CurrentmhnPolicy CP.PHAR.426

Clinical Policy: Risankizumab-rzaa (Skyrizi)

Defines medical necessity criteria, dosing limits, prior authorization and continuation requirements for risankizumab-rzaa (Skyrizi) across FDA-approved indications (plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis) for Medicaid line of business.

Policy Summary

Payermhn

PolicyClinical Policy: Risankizumab-rzaa (Skyrizi)

Policy CodePolicy CP.PHAR.426

Change TypeAdded UC indicationdosing/score updatesprohibited combinations expanded

Effective DateJun 4, 2019

Next Review Date

Key ActionProvider must submit chart notes, labs, or other clinical information supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added Ulcerative Colitis indication to criteria (RT4).

For UC initial criteria, added option for modified Mayo Score ≥ 5 and added Mayo Endoscopic Score > 2 as defining moderate-to-severe UC.

Added prohibited combination use with many bDMARDs, JAKi, and other potent immunosuppressants in Section III.B.

Added HCPCS codes J2327, C9399, and J3590 to coding implications.

Extended initial approval durations to 12 months for chronic conditions.

4FDA-approved indications covered

12 monthsTypical approval duration

≥3 months

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Required trial duration for most comparators

150 mgMax SC dose for PsO/PsA per schedule

Coverage Summary

Policy CP.PHAR.426 (Effective: 06.04.19; Last review: 11.25) covers risankizumab‑rzaa (Skyrizi) as covered_with_criteria for its FDA‑approved indications — moderate‑to‑severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), moderately to severely active Crohn’s disease (CD), and moderately to severely active ulcerative colitis (UC). The policy defines indication‑specific induction and maintenance dosing and step‑therapy/prior authorization requirements, and is written for the Medicaid line of business. Typical approval duration for chronic indications is 12 months (initial and continued therapy durations).

Quick Facts / Thresholds

FDA‑approved indications covered4 (plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis)

Typical approval duration12 months

Required trial duration for most comparators>= 3 months (consecutive)

Max subcutaneous dose for PsO/PsA150 mg (SC) at weeks 0 and 4, then every 12 weeks

Plaque Psoriasis BSA threshold>= 3% total body surface area

Ulcerative Colitis activity thresholdsMayo Score >= 6; modified Mayo Score >= 5; Mayo Endoscopic Score >= 2

Required trial duration noted in UC initial criteria8‑week trial of systemic corticosteroids required (unless contraindicated or prior biologic failure)

Initial Therapy Criteria (by indication)

Continuation Therapy Criteria

Exclusions / Prohibited Combinations

The policy expressly prohibits combination use of risankizumab with other biological disease‑modifying antirheumatic drugs (bDMARDs) and potent immunosuppressants listed in Section III.B (including but not limited to tumor necrosis factor antagonists, interleukin agents, JAK inhibitors, anti‑CD20 antibodies, Orencia, Entyvio, Sotyktu, and Velsipity). Requests for combination therapy are not authorized and may be denied due to additive immunosuppression and increased risk of neutropenia and serious infections; therefore combination‑use requests present a risk of denial.

Provider Actions & Authorization Requirements

Documentation Required

Submit supporting documentation for approval

Provider must submit office chart notes, laboratory results, and other clinical information that documents diagnosis, prior therapy trials/failures, relevant scoring (e.g., Mayo/modified Mayo/Mayo Endoscopic Score for UC), and dosing to support that member meets all approval criteria.

Prior Authorization

Prior authorization required

Prior authorization may be required per plan rules for comparator biologics including adalimumab products, Taltz (ixekizumab), ustekinumab products, Otezla (apremilast), and Xeljanz/Xeljanz XR depending on indication; obtain PA if applicable before dispensing.

Applicable Codes

HCPCS - risankizumab-rzaa IV/administration codes referencedHCPCS

J2327	Injection, Risankizumab-rzaa, intravenous, 1 mg
C9399	Unclassified drugs or biologicals
J3590	Unclassified biologics

Coding history: HCPCS code J2327 (injection, risankizumab‑rzaa, IV, 1 mg) was added on Feb 13, 2023. HCPCS codes C9399 and J3590 were added on 01.22.24, per the policy's coding revisions and revision log.

Clinical Evidence

Prescribing InfoSkyrizi PI, AbbVie Inc.; dosing and FDA‑approved indications (PsO, PsA, CD, UC)

Phase 2a AsthmaNot beneficial in severe asthma; increased rate/time to asthma worsening vs placebo (NEJM 2021)

Supporting references include the Skyrizi Prescribing Information (AbbVie; September 2025) for approved dosing and indications, and clinical evidence such as the NEJM phase 2a severe asthma trial (Brightling et al., NEJM 2021) which found risankizumab was not beneficial and was associated with increased asthma worsening; safety considerations and contraindications (e.g., hypersensitivity) are summarized in the policy background and appendices.

Background & Definitions

Background: Risankizumab‑rzaa (Skyrizi) is an interleukin‑23 (IL‑23) blocker with FDA approvals for moderate‑to‑severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), moderately to severely active Crohn’s disease (CD), and moderately to severely active ulcerative colitis (UC). The policy incorporates indication‑specific induction and maintenance dosing (e.g., PsO/PsA: 150 mg SC at weeks 0 and 4 then every 12 weeks; CD induction: 600 mg IV at weeks 0, 4, 8 with maintenance 360 mg SC at week 12 and every 8 weeks; UC induction: 1,200 mg IV at weeks 0, 4, 8 with maintenance 360 mg SC at week 12 and every 8 weeks). Comparator step therapy (conventional immunomodulators, corticosteroids, or specified biologics such as adalimumab, ustekinumab, Taltz, Otezla, etc.) and prior authorization requirements are detailed per indication. Contraindications include history of serious hypersensitivity to risankizumab or excipients; safety considerations note risk of additive immunosuppression when combined with other immunomodulators and reference the asthma trial showing lack of benefit and potential harm in severe asthma.

Term	Definition
bDMARD
biological disease-modifying antirheumatic drug
JAKi
Janus kinase inhibitor
MTX
methotrexate
PsO
plaque psoriasis
CD
Crohn's disease
UC
ulcerative colitis

Revision History

02.13.23coding_addition

HCPCS code J2327 (Injection, Risankizumab-rzaa, IV, 1 mg) added to coding implications.

01.22.24coding_addition

HCPCS codes C9399 and J3590 added to coding implications.

07.23.24indication_added

Ulcerative Colitis indication added to the policy criteria (RT4) with UC-specific induction and maintenance dosing.

Policy Summary

Payermhn

PolicyClinical Policy: Risankizumab-rzaa (Skyrizi)

Policy CodePolicy CP.PHAR.426

Change TypeAdded UC indicationdosing/score updatesprohibited combinations expanded

Effective DateJun 4, 2019

Next Review Date

Key ActionProvider must submit chart notes, labs, or other clinical information supporting that member has met all approval criteria.

SourceLink

On This Page

Billing Rule

Dose/quantity limits for vial/cartridge requests (CD/UC)

When requests are for vial or pre-filled cartridge formulations, quantity is limited to one single-dose vial or one pre-filled cartridge per dose for Crohn's disease and one pre-filled cartridge per dose for ulcerative colitis as specified in dosing limits.

Denial Risk

Combination therapy exclusion

Requests for concomitant use of risankizumab with other biological DMARDs or potent immunosuppressants (including listed TNF antagonists, interleukin agents, JAK inhibitors, anti-CD20 agents, Orencia, Entyvio, Sotyktu, Velsipity, etc.) are not authorized and may be denied due to additive immunosuppression and infection risk.

Documentation Required

UC activity scoring required

For UC initial approval, provide documentation of disease activity using a Mayo Score ≥ 6, modified Mayo Score ≥ 5, or Mayo Endoscopic Score ≥ 2 (per Appendix F) to demonstrate moderate-to-severe ulcerative colitis.

Step Therapy

Step therapy through conventional or specified biologics

Initial approval requires documented trials or failures of conventional immunomodulators or corticosteroids and/or specified biologics as outlined per indication (e.g., methotrexate, cyclosporine, acitretin, azathioprine/6-MP/MTX; and for biologic step therapy: one adalimumab product, Taltz, ustekinumab, Otezla, Xeljanz as applicable). Exceptions apply if the member has previously failed a biologic for the condition or has contraindications.

08.24pt_committee_approval

P&T approval recorded for revisions including addition of the Ulcerative Colitis indication and related criteria.

01.23.25criteria_revision

For UC initial criteria, added option for documentation of modified Mayo Score ≥ 5 and removed redirection to preferred adalimumab products because adalimumab is not recommended per 2024 AGA guidelines.

05.25pt_committee_approval

P&T approval recorded for the 2Q 2025 annual review changes including UC scoring option and removal of adalimumab redirection.

04.23.25criteria_revision

Revised UC step options to include step through preferred adalimumab or preferred ustekinumab products; later modifications removed adalimumab redirection per AGA guidance.

06.25pt_committee_approval

P&T approval recorded for April SDC updates including Stelara biosimilar preferences and UC step revisions.

2022-2024agent_additions

Section III.B updated between 2022 and 2024 to add multiple agents (e.g., Bimzelx, Omvoh, Sotyktu, Velsipity, Spevigo and biosimilar verbiage) to the prohibited combination list.

11.25finalizationLatest

Policy finalization recorded with extended initial approval durations to 12 months and other consolidated updates (final review date 11.25).

09.04.25approval_duration_changeLatest

Initial and continued approval durations extended/confirmed to 12 months for chronic conditions.