CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ustekinumab (intravenous and subcutaneous) for Crohn's Disease and Ulcerative Colitis

Coverage and medical necessity criteria for ustekinumab (Stelara and biosimilars) for Crohn's disease and ulcerative colitis for Medicaid, Commercial, and MMP members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUstekinumab (intravenous and subcutaneous) for Crohn's Disease and Ulcerative Colitis

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01/01/2020

Next Review Date06/25/2025

Key ActionSubmit prior authorization with documentation of age, objective disease severity, vaccination and TB screening, absence of active infection, and prior trial/failure of infliximab or adalimumab.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J3357,J3358primary HCPCS codes listed

520maximum IV induction units

90 mgsubcutaneous maintenance dose

~70ICD-10 codes listed

Coverage Criteria for Ustekinumab

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

General prerequisites: Patient is ≥18 years of age (unless otherwise specified); physician has assessed baseline disease severity using an objective measure/tool; patient is up to date with vaccinations per current guidelines; patient has been evaluated and screened for latent tuberculosis prior to initiating therapy and will receive ongoing TB monitoring during treatment; patient does not have an active infection and will not receive live vaccines during therapy; patient is not on concurrent treatment with an injectable biologic response modifier (including TNF-inhibitors) or IL-inhibitors or specified oral non-biologic agents.

General prerequisites for initiation

Stelara IV specific: If the request is for Stelara (ustekinumab) IV, the member has had an inadequate response, intolerance, or contraindication to at least a 6-month trial of an available ustekinumab biosimilar (e.g., Otulfi, Selarsdi, Steqeyma, Yesintek) at maximum tolerated doses.

IV formulation authorization requirement

Crohn's disease criteria: Must be prescribed by, or in consultation with, a gastroenterology specialist; documented moderate to severe active Crohn's disease; and documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of infliximab IV or adalimumab.

FDA-indication aligned requirement for Crohn's disease

Ulcerative colitis criteria: Must be prescribed by, or in consultation with, a gastroenterology specialist; documented moderate to severe active ulcerative colitis; and inadequate response, intolerance, or contraindication to at least a 3-month trial of infliximab IV or adalimumab at maximum tolerated doses.

FDA-indication aligned requirement for ulcerative colitis

General coverage application — Covered when consistent with Neighborhood's clinical criteria and FDA-approved labeling

Covered when consistent with Neighborhood's clinical criteria and FDA-approved labeling.

Coverage preconditions: Use is consistent with FDA-approved labeling or relevant clinical literature, and documentation is submitted by the prescriber for individual consideration.

Applies to review of coverage requests; for INTEGRITY (Medicare-Medicaid Plan) members these criteria apply only in the absence of applicable NCD/LCD.

Coverage is not permitted when the patient has an active infection or clinically important localized infection. Prior to initiation, members must be screened for latent tuberculosis and have an ongoing TB monitoring plan during therapy. Patients must be up to date with vaccinations before starting ustekinumab and must not receive live vaccines during therapy. Concurrent use with other injectable biologic response modifiers (including TNF‑inhibitors such as adalimumab and infliximab) or IL‑inhibitors (for example, secukinumab, guselkumab, tildrakizumab, risankizumab, bimekizumab, mirikizumab) is excluded, as is concurrent use with specified oral non‑biologic immunomodulatory agents (for example, apremilast, tofacitinib, baricitinib, upadacitinib, etrasimod).

For members enrolled in Neighborhood's INTEGRITY (Medicare‑Medicaid Plan) program, Neighborhood's clinical coverage criteria for ustekinumab apply only in the absence of an applicable CMS National Coverage Determination (NCD) or Local Coverage Determination (LCD). Where an NCD, LCD, or Local Coverage Article (LCA) exists, compliance with those CMS policies is required and will govern coverage; Neighborhood will consider additional indications at its discretion and will give individual consideration to requests based on prescriber‑submitted information.

Step therapy requires documentation of prior failure, intolerance, or contraindication to at least a 3‑month trial of infliximab IV or adalimumab at maximum tolerated doses for both Crohn's disease and ulcerative colitis. Exceptions include members who are MMP members previously treated with ustekinumab within the past 365 days (not subject to step therapy) or patients with documented contraindications or intolerance preventing adequate trials of the preferred agents; such exceptions must be clearly documented by the prescriber.

Requests for ustekinumab that are not consistent with FDA‑approved labeling or the relevant clinical literature and Neighborhood's clinical criteria may be considered not medically necessary and denied. The plan will perform individual consideration using information submitted by the prescriber, but the policy was designed to ensure use aligns with medically accepted indications and supporting evidence.

Billing and Code Tables

HCPCS CodesHCPCS

J3357	Ustekinumab, for subcutaneous injection, 1 mg; 1 billable unit = 1 mg
J3358	Ustekinumab, for intravenous injection, 1 mg; 1 billable unit = 1 mg
Q9996	Ustekinumab-ttwe (pyzchiva), subcutaneous, biosimilar, 1mg; 1 billable unit = 1 mg
Q9997	Ustekinumab-ttwe (pyzchiva), intravenous, biosimilar, 1 mg; 1 billable unit = 1 mg
Q9998	Ustekinumab-aekn (selarsdi SC, IV), biosimilar, 1 mg; 1 billable unit = 1 mg
Q9999	Ustekinumab-aauz (Otulfi SC, IV), biosimilar, 1mg; 1 billable unit = 1 mg
J3590	Ustekinumab-kfce (Yesintek SC, IV) or Ustekinumab-stba (Steqeyma SC, IV)
Q5137	Ustekinumab-auub (Wezlana SC); 1 mg; 1 billable unit = 1 mg
Q5138	Ustekinumab-auub (Wezlana IV); 1 mg; 1 billable unit = 1 mg

Subcutaneous (J3357) — covered diagnosesHCPCS | ICD-10 | mixedCovered

J3357

Subcutaneous (ustekinumab) — listed with multiple ICD-10 diagnosis codes

Intravenous (J3358) — covered diagnosesHCPCS | ICD-10 | mixedCovered

J3358

Intravenous (ustekinumab) — listed with multiple ICD-10 diagnosis codes

All ICD-10 codes listed in appendicesICD-10Covered

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 78

1/8

IV induction dose by weight

≤ 55 kg260 mg (one-time IV induction dose)

> 55 kg to 85 kg390 mg (one-time IV induction dose)

> 85 kg520 mg (one-time IV induction dose; maximum billable units)

Subcutaneous maintenance interval/dose

Maintenance dose90 mg subcutaneous administered 8 weeks after the initial IV induction dose, then every 8 weeks thereafter

Formulation units90 billable units per dose (1 unit = 1 mg)

Timing noteInitial SC maintenance begins 8 weeks after the single IV loading dose

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for all requests for ustekinumab (including J3357, J3358 and listed biosimilar/Q-code equivalents). Requests will be reviewed against Neighborhood clinical criteria.

Applies to subcutaneous and intravenous formulations and biosimilars
Prior auth required for both new starts and dose/formulation changes

Documentation Required

Required Clinical Justification

Requests must include prescriber-submitted clinical justification and documentation to allow individualized review. Neighborhood will give individual consideration to each request based on the information provided by the prescriber and other information available to the plan.

Clinical course and rationale for ustekinumab over alternative therapies
Specialist consultation notes when required by indication (e.g., gastroenterology for Crohn's/UC)

Documentation Required

Required Documentation

Specific documentation required with the authorization request includes baseline objective disease severity, patient age, vaccination status, TB screening results, and prior treatment history including trials of preferred agents.

Patient age and diagnosis
Objective baseline disease severity assessment (e.g., validated scoring tool or clinical documentation)
Up-to-date vaccination records and documentation that live vaccines will not be given during therapy
Latent TB screening results and plan for ongoing TB monitoring
History of prior therapies, including dates, doses, and reasons for discontinuation (failure, intolerance, or contraindication)

Step Therapy

Step Therapy Requirements

Step therapy requirements apply unless member received ustekinumab within the past 365 days or has documented contraindication/intolerance. For Crohn's disease and ulcerative colitis, members must have had an inadequate response, intolerance, or contraindication to at least a 3-month trial of infliximab IV or adalimumab at maximum tolerated doses prior to approval of ustekinumab (except where Stelara IV criteria specify a 6-month ustekinumab trial).

Step therapy may be waived for documented contraindication or intolerance
MMP members with prior ustekinumab within 365 days are not subject to step therapy

Denial Risk

Denial Risk for Nonconcordant Use

Requests that are not consistent with FDA labeling, Neighborhood clinical criteria, or relevant clinical literature may be denied. Potential denial triggers include active infection, absence of documented TB screening, incomplete vaccination status, lack of required prior therapy trials, or insufficient clinical justification.

Active infection or clinically important localized infection
No documented latent TB screening prior to initiation
Recent administration of live vaccines or incomplete vaccination status
Insufficient documentation of prior adequate trials of infliximab IV or adalimumab when required
Use outside of FDA-approved indications without supportive literature or rationale

Clinical Definitions and Code Keys

Clinical response and remission definitions

Crohn's clinical responseDefined as a reduction in Crohn's Disease Activity Index (CDAI) score by 100 points

Crohn's clinical remissionDefined as CDAI score < 150

Psoriasis outcome (PASI)Primary psoriasis efficacy endpoint reported as PASI 75 (≥75% reduction in Psoriasis Area and Severity Index)

Physician's Global Assessment (PGA)Used as a treatment success measure in psoriasis trials alongside PASI

J3357 — Subcutaneous administration (HCPCS)

HCPCS codeJ3357 — Ustekinumab, for subcutaneous injection, 1 mg (1 billable unit = 1 mg)

UsageListed for subcutaneous administration and associated with multiple ICD-10 Crohn's and UC diagnosis codes in the appendices

Related codesIncludes biosimilar/Q-codes listed elsewhere in HCPCS group for subcutaneous formulations

J3358 — Intravenous administration (HCPCS)

HCPCS codeJ3358 — Ustekinumab, for intravenous injection, 1 mg (1 billable unit = 1 mg)

UsageListed for intravenous induction administration and associated with multiple ICD-10 Crohn's and UC diagnosis codes in the appendices

Max units (per dose)Intravenous induction max = 520 billable units (per dosing table)

OpenPayer

Ustekinumab (intravenous and subcutaneous) for Crohn's Disease and Ulcerative Colitis

Coverage Criteria for Ustekinumab

Billing and Code Tables

Provider Requirements and Prior Authorization

Background and Indications

Clinical Definitions and Code Keys

Policy Revision History