Il 12 23 Inhibitor denied for failing step 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 IL-12/23 Inhibitors on Step-Therapy Grounds

Step-therapy (sometimes called "fail-first") means Cigna requires patients to try and fail one or more less-expensive or lower-tier therapies before it will approve a biologic like an IL-12/23 inhibitor. In practice this often means trying a conventional systemic agent (such as a traditional immunosuppressant or a first-line biologic in a related class) before Cigna will authorize this drug. A step-therapy denial usually means Cigna's records do not reflect an adequate trial of the required predecessor therapy — even when one occurred.

Step-therapy denials are among the most frequently overturned on appeal, particularly when prior treatment history is well-documented.

## Your Federal Appeal Rights

• Internal appeal: ACA §2719 and ERISA §503 require a full-and-fair internal appeal. Several states also have step-therapy override laws that require insurers to grant exceptions when certain clinical criteria are met; check whether your state's law applies to your plan type.
• External review: After an adverse internal decision, independent external review is available. File within approximately four months of the final internal denial.
• Expedited option: Request expedited review if waiting for the standard timeline would seriously harm your health.

## What to Gather Before You File

1. Cigna's step-therapy protocol for this drug: Obtain the current published coverage policy, which will list exactly which agents must be tried and the required duration or outcome criteria. Your appeal addresses each required step explicitly. 2. Prior-treatment history (most important document): A complete dated log — prepared or confirmed by the prescriber — listing every relevant therapy tried, the specific time period, the clinical response or lack thereof, and the exact reason for discontinuation. Pharmacy records or EOBs can corroborate. 3. Prescriber medical-necessity letter: The prescriber explains why each required predecessor therapy was inadequate (inefficacy, intolerance, contraindication per the prescriber's clinical judgment) or why proceeding directly to the IL-12/23 inhibitor is medically necessary, citing the applicable specialty society guideline organization. 4. Diagnosis and severity documentation: Objective evidence that the condition warrants biologic therapy and that the patient's current severity reflects inadequate disease control. 5. FDA prescribing information: Confirms the prescribed drug is approved for the patient's condition.

## Criteria-Mapping Structure

For each step Cigna requires, provide a direct answer:

| Required Step-Therapy Agent | Duration Required by Policy | Documented Trial (Dates) | Outcome / Reason Not Used | |---|---|---|---| | [Step 1 agent per Cigna policy] | [Per policy] | [Start–End date from chart/Rx] | [Inadequate response / intolerance / contraindication] | | [Step 2 agent per Cigna policy] | [Per policy] | [Start–End date from chart/Rx] | [Inadequate response / intolerance / contraindication] |

If a required step agent was never tried because the prescriber determined it was contraindicated or inappropriate, document that clinical judgment explicitly in the prescriber's letter, citing the chart.