Il 12 23 Inhibitor denied for missing prior authorization 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 Requires Prior Authorization for IL-12/23 Inhibitors

Cigna, like most major insurers, requires prior authorization (PA) before approving high-cost biologics such as IL-12/23 inhibitors. A "prior-auth-required" denial means a claim was submitted — or a PA request was filed — without the information Cigna needs to evaluate whether the drug meets its coverage criteria. This is one of the most common biologic denials and is frequently resolved on appeal or through a complete PA resubmission.

The denial is not a final coverage decision. It is an administrative gate, and it is fully appealable.

## Your Federal Appeal Rights

• Internal appeal: ACA §2719 and ERISA §503 guarantee the right to a full-and-fair internal review. File a written appeal, including all clinical documentation, within the deadline on your denial letter.
• External review: If the internal appeal fails, independent external review is available. The standard window is within approximately four months of the final internal adverse determination. An IRO — not affiliated with Cigna — reviews the case.
• Expedited review: When your clinical situation is urgent, request expedited processing. Expedited internal reviews are typically decided within 72 hours or less; expedited external reviews follow a similar abbreviated timeline.

## What to Gather Before You File

1. The denial letter and PA determination: Read the denial carefully — it must state exactly which criteria were not met or which information was missing. Your appeal addresses those points specifically. 2. Cigna's current coverage policy: Obtain the current medical coverage policy for the prescribed IL-12/23 inhibitor from Cigna's website. This lists every PA criterion you must document. 3. FDA-approved prescribing information: Confirm the drug is being prescribed for an FDA-approved indication that matches the patient's confirmed diagnosis. 4. Prescriber medical-necessity letter: A detailed letter addressing each PA criterion by name, citing specific chart entries, dates, and clinical findings. 5. Diagnosis and severity documentation: Objective clinical findings supporting the diagnosis and its severity as documented in the treating specialist's notes. 6. Prior-treatment history: A complete dated log of all previously tried therapies, doses attempted (per the prescriber's records), and specific documented outcomes.

## Criteria-Mapping Structure

PA appeals succeed when every criterion is answered. Obtain the PA criteria from your denial letter and Cigna's policy, then complete this structure:

| PA Criterion | Met? | Chart Evidence (Date, Note Type) | |---|---|---| | Confirmed diagnosis by appropriate specialist | Yes/No | [Reference] | | Documented failure of required step-therapy agents | Yes/No | [Reference] | | Disease severity meets policy threshold | Yes/No | [Reference] | | Prescribed by qualifying provider type | Yes/No | [Reference] | | No active contraindication per prescriber | Yes/No | [Reference] |

Leave no row blank. A single unanswered criterion is often the sole reason an appeal is overturned.