ModifiedColorado Rocky Mountain Health PlansPolicy 2025D0116G

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

This medical benefit drug policy governs prior authorization and medical necessity criteria for intravenous Skyrizi (risankizumab-rzaa) used as induction therapy for moderately to severely active Crohn's disease or ulcerative colitis under the UnitedHealthcare commercial medical benefit.

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy 2025D0116G

Change TypeClarification — benefit channel for self‑administered productarchival of prior version

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Skyrizi under the medical benefit for IV induction; authorization will be issued for three IV induction doses when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying that self-administered subcutaneous Skyrizi is obtained under the pharmacy benefit unless otherwise specified in the member's benefit plan.

Archived previous policy version 2025D0116F.

3induction IV doses authorized

J2327HCPCS code listed

ADVANCE & MOTIVATETrials cited

45%

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COMMAND Week 52 remission

Coverage Criteria for Intravenous Skyrizi (risankizumab-rzaa)

Initial Therapy — Crohn's disease

Covered when ALL of the following are met for Crohn's disease:

CD Induction Criteria: Diagnosis of moderately to severely active Crohn's disease;

Supported by ADVANCE and MOTIVATE induction trials (IV risankizumab at weeks 0,4,8).

Dosing regimen: Skyrizi will be administered as three intravenous induction doses in accordance with the U.S. FDA–labeled dosing for Crohn's disease (IV risankizumab at weeks 0, 4, and 8); authorization will be issued for 3 induction doses.3 IV induction doses

Requests that do not specify administration as three IV induction doses risk denial.

No concurrent targeted immunomodulator: Patient is not receiving Skyrizi in combination with another targeted immunomodulator (e.g., adalimumab, certolizumab, vedolizumab, mirikizumab, upadacitinib, guselkumab, ustekinumab).

Combination targeted therapy is not permitted per policy.

Prior therapy

Conventional therapy failure: History of failure to at least one conventional therapy at up to maximally indicated doses unless contraindicated or not tolerated (examples: corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate).documented in medical record
Conventional therapies listed in policy.
Prior targeted immunomodulator: Prior treatment with a targeted immunomodulator FDA‑approved for Crohn's disease (e.g., adalimumab, certolizumab, vedolizumab, mirikizumab, upadacitinib, guselkumab, ustekinumab).documented in medical record
Reflects populations enrolled in ADVANCE and MOTIVATE.

Clinical trial support: Indication and dosing consistent with the populations and regimens studied in phase 3 induction trials (ADVANCE, MOTIVATE).

Efficacy demonstrated for IV risankizumab induction in ADVANCE/MOTIVATE.

Initial Therapy — Ulcerative colitis

Covered when ALL of the following are met for ulcerative colitis:

UC Induction Criteria: Diagnosis of moderately to severely active ulcerative colitis;

Supported by INSPIRE induction trial and COMMAND maintenance data.

Dosing regimen: Skyrizi will be administered as three intravenous induction doses in accordance with the U.S. FDA–labeled dosing for ulcerative colitis (IV risankizumab at weeks 0, 4, and 8); authorization will be issued for 3 induction doses.3 IV induction doses

Induction regimen consistent with INSPIRE study.

No concurrent targeted immunomodulator: Patient is not receiving Skyrizi in combination with another targeted immunomodulator (examples include adalimumab, vedolizumab, mirikizumab, upadacitinib, golimumab, guselkumab, tofacitinib, ustekinumab, ozanimod).

Combination targeted therapy is not permitted per policy.

Initial and Maintenance Coverage Criteria

Covered when ALL of the following are met (reflecting populations studied and FDA indications):

Indication: Member has moderately to severely active Crohn's disease or moderately to severely active ulcerative colitis (FDA‑labeled indications).FDA‑labeled indications

See FDA indications section.

Prior therapy history: Documentation of prior inadequate response or intolerance to one or more conventional therapies or biologics (and for UC may include JAK inhibitors or S1PR modulators) as appropriate to the disease and consistent with trial populations.as documented in medical record

INSPIRE, ADVANCE/MOTIVATE, and FORTIFY/COMMAND enrolled patients with prior failures of biologics or conventional therapy.

Dosing regimen and maintenance plan: Provider plans to use induction IV risankizumab (600 mg or 1200 mg at weeks 0, 4, and 8) followed by subcutaneous maintenance risankizumab (180 mg or 360 mg every 8 weeks) or an equivalent FDA‑approved regimen.

Self-administered subcutaneous Skyrizi (risankizumab-rzaa) is generally obtained under the pharmacy benefit. An exception exists for members enrolled in UnitedHealthcare of California plans with a delegated provider group performing the prior authorization review — in those cases the self-administered product may be obtained under the medical benefit.

FDA approval or labeling alone does not guarantee coverage; coverage determinations must reference the member's specific benefit plan. When applying this policy, providers should consult the member-specific benefit plan document because the member plan governs in the event of a conflict and plan terms may differ from the standard policy.

Use of risankizumab outside the FDA‑indicated populations or dosing regimens, or requests submitted without documentation of prior therapies and verification of benefit coverage, may be considered not medically necessary. Providers must check the member-specific benefit plan and any applicable federal or state mandates and supply supporting documentation demonstrating eligibility and prior treatment as defined by the plan.

Coding, Dosing, and Diagnosis Codes

Covered HCPCSHCPCSCovered

J2327

Injection, risankizumab-rzaa, intravenous, 1 mg.

Crohn's disease diagnosis codesICD-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

Ulcerative colitis and related diagnosis codesICD-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

Affected billing/codingmixed

affected codes

Placeholder from policy indicating affected codes for prior authorization/coverage (document references affected codes generically).

inv-11: Induction dosing — IV risankizumab 600 mg or 1200 mg at weeks 0, 4, and 8.

Induction regimenIntravenous risankizumab 600 mg or 1200 mg administered at Weeks 0, 4, and 8 (three IV induction doses)

Induction dosing optionsTwo IV induction dose levels studied: 600 mg and 1200 mg

Authorization notePrior authorization will be issued for three IV induction doses when medical necessity criteria are met

inv-12: Maintenance dosing — Subcutaneous risankizumab 180 mg or 360 mg every 8 weeks (after induction).

Maintenance regimenSubcutaneous risankizumab 180 mg or 360 mg every 8 weeks after induction

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required — IV Induction

Prior authorization is required when Skyrizi (risankizumab-rzaa) is administered under the medical benefit. Requests for IV induction must specify administration of three intravenous induction doses consistent with FDA‑labeled induction dosing for Crohn's disease or ulcerative colitis. Authorization, when criteria are met, will be issued for three IV induction doses.

J2327 (Injection, risankizumab-rzaa, intravenous, 1 mg)
Prescribed by or in consultation with a gastroenterologist for CD or UC when requesting IV induction authorization

Note

Prior Authorization and Benefit Channel — Verify Benefit

Determine whether the member's plan covers self‑administered subcutaneous Skyrizi under the pharmacy benefit or the medical benefit; by default self‑administered SC Skyrizi is obtained under the pharmacy benefit unless the member's benefit plan specifies otherwise. For members in delegated plans (e.g., certain UnitedHealthcare of California plans), the prior authorization review may result in medical benefit handling for self‑administered Skyrizi. In all cases, the member‑specific benefit plan document governs.

Background on Risankizumab (Skyrizi)

Skyrizi (risankizumab‑rzaa) is a humanized IgG1 monoclonal antibody that selectively binds the p19 subunit of interleukin‑23 (IL‑23), inhibiting downstream pro‑inflammatory cytokine release. Intravenous risankizumab was evaluated in phase 3 induction trials (ADVANCE and MOTIVATE) for moderately to severely active Crohn's disease and demonstrated statistically significant improvements in clinical remission and endoscopic response at Week 12.

Definitions and Trial References

inv-22: Skyrizi (risankizumab-rzaa) — short key value definition noting IL-23 p19 inhibitor.

AgentSkyrizi (risankizumab-rzaa)

Drug classHumanized IgG1 monoclonal antibody targeting interleukin‑23 (IL‑23) p19 subunit

MechanismSelectively binds the p19 subunit of IL‑23 and inhibits downstream pro‑inflammatory cytokine release

inv-23: ADVANCE and MOTIVATE trials — phase 3 induction studies design summary for Crohn's disease.

Trial designADVANCE and MOTIVATE were randomized, double‑masked, placebo‑controlled phase 3 induction studies in patients aged 16–80 with moderately to severely active Crohn's disease

Dosing in trialsParticipants were randomized to IV risankizumab 600 mg, 1200 mg, or placebo given at Weeks 0, 4, and 8

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy 2025D0116G

Change TypeClarification — benefit channel for self‑administered productarchival of prior version

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Skyrizi under the medical benefit for IV induction; authorization will be issued for three IV induction doses when criteria are met.

SourceLink

On This Page

Prior therapy

Inadequate response to conventional therapy: Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine).documented in medical record
INSPIRE enrolled patients with prior inadequate response to conventional therapies.
Prior targeted immunomodulator: Patient has been previously treated with a targeted immunomodulator FDA‑approved for ulcerative colitis (e.g., adalimumab, vedolizumab, mirikizumab, upadacitinib, golimumab, guselkumab, tofacitinib, ustekinumab, ozanimod).documented in medical record
Reflects populations enrolled in UC trials.

Provider specialty: Prescribed by or in consultation with a gastroenterologist when requesting IV induction dosing under the medical benefit.

Per policy documentation requirements.

dosing consistent with trials/FDA label

FORTIFY and COMMAND demonstrated maintenance efficacy for 180 mg and 360 mg every 8 weeks.

Benefit verification: Coverage is subject to the member‑specific benefit plan; self‑administered subcutaneous Skyrizi is typically covered under the pharmacy benefit unless the member's plan or a delegated arrangement specifies the medical benefit.member plan governs

FDA approval alone is not a basis for coverage; benefit verification required.

Documentation and prescriber: Documentation must support member eligibility, prior therapies, and planned dosing; IV induction requests should be prescribed by or in consultation with a gastroenterologist as applicable.medical record documentation

Supporting documentation should reflect trial‑like prior therapy history when required.

FORTIFY evaluated SC risankizumab 180 mg and 360 mg given every 8 weeks for maintenance following IV induction

Efficacy noteFORTIFY showed higher CDAI clinical remission rates with 360 mg versus placebo at Week 52

Check for applicable federal or state mandates that may affect benefit channel
If benefit plan conflicts with this policy, the member specific benefit plan document controls

Documentation Required

Member‑Specific Benefit Verification Required

Providers must verify member‑specific benefits and coverage prior to submission. Coverage determination and any exceptions are governed by the member's benefit plan; supporting documentation should be provided with the request to demonstrate medical necessity (e.g., prior therapy history, documentation of inadequate response/intolerance, prescribing clinician specialty documentation).

Verify member eligibility and benefit limitations before requesting authorization
Include clinical records showing prior therapy trials, reasons for failure or intolerance, and specialty consultation notes as applicable

Step Therapy

Prior Therapy Requirements and Expectations

For maintenance therapy medical necessity, and to support induction requests, documentation must show prior failure, intolerance, or contraindication to conventional therapies (unless otherwise specified) OR prior treatment with an FDA‑approved targeted immunomodulator for the indication. Examples of conventional therapies include corticosteroids (e.g., prednisone, methylprednisolone, budesonide), 6‑mercaptopurine, azathioprine, and methotrexate. Clinical trial populations typically had prior inadequate response or intolerance to biologics, JAK inhibitors, and/or S1P receptor modulators as applicable — include this history when relevant.

For Crohn's disease: documentation of failure/intolerance to at least one conventional therapy OR prior treatment with a targeted immunomodulator approved for CD
For Ulcerative colitis: documentation of inadequate response to corticosteroids and/or immunosuppressants OR prior treatment with a targeted immunomodulator approved for UC
Do not combine Skyrizi with another targeted immunomodulator

Primary endpointsCoprimary endpoints at Week 12 were clinical remission (CDAI or patient‑reported stool frequency and abdominal pain) and endoscopic response

inv-24: CDAI clinical remission definition as used in ADVANCE/MOTIVATE.

Definition usedClinical remission defined by Crohn's Disease Activity Index (CDAI) as the coprimary endpoint in ADVANCE and MOTIVATE induction studies

PopulationTrials enrolled patients with moderately to severely active Crohn's disease, many with prior inadequate response or intolerance to biologics or conventional therapy

TimingCDAI clinical remission assessed at Week 12 in the induction studies

inv-25: Modified Mayo Score (mMS) clinical remission as used in INSPIRE/COMMAND.

mMS componentsModified Mayo Score (mMS) is a 3‑component Mayo score (0–9) including stool frequency, rectal bleeding, and centrally read endoscopy score

Clinical remission definitionClinical remission in INSPIRE/COMMAND was defined using the mMS at Week 12 (INSPIRE) and Week 52 (COMMAND) as the primary endpoints

Study dosing contextINSPIRE induction used IV risankizumab 1200 mg at Weeks 0, 4, and 8; COMMAND evaluated SC maintenance 180 mg or 360 mg every 8 weeks following induction