Neighborhood Health Plan RI ustekinumab Coverage

Coverage and Medical Necessity Criteria

inv-01: Initial Approval — IBD

Covered when ALL of the following are met:

Patient eligibility and baseline requirements: Patient is at least 18 years of age (unless otherwise specified); physician has assessed baseline disease severity using an objective measure; patient is up to date with vaccinations per current guidelines; patient screened for latent tuberculosis prior to initiation and will receive ongoing TB monitoring; no active infection; patient will not receive live vaccines during therapy; patient is not on concurrent injectable biologic response modifiers or certain oral non-biologic agents.

From general initial approval criteria.

Specialty prescribing/consultation: Must be prescribed by, or in consultation with, a gastroenterology specialist for Crohn's disease and ulcerative colitis.

Specific to IBD indications.

Prior therapy requirements for Crohn's Disease: Documented moderate-to-severe active Crohn's disease AND documented failure, intolerance, or inadequate response at maximum tolerated doses to a minimum 3-month trial of infliximab IV or adalimumab.3-month trial

Also requires specialist involvement.

Prior therapy requirements for Ulcerative Colitis: 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.3-month trial

Also requires specialist involvement.

IV induction and maintenance dosing: One-time IV induction dose based on weight: ≤55 kg = 260 mg; >55–85 kg = 390 mg; >85 kg = 520 mg. Subcutaneous maintenance: 90 mg given 8 weeks after the initial IV dose, then every 8 weeks thereafter. One loading (IV induction) dose per lifetime.weight-based doses

MMP members with prior receipt within 365 days are exempt from step therapy requirements.

inv-02: General coverage criteria / P&T committee rationale

Covered when consistent with FDA labeling and plan criteria adopted by P&T committee

P&T-based coverage: Use must align with FDA-approved labeling and/or relevant clinical literature; prescriber must provide information supporting the indication and prior therapy where applicable.

Neighborhood will give individual consideration to each request and will apply NCD/LCD where applicable.

Coverage is not provided for members who have an active infection or who are receiving live vaccines during ustekinumab therapy. Such conditions must be resolved and live vaccines discontinued before initiating or continuing treatment with ustekinumab. Providers must document absence of clinically important localized infections and confirm vaccination status as part of the clinical record prior to authorization.

Where applicable, Centers for Medicare & Medicaid Services determinations take precedence: if a relevant NCD, LCD, or LCA exists for a Medicare member, those CMS policies supersede the plan criteria. Neighborhood will apply NCD/LCD requirements when present and may consider additional indications at the plan’s discretion; the plan will give individual consideration to each request based on submitted clinical information.

Requests that do not document moderate-to-severe disease (for Crohn’s disease or ulcerative colitis), lack evidence of specialist prescribing or consultation, or fail to show required prior trials of specified biologics may be considered not medically necessary. For IBD, the policy requires documentation of a minimum 3-month trial of infliximab IV or adalimumab (or documentation of contraindication/intolerance) at maximum tolerated doses before coverage will be approved.

Requests that are inconsistent with FDA-approved labeling or the relevant clinical literature, or that do not align with the clinical coverage criteria adopted by the P&T committee, may be denied as not medically necessary. The plan will review prescriber-submitted information and other available clinical data to determine whether the requested use is supported by accepted indications and evidence.

Billing and Diagnosis/Coding

HCPCS Codes listedHCPCS

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

Max Units (per dose and over time)mixed

520 billable units	Intravenous induction max units for Crohn's/UC (520 units = 520 mg) per induction
90 billable units	Subcutaneous maintenance unit quantity (90 units 8 weeks after induction & every 8 weeks thereafter for IBD)
90 billable units	Subcutaneous loading/maintenance units for plaque psoriasis (90 units at weeks 0 & 4; maintenance every 12 weeks)
45 billable units	Psoriatic arthritis dosing units (45 units at weeks 0 & 4; maintenance every 12 weeks)

Subcutaneous (J3357) — Crohn's disease codesmixedCovered

J3357	Subcutaneous ustekinumab
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

1–10 of 29

1/3

Ulcerative colitis codes associated with J3357/J3358 usemixedCovered

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 42

1/5

Other indicated / related diagnosesICD-10Covered

K52.1	Toxic gastroenteritis and colitis
L40.0	Psoriasis vulgaris
L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis
L40.59	Other psoriatic arthropathy
R19.7	Diarrhea, unspecified

Intravenous (J3358)HCPCSCovered

J3358

Intravenous ustekinumab

Weight-based IV induction thresholds

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

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

IV induction dose >85 kg520 mg (one-time IV induction)

Medicare Part B covered diagnosis codes

Medicare Part B coverage referenceMedicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals.

NCD/LCD/LCA applicability

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for this medication. Requests may be denied if the submitted documentation does not demonstrate that the member meets the clinical criteria (including age, documented baseline disease severity, vaccination status, TB screening and monitoring, absence of active infection, and prior adequate trials of required therapies).

Prior authorization required for non‑MMP members unless exempt per policy.
Denial triggers include missing documentation of moderate-to-severe disease or absence of required prior therapy trials (minimum 3 months for infliximab IV or adalimumab).

Step Therapy

Step Therapy Preference and Exemption

Step Therapy Preference: The P&T Committee prefers use of more cost‑effective options first when clinically appropriate. MMP members who have received this medication within the past 365 days are exempt from Step Therapy Requirements.

P&T preference to consider cost‑effective alternatives before approving higher‑cost agents when clinically appropriate.

Clinical Background

Ustekinumab is a human monoclonal antibody that antagonizes interleukin-12 and interleukin-23 signaling, targeting the p40 subunit shared by both cytokines. It is approved for use in adult patients with moderate to severe Crohn’s disease and ulcerative colitis after failure or intolerance of other therapies. For IBD indications the plan’s dosing approach follows labeled regimens: a one-time weight‑based IV induction dose (≤55 kg = 260 mg; >55–85 kg = 390 mg; >85 kg = 520 mg) followed by subcutaneous maintenance of 90 mg given 8 weeks after the IV dose and then every 8 weeks thereafter. The P&T committee reviewed the evidence and adopted these criteria to align use with FDA labeling and relevant clinical literature while encouraging cost‑effective care.

Clinical Definitions and References

Clinical response/remission (IBD)

Clinical response (IBD trials)Defined as a reduction in the Crohn's Disease Activity Index (CDAI) score by 100 points at Week 6.

Clinical remission (IBD trials)Defined as a CDAI score of less than 150.

Trial outcomes summaryInduction studies (CD-1, CD-2) showed significantly higher proportions achieving CDAI-100 response and CDAI <150 with ustekinumab versus placebo at Week 6; maintenance studies demonstrated higher remission and corticosteroid-free remission at later timepoints.

CMS / Medicare references

Medicare Part B policy sourceMedicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals.

NCD/LCD/LCA lookupNCDs, LCDs, and LCAs can be found at the CMS Medicare Coverage Database: https://www.cms.gov/medicare-coverage-database/search.aspx.

OpenPayer

Ustekinumab (intravenous and subcutaneous) for Crohn's disease and ulcerative colitis — Coverage Criteria

Coverage and Medical Necessity Criteria

Billing and Diagnosis/Coding

Provider Requirements, Prior Authorization, and Documentation

Clinical Background

Clinical Definitions and References