Remicade (infliximab) denied as non-formulary 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 May Deny Remicade (Infliximab) as Non-Formulary

UnitedHealthcare's pharmacy or medical benefit formulary may exclude Remicade (infliximab) outright, place it on a restricted tier, or prefer a biosimilar infliximab product in its place. A non-formulary denial means the specific product as submitted does not appear on the covered drug list for the patient's plan, or appears only with conditions (such as prior authorization or step-through a preferred alternative) that were not met at the time of the claim.

## Why This Denial Is Appealable

Non-formulary denials are appealable through a formulary exception process. Under federal law and most plan documents, patients have the right to request a formulary exception when a covered formulary alternative would be medically inappropriate or clinically inferior for their specific situation. If there is a documented clinical reason why the patient cannot use the formulary-preferred product — prior failure, intolerance, a clinical characteristic that distinguishes branded Remicade from a biosimilar in this patient's case — the exception can be granted.

## Federal Appeal Framework

• Internal appeal / formulary exception: ACA §2719 and ERISA §503 establish the right to a full-and-fair review. Many plans have a parallel formulary exception pathway; use both simultaneously.
• External review: After a final internal denial, an independent external review is available within approximately four months. External reviewers assess whether the non-formulary product is medically necessary given the alternatives available.
• Expedited review: Available when delay would seriously jeopardize health. Request simultaneously with standard appeal.

## Documentation to Gather

1. UHC formulary for the patient's plan year — confirm which infliximab products are on the formulary, at what tier, and what conditions apply. Identify the preferred alternative UHC would cover. 2. Prescriber letter explaining product specificity — if the prescriber has a clinical reason for branded Remicade over a biosimilar (e.g., prior documented response, stability on current product, a clinical characteristic relevant to this patient), that must be articulated in detail. 3. Prior-treatment history — if the patient has previously tried the formulary-preferred alternative and failed, or experienced an adverse event, provide dated records. 4. Diagnosis and disease-stability documentation — chart notes showing current disease status and the clinical rationale for continuing or initiating Remicade specifically.

## Criteria-Mapping Structure

| Non-Formulary Exception Criterion (from UHC policy) | Patient-Specific Response | |---|---| | Preferred formulary alternative identified | Name of UHC-preferred product | | Reason preferred alternative is inappropriate | Clinical rationale from prescriber + chart evidence | | Prior trial of preferred alternative (if required) | Dated records of prior use and outcome | | Any additional exception criteria | Corresponding documentation |

If the plan is a fully-insured plan, also check your state insurance department's rules — many states require insurers to have expedited formulary exception processes with defined turnaround times that may be faster than the standard internal appeal timeline.