Currentsierra health and lifePolicy 2025D0116G

Skyrizi® (Risankizumab-Rzaa) – Commercial Medical Benefit Drug Policy

Medical benefit drug policy for provider-administered intravenous Skyrizi (risankizumab-rzaa) covering indications, medical necessity criteria, applicable codes, and related coverage notes for Crohn's disease and ulcerative colitis. Self-administered subcutaneous Skyrizi is generally covered under the pharmacy benefit unless plan-specific exceptions apply.

Policy Summary

Payersierra health and life

PolicySkyrizi® (Risankizumab-Rzaa) – Commercial Medical Benefit Drug Policy

Policy CodePolicy 2025D0116G

Change TypeCoverage clarification (pharmacy vs medical benefit)

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization for 3 intravenous induction doses; ensure documentation of diagnosis and prior-therapy failure/intolerance per criteria.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying that self-administered subcutaneous Skyrizi is obtained under the pharmacy benefit unless specified in the member's benefit plan; exception noted for certain UnitedHealthcare of California delegated plans.

2Covered Indications (IV)

3Induction Doses Authorized

1HCPCS codes listed

Coverage Summary

This medical benefit drug policy addresses provider‑administered intravenous Skyrizi (risankizumab‑rzaa) (HCPCS J2327) for induction treatment of moderately to severely active Crohn's disease and ulcerative colitis, including criteria, applicable codes, and coverage notes. Authorization is issued for 3 induction doses when criteria are met. Self‑administered subcutaneous Skyrizi is generally obtained under the pharmacy benefit unless the member's benefit plan specifies otherwise; exception: members in UnitedHealthcare of California plans with a delegated provider group conducting prior authorization review may obtain self‑administered Skyrizi under the medical benefit.

Initial Therapy Criteria (Induction)

Crohn's Disease 6 Proven (Induction) Coverage

Skyrizi is proven for the treatment of Crohn's disease (CD) when ALL of the following criteria are met:

ALL of the following

Diagnosis of moderately to severely active Crohn's disease.
Skyrizi is to be administered as three intravenous induction doses.
Skyrizi induction dosing is in accordance with the United States Food and Drug Administration (FDA) labeled dosing for Crohn’s disease.
Patient is not receiving Skyrizi in combination with another targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Entyvio (vedolizumab), Omvoh (mirikizumab-mrkz), Rinvoq (upadacitinib), Tremfya (guselkumab), ustekinumab).
Prescribed by or in consultation with a gastroenterologist.
Authorization will be issued for 3 induction doses.

General Coverage Rationale (IV Skyrizi)

General Coverage Rationale (IV Skyrizi):

ALL of the following

This policy refers to Skyrizi (risankizumab-rzaa) injection for intravenous use. Self-administered subcutaneous Skyrizi is obtained under the pharmacy benefit unless otherwise specified by the member’s benefit plan; exception applies for certain UnitedHealthcare of California delegated reviews.
Skyrizi intravenous induction will be authorized as three induction doses when criteria are met; dosing must follow the FDA-labeled induction regimen for the indicated inflammatory bowel disease.
Skyrizi must not be used in combination with another targeted immunomodulator (examples include adalimumab, certolizumab, vedolizumab, mirikizumab, upadacitinib, guselkumab, ustekinumab, tofacitinib, golimumab, ozanimod).
For medical necessity of continuation beyond induction, members should meet the applicable continuation criteria in this policy (including prior therapy requirements or prior targeted immunomodulator exposure) and treatment should be prescribed by or in consultation with a gastroenterologist.

Provider Actions & Authorization

Prior Authorization

Prior authorization for IV Skyrizi induction

Authorization will be issued for 3 intravenous induction doses; induction must follow FDA-labeled dosing and member must meet diagnosis and prior-therapy criteria as specified.

J2327
Authorization will be issued for 3 intravenous induction doses; induction must follow FDA-labeled dosing and member must meet diagnosis and prior-therapy criteria as specified.

Documentation Required

Therapy history documentation

Provider must document diagnosis of moderately to severely active CD or UC and prior therapy failure/intolerance or contraindication when required.

Documentation Required

Specialty prescriber requirement for UC

For ulcerative colitis, Skyrizi must be prescribed by or in consultation with a gastroenterologist.

Applicable Codes

HCPCS - Provider-administered risankizumab (intravenous)HCPCSCovered

J2327

Injection, risankizumab-rzaa, intravenous, 1 mg

ICD-10 Codes - Crohn's disease diagnoses (examples listed)ICD-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

1–10 of 28

1/3

ICD-10 Codes - Ulcerative colitis diagnoses (examples listed)ICD-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
K51.018	Ulcerative (chronic) pancolitis with other complication
K51.019	Ulcerative (chronic) pancolitis with unspecified complications
K51.20	Ulcerative (chronic) proctitis without complications
K51.211	Ulcerative (chronic) proctitis with rectal bleeding
K51.212	Ulcerative (chronic) proctitis with intestinal obstruction

1–10 of 50

1/5

Clinical Evidence

Phase 3: induction superiorINSPIRE — UC induction (week 12): clinical remission 24% vs 8% placebo

Phase 3: maintenance superiorCOMMAND — UC maintenance (week 52): clinical remission 45% vs 26% placebo

1200 mg IV inductionINSPIRE induction dosing: IV at weeks 0,4,8; maintenance SC 180/360 mg q8w in COMMAND

ADVANCE / MOTIVATE — Phase 3 randomized, double‑masked, placebo‑controlled induction trials in moderately to severely active Crohn's disease showing significant clinical remission and endoscopic response at Week 12 versus placebo.

FORTIFY — Phase 3 maintenance withdrawal study demonstrating subcutaneous risankizumab maintained remission and endoscopic response in Crohn's disease.

INSPIRE — 12‑week intravenous induction study in moderately to severely active ulcerative colitis showing higher clinical remission, clinical response, and endoscopic improvement with risankizumab versus placebo.

COMMAND — Maintenance study evaluating subcutaneous risankizumab (180 mg or 360 mg every 8 weeks) showing superior Week 52 clinical remission and key secondary endpoints versus placebo.

Background

Skyrizi is a humanized IgG1 monoclonal antibody that selectively binds the p19 subunit of interleukin‑23 (IL‑23), inhibiting IL‑23 interaction with its receptor and downstream pro‑inflammatory signaling. The FDA‑labeled indications include moderate‑to‑severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis. The intravenous formulation is used for induction in inflammatory bowel disease per FDA labeling, while the self‑administered subcutaneous product is obtained under the pharmacy benefit in most cases unless the member's plan specifies an exception.

Skyrizi (risankizumab‑rzaa): a monoclonal antibody IL‑23 p19 antagonist; IV formulation is referenced in this medical benefit policy.

Revision History

2025-10-01policy_revisionLatest

Added language clarifying that self-administered subcutaneous Skyrizi is obtained under the pharmacy benefit unless otherwise specified in the member's benefit plan documents; exception noted that for members enrolled in UnitedHealthcare of California plans with a delegated provider group conducting the prior authorization review, the self-administered Skyrizi may be obtained under the medical benefit. Archived previous policy version 2025D0116F.

2025-10-01effective_dateLatest

Policy effective date set to October 1, 2025 (Policy Number: 2025D0116G).