Remicade (infliximab) denied as not FDA-approved for this use 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 denies Remicade as "not FDA-approved"

When UHC's commercial medical benefit issues a "not FDA-approved" denial on Remicade (J1745) — rather than a step-therapy or non-preferred-biosimilar denial — the reviewer is almost always anchoring on one of three labeling triggers buried in the Infliximab (Avsola®, Inflectra®, Remicade®, & Renflexis®) – UnitedHealthcare Commercial Medical Benefit Drug Policy (eff. 02.01.2026): (1) the indication is off-label (e.g., hidradenitis suppurativa, sarcoidosis, Behçet's, pyoderma gangrenosum, Takayasu arteritis); (2) dosing exceeds the FDA label (>10 mg/kg or intervals shorter than q4wk for IBD escalation); or (3) the regimen pairs infliximab with another targeted immunomodulator for the same indication, which the policy expressly forbids and which falls outside any FDA label.

The policy is explicit: "dosing must be according to FDA-labeled dosing for the indication" and the patient must "not be receiving infliximab in combination with another systemic targeted immunomodulator… for treatment of the same indication." Optum (UHC's PBM) routes Remicade through the medical benefit, not pharmacy, so the appeal channel is the UHC Provider Portal medical PA reconsideration — not OptumRx formulary exception. Submitting through the wrong channel produces a 30-day round-trip and a duplicate denial.

The regulatory hook for an off-label fight is Pinto v. Aetna Life Insurance Co., 2014 WL 7404059 (10th Cir.), which under ERISA places the burden on the plan to substantiate an "experimental/investigational" or "not medically necessary" finding with evidence — not on the member to disprove it. Pair that with 29 CFR §2560.503-1(g)(1)(v)(A): UHC must, on request, disclose the specific internal rule, guideline, or clinical protocol relied on. Demand the MCG/InterQual citation, the UHC Medical Policy version, and the reviewing physician's specialty match (29 CFR §2560.503-1(h)(3)(iii) — same or similar specialty for adverse benefit determinations).

For self-funded ERISA plans this is the entire battlefield. For fully insured commercial plans, escalate after the second-level internal denial to your state DOI (in NY, the DFS external appeal under Insurance Law §4914 forces an IRO review within 30 days; in Texas, an IRO under TIC §4202). For ACA-marketplace UHC plans, invoke 45 CFR §156.122(c) formulary exception — UHC must grant access if the prescriber attests the preferred drugs would be ineffective or harmful.

Tactical tip: Frame the appeal letter around peer-reviewed off-label evidence (NCCN Compendium, AHFS, DrugDex Level 2B or higher — UHC's own policy recognizes compendia for off-label coverage under §1861(t)(2) analog language). Cite the specific compendium entry, attach the full-text supporting RCT, and request a peer-to-peer with a board-certified specialist in the treating discipline. If UHC assigns a non-specialist reviewer, that itself is an ERISA §503-1(h)(3)(iii) violation and grounds for de novo review in federal court.