Skyrizi denials in California external review
In the California DMHC record, independent physician reviewers decided 49 published external-review cases involving Skyriziand overturned the plan’s denial in 91.8%. That is a historical result among cases that reached this program, not a forecast for an individual appeal.
By condition
| Condition | Decisions | Overturned |
|---|---|---|
| Psoriasis | 26 | 100% |
| Crohn's Disease | 15 | 80% |
What the reviewers wrote
Where the denial was overturned
Nature of Statutory Criteria/Case Summary: A patient’s parent has requested authorization and coverage for Skyrizi 600 mg infusions every four weeks, and if so, infusion therapy to take place in a hospital-based outpatient infusion center.The U.S. Food and Drug Administration (FDA) has approved Skyrizi for the treatment of Crohn’s disease in adult patients based on extensive studies demonstrating its safety and efficacy. Despite the lack of FDA approval for Skyrizi in pediatric patients, this patient has reportedly already failed the available FDA-approved alternatives. According to one study, data suggest that Skyrizi is “safe and effective in inducing and maintaining remission in children with highly-refractory Crohn’s disease.
Findings: The physician reviewer found that the patient’s parent has requested authorization and coverage for Skyrizi (risankizumab-rzaa) 600 mg IV induction infusion at week 0, week 4, and week 8, and administration of Skyrizi induction infusions at a hospital outpatient infusion center. The U.S. Food and Drug Administration (FDA) has approved risankizumab-rzaa under the brand name Skyrizi for the treatment of adult patients with Crohn’s disease (CD), and its safety and efficacy are well established. Notably, one study reported that “preliminary data suggest that [risankizumab] is safe and effective in inducing and maintaining remission in children with highly-refractory CD. This includes also children previously failing ustekinumab and children younger than 16 years”.
Where the denial was upheld
Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary:The parent of a patient has requested authorization and coverage for dual targeted therapy with Skyrizi (risankizumab) and Rinvoq (upadacitinib). A small retrospective study has demonstrated efficacy with combination biologic and JAK inhibitor therapy in select adult patients with medically complex Crohn’s disease. However, most patients in that study had undergone prior inflammatory bowel disease surgeries, including ileostomies. There is insufficient evidence supporting the safety and efficacy of dual targeted therapy with risankizumab and upadacitinib in pediatric patients with Crohn’s disease, including those with growth delay and persistent ileitis.
Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient’s parent has requested authorization and coverage for Rinvoq in combination with Skyrizi.The combination of Rinvoq with Skyrizi is not supported as medically necessary for this pediatric patient with refractory Crohn’s disease. Currently, both medications are approved for adult patients with Crohn’s disease. There is insufficient evidence to establish the safety and efficacy of dual advanced therapy with these agents in the pediatric population. While Rinvoq has demonstrated efficacy in pediatric patients in limited studies, data supporting combination therapy remain limited.Guidelines do not endorse routine use of dual advanced therapy for Crohn’s disease. Available evidence suggests that Rinvoq monotherapy may be an appropriate option for patients who have failed other treatments.
Figures and quotations on this page come from 42,749 published decisions in the California DMHC Independent Medical Review dataset. These are California external-review outcomes. Other state and federal programs have different eligibility rules, processes, and current availability; the rates here do not transfer to those programs or predict an individual result. Excerpts are quoted verbatim from the public record and describe this treatment generally, not any individual case.
Why plans deny Skyrizi — and what reviewed cases show
Skyrizi (risankizumab) is FDA-approved for: crohn's disease (adults); ulcerative colitis (adults); plaque psoriasis and psoriatic arthritis (adults). An on-label indication can be important evidence when a denial frames the requested use as unproven or cosmetic.
“Fail a TNF blocker first” step therapy
As a newer IL-23 agent, Skyrizi commonly sits behind older TNF blockers (adalimumab, infliximab) on formularies. The denial letter says step therapy; the clinical question is whether a TNF blocker is actually appropriate for you — prior TNF failure, intolerance, or specific clinical reasons for selecting an IL-23 mechanism are what reviewers weigh.
Non-formulary or preferred-alternative denial
Plans that prefer a different biologic for IBD deny Skyrizi as non-preferred. Formulary exception processes exist precisely for this: the prescriber states why the preferred alternatives would be less effective or cause adverse effects for you specifically.
Induction vs. maintenance plumbing
Skyrizi's IBD regimens involve intravenous induction before subcutaneous maintenance. Requests sometimes get denied mid-transition because the plan's criteria or billing pathway treats the two phases inconsistently — a process failure dressed as a coverage decision.
“Try the preferred biologic first” has a formal exit: a step-therapy or formulary exception supported by the prescriber's statement of prior failures, contraindications, or mechanism-specific clinical rationale. Plans must decide these quickly once the statement is submitted.
Evidence cited in overturned Skyrizi decisions
- If TNF blockers were tried and failed — or are clinically inappropriate — have the prescriber document exactly that; it converts a step-therapy denial into an exception grant.
- Keep the FDA-approved indication front and center: Skyrizi is approved for moderately to severely active Crohn's disease and ulcerative colitis in adults.
- For mid-course denials, point out that induction already happened and interrupting the transition to maintenance abandons therapy the plan already paid to start.
- Ask which criteria document was applied and whether a gastroenterologist reviewed the file.
The published California record contains 49 external-review decisions involving Skyrizi; 91.8% were overturned. This historical rate does not predict another case. For the full class-wide picture — step therapy, biosimilar switching, dose caps, and the record for every IBD biologic — see the Crohn’s & colitis biologic appeal guide.
These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Skyrizi, then check the rights and deadlines that apply to your plan.
SOURCE: CALIFORNIA DMHC INDEPENDENT MEDICAL REVIEW OUTCOMES (CHHS OPEN DATA) · AGGREGATES + DEIDENTIFIED DECISION EXCERPTS/REFERENCE IDS · METHODOLOGY