Il 12 23 Inhibitor denied due to quantity / dose limits 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 Applies Quantity Limits to IL-12/23 Inhibitors

Cigna imposes quantity limits on IL-12/23 inhibitors to align dispensing to the dosing regimen specified in the FDA-approved prescribing information and to the plan's coverage policy. A quantity-limit denial typically means the amount prescribed or dispensed — whether measured in vials, syringes, pens, or days' supply — exceeds what Cigna's system will approve without additional review. This can happen for several reasons: the prescribed quantity reflects a loading-dose schedule, a weight-based adjustment, or an off-cycle fill that Cigna's automated system did not recognize.

Quantity-limit denials are fully appealable.

## Your Federal Appeal Rights

• Internal appeal: Under ACA §2719 and ERISA §503, submit a written internal appeal within the deadline on your denial notice. The appeal must include clinical justification for the quantity prescribed.
• External review: If the internal appeal is denied, you may request independent external review within approximately four months of the final internal adverse decision.
• Expedited option: If running out of medication would seriously jeopardize your health, request expedited review — typically resolved within 72 hours or fewer.

## What to Gather Before You File

1. The FDA-approved prescribing information: The label specifies the approved dosing regimen, including any induction/loading-dose schedules and maintenance dosing. If the quantity prescribed is consistent with the label, cite this directly in your appeal. 2. Prescriber letter explaining the prescribed quantity: The prescriber should document why the quantity ordered aligns with the FDA label and the patient's clinical needs — for example, whether an induction schedule, a dose adjustment for clinical response, or a supply-period alignment is involved. 3. Pharmacy dispensing record: The fill history showing what has been dispensed and when, to clarify that no duplicate supply is being requested. 4. Cigna's current quantity-limit policy: Obtain the specific quantity-limit table from Cigna's coverage policy for this drug so your prescriber can address exactly where the discrepancy lies. 5. Clinical chart notes: Notes documenting treatment response, dose rationale, and any clinical reason for a quantity that differs from a simple 28- or 30-day maintenance fill.

## Criteria-Mapping Structure

Quantity-limit appeals focus on demonstrating that the quantity requested is medically justified and label-consistent:

| Issue | Your Response | Supporting Document | |---|---|---| | FDA label permits requested quantity/schedule | [Yes — cite label section] | FDA prescribing information | | Prescriber documents clinical rationale | [Rationale summary] | Prescriber letter (date) | | No duplicate supply exists | [Confirm last fill date] | Pharmacy dispensing record | | Cigna policy allows exception for this circumstance | [Cite policy provision] | Cigna coverage policy |

A concise, document-backed appeal that ties the quantity to the FDA label is the most efficient path to overturning a quantity-limit denial.