Infliximab (Remicade) and infliximab biosimilars notification policy
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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.
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.
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
RA detailed in chunk 4
PS detailed in chunks 5-6
PsA detailed in chunks 6-7
AS detailed in chunks 7-8
CD detailed in chunks 8-9
UC detailed in chunks 9-10
Chunk 11
Chunk 11
Chunk 12
Chunk 12-13
Chunk 11-12
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.
based on historical updates and policy text
July 2026 change
aligns with updated clinical guidelines; July 2026
aligns with updated clinical guidelines; July 2026
November 2025 update
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
Prior Authorization, Documentation, and Operational Steps
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.
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.
- CD/UC: must document moderately to severely active disease per policy requirements (symptoms + objective inflammation OR structural/extent criteria OR steroid-dependence)
- Requests lacking required medical record documentation may be denied
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
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
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