CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Skyrizi (risankizumab-rzaa) — Intravenous and Subcutaneous Coverage Criteria

Clinical coverage criteria for risankizumab (Skyrizi) intravenous (IV) and subcutaneous (SC) formulations across Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) members (Rhode Island). Defines initial approval, renewal criteria, dosing, quantity limits, and covered diagnosis codes for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySkyrizi (risankizumab-rzaa) — Intravenous and Subcutaneous Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2023

Next Review Date

Key ActionPrescribers must submit prior authorization with documentation of baseline disease severity, prior medication trials (with durations and reasons for failure/intolerance), vaccination status, TB screening, and specialist consultation as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Indications addressed (Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis)

365MMP lookback for prior therapy exemption (days)

12Typical authorization renewal period (months)

J2327HCPCS billing code listed for IV risankizumab

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Clinical Coverage Criteria for Skyrizi (risankizumab-rzaa)

Initial Approval Criteria — General requirements

Coverage requires ALL of the following general baseline safety and administrative checks:

ALL of the following

Member is ≥ 18 years of age≥ 18 years
Prescribing physician has assessed baseline disease severity using an objective measurement tool
Member is up to date with age-appropriate vaccinations prior to initiating therapy
Patient has been evaluated and screened for latent tuberculosis (TB) prior to initiating treatment and will be monitored during treatment
Member does not have an active infection (including clinically important localized infections)
Member will not receive live vaccines during therapy
Member is not on concomitant treatment with another injectable biologic response modifier (e.g., TNF inhibitors) or specified IL-inhibitors or certain oral agents
Document discontinuation of prior biologics as applicable

Moderate to severe plaque psoriasis — Initial approval

Coverage when ALL of the following are met (prescriber is or consults with dermatology or rheumatology):

ALL of the following

Prescribed by, or in consultation with, a specialist in dermatology or rheumatology
Disease severity documentation (ANY of the following)
- >= 10% body surface area (BSA) affected≥ 10% BSA (or involvement of crucial body areas)
- Crucial body areas affected (hands, face, neck, scalp, genitals/groin, intertriginous areas, feet)
Prior systemic/phototherapy failure/intolerance (ONE of)

Active psoriatic arthritis (PsA) — Initial approval

Coverage when ALL of the following are met (prescriber is or consults with dermatology or rheumatology):

ALL of the following

Prescribed by, or in consultation with, a specialist in dermatology or rheumatology
Documented moderate to severe active psoriatic arthritis
Prior treatment failures depending on disease phenotype (ONE of)
- For predominantly axial disease or active enthesitis and/or dactylitis: inadequate response or intolerance to at least two NSAIDs unless contraindicated
- For peripheral arthritis: inadequate response to at least a 3-month trial of one oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine, hydroxychloroquine) unless intolerant

Crohn's disease — Initial approval

Coverage when ALL of the following are met (prescriber is or consults with gastroenterology):

ALL of the following

Prescribed by, or in consultation with, a gastroenterologist
Documented moderate to severe active Crohn's disease
Inadequate response, intolerance, or contraindication to at least a 3-month trial of infliximab IV or adalimumab at maximum tolerated doses
Inadequate response, intolerance, or contraindication to at least a 6-month trial of ustekinumab at maximum tolerated doses

Ulcerative colitis — Initial approval

Coverage when ALL of the following are met (prescriber is or consults with gastroenterology):

ALL of the following

Prescribed by, or in consultation with, a gastroenterologist
Documented moderate to severe ulcerative colitis
Inadequate response, intolerance, or contraindication to at least a 3-month trial of infliximab IV or adalimumab at maximum tolerated doses
Inadequate response, intolerance, or contraindication to at least a 6-month trial of ustekinumab (or biosimilar) at maximum tolerated doses

Exemption for MMP members

Special consideration applies to Medicare-Medicaid Plan (MMP) members:

ALL of the following

MMP members who have previously received this medication within the past 365 days are not subject to therapy step requirements
Cross-note: MMP prior therapy exemption — prescriber should document prior receipt per provider action

IV Induction Non-renewability

Specific limitation for IV formulation:

ALL of the following

Skyrizi IV induction doses are not renewable (one-time induction only)
Aligns with provider action: IV induction non-renewability; requests for repeat IV induction will be denied

Actions Required from Prescribers and Billing Notes

Prior Authorization

Prior authorization required with documented trials

Prior authorization is required. Submit documentation of baseline disease severity, prior medication trials including duration and reason for failure or intolerance, vaccination status, TB screening results, and evidence of specialist prescribing or consultation when applicable.

Baseline disease severity (objective measures preferred)
Prior medication trials: drug names, trial durations, and reasons for failure/intolerance
Up-to-date age-appropriate vaccinations prior to initiating therapy
Documentation of evaluation/screening for latent tuberculosis (TB)
Specialist consultation or prescribing note (dermatology, rheumatology, or gastroenterology) as applicable

Documentation Required

Objective measurement and monitoring

Relevant Billing and Diagnosis Codes

HCPCS / BillingHCPCS

J2327

Injection, risankizumab-rzaa, intravenous, 1 mg (listed in doc as HCPCS for IV)

NDC / Product identifiersNDC

00074-5015-xx	Skyrizi carton containing one 600 mg/10 mL single-dose vial (format in document)
0074-2100-XX	Skyrizi 150 mg/mL single-dose pen (NDC format listed)
0074-1050-xx	Skyrizi 50 mg/mL single-dose prefilled syringe (NDC format listed)

Covered diagnosis codes (ICD-10)ICD-10Covered

K50.011	Crohn's disease of small intestine without complications
K50.012	Crohn's disease of small intestine with rectal bleeding
K50.013	Crohn's disease of small intestine with intestinal obstruction
K50.014	Crohn's disease of small intestine with fistula
K50.018	Crohn's disease of small intestine with abscess
K50.019	Crohn's disease of small intestine with other complication
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
K50.113	Crohn's disease of large intestine with fistula

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Clinical and Administrative Background

Risankizumab (Skyrizi) is an interleukin‑23 (IL‑23) antagonist indicated for moderate‑to‑severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, for active psoriatic arthritis in adults, and for moderately‑to‑severely active Crohn’s disease. Clinical trial summaries and the product literature support efficacy across these indications with both intravenous (IV) and subcutaneous (SC) formulations.

For inflammatory bowel disease, clinical studies evaluated an IV induction regimen (typically administered at Weeks 0, 4, and 8) with a recommended Crohn’s induction dose of 600 mg IV and an ulcerative colitis induction option that included higher IV dosing; evidence showed no added benefit with the higher 1,200 mg Crohn’s dose and supported the 600 mg regimen. Maintenance therapy is given by subcutaneous (SC) dosing beginning at Week 12 and continuing every 8 or 12 weeks depending on indication and regimen.

Dosing and billing details reflect the IV and SC pathways: IV induction is a one‑time induction course and is not renewable, while SC dosing (for plaque psoriasis, psoriatic arthritis, and maintenance IBD) follows labeled maintenance schedules (for example, 150 mg SC at Week 0, Week 4, then every 12 weeks for plaque psoriasis/psoriatic arthritis; Crohn’s maintenance 360 mg SC at Week 12 and every 8 weeks thereafter).

Neighborhood Health Plan of Rhode Island aligns coverage with FDA labeling and relevant clinical literature, applying specialist prescribing expectations, baseline safety checks (age ≥ 18 years, vaccination and TB screening, infection status), and utilization controls (including IV induction non‑renewability and documentation of prior therapies) to ensure use consistent with the evidence base and labeling.

Defined Terms

Definitions

MMPMedicare-Medicaid Plan

BSABody Surface Area

CDAICrohn's Disease Activity Index

IV inductionInitial intravenous loading regimen (typically Weeks 0, 4, and 8) as described for Crohn's and ulcerative colitis

Clinical Thresholds

Thresholds

Age≥ 18 years

Plaque psoriasis BSA threshold≥ 10% BSA (or involvement of crucial body areas)