Il 12 23 Inhibitor denied as non-formulary by Cigna?

Cigna requires prior authorization for ustekinumab (Stelara and biosimilars) and the same criteria apply across the IL-12/23 inhibitor class. The SC formulation is covered for Crohn's disease (CD), plaque psoriasis (PsO), psoriatic arthritis (PsA), and ulcerative colitis (UC), while the IV formulation is covered for CD and UC. Prior authorization is required for benefit coverage of ustekinumab intravenous, and approval is recommended only for those who meet the Criteria and Dosing for the listed indications. Initial therapy is approved for 6 months if criteria are met; continuation/re-authorization is approved for 1 year if the patient has been established on the drug for at least 3–6 months and continues to respond. The medication must be prescribed by or in consultation with a specialist in the condition being treated, and certain approvals are limited to 30 days when that is an adequate duration. Concurrent use with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition is not allowed because combination therapy is generally not recommended due to a potentially higher rate of adverse events and lack of controlled clinical data supporting additive efficacy , though conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) are not excluded. Through the Preferred Specialty Management program, the patient is required to meet the standard PA criteria and to try ALL of the Preferred Products prior to approval of a Non-Preferred Product. Pediatric dosing for PsA/PsO follows weight-based limits: pediatric patients ≥12 years weighing 60–100 kg receive 45 mg SC at Week 0, Week 4, then Q12W; those weighing <60 kg receive 90 mg SC at Week 0, Week 4, then Q12W.

- For step-therapy denials in IBD: AGA Clinical Guidelines on the Management of Moderate-to-Severe Ulcerative Colitis and Crohn's Disease support ustekinumab as a first-line biologic option, particularly in TNF-naïve patients; the UNITI-1, UNITI-2, IM-UNITI, and UNIFI pivotal trials demonstrated efficacy that does not require failure of every preferred product if medically inappropriate. - For psoriasis/PsA step-therapy denials: AAD-NPF Joint Guidelines (2019) and ACR/NPF PsA guidelines list ustekinumab as a recommended biologic; cite PHOENIX 1 & 2 (PsO) and PSUMMIT 1 & 2 (PsA) showing durable PASI 75 and ACR20 responses, supporting medical necessity when TNF inhibitors are contraindicated (e.g., demyelinating disease, CHF, latent TB risk). - For combination-therapy denials: cite that conventional synthetic DMARDs (methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) are NOT excluded from concurrent use , so co-prescription with MTX should not trigger denial. - For specialist-prescriber denials: provide attestation from a rheumatologist/GI/derm or documented consult note, satisfying the requirement that the medication be prescribed by or in consultation with a specialist . - For non-FDA indication denials in AS/nr-axSpA: cite the TOPAS open-label study which showed 65% of patients (95% CI: 41%, 85%) achieved an ASAS40 response at Week 24 , supporting off-label medical necessity when ACR/SPARTAN-recommended TNFi and IL-17 options have failed or are contraindicated. - For continuation/reauthorization denials: submit objective response data (PASI improvement, Mayo/CDAI reduction, HBI, joint counts) showing the patient meets the established-therapy criterion of established on the requested drug for at least 3 months . - For non-preferred biosimilar denials on Employer/IFP plans: request a formulary exception citing significant allergy/intolerance to inactive ingredients in preferred products, per documentation supporting that formulation differences in inactive ingredients would result in a significant allergy .

## Why Cigna Denies IL-12/23 Inhibitors as Non-Formulary

When Cigna places a biologic such as an IL-12/23 inhibitor on a non-formulary tier or excludes it from coverage entirely, the denial means the drug does not appear on the plan's preferred drug list for your benefit year. Cigna may instead prefer a competing biologic in the same class or in a related class (such as an IL-17 or TNF inhibitor) that the plan has negotiated preferred pricing for. Non-formulary denials are common for biologics and are not a clinical judgment — they are a coverage structure decision.

Despite being a formulary decision, non-formulary denials carry the same appeal rights as any other denial.

## Your Federal Appeal Rights

• Internal appeal (formulary exception): ACA §2719 and ERISA §503 require that plans provide a formulary exception process. You can request an exception on the grounds that every formulary alternative is contraindicated, has been tried and failed, or is clinically inferior for this patient's specific situation. Submit within the deadline on your denial notice.
• External review: If the exception request is denied internally, escalate to independent external review within the window described in your denial letter (typically within approximately four months of the final internal decision).
• Expedited pathway: Available if delay would seriously jeopardize health or ability to function.

## What to Gather Before You File

1. List of formulary alternatives: Obtain Cigna's current formulary and identify which biologics are preferred. Your prescriber needs to address each one. 2. Prescriber letter on formulary alternatives: For each Cigna-preferred alternative, the prescriber should document whether it has been tried (with dates and outcomes), is medically contraindicated for this patient, or is otherwise clinically inappropriate — citing the patient's chart, not just opinion. 3. Diagnosis and severity documentation: Chart notes confirming the condition, its severity, and why this specific mechanism of action (IL-12/23 inhibition) is medically appropriate. 4. Prior-treatment history: Dates, agents tried, outcomes, and reasons for discontinuation. 5. FDA label alignment: Confirm the prescribed IL-12/23 inhibitor is FDA-approved for the patient's condition. The label is a key document to include.

## Criteria-Mapping Structure

For a formulary exception, the standard is typically that the patient cannot achieve the same clinical outcome on a formulary drug. Map your evidence:

| Formulary Alternative | Tried? (Date/Outcome) | Contraindicated? | Clinically Inferior Reason | |---|---|---|---| | [Preferred biologic A] | [Yes/No — detail] | [Yes/No — basis] | [Chart reference] | | [Preferred biologic B] | [Yes/No — detail] | [Yes/No — basis] | [Chart reference] |

A complete table, backed by chart citations, gives the reviewer a clear basis for granting the exception. Incomplete responses are the leading cause of exception denials.