Risankizumab-rzaa (Skyrizi) IV infusion — Induction for Crohn's disease and Ulcerative Colitis
Customize your policy alerts
Sign up for all Blue Cross Blue Shield - North Carolina policy alerts
Know when Blue Cross Blue Shield - North Carolina releases new policies or updates existing guidance.
Monitor payer policy activity
Covers medical necessity and prior-authorization requirements for risankizumab-rzaa (Skyrizi) intravenous infusion for adults with moderately to severely active Crohn's disease or ulcerative colitis; applies to Blue Cross Blue Shield North Carolina members and treating providers.
For Crohn's disease: removed required trial and failure of conventional therapy and replaced allowance for severely active disease with required demonstration of moderately to severely active disease by documented symptoms plus evidence of active inflammation OR significant extent/upper GI involvement OR corticosteroid-dependence/refractory to oral corticosteroids.
For ulcerative colitis: removed required trial and failure of conventional therapy and required demonstration of moderately to severely active disease by documented symptoms plus evidence of active inflammation or high-risk disease (with confirmatory criteria) OR corticosteroid-dependence/refractory to oral corticosteroids.
Added allowance for patients currently established on a biologic or systemic immunomodulator (not the requested agent) who have had positive clinical benefit from that agent.
Duration of induction approval adjusted to 90 days to allow scheduling all induction doses after authorization approval.
Coverage Criteria for Risankizumab-rzaa (IV)
Initial induction — Crohn's disease (IV)
Covered when ALL of the following are met:
medical record documentation required
Disease activity evidence
- Symptom plus objective inflammation: Symptoms consistent with active CD AND evidence of active inflammation (active inflammatory disease on cross-sectional imaging [MRE, CTE], intestinal ultrasound, or pelvic MRI for perianal disease; OR biomarker evidence such as elevated fecal calprotectin, elevated CRP, elevated ESR, or low serum albumin)
both required; medical record documentation required
- Significant extent or upper GI involvement: Significant extent of disease or upper GI involvement on radiographic or endoscopic assessment (e.g., large/deep mucosal lesions, fistulas or perianal abscesses, intestinal strictures, extensive disease [ileal involvement >40 cm or pancolitis], prior bowel resection)
medical record documentation required
- Corticosteroid-dependence or refractory to oral corticosteroids
medical record documentation required
medical record documentation required
see dosing table and duration (induction approval 90 days); medical record documentation required
Initial induction — Ulcerative colitis (IV)
Covered when ALL of the following are met:
medical record documentation required
Disease activity evidence
- Symptom plus endoscopic/other inflammation: Symptoms consistent with active UC AND evidence of active inflammation or high‑risk disease confirmed by ONE of: moderate to severe endoscopic activity on validated tool (MES, UCEIS), active inflammatory disease on intestinal ultrasound (IUS), or biomarker evidence (elevated fecal calprotectin, CRP, ESR, or low albumin)
both required for this subnode; medical record documentation required
- High-risk features: Presence of at least one poor prognostic factor (e.g., age <40 at diagnosis, extensive colitis, hospitalization for colitis)
medical record documentation required
- Corticosteroid-dependence or refractory to oral corticosteroids
medical record documentation required
medical record documentation required
see dosing table and duration (induction approval 90 days); medical record documentation required
The use of risankizumab-rzaa (Skyrizi) in combination with another biologic immunomodulator agent or with ozanimod (Zeposia) is excluded and will not be approved. Requests that propose concomitant therapy with any other biologic immunomodulator or with Zeposia should be denied per policy.
Subcutaneous risankizumab dosing (including 150 mg, 90 mg, 180 mg, or 360 mg SC injections) is not covered as a substitute for the required intravenous induction. Authorization is limited to initiation of therapy via the IV infusion schedule; requests that seek SC doses in place of the IV induction should be considered not medically necessary.
Coding and Units
| J2327 | Injection, risankizumab-rzaa, 1 mg (HCPCS) |
Provider Actions, Prior Authorization and Documentation
Prior Authorization Required
Prior authorization is required for risankizumab-rzaa (Skyrizi) IV induction for Crohn's disease and ulcerative colitis. Requests must document the planned induction dosing and must not exceed the policy's maximum units for the approval period. For billing, use HCPCS J2327 for risankizumab IV infusions. If urgent treatment is needed, contact Blue Cross Blue Shield - North Carolina prior authorization services for expedited review.
- Induction dosing (Crohn's): 600 mg IV at week 0, week 4, and week 8 (maximum units for CD induction = 1800).
- Induction dosing (Ulcerative colitis): 1200 mg IV at week 0, week 4, and week 8 (policy maximum units shown above).
- Billing HCPCS: J2327
Step Therapy and Exceptions
Step therapy preference is for patients who are currently established on, and have derived benefit from, a different FDA‑approved biologic or systemic immunomodulator agent for Crohn's disease or ulcerative colitis. Exceptions to step therapy may be granted when the patient has had an inadequate response to both an infliximab product and an ustekinumab product, or has documented intolerance, FDA‑labeled contraindication, or hypersensitivity to both agents. Medical record documentation is required to support exceptions.
- Member must be currently established on a different biologic or systemic immunomodulator and have documented clinical benefit from that agent.
- Step therapy exception criteria: inadequate response to both an infliximab product AND an ustekinumab product, OR intolerance/contraindication/hypersensitivity to BOTH agents (medical records required).
Required Documentation
Documented medical records must include objective evidence of active disease and prior treatment history. Provide clinical notes describing symptoms, relevant laboratory or biomarker results, imaging or endoscopy reports demonstrating active inflammation or extent of disease, and documentation of corticosteroid dependence or refractoriness when applicable. Include records showing prior biologic or immunomodulator use and clinical benefit or failure, and documentation of any contraindications or hypersensitivity.
- Symptoms consistent with active disease (e.g., diarrhea, abdominal pain, weight loss, rectal bleeding, urgency) — include clinical visit notes.
- Evidence of inflammation: cross-sectional imaging (MRE, CTE), intestinal ultrasound, pelvic MRI for perianal disease, or endoscopy reports (e.g., Mayo Endoscopic Subscore, UCEIS) — include the report.
- Biomarkers: fecal calprotectin, CRP, ESR, serum albumin — include lab results.
- Prior treatment history: records of prior biologic/systemic immunomodulator use, dates, dosing, and objective clinical response or adverse reactions.
- Documentation of corticosteroid-dependence or steroid-refractory disease when claimed.
Triggers for Denial
Applications lacking complete documentation are at high risk for denial. Common denial triggers include absence of clear documentation of moderately to severely active disease, missing objective evidence of active inflammation (imaging/endoscopy/biomarkers), no documentation of prior biologic or immunomodulator therapy or benefit when required by step therapy, requests exceeding maximum allowed units, and use of risankizumab in combination with another biologic or Zeposia. Ensure TB testing per prescribing information is completed and treated if positive.
- Missing medical record documentation for symptoms and objective inflammation.
- No documentation of trial and inadequate response to required prior agents (infliximab and ustekinumab) when applicable.
- Request exceeds maximum units for the approval period (see prior auth block for induction limits).
- Concurrent use with another biologic immunomodulator or Zeposia.
- No documentation of TB testing and management when indicated.
Definitions and Clinical Terms
Background
Risankizumab-rzaa (Skyrizi) is FDA-approved for intravenous induction treatment of adults with moderately to severely active Crohn's disease and ulcerative colitis. Induction therapy is administered as IV infusions (per FDA-labeled regimens) with a defined duration of approval for induction of 90 days; dosing and billing for the IV product are captured under HCPCS J2327.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.