Modifiedsierra health and lifePolicy 2025D0116G

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

Medical benefit drug policy governing use of intravenous Skyrizi for moderately to severely active Crohn's disease and ulcerative colitis under Sierra Health and Life/UnitedHealthcare commercial medical benefit; affects providers requesting medical‑benefit administration and prior authorization for inpatient/infused dosing.

Policy Summary

Payersierra health and life

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

Policy CodePolicy 2025D0116G

Change TypeOperational clarificationarchived prior version

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for intravenous Skyrizi (J2327); authorization issued for three induction doses when medical necessity criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added language to clarify Skyrizi (risankizumab-rzaa) for self-administered subcutaneous injection is obtained under the pharmacy benefit, unless otherwise specified in the member's benefit plan documents; 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.

3induction IV doses authorized

J2327IV HCPCS

Multiple K50/K51diagnosis codes listed

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approved indications

Coverage Criteria for Intravenous Skyrizi (risankizumab-rzaa)

Initial Induction — Crohn's disease

Covered when ALL of the following are met

Crohn initial induction: Diagnosis of moderately to severely active Crohn's disease; Skyrizi to be administered as three intravenous induction doses in accordance with FDA-labeled dosing for Crohn's disease; patient is not receiving Skyrizi in combination with another targeted immunomodulator; prescribed by or in consultation with a gastroenterologist

Authorization issued for 3 induction doses

Prior therapy for Crohn: Either history of failure or intolerance to one conventional therapy at maximally indicated doses (corticosteroids, 6-mercaptopurine, azathioprine, or methotrexate) unless contraindicated OR prior treatment with a targeted immunomodulator FDA-approved for Crohn's disease (e.g., adalimumab, certolizumab, vedolizumab, mirikizumab, upadacitinib, guselkumab, ustekinumab)

From policy requirements

Initial Induction — Ulcerative colitis

Covered when ALL of the following are met

UC initial induction: Diagnosis of moderately to severely active ulcerative colitis; Skyrizi to be administered as three intravenous induction doses in accordance with FDA-labeled dosing for ulcerative colitis; patient is not receiving Skyrizi in combination with another targeted immunomodulator; prescribed by or in consultation with a gastroenterologist

Authorization issued for 3 induction doses

Prior therapy for UC: Either prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine) OR prior treatment with a targeted immunomodulator FDA-approved for ulcerative colitis (e.g., adalimumab, vedolizumab, mirikizumab, upadacitinib, golimumab, guselkumab, tofacitinib, ustekinumab, ozanimod)

From policy requirements

Clinical trial evidence groups

Clinical trial evidence demonstrates risankizumab is effective for induction and maintenance in adult Crohn's disease and ulcerative colitis in specified populations

Crohn's induction evidence: ADVANCE and MOTIVATE randomized adults with moderately to severely active Crohn's disease (many with prior inadequate response or intolerance to biologics or conventional therapy) to IV risankizumab (600 mg or 1200 mg) at weeks 0, 4, and 8; coprimary endpoints (clinical remission and endoscopic response) were met at week 12week 12 endpoints met

All coprimary endpoints met (p<=0.0001)

Crohn's maintenance evidence: FORTIFY enrolled responders to induction and randomized them to subcutaneous risankizumab 180 mg or 360 mg q8w versus withdrawal; at week 52 risankizumab showed higher clinical remission and endoscopic response versus placeboweek 52 endpoints met

Dose-response observed; safety similar across groups

Ulcerative colitis induction evidence:

Use of Skyrizi in combination with another targeted immunomodulator is explicitly excluded. The policy lists examples of targeted immunomodulators that must not be used concurrently with intravenous risankizumab for Crohn's disease or ulcerative colitis (for example: adalimumab, certolizumab, vedolizumab, mirikizumab, upadacitinib, guselkumab, ustekinumab, among others).

Induction dosing must follow the FDA‑labeled intravenous regimen: authorization is issued for three induction doses administered per the U.S. FDA labeled schedule for the indicated disease. Requests that propose dosing outside the FDA‑labeled IV induction regimen may not meet the criteria and are subject to denial.

FDA approval information for Skyrizi (risankizumab‑rzaa) is provided for informational purposes only. The FDA indicates Skyrizi is an interleukin‑23 antagonist approved for, among other indications, moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis in adults.

However, FDA approval alone is not a basis for coverage; coverage decisions follow the policy's medical necessity criteria and the member's specific benefit plan.

Requests that do not meet the policy's diagnostic, dosing, or prior therapy criteria are considered not medically necessary. Examples include requests for patients without a diagnosis of moderately to severely active Crohn's disease or ulcerative colitis, requests that do not follow the three intravenous induction doses per FDA‑labeled dosing, or requests for concomitant use with another targeted immunomodulator.

When a request is denied for not meeting these criteria, the denial rationale should reference the specific unmet requirement (diagnosis, FDA‑labeled IV induction dosing, combination therapy exclusion, or prior therapy requirements) from the policy to support the decision.

Coding and Diagnosis Codes

Covered HCPCSHCPCSCovered

J2327

Injection, risankizumab-rzaa, intravenous, 1 mg.

Crohn's disease ICD-10 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 ICD-10 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

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for IV Skyrizi (J2327) when medical necessity criteria are met. Approvals for intravenous induction will be issued for three induction doses consistent with FDA‑labeled dosing for Crohn's disease or ulcerative colitis.

Intravenous Skyrizi (J2327): prior authorization required; authorization issued for 3 induction doses
Dosing must follow FDA‑labeled induction regimen for CD or UC

Billing Rule

Benefit Channel and Prior Authorization Handling

Self‑administered subcutaneous Skyrizi is typically obtained under the pharmacy benefit unless the member's specific benefit plan documents state otherwise. For members enrolled in UnitedHealthcare of California plans where a delegated provider group conducts the prior authorization review, the self‑administered Skyrizi may be processed under the medical benefit. Always verify the member specific benefit plan.

Background and Policy Scope

Skyrizi (risankizumab‑rzaa) is a humanized IgG1 monoclonal antibody that selectively binds the p19 subunit of interleukin‑23 (IL‑23), thereby inhibiting IL‑23 mediated inflammatory signaling. It belongs to the class of IL‑23 p19 antagonists used to modulate immune responses in inflammatory diseases.

Intravenous risankizumab induction regimens were studied in randomized phase 3 induction trials (ADVANCE and MOTIVATE for Crohn's disease; INSPIRE for ulcerative colitis) which demonstrated improved clinical remission and endoscopic response compared with placebo in adults with moderately to severely active disease.

Definitions and Trial Endpoints

Skyrizi (risankizumab-rzaa) — key drug definition and target

Generic namerisankizumab-rzaa

Brand nameSkyrizi

Mechanism of actionHumanized IgG1 monoclonal antibody that selectively binds the p19 subunit of interleukin-23 (IL-23)

Pharmacologic effectInhibits IL-23 interaction with its receptor, reducing release of pro‑inflammatory cytokines and chemokines

Formulation relevant to policyIntravenous formulation used for induction dosing (studied at 600 mg and 1200 mg IV)

ADVANCE and MOTIVATE trial endpoints — coprimary endpoints for induction trials

Policy Summary

Payersierra health and life

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

Policy CodePolicy 2025D0116G

Change TypeOperational clarificationarchived prior version

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for intravenous Skyrizi (J2327); authorization issued for three induction doses when medical necessity criteria are met.

SourceLink

On This Page

INSPIRE randomized 966 subjects with moderately to severely active UC to IV risankizumab 1200 mg at weeks 0, 4, and 8; risankizumab achieved higher clinical remission and response vs placebo at week 12 (mMS) in a population with substantial prior biologic/JAKi/S1PRM failure

week 12 mMS remission

Population included many with prior biologic/JAKi/S1PRM failure

Ulcerative colitis maintenance evidence: COMMAND randomized responders to subcutaneous risankizumab 180 mg or 360 mg q8w versus placebo and demonstrated higher clinical remission at week 52 and improvement in key secondary endpoints including steroid-free remission and endoscopic improvementweek 52 mMS remission

Key secondary endpoints improved

Self‑administered SC Skyrizi: pharmacy benefit by default
UnitedHealthcare of California delegated plans: SC Skyrizi may be under medical benefit
Verify member specific benefit plan documents for benefit-channel determination

Step Therapy

Step Therapy / Prior Treatment Requirements

Maintenance coverage requires documentation of prior treatment history. For Crohn's disease, there must be history of failure, intolerance, or contraindication to at least one conventional therapy (e.g., corticosteroids, azathioprine, 6‑mercaptopurine, methotrexate) unless the patient has previously been treated with an FDA‑approved targeted immunomodulator for Crohn's disease. For ulcerative colitis, there must be prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine) or prior treatment with an FDA‑approved targeted immunomodulator for UC.

Crohn's disease: failure/intolerance to one conventional therapy (listed) OR prior treatment with an FDA‑approved targeted immunomodulator for CD
Ulcerative colitis: inadequate response to corticosteroids/immunosuppressants OR prior treatment with an FDA‑approved targeted immunomodulator for UC

Documentation Required

Required Documentation

Prescriptions should be written by or in consultation with a gastroenterologist. Documentation submitted with the prior authorization must support the diagnosis (moderately to severely active Crohn's disease or ulcerative colitis), disease severity, prior therapy history (including reasons for discontinuation such as lack of efficacy or adverse effects), and treatment plan confirming Skyrizi will not be used in combination with another targeted immunomodulator.

Prescriber: gastroenterologist or documented gastroenterology consultation
Documentation: diagnosis, disease severity (e.g., clinical scores, endoscopy findings), prior treatment history and outcomes, contraindications/intolerances
Must confirm Skyrizi will not be combined with other targeted immunomodulators

Documentation Required

Documentation and Reference Requirement

Decisions must reference the member specific benefit plan document. In the event of a conflict between this policy and the member's benefit plan, the member specific plan governs. Check for and apply any applicable federal or state mandates prior to coverage determination.

Member specific benefit plan document governs in case of conflict with this policy
Confirm applicable federal/state mandates before making coverage decisions
This policy interprets UnitedHealthcare standard benefit plans and is informational

ADVANCE and MOTIVATE phase 3 randomized, double‑masked, placebo‑controlled induction studies

PopulationAdults (aged 16–80) with moderately to severely active Crohn's disease, many with prior inadequate response or intolerance to biologics or conventional therapy

Coprimary clinical remission endpointsClinical remission defined by Crohn's Disease Activity Index (CDAI) or patient‑reported outcome criteria (average daily stool frequency and abdominal pain score)

Coprimary objective endoscopic endpointEndoscopic response at Week 12

Dosing regimen studiedSingle IV doses of risankizumab (600 mg or 1200 mg) at Weeks 0, 4, and 8

modified Mayo score (mMS) — definition and trial use

NameModified Mayo score (mMS)

Use in trialsPrimary endpoint for clinical remission in INSPIRE (UC) at Week 12 and used as the clinical remission measure in COMMAND at Week 52

Components referencedmMS used to define clinical remission and clinical response, and to assess endoscopic and histologic endoscopic mucosal improvement

Example resultsIn INSPIRE, total population clinical remission by mMS was 24% with risankizumab vs. 8% with placebo at Week 12

CDAI / patient-reported PRO remission criteria — definitions used as coprimary clinical remission endpoints in Crohn's trials

CDAICrohn's Disease Activity Index (CDAI) used to define clinical remission in ADVANCE and MOTIVATE induction trials

Patient‑reported PRO criteriaAverage daily stool frequency and abdominal pain score used as an alternative coprimary clinical remission definition

Endpoint timingCoprimary clinical remission endpoints assessed at Week 12 in induction trials

Reported outcomesAll coprimary endpoints at Week 12 were met in both trials with both doses (p ≤ 0.0001)