Remicade (infliximab) denied for failing step therapy by UnitedHealthcare?

This UnitedHealthcare commercial policy (effective 02.01.2026) addresses the use of infliximab products including Avsola, Inflectra, Remicade, and Renflexis , and applies to billing codes J1745, Q5103, Q5104, and Q5121 . UHC designates Avsola and Inflectra as the preferred infliximab products for UHC commercial plans , and members already on Remicade, Renflexis, or other non-preferred infliximab product will be required to change therapy to Inflectra or Avsola unless they meet the exception criteria . To obtain Remicade specifically, the policy requires documentation of a trial of at least 14 weeks of Inflectra or Avsola resulting in minimal clinical response, OR a physician attestation that in their clinical opinion the clinical response would be expected to be superior with Remicade than with Inflectra and Avsola , or alternatively documentation of intolerance, contraindication, or adverse event to the preferred biosimilars with a physician attestation that the same event would not be expected to occur with Remicade . Indication-specific criteria require disease-appropriate step therapy — for example, ankylosing spondylitis requires history of failure to two NSAIDs at maximally indicated doses, each used for at least 4 weeks, unless contraindicated, or prior treatment with a systemic targeted immunomodulator FDA-approved for ankylosing spondylitis ; plaque psoriasis requires greater than or equal to 3% body surface area involvement, or palmoplantar, facial, or genital involvement plus failure of a topical therapy. Patients must not be receiving infliximab in combination with another systemic targeted immunomodulator (e.g., adalimumab, Cimzia, Enbrel, Orencia, Simponi, Rinvoq, Xeljanz) for treatment of the same indication , and dosing must be according to FDA-labeled dosing for the indication . Prior authorization is required, and the policy notes the patient must not have FDA-labeled contraindications and must be tested for latent TB per prescribing information, with treatment begun if positive .

- For forced biosimilar switching: cite the ACR position that coverage for non-preferred products should consider patient-specific exception criteria, and ACR has urged UHC to allow existing patients to continue on their current medication and proposed additional exception criteria for patient protection ; also reference AGA's negotiated exceptions that adult patients currently on induction of Remicade for less than 18 months will not be required to switch, and adult patients having a flare of active disease, and hence are not stable, will not be required to switch - For pediatric IBD denials of Remicade continuation: cite United's agreement to modify its coverage policy to allow pediatric patients 16 years of age and younger currently on Remicade to remain on Remicade if that is the recommendation of the treating physician , supported by NASPGHAN/AGA/ACG/ASGE consensus - For step therapy in Crohn's disease: cite the ACG Clinical Guideline for Crohn's Disease in Adults and AGA Care Pathway recommending early anti-TNF therapy for moderate-to-severe disease and high-risk features (fistulizing, stricturing, perianal, young age at diagnosis) — aligns with UHC's own high-risk criteria language - For step therapy in rheumatoid arthritis: cite the 2021 ACR Guideline for RA Treatment supporting biologic DMARDs (including TNFi) after inadequate response to methotrexate; for ankylosing spondylitis cite the 2019 ACR/SAA/SPARTAN AS Guideline strongly recommending TNFi after NSAID failure - For plaque psoriasis criteria: cite the AAD-NPF 2019 Guidelines of Care for the Management of Psoriasis with Biologics supporting infliximab for moderate-to-severe disease and special-site involvement (palmoplantar, facial, genital), matching UHC's BSA/special-site criteria - For non-medical switching/efficacy concerns: cite the NOR-SWITCH randomized controlled trial (Jørgensen et al., Lancet 2017) demonstrating non-inferiority of CT-P13 biosimilar to originator infliximab — but conversely, a documented loss of response or infusion reaction on a biosimilar meets UHC's own exception pathway for Remicade - For concomitant biologic denial: clarify in the appeal that the patient is transitioning therapies (not on simultaneous biologics) with appropriate washout, addressing UHC's combination-therapy exclusion language

## Why UnitedHealthcare Requires Step Therapy for Infliximab (Remicade) — and Why You Can Challenge It

UnitedHealthcare's standard approach to biologic therapy for inflammatory conditions requires that patients try and fail one or more preferred agents — typically conventional immunosuppressants and sometimes a different biologic — before infliximab will be authorized. This is called step therapy, and the denial means UHC believes the required prior steps have not been documented to its satisfaction.

Step-therapy denials are among the most successfully appealed coverage decisions. The core argument is that the required prior steps have already been completed, are clinically contraindicated, or are inappropriate given the patient's specific condition and disease course. Most states also have "step-therapy override" laws requiring insurers to waive the protocol when a patient has already tried the required drug, when it is contraindicated, or when the treating physician documents that the required therapy is unlikely to be effective.

## The Federal Appeal Framework

• Internal appeal: Submit within 180 days of denial. UHC must decide within 30 days for pre-service appeals and 60 days for post-service.
• External review (ACA §2719): Available after final internal denial, or after 72 hours in urgent situations. An independent reviewer examines whether UHC's step-therapy protocol is medically appropriate as applied to your case. The standard window is approximately 4 months from the final denial.
• ERISA §503: Employer-plan members are entitled to full disclosure of the specific step-therapy criteria applied and a meaningful opportunity to respond.
• State override: If your plan is subject to state insurance law (not a self-funded ERISA plan), check whether your state has a step-therapy override statute — many now require insurers to grant exceptions within a defined timeframe.

## Documentation to Gather

• Prior therapy records: Dated prescriptions, pharmacy records, infusion logs, or physician notes showing every prior agent tried, the duration of treatment, and the clinical outcome or reason for discontinuation.
• Intolerance or contraindication evidence: If a required prior drug cannot be used, obtain a physician letter citing the specific clinical reason, supported by chart notes or lab results.
• Specialist opinion: A rheumatologist, gastroenterologist, or other relevant specialist letter explaining why infliximab is the appropriate choice given the patient's disease history and why the step-therapy sequence is not appropriate in this case.
• Disease severity documentation: Current clinical markers, imaging, or procedural findings showing active disease that requires treatment without further delay.
• UHC's step-therapy protocol: Request the exact version of UHC's Coverage Determination Guideline that was applied to this denial, including the list of required prior drugs.

## Criteria-Mapping Strategy

Obtain UHC's published step-therapy criteria and list each required prior step. For each step, provide documented evidence showing it was completed, is contraindicated, or is clinically inappropriate. If the protocol was followed and the patient still failed, make that explicit with dates and outcomes. If asking for an override, frame the letter around the clinical-exception standard in UHC's own policy language, and reference the applicable specialist society guideline organization (e.g., ACR, AGA, or ECCO) that supports direct use of infliximab in your patient's clinical situation.