104, Q5121, Q5103

Denial Risk

Requests Missing Updated Disease Demonstration May Be Denied

Requests that do not meet the updated disease-specific demonstration requirements may be denied. Examples include Crohn's disease (CD) or ulcerative colitis (UC) requests lacking documentation of moderately to severely active disease (symptoms of active disease plus objective evidence of active inflammation or high‑risk disease, significant extent/upper GI involvement on imaging/endoscopy, or corticosteroid-dependence/refractory status). Missing medical record documentation of prior therapy trials, intolerances, or positive clinical benefit from an existing biologic/systemic immunomodulator may also trigger denial.

Clinical and Policy Background

Infliximab (Remicade) and its biosimilars are intravenous tumor necrosis factor-alpha (TNF-α) inhibitors administered by infusion and indicated across multiple immune-mediated inflammatory diseases. These agents are used for conditions such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis, with some pediatric approvals for inflammatory bowel disease. The policy applies to infliximab and named biosimilars when given by a healthcare professional in an infusion setting and references FDA labeling, compendia-supported dosing, and required monitoring (including latent TB testing) as part of medical necessity determinations.

Definitions and Product List

Restricted products — infliximab and specified biosimilars

Primary branded productinfliximab (Remicade) intravenous infusion for administration by a healthcare professional

Biosimilar: Renflexisinfliximab-abda (Renflexis) intravenous infusion for administration by a healthcare professional

Biosimilar: Avsolainfliximab-axxq (Avsola) intravenous infusion for administration by a healthcare professional

Biosimilar: Inflectrainfliximab-dyyb (Inflectra) intravenous infusion for administration by a healthcare professional

Established on a biologic or systemic immunomodulator — continuation allowance

Allow continuation for established patientsFor RA, PS, PsA, AS, CD, and UC: patients currently established on an FDA‑approved biologic or systemic immunomodulator for the requested indication who have had positive clinical benefit may continue therapy (July 2026 change).

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyInfliximab (Remicade) and infliximab biosimilars notification policy

Policy CodePolicy N/A

Change TypeCriteria revisions and allowances (July 2026Nov 2025 site-of-care update)

Effective DateJuly 2026

Next Review DateN/A

SourceLink

On This Page

Step Therapy

Step Therapy Requirements

Step therapy requirements apply across many indications. In general, patients must have tried and had an inadequate response to specified conventional agents (typically ≥3 months) or demonstrate intolerance/contraindication to those agents as documented in the medical record. For some indications and per policy updates, patients currently established on an FDA‑approved biologic or systemic immunomodulator with documented positive clinical benefit are allowed to continue the requested infliximab product. For infliximab products specifically, prior step through preferred infliximab products (Avsola [Q5121] and Inflectra [Q5103]) is required before approval of Remicade or non‑preferred infliximab biosimilars unless documented intolerance, contraindication, or clinical rationale to bypass preferred products is provided.

Typical step therapy: trial of conventional agents ≥3 months (e.g., methotrexate titrated to 25 mg/week or other conventional DMARDs) with medical record documentation
Allowance: patients established on an FDA‑approved biologic/systemic immunomodulator with documented positive clinical benefit may bypass some step requirements per indication updates
Infliximab product step: preferred products Avsola (Q5121) and Inflectra (Q5103) generally required prior to Remicade or non‑preferred biosimilars unless intolerance/contraindication documented