CurrentUnitedHealthcarePolicy CS2025D00116H

Skyrizi (risankizumab-rzaa) IV for Crohn's disease and ulcerative colitis

Defines medical benefit coverage criteria for intravenous Skyrizi (risankizumab-rzaa) induction therapy for moderately to severely active Crohn's disease and ulcerative colitis in adults, applicable to UnitedHealthcare Community Plan except where state-specific policies apply. Pharmacy benefit (subcutaneous) is excluded from this policy.

Policy Summary

PayerUnitedHealthcare

PolicySkyrizi (risankizumab-rzaa) IV for Crohn's disease and ulcerative colitis

Policy CodePolicy CS2025D00116H

Change TypeApplication (state-specific exclusion added)

Effective DateOct 1, 2025

Next Review Date

Key ActionAuthorization will be issued for three intravenous induction doses; include documentation of prior treatments (two failed biologic DMARDs), dates, durations, and reasons for failure/contraindication/intolerance.

POLICY UPDATE CHANGES

Application Arizona: Added language indicating the Medical Benefit Drug Policy does not apply to Arizona and to refer to the state's Medicaid clinical policy.

2Indications covered (CD, UC)

3Authorization induction doses

1HCPCS drug code listed

Coverage Summary

This policy defines medical benefit coverage for intravenous Skyrizi (risankizumab-rzaa) induction therapy for adults with moderately to severely active Crohn's disease and ulcerative colitis. Self-administered subcutaneous Skyrizi is obtained under the pharmacy benefit and is excluded from this medical-benefit policy. The policy applies to UnitedHealthcare Community Plan members except where state-specific policies supersede (for example, Arizona — refer to the state's Medicaid clinical policy).

Initial Therapy Criteria — Induction (IV)

Crohn's Disease - Medically Necessary (Induction IV)

Skyrizi is medically necessary for Crohn's disease when ALL of the following are met:

ALL of the following

ONE of
- Diagnosis of moderately to severely active Crohn's disease
- Current corticosteroid therapy (e.g., prednisone, methylprednisolone, budesonide)
- History of failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced: 6-mercaptopurine (Purinethol), methotrexate (Rheumatrex, Trexall), azathioprine (Imuran)
Patient has been previously treated with targeted immunomodulator FDA-approved for the treatment of Crohn's disease (examples: adalimumab; certolizumab [Cimzia]; vedolizumab [Entyvio]; mirikizumab [Omvoh]; upadacitinib [Rinvoq]; guselkumab [Tremfya]; ustekinumab)
History of failure, contraindication, or intolerance to two biologic DMARDs FDA-approved for the treatment of Crohn's disease (document drug, date, and duration of trial)
Skyrizi is to be administered as three intravenous induction doses
Patient is not receiving Skyrizi in combination with another targeted immunomodulator (examples listed: adalimumab, certolizumab [Cimzia], ustekinumab)
Skyrizi induction dosing is in accordance with the FDA labeled dosing for Crohn's disease
Prescribed by or in consultation with a gastroenterologist

Ulcerative Colitis - Medically Necessary (Induction IV)

Skyrizi is medically necessary for ulcerative colitis when ALL of the following are met:

ALL of the following

ONE of
- Diagnosis of moderately to severely active ulcerative colitis
- Prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine)
Patient has been previously treated with a targeted immunomodulator FDA-approved for the treatment of ulcerative colitis (examples: golimumab [Simponi]; guselkumab [Tremfya]; tofacitinib [Xeljanz/XR]; ustekinumab; ozanimod [Zeposia])
Skyrizi is to be administered as three intravenous induction doses

Continuation / Maintenance Criteria

Although formal continuation criteria are not listed in the policy, maintenance efficacy was demonstrated in phase 3 trials: FORTIFY showed higher clinical remission and endoscopic response with risankizumab maintenance dosing (360 mg SC every 8 weeks) at Week 52 versus placebo for Crohn's disease, and COMMAND demonstrated higher clinical remission at Week 52 for ulcerative colitis with risankizumab maintenance dosing. Continuation of therapy should align with the FDA‑labeled maintenance dosing and be supported by prescriber documentation of response and appropriate specialist oversight.

Provider Actions & Authorization Requirements

Prior Authorization

Authorization for IV induction doses

Authorization will be issued for three intravenous induction doses. Documentation must include prior treatments documenting failure, contraindication, or intolerance to two biologic DMARDs — include the drug names, dates and duration of each trial, and reasons for failure/contraindication/intolerance.

Authorization: 3 IV induction doses
Document two failed biologic DMARDs with drug name, trial dates, duration, and reason for failure/contraindication/intolerance

Documentation Required

Specialist prescribing requirement

Skyrizi IV must be prescribed by or in consultation with a gastroenterologist. Include either the gastroenterologist’s consult or the prescriber’s specialty in the authorization documentation.

Prescriber is a gastroenterologist or documentation of gastroenterology consult included

Billing Rule

Benefit boundary - route/benefit

Intravenous Skyrizi is managed under the medical benefit; self‑administered subcutaneous Skyrizi is obtained under the pharmacy benefit. Use HCPCS code J2327 for IV risankizumab‑rzaa.

Medical benefit: IV Skyrizi (HCPCS J2327)
Pharmacy benefit: subcutaneous (self‑administered) Skyrizi

Applicable Codes

HCPCS - Drug/J-code for IV risankizumab-rzaaHCPCSCovered

J2327

Injection, risankizumab-rzaa, intravenous

Diagnosis codes - Crohn's disease and related (ICD-10)ICD-10

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

Diagnosis codes - Ulcerative colitis and related (ICD-10)ICD-10

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 Summary

ADVANCE:45%CDAI clinical remission (risankizumab 600 mg) vs placebo 25% at week 12

MOTIVATE:42%CDAI clinical remission (risankizumab) vs placebo 20% at week 12

INSPIRE:24%UC induction clinical remission risankizumab vs placebo 8% at week 12

COMMAND:45%UC maintenance clinical remission risankizumab vs placebo 26% at week 52

Phase 3 trial summary: ADVANCE and MOTIVATE were randomized, double‑masked, placebo‑controlled induction studies in moderately to severely active Crohn's disease demonstrating induction remission rates around 42–45% with risankizumab versus 20–25% with placebo and improved endoscopic response at Week 12; FORTIFY, a randomized withdrawal maintenance study, showed higher clinical remission and endoscopic response at Week 52 with risankizumab (notably 360 mg SC every 8 weeks) versus placebo. For ulcerative colitis, INSPIRE (induction) reported clinical remission 24% with risankizumab versus 8% placebo at Week 12, and COMMAND (maintenance) showed clinical remission 45% with risankizumab versus 26% with placebo at Week 52. Overall safety profiles were acceptable with similar rates of adverse events across groups in these studies.

Background

Background: Skyrizi (risankizumab‑rzaa) is a humanized IgG1 monoclonal antibody that selectively binds the p19 subunit of interleukin‑23 (IL‑23), inhibiting its interaction with the IL‑23 receptor and downstream pro‑inflammatory signaling. It has been studied and indicated for moderately to severely active Crohn's disease and ulcerative colitis in adults in the referenced phase 3 trials.

Targeted immunomodulator: biologic or small molecule therapy FDA‑approved for Crohn's disease or ulcerative colitis (examples provided in the policy).