Skyrizi Denied by Insurance? How to Appeal

Skyrizi (risankizumab-rzaa) is an IL-23 inhibitor approved by the FDA for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. At $80,000 to $100,000 per year, it is one of the most expensive biologics — and one of the most frequently denied. Insurance denials most commonly involve step therapy requirements, severity threshold documentation, and non-preferred biologic designations. All of these are challengeable with the right clinical evidence.

Why Insurers Deny Skyrizi

TNF inhibitor step therapy required. Most commercial plans require trial and failure of TNF inhibitors — adalimumab biosimilars, etanercept, infliximab biosimilars — before approving IL-23 inhibitors like Skyrizi. This requirement can be challenged when head-to-head clinical data shows Skyrizi's superiority to the required step therapy agents.

Prior IL-17 inhibitor step required for psoriasis. Some plans require failure of an IL-17 inhibitor (secukinumab/Cosentyx, ixekizumab/Taltz) before approving IL-23 inhibitors. Document clinical reasons why IL-17 inhibitors are inadequate or contraindicated for your patient.

Severity criteria not documented. Plans require documented moderate-to-severe disease: for psoriasis, BSA (Body Surface Area) at least 10%, IGA score at least 3, or PASI score at least 10; plus documented inadequate response to conventional systemic therapies (methotrexate, cyclosporine, acitretin). If severity scores are not explicitly documented with dates, the authorization will be denied.

Non-preferred IL-23 biologic designation. Your plan may prefer guselkumab (Tremfya) or tildrakizumab (Ilumya) over Skyrizi as the formulary IL-23 inhibitor. A clinical justification for the prescriber's selection of Skyrizi over the preferred IL-23 alternative is needed to overcome the non-preferred designation.

Inadequate documentation of prior therapy failure. For Crohn's disease and ulcerative colitis indications, insurers require documented failure of conventional therapy (corticosteroids, azathioprine, 6-MP) and typically prior anti-TNF failure. The documentation must specify agents, doses, duration, and reason for failure or intolerance.

How to Appeal a Skyrizi Denial

Step 1: Document Disease Severity with Validated Measures

For psoriasis: record BSA percentage, IGA score, PASI score (or simplified PASI), DLQI score (a score of 11 or higher indicates large effect on quality of life), and whether special sites are involved (hands, feet, face, scalp, genitalia, nails — involvement of these areas supports severity even if BSA is below 10%). For psoriatic arthritis: record swollen joint count, tender joint count, DAS28-CRP, DAPSA, or PASDAS, and assess for enthesitis and dactylitis. For Crohn's disease: CDAI score, Harvey-Bradshaw Index, CRP, fecal calprotectin, and endoscopic findings.

Step 2: Document Prior Therapy Failures in Detail

For each prior therapy trial, document: drug name, dose, duration, dates of use, and reason for failure (inadequate efficacy, intolerance, contraindication). For biologics, include reason for switching. "Failed Humira" is insufficient; "Adalimumab 40 mg biweekly from [date] to [date] — discontinued for inadequate PASI response, PASI 50 not achieved at week 12" is the documentation standard.

Step 3: Use Head-to-Head Clinical Data to Challenge TNF Step Therapy

If the plan requires adalimumab biosimilar first, cite the IMMvent and UltIMMa-1/2 trial data: risankizumab demonstrated statistically superior PASI 90 response rates (74% versus 54% in IMMvent, p<0.001) and PASI 100 response rates versus adalimumab in head-to-head comparisons. Requiring a patient to fail a drug that has been demonstrated in randomized clinical trials to be inferior to the prescribed treatment is clinically inappropriate.

Step 4: For Crohn's and UC — Cite AGA and ACG Guidelines

The American Gastroenterological Association (AGA) and the American College of Gastroenterology (ACG) provide clinical practice guidelines recommending risankizumab for moderately to severely active Crohn's disease. The ADVANCE, MOTIVATE, and FORTIFY trials established superior efficacy to placebo in induction and maintenance, including in patients who had failed prior anti-TNF therapy. Cite this evidence to counter any step therapy or experimental designation.

Step 5: Request Peer-to-Peer Review

Your dermatologist, rheumatologist, or gastroenterologist should request a peer-to-peer conversation with the insurer's medical director. The peer-to-peer is the fastest path to reversal when the denial is based on step therapy that head-to-head data contradicts, or when the insurer's reviewer is not a specialist in the relevant condition.

Step 6: Submit the Formal Appeal

Write a comprehensive appeal letter addressing each denial criterion point by point, citing FDA approval for the specific indication, head-to-head trial data, specialty society guideline support, disease severity documentation, and prior therapy failure records. File within the applicable deadline and follow up with External Independent Review: Complete Guide" class="auto-link">external review if the internal appeal is denied.

What to Include in Your Appeal

• Denial letter with the specific step therapy, severity, or documentation criterion cited
• Validated disease severity scores (PASI, BSA, IGA for psoriasis; CDAI for Crohn's) with dates
• Documented prior therapy failures with specific agents, doses, duration, and clinical outcomes
• IMMvent/UltIMMa head-to-head trial data if challenging TNF inhibitor step therapy
• AAD/NPF, ACR, AGA, or ACG guideline excerpt supporting Skyrizi for your indication
• Prescriber's letter of medical necessity explaining clinical rationale and guideline support
• FDA approval documentation for the specific Skyrizi indication

Fight Back With ClaimBack

Skyrizi denials are winnable when you present the right combination of disease severity documentation, prior therapy failure records, and head-to-head clinical trial data. ClaimBack generates a professional appeal letter citing AbbVie trial data, AAD/ACR/AGA guidelines, and your specific clinical evidence. ClaimBack generates a professional appeal letter in 3 minutes.

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Related Reading

• How to Write an Insurance Appeal Letter
• What Is Medical Necessity?
• Internal vs External Insurance Appeal