CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ustekinumab (Stelara/Wezlana) — Prior Authorization and Coverage Criteria

Defines prior authorization, documentation, prescriber specialty, and approval criteria for ustekinumab (Stelara/Wezlana) for FDA‑approved indications and a compendial use (immune checkpoint inhibitor–related toxicity) for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUstekinumab (Stelara/Wezlana) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain required chart documentation (diagnosis‑specific notes, prior therapy history, and TB test results for biologic‑naïve patients) to support prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4listed FDA‑approved indications (PsO, PsA, CD, UC)

12 moauthorization period for most covered indications

6 moauthorization period for immune checkpoint inhibitor‑related toxicity

TB test ≤6 morequired TB screening for biologic‑naïve patients

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Coverage Criteria and Safety Rules

Initial Therapy — Plaque psoriasis

Covered for plaque psoriasis when ALL of the following are met

Age and indication: Member is 6 years of age or older and has moderate to severe plaque psoriasis

(FDA‑approved age)

Prior biologic or severity/BSA criteria: Either member previously received a biologic or targeted synthetic drug for plaque psoriasis OR one of the following severity criteria is met: crucial body areas are affected (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas); ≥10% body surface area (BSA) affected; or ≥3% BSA affected with inadequate response or intolerance to phototherapy (e.g., UVB, PUVA) or to methotrexate, cyclosporine, or acitretin, or a clinical reason to avoid those agentsBSA thresholds as specified

See Appendix for clinical reasons to avoid conventional agents

Initial Therapy — Psoriatic arthritis

Covered for psoriatic arthritis when ALL of the following are met

Age and indication: Member is 6 years of age or older and has active psoriatic arthritis

(FDA‑approved age)

Prior biologic or inadequate response/clinical features: Either member previously received a biologic or targeted synthetic drug for PsA OR member has inadequate response or intolerance to methotrexate, leflunomide, or another conventional synthetic DMARD given at adequate dose and duration, or has enthesitis, or has severe disease

Conventional DMARDs must have been given at adequate dose and duration or be contraindicated; clinical reasons to avoid should be documented

Initial Therapy — Crohn's disease

Covered for Crohn's disease when ALL of the following are met

Age and indication: Member is an adult with moderately to severely active Crohn's disease

Authorization of 12 months may be granted when criteria are met

Initial Therapy — Ulcerative colitis

Covered for ulcerative colitis when ALL of the following are met

Age and indication: Member is an adult with moderately to severely active ulcerative colitis

Authorization of 12 months may be granted when criteria are met

Initial Therapy — Immune checkpoint inhibitor‑related toxicity

Covered (compendial) for immune checkpoint inhibitor‑related toxicity when ALL are met

Indication: Member has immune checkpoint inhibitor‑related diarrhea or colitis

Compendial use

Prior therapy requirement: Member has had an inadequate response, intolerance, or contraindication to infliximab or vedolizumab

Authorization of 6 months may be granted when criteria are met

Continuation Therapy — Renewal criteria (ALL required)

Continuation criteria — authorization may be renewed when ALL of the following are met

Positive clinical response: Member demonstrates improvement from baseline or low disease activity/remission as defined per indication (examples: reduced BSA or improvement in signs and symptoms for PsO; reduced swollen/tender joint counts, improvement in dactylitis/enthesitis/skin/functional status/CRP for PsA; remission or improvement in symptoms, weight, labs, imaging, endoscopy, or disease activity scores for CD; remission or improvement in stool frequency, bleeding, urgency, CRP, fecal calprotectin, mucosal appearance, or disease scores for UC)

Continuation requests require chart notes documenting response

Initial criteria maintained for checkpoint toxicity: For immune checkpoint inhibitor‑related toxicity, continuation requires meeting all initial authorization criteria

Authorization for checkpoint toxicity typically limited to 6 months

Safety prerequisite for all indications

TB screening: Biologic‑naïve members must have a documented negative TB test (TST or IGRA) within 6 months prior to initiating therapy; if screening is positive, further evaluation to exclude active TB is required and latent TB must be treated prior to initiationTB test within 6 months

Do not administer the drug to members with active tuberculosis infection

Requests for indications other than the listed FDA‑approved indications (plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis) and the compendial use for immune checkpoint inhibitor‑related toxicity are not covered. Such uses are considered experimental/investigational and not medically necessary and may be denied.

Prior to initiating therapy, biologic‑naïve members must have a documented negative tuberculosis (TB) test (TST or IGRA) within 6 months. If TB screening is positive, further testing to exclude active disease (for example, chest x‑ray) is required. Do not administer the requested medication to members with active TB infection; latent TB must be treated before starting therapy.

Use of ustekinumab for indications not listed in this policy (outside the specified FDA‑approved indications and the compendial use for immune checkpoint inhibitor‑related toxicity) is considered experimental/investigational and not medically necessary.

Authorization Durations, Documentation, and Prior Therapy

Prior Authorization

Authorization durations

Authorization durations vary by indication. For most labeled and compendial indications (plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis) authorization of up to 12 months may be granted when the applicable clinical criteria are met. For immune checkpoint inhibitor–related toxicity (diarrhea/colitis), authorization of up to 6 months may be granted when the member has had an inadequate response, intolerance, or contraindication to infliximab or vedolizumab.

12-month authorizations: PsO, PsA, Crohn's disease, Ulcerative colitis
6-month authorizations: Immune checkpoint inhibitor–related diarrhea/colitis (after inadequate response/intolerance/contraindication to infliximab or vedolizumab)

Documentation Required

Clinical reasons to avoid comparators

When a prior therapy is not being used and the request relies on a contraindication or intolerance to an alternative agent, document a clinical reason to avoid the comparator. Examples include hepatic disease, pregnancy or planning pregnancy, breastfeeding, drug–drug interaction, risk of treatment‑related toxicity, significant comorbidity (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension), hypersensitivity, or prior intolerance/adverse event.

Clinical Thresholds and Coding-relevant Values

Psoriasis BSA threshold

Psoriasis BSA thresholdAuthorization allowed when ≥10% BSA affected, or ≥3% BSA when the member also has inadequate response/intolerance to phototherapy or methotrexate/cyclosporine/acitretin, or has a clinical reason to avoid those agents

Crucial body areas exceptionPresence of disease in crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) qualifies regardless of BSA

Age requirementMember must be ≥6 years of age for plaque psoriasis indications

TB screening window

TB screening windowBiologic‑naïve members must have a documented negative TB test (TST or IGRA) within 6 months prior to initiating therapy

Positive TB test follow-upIf TB screening is positive, further testing (e.g., chest x‑ray) is required to exclude active disease before treatment

Background and Scope Summary

Ustekinumab (Stelara/Wezlana) is authorized under this policy for the FDA‑approved indications: moderate‑to‑severe plaque psoriasis and active psoriatic arthritis in patients aged ≥6 years, and moderately to severely active Crohn's disease and ulcerative colitis in adults. The policy also provides for a compendial use in the treatment of immune checkpoint inhibitor‑related diarrhea/colitis when required prior therapies (infliximab or vedolizumab) have failed or are contraindicated. For safety, biologic‑naïve members must have a documented negative TB test (TST or IGRA) within 6 months prior to initiation; active TB is an exclusion and must not be treated with the requested medication.

FDA Indications and Compendial Uses

FDA‑Approved Indications

Plaque psoriasis (PsO)Moderate to severe plaque psoriasis in patients 6 years and older who are candidates for phototherapy or systemic therapy

Psoriatic arthritis (PsA)Active psoriatic arthritis in patients 6 years and older

Crohn's disease (CD)Moderately to severely active Crohn's disease in adults

Ulcerative colitis (UC)Moderately to severely active ulcerative colitis in adults

Compendial Use

Compendial indicationImmune checkpoint inhibitor‑related toxicity (diarrhea/colitis)

Scope

References, Citations, and Revision Notices

Note

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