CurrentBaylor Scott & White Health PlanPolicy 239

Infliximab Products (including biosimilars)

Defines prior authorization and medical necessity criteria for infliximab and infliximab biosimilar products for Baylor Scott & White Health Plan members; applies to medical benefit administration across plan types.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyInfliximab Products (including biosimilars)

Policy CodePolicy 239

Change TypeNo material change

Effective DateSep 1, 2025

Next Review DateAug 11, 202658d

Key ActionPrior authorization required for nonpreferred infliximab biosimilars unless patient meets trial/intolerance and attestation criteria; preferred products (Renflexis, Remicade, unbranded infliximab) do not require prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3preferred infliximab products named

4nonpreferred biosimilars listed

5HCPCS codes included

09/01/2025policy effective

Coverage Criteria for Infliximab Biosimilars

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 criteria for use of nonpreferred infliximab biosimilars

BSWHP may find it medically necessary to use a nonpreferred infliximab biosimilar instead of preferred products when ALL of the following condition groups are satisfied:

Root

Primary justification (one required)
- Option a: Both of the following: (i) History of a trial of at least 14 weeks of preferred agents resulting in minimal clinical response and residual disease activity; AND (ii) Physician attests clinical response would be expected to be superior with the nonpreferred biosimilar compared with preferred agents.14 weeks
  Physician attestation required
- Option b: Both of the following: (i) History of intolerance or adverse event to preferred agents; AND (ii) Physician attests the same intolerance/adverse event would not be expected with the nonpreferred biosimilar.
  Physician attestation required
Additional required conditions (all must be true): All of the following must be true: (a) Patient has NOT had a loss of favorable response after established maintenance therapy with preferred agents; AND (b) Patient has NOT developed neutralizing antibodies to any infliximab product that led to attenuation of efficacy; AND (c) Patient has not previously been stable on a preferred agent and switched to a nonpreferred infliximab biosimilar product.
These are exclusionary conditions

Operational note: This coverage determination is in addition to medical policy #215 (Medications Covered Under Medical Insurance Policy).

The policy excludes members who have experienced loss of a previously favorable clinical response during established maintenance therapy with preferred infliximab products. It also excludes members who have developed neutralizing antibodies to any infliximab product that led to attenuation of efficacy. Additionally, patients who were previously stable on a preferred infliximab agent and then switched to a nonpreferred infliximab biosimilar are not eligible under the conditions that would support approval of a nonpreferred product.

Use of a nonpreferred infliximab biosimilar is allowed only when the policy’s trial or intolerance criteria and required physician attestation have been satisfied. Requests that do not document either: (1) a history of a trial of preferred agents for at least 14 weeks demonstrating minimal clinical response with residual disease activity plus a physician attestation that clinical response is expected to be superior with the nonpreferred biosimilar, or (2) documented intolerance/adverse event to preferred agents with physician attestation that the same intolerance is not expected with the nonpreferred biosimilar, do not meet the policy requirements and are not supported. In addition, the additional continuation/stability conditions (no prior loss of favorable response, no neutralizing antibodies causing attenuation, and no prior stable preferred-agent-to-nonpreferred switch) must be satisfied.

Initial Therapy Requirements

Initial therapy requirements for nonpreferred biosimilars

Initial therapy for nonpreferred biosimilar: Prior to approving a nonpreferred infliximab biosimilar, the patient must have a trial of preferred infliximab products for at least 14 weeks with minimal clinical response, OR documented intolerance/adverse event to preferred agents with physician attestation; additional policy conditions must also be satisfied.14 weeks

Physician attestation required

Continuation / Stability Requirements

Continuation / stability requirements for ongoing therapy with infliximab products

Continuation / stability conditions

Continuation stability: Patient must NOT have had loss of a favorable response after established maintenance therapy with preferred agents; must NOT have developed neutralizing antibodies to any infliximab product that have led to attenuation of efficacy; and must NOT have been previously stable on a preferred agent and then switched to a nonpreferred infliximab biosimilar.

These conditions preclude switching to a nonpreferred biosimilar

Provider Actions, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Renflexis™, Remicade®, and unbranded infliximab do NOT require prior authorization. All other infliximab biosimilar products require prior authorization. For Medicare, follow applicable NCD/LCD; if none, see medical policy #215. For Medicaid, confirm Texas Medicaid guidance (TMPPM) and HB154 where applicable.

Preferred products (no prior authorization): Renflexis™ (infliximab-abda), Remicade® (infliximab), unbranded infliximab
All other infliximab biosimilars: prior authorization required

Step Therapy

Step / Trial Requirements

BSWHP requires a documented trial of preferred infliximab agents before approving a nonpreferred infliximab biosimilar unless criteria for intolerance/adverse event or physician attestation of superior expected response are met.

Required trial: at least 14 weeks of therapy with preferred agents with minimal clinical response and residual disease activity
Denial triggers include: prior loss of favorable response on preferred maintenance therapy; development of neutralizing antibodies to any infliximab product leading to reduced efficacy; prior stability on a preferred agent followed by a switch to a nonpreferred biosimilar

Documentation Required

Required Documentation

Documentation must include clinical details supporting the request and a physician attestation addressing intolerance/response history and expected clinical benefit with the requested nonpreferred biosimilar.

Physician attestation that either: (a) after ≥14 weeks on preferred agents the patient had minimal clinical response and the physician expects superior response with the nonpreferred biosimilar; OR (b) the patient had an intolerance/adverse event to preferred agents and the physician attests the same intolerance would not be expected with the nonpreferred biosimilar
Clinical documentation of trial dates, treatment response, adverse events/intolerance, and any antibody testing or other relevant labs
For approvals, documentation must also show that the patient has NOT had loss of favorable response during established maintenance with preferred agents, has NOT developed neutralizing antibodies that attenuated efficacy, and was NOT previously stable on a preferred agent and then switched to a nonpreferred infliximab biosimilar

Denial Risk

Denial Triggers for Nonpreferred Infliximab Biosimilars

Requests lacking the required trial, physician attestation, or supporting clinical documentation are likely to be denied.

Missing physician attestation addressing expected superior response or intolerance rationale
No documentation of ≥14-week trial and minimal clinical response for step requirement
Evidence of prior loss of response on preferred maintenance therapy, presence of neutralizing antibodies causing attenuation, or prior stability on a preferred agent with subsequent switch to a nonpreferred biosimilar

Step Therapy Requirements

Step	Requirement	Duration / Threshold	Documentation required
1
Trial of preferred infliximab products (Renflexis, Remicade, or unbranded infliximab) prior to approval of a nonpreferred infliximab biosimilar unless documented intolerance
>= 14 weeks when trial pathway is used (minimal clinical response to preferred agents required)
Physician attestation of trial duration and that clinical response would be expected to be superior with the nonpreferred biosimilar; or attestation documenting intolerance/adverse event to preferred agents and that the same adverse event would not be expected with the nonpreferred biosimilar

Coding — HCPCS / Billing Codes

HCPCS CodesHCPCS

J1745	Injection, infliximab, excludes biosimilar, 10 mg
Q5103	Injection, infliximab-dyyb, biosimilar (Inflectra), 10 mg
Q5104	Injection, infliximab-abda, biosimilar (Renflexis), 10 mg
Q5109	Injection, infliximab-qbtx, biosimilar (Ixifi), 10 mg
Q5121	Injection, infliximab-axxq, biosimilar (Avsola), 10 mg

Preferred and Nonpreferred Biosimilars

Billing Rule

Preferred infliximab products and PA for other biosimilars

Renflexis, Remicade, and unbranded infliximab are the preferred infliximab products for BSWHP; other infliximab biosimilars require prior authorization and must meet the policy's additional criteria.

Preferred products named: Renflexis (infliximab‑abda), Remicade (infliximab), and unbranded infliximab.
Nonpreferred biosimilars (e.g., Avsola, Inflectra, Ixifi) require prior authorization and coverage criteria.

Background

Infliximab is a genetically engineered chimeric human/mouse monoclonal antibody that targets tumor necrosis factor alfa (TNF‑alpha), a key pro‑inflammatory cytokine. It is used as a TNF‑alpha inhibitor across multiple inflammatory diseases, with biosimilar products developed to be highly similar to the reference product. The policy lists several infliximab biosimilars and identifies preferred infliximab products for the plan.

Definitions

Biosimilar — definition and related terms

Definition of biosimilarA biological product approved based on data demonstrating high similarity to an FDA-approved reference product with no clinically meaningful differences.

Examples of infliximab biosimilarsAvsola (infliximab-axxq); Inflectra (infliximab-dyyb); Ixifi (infliximab-qbtx); Renflexis (infliximab-abda).

Reference productRemicade (infliximab) and unbranded infliximab are the FDA‑approved reference products to which the listed biosimilars are compared.

Clinical equivalence implicationBiosimilars are highly similar to the reference product with no clinically meaningful differences in safety, purity, or potency per FDA biosimilarity standards.

Therapeutic contextInfliximab and its biosimilars target TNF‑alpha and are used across inflammatory conditions such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.