CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-0671

Skyrizi® (risankizumab-rzaa) Intravenous

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This policy governs prior authorization, dosing, and medical necessity criteria for intravenous Skyrizi in adults with moderate to severe active Crohn's disease or ulcerative colitis. It applies to initial induction therapy, which is limited to 3 doses and is not renewable.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicySkyrizi® (risankizumab-rzaa) Intravenous

Policy CodePolicy SHP-0671

Change TypeNo material change

Effective DateN/A

Last ReviewMar 3, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for initial intravenous Skyrizi induction; authorization covers 3 doses over 11 weeks and may not be renewed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum member age

11 weeksInitial authorization validity

3Initial induction doses

600 mgCrohn's disease induction dose

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CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-0671

Skyrizi® (risankizumab-rzaa) Intravenous

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Sign up for security_health_plan_of_wisconsin_inc Policy SHP-0671 alerts

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Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicySkyrizi® (risankizumab-rzaa) Intravenous

Policy CodePolicy SHP-0671

Change TypeNo material change

Effective DateN/A

Last ReviewMar 3, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for initial intravenous Skyrizi induction; authorization covers 3 doses over 11 weeks and may not be renewed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum member age

11 weeksInitial authorization validity

3Initial induction doses

600 mgCrohn's disease induction dose

Ulcerative colitis induction dose

Coverage Criteria

General Initial Approval Criteria

Covered when ALL of the following general requirements are met.

General initial approval requirements: Member is at least 18 years of age; baseline disease severity has been assessed using an objective measure or tool; the member is up to date with all age-appropriate vaccinations before therapy; the member has been evaluated and screened for latent tuberculosis infection before treatment, with ongoing TB monitoring planned; the member does not have an active infection, including a clinically important localized infection; the provider confirms that live vaccines will not be administered during therapy; the member is not receiving another biologic therapy or targeted synthetic therapy; and baseline liver enzymes and bilirubin levels have been obtained before treatment.Age 18 years or older

All listed requirements must be satisfied.

Initial Therapy - Crohn's Disease

Covered for Crohn's disease when ALL of the following are met, including at least ONE treatment-pathway option.

Crohn's disease criteria

Qualifying treatment pathway
- Conventional immunosuppressive therapy failure: Documented failure, contraindication, or ineffective response at maximum tolerated doses to a trial of corticosteroids or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate.Maximum tolerated dose
- TNF modifier failure: Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of a TNF modifier, such as adalimumab, certolizumab, or infliximab.Minimum 3 months
- High-risk disease: Member has evidence of high-risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary.High-risk disease
- Established therapy:

Initial Therapy - Ulcerative Colitis

Covered for ulcerative colitis when ALL of the following are met, including at least ONE treatment-pathway option.

Ulcerative colitis criteria

Qualifying treatment pathway
- Conventional therapy failure: Documented failure or ineffective response to a minimum 3-month trial of conventional therapy, including aminosalicylates, corticosteroids, or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate, at maximum tolerated doses, unless contraindication or intolerance exists.Minimum 3 months; maximum tolerated doses
  Three months of corticosteroids are not required if early non-response is confirmed.
- TNF modifier failure: Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of a TNF modifier, such as adalimumab, golimumab, or infliximab.Minimum 3 months

Renewal Criteria

Renewal is not available under this policy.

Authorization duration: The duration of authorization has not been exceeded; however, the initial authorization is limited to 11 weeks and prior authorization validity may not be renewed.Initial authorization limited to 11 weeks

The initial authorization covers the induction course; renewal is not available under this policy.

Therapy must not be initiated when the member has an active infection, including a clinically important localized infection. The provider must confirm that no active infection is present before intravenous Skyrizi induction begins.

Coverage requires that the member is not receiving concurrent treatment with another biologic therapy or targeted synthetic therapy when intravenous Skyrizi induction is initiated.

The provider must confirm that live vaccines will not be administered during therapy. Live vaccination during intravenous Skyrizi induction does not meet the policy’s initial approval requirements.

Coding and Dosing

HCPCS CodeHCPCSCovered

J2327

Injection, risankizumab-rzaa, intravenous, 1 mg; 1 billable unit = 1 mg

NDCNDCCovered

00074-5015-xx

Skyrizi carton containing one 600 mg/10 mL single-dose vial

Covered Diagnosis Codes - Crohn's DiseaseICD-10Covered

K50.00	Crohn's disease of small intestine without complications
K50.011	Crohn's disease of small intestine with rectal bleeding
K50.012	Crohn's disease of small intestine with intestinal obstruction
K50.013	Crohn's disease of small intestine with fistula
K50.014	Crohn's disease of small intestine with abscess
K50.018	Crohn's disease of small intestine with other complication
K50.019	Crohn's disease of small intestine with unspecified complications
K50.10	Crohn's disease of large intestine without complications
K50.111	Crohn's disease of large intestine with rectal bleeding
K50.112	Crohn's disease of large intestine with intestinal obstruction

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Covered Diagnosis Codes - Ulcerative ColitisICD-10Covered

K51.00	Ulcerative (chronic) pancolitis without complications
K51.011	Ulcerative (chronic) pancolitis with rectal bleeding
K51.012	Ulcerative (chronic) pancolitis with intestinal obstruction
K51.013	Ulcerative (chronic) pancolitis with fistula
K51.014	Ulcerative (chronic) pancolitis with abscess

Covered Diagnosis CodesICD-10Covered

K50.812	Crohn's disease of both small and large intestine with rectal bleeding.
K50.813	Crohn's disease of both small and large intestine with intestinal obstruction.
K50.814	Crohn's disease of both small and large intestine with fistula.
K50.818	Crohn's disease of both small and large intestine with abscess.
K50.819	Crohn's disease of both small and large intestine with other complication.
K50.90	Crohn's disease, unspecified, without complications.
K50.911	Crohn's disease, unspecified, with rectal bleeding.
K50.912	Crohn's disease, unspecified, with intestinal obstruction.
K50.913	Crohn's disease, unspecified, with fistula.
K50.914	Crohn's disease, unspecified, with abscess.

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Crohn's Disease Induction Dose

Billable units per dose600 billable units

Equivalent amount600 mg

Administration scheduleWeek 0, Week 4, and Week 8

Ulcerative Colitis Induction Dose

Billable units per dose1200 billable units

Equivalent amount1200 mg

Authorization and Provider Actions

Prior Authorization

Initial Authorization Only

Prior authorization is required for initial Skyrizi therapy. Initial authorization is valid for 11 weeks and covers the 3-dose induction course; renewal is not available.

Initial authorization: 11 weeks.
Induction course: 3 doses.

Step Therapy

Crohn’s Disease Prior Therapy

Document the member’s prior Crohn’s disease treatment history and the applicable rationale for Skyrizi. Coverage requires documented failure, contraindication, or ineffective response at maximum tolerated doses to qualifying prior therapy, unless the member meets another listed pathway.

Corticosteroid or immunomodulator trial; or
Minimum 3-month trial of a TNF modifier; or
High-risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary; or

Policy Background

Skyrizi (risankizumab-rzaa) is authorized under this policy as intravenous induction therapy for adults with moderate to severe active Crohn’s disease or ulcerative colitis. Induction is administered at Weeks 0, 4, and 8, followed by subcutaneous maintenance therapy. Before treatment begins, the policy requires objective baseline disease assessment and safety checks addressing infection, vaccination status, tuberculosis, laboratory results, and concurrent biologic or targeted synthetic therapy.

Definitions

Crohn's Disease (CD)

Disease activityDocumented moderate to severe active Crohn's disease

Prior-treatment pathwayFailure, contraindication, or ineffective response at maximum tolerated doses to corticosteroids or immunomodulators, or to a minimum 3-month TNF modifier trial

Alternative pathwaysHigh-risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary, or established biologic or targeted synthetic therapy for Crohn's disease

Ulcerative Colitis (UC)

Disease activityDocumented moderate to severe active ulcerative colitis

Conventional-therapy pathwayFailure or ineffective response to a minimum 3-month trial of conventional therapy at maximum tolerated doses, unless contraindicated or intolerant

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicySkyrizi® (risankizumab-rzaa) Intravenous

Policy CodePolicy SHP-0671

Change TypeNo material change

Effective DateN/A

Last ReviewMar 3, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for initial intravenous Skyrizi induction; authorization covers 3 doses over 11 weeks and may not be renewed.

SourceLink

On This Page

Member is already established on a biologic or targeted synthetic therapy for treatment of Crohn's disease.

Established therapy: Member is already established on a biologic or targeted synthetic therapy for treatment of ulcerative colitis.Established therapy

Administration schedule

Week 0, Week 4, and Week 8

Ulcerative Colitis Conventional Therapy Trial

Required trial durationMinimum 3 months

Therapy coveredConventional therapy, including aminosalicylates, corticosteroids, or immunomodulators, at maximum tolerated doses

ExceptionThree months of corticosteroids are not required if early non-response is confirmed

TNF Modifier Trial

Required trial durationMinimum 3 months

Dose requirementTherapy must be tried at maximum tolerated doses

Qualifying outcomeDocumented failure, contraindication, or ineffective response

Member is already established on a biologic or targeted synthetic therapy for Crohn’s disease.

Documentation Required

Crohn’s Disease Medical Necessity Documentation

Document moderate to severe active Crohn’s disease and the applicable treatment history supporting medical necessity. The record must substantiate the qualifying prior-therapy failure, contraindication, ineffective response, high-risk disease rationale, or established biologic/targeted synthetic therapy pathway.

Documented moderate to severe active disease.
Document the applicable qualifying treatment history or clinical rationale.

Step Therapy

Ulcerative Colitis Prior Therapy

Document the member’s prior ulcerative colitis treatment history and the applicable rationale for Skyrizi. Coverage requires documented failure, contraindication, intolerance, or ineffective response to qualifying conventional therapy or a TNF modifier, unless the member is already established on a biologic or targeted synthetic therapy.

Minimum 3-month trial of conventional therapy at maximum tolerated doses, unless contraindicated or not tolerated; or
Minimum 3-month trial of a TNF modifier; or
Member is already established on a biologic or targeted synthetic therapy for ulcerative colitis.
Three months of corticosteroids are not required when early non-response is confirmed.

Documentation Required

Ulcerative Colitis Medical Necessity Documentation

Document moderate to severe active ulcerative colitis and the applicable treatment history supporting medical necessity. The record must substantiate qualifying conventional-therapy or TNF-modifier history, or established biologic/targeted synthetic therapy.

Documented moderate to severe active disease.
Document the applicable qualifying treatment history or exception.

Documentation Required

Baseline Safety and Monitoring Documentation

Before initiating therapy, document baseline eligibility, disease assessment, vaccination status, infection screening, and safety monitoring plans. The member must be at least 18 years old and meet all listed safety requirements.

Member is at least 18 years of age.
Baseline disease severity assessed with an objective measure or tool.
Age-appropriate vaccinations are current before treatment.
Latent tuberculosis screening completed before treatment, with ongoing TB monitoring.
No active infection, including clinically important localized infection.
No live vaccines during therapy.
No concurrent biologic or targeted synthetic therapy.
Baseline liver enzymes and bilirubin obtained before initiation.

Denial Risk

Safety and Baseline Requirements Not Met

Coverage may be denied when baseline eligibility, disease assessment, vaccination, infection screening, or safety requirements are not met or documented.

Age or objective disease-severity assessment requirement is not met.
Vaccination, TB screening/monitoring, infection, or live-vaccine requirement is not met.
Concurrent biologic or targeted synthetic therapy is present.
Baseline liver enzymes and bilirubin are not obtained.

Denial Risk

Disease or Treatment Criteria Not Met

Coverage may be denied when the record does not establish moderate to severe active Crohn’s disease or ulcerative colitis and the applicable qualifying treatment history or clinical pathway.

Missing documentation of moderate to severe active disease.
Missing or inadequate prior conventional therapy, immunomodulator, corticosteroid, or TNF-modifier history when required.
No documented contraindication, intolerance, ineffective response, high-risk disease rationale, or established biologic/targeted synthetic therapy when relied upon.

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Denial Risk

Renewal Not Available

Initial authorization cannot be renewed. Authorization is limited to the 11-week induction period and does not extend to subsequent maintenance therapy.

Renewal validity: not available.
Authorization duration may not exceed the initial 11-week period.

Denial Risk

Dose or Schedule Exceeds Policy Limits

Do not request or bill doses or administration schedules outside the policy’s induction limits at Weeks 0, 4, and 8. The maximum induction dose is 600 mg for Crohn’s disease and 1200 mg for ulcerative colitis at each listed week.

Crohn’s disease: 600 billable units (600 mg) at Weeks 0, 4, and 8.
Ulcerative colitis: 1200 billable units (1200 mg) at Weeks 0, 4, and 8.
Subcutaneous maintenance therapy after induction is outside the initial authorization period.

Alternative pathwaysFailure, contraindication, or ineffective response to a minimum 3-month TNF modifier trial, or established biologic or targeted synthetic therapy for ulcerative colitis

Early Non-response

Applicable conditionUlcerative colitis conventional-therapy pathway

Standard requirementA three-month period of corticosteroid therapy is generally part of the conventional-therapy trial requirement

ExceptionThree months of corticosteroids are not required when early non-response is confirmed