Il 12 23 Inhibitor denied as duplicate or overlapping therapy 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 an IL-12/23 Inhibitor as Duplicate Therapy — and Why That Denial Is Appealable

Cigna may issue a duplicate-therapy denial for an IL-12/23 inhibitor (such as ustekinumab) when another biologic or targeted therapy appears on your active medication list and the plan's utilization management system classifies both as treating the same condition. This most commonly arises when a patient is transitioning between biologics, when a second biologic is being added for a comorbid condition (for example, psoriasis and Crohn's disease simultaneously), or when an older agent remains in the claims history even though it has been discontinued.

A duplicate-therapy denial for an IL-12/23 inhibitor is clinically contestable because the mechanism of action — targeting the p40 subunit shared by interleukin-12 and interleukin-23 — is pharmacologically distinct from TNF inhibitors, IL-17 inhibitors, IL-23 selective inhibitors, and other biologic classes. Treating mechanistically distinct agents as duplicates misapplies the duplicate-therapy concept and ignores the clinical rationale for biologic selection.

## Your Federal Appeal Rights

• ACA §2719: Non-grandfathered plans must offer internal appeals and binding external review by an accredited IRO.
• ERISA §503: Employer-sponsored plan members are entitled to a full-and-fair review with access to the clinical criteria used.
• Timeline: File your internal appeal within 180 days of the denial notice. External review is generally available for approximately four months after exhausting internal remedies. Expedited review (72 hours) is available when delay would seriously harm your health — for example, in active moderate-to-severe Crohn's disease flare or rapidly worsening plaque psoriasis.

## Documentation to Gather Before You Appeal

1. Active medication reconciliation — a current, dated medication list from your prescriber confirming which biologics are actually active versus discontinued, with stop dates for any prior agents. 2. Diagnosis documentation — specialist notes confirming the diagnosis (and any comorbid conditions) for which the IL-12/23 inhibitor is prescribed. 3. Prior biologic history — for each biologic previously or concurrently used, provide the drug name, mechanism class, dates of use, clinical response, and reason for change or transition. 4. Prescriber letter — your physician should explain the mechanistic distinction between the IL-12/23 inhibitor and any other agent Cigna identified as duplicative, and state why the clinical situation warrants this specific agent. 5. FDA prescribing label and Cigna's coverage policy — confirm the approved indication matches your diagnosis; obtain Cigna's published coverage criteria and address each requirement.

## Criteria-Mapping Structure

Open your appeal with a clear statement of which drugs Cigna flagged as duplicative and why they are not. Use a mechanism-of-action comparison table if your prescriber can provide one. Then map your clinical facts to Cigna's coverage criteria in a two-column table. Attach the medication reconciliation and prior-treatment history as numbered exhibits.