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

## UnitedHealthcare Non-Formulary Denial of Remicade — Anchoring the Appeal to the Biosimilar-Preference NQTL

UHC's 02.01.2026 Commercial Medical Benefit Drug Policy for infliximab is the controlling document, and a non-formulary denial of Remicade is mechanically driven by a single sentence in that policy: Avsola and Inflectra are the preferred infliximab products, and Remicade is reachable only through three narrow exception pathways. Treating this as a generic formulary fight wastes the appeal — the denial is a step-therapy / biosimilar-substitution NQTL governed by 29 CFR §2590.712 and, for fully-insured plans, the carve-out at 29 USC §1185d permitting override when stability or contraindication is documented.

The appeal must therefore satisfy one of UHC's three exception keys verbatim: (1) at least 14 weeks of Inflectra or Avsola with minimal clinical response (document trough levels, CRP/fecal calprotectin, Mayo/CDAI/PASI scores, and Antibodies-to-Infliximab assays — UHC's medical reviewers at OptumRx specialty (the Optum Frontier Therapies / BriovaRx channel for J1745 buy-and-bill) reject narrative "didn't work" language without serology); (2) a physician attestation of expected superior response with Remicade — this is the cleanest lever for patients stabilized on Remicade pre-policy, paired with citations to Pinto v. Aetna, 740 F.3d 1297 (10th Cir. 2014), which places the burden on the plan to substantiate non-coverage when the treating physician has rendered a reasoned clinical judgment; or (3) intolerance/contraindication with attestation that the same adverse event would not recur with the originator (most defensible where the AE is excipient-mediated — polysorbate 80 concentration and citrate buffer differ between Remicade and the biosimilars).

Indication-specific gating still applies on appeal. For AS, attach NSAID failure logs (two agents, ≥4 weeks each at maximal dose) or prior TNF/IL-17 use. For plaque psoriasis, document ≥3% BSA or palmoplantar/facial/genital involvement plus topical failure. Confirm latent TB testing (QFT-Gold or T-SPOT) is in the chart — UHC auto-denies on missing TB screen even when substantive criteria are met. Confirm no concurrent systemic targeted immunomodulator.

Tactical closer: Submit the appeal via the OptumRx Provider Portal for pharmacy-billed conversions, or through UHC Provider Portal (Prior Authorization and Notification tool) for medical-benefit J1745 buy-and-bill — the wrong channel triggers a 14-day routing delay that often blows the ERISA 30-day urgent clock under 29 CFR §2560.503-1(f)(2)(i). If denied at Level 2, escalate simultaneously to the state DOI (for fully-insured plans) and request an IRO external review citing NQTL parity disparity between the biosimilar mandate and analogous medical-surgical stability protections.