Neighborhood Health Plan RI ustekinumab SC Coverage

Coverage Criteria for Ustekinumab (SC biosimilars)

Initial Therapy - Moderate to severe plaque psoriasis

Authorization of 6 months may be granted when ALL of the following are met:

Prescriber: Ustekinumab is prescribed by, or in consultation with, a specialist in dermatology or rheumatology

Disease extent: At least 10% of body surface area (BSA) affected OR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected

Prior topical/systemic/phototherapy: Either inadequate response or intolerance to ≥3 months of methotrexate, cyclosporine, or acitretin OR inadequate response to ≥3 months of phototherapy (unless intolerance)3 months

Biologic trial: Inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses3 months

Dosing must follow FDA-approved weight-based loading and maintenance schedule for subcutaneous ustekinumab (adult and pediatric weight bands as specified in policy)see dosing details

General requirements: Submission of the member's chart/medical record; pretreatment TB screening (unless exempt); member free of clinically important active infection; no live vaccines during therapy; baseline disease severity assessed with an objective measure/tool

Formulary/step requirement: Formulary ustekinumab biosimilar will pay within the quantity limit if there is at least one paid claim of at least a 30-day supply within the last 365 days for a biologic30-day claim within 365 days

Initial Therapy - Active psoriatic arthritis

Authorization of 6 months may be granted when ALL of the following are met:

Prescriber: Ustekinumab is prescribed by, or in consultation with, a specialist in dermatology or rheumatology

Disease severity: Documented moderate to severe active psoriatic arthritis

Prior therapy - axial/enthesitis/dactylitis: If predominantly axial disease or active enthesitis and/or dactylitis: inadequate response or intolerance to ≥2 NSAIDs unless contraindicated2 NSAIDs

Prior therapy - peripheral arthritis: If peripheral arthritis: inadequate response to ≥3 months of one oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine, hydroxychloroquine) unless intolerance/contraindication

Initial Therapy - Crohn's disease

Authorization of 6 months may be granted when ALL of the following are met:

Age: Member is 18 years of age or older>=18

Prescriber: Prescribed by, or in consultation with, a gastroenterology specialist

Disease severity: Documented moderate to severe active Crohn's disease

Prior biologic trial: Inadequate response, intolerance, or contraindication to infliximab IV or adalimumab for ≥3 months at maximum tolerated doses3 months

Initial Therapy - Ulcerative colitis

Authorization of 6 months may be granted when ALL of the following are met:

Age: Member is 18 years of age or older>=18

Prescriber: Prescribed by, or in consultation with, a gastroenterology specialist

Disease severity: Documented moderate to severe ulcerative colitis

Prior biologic trial: Inadequate response, intolerance, or contraindication to infliximab IV or adalimumab for ≥3 months at maximum tolerated doses3 months

Initial Therapy - Hidradenitis suppurativa

Authorization of 6 months may be granted when ALL of the following are met:

Age: Member is 18 years of age or older>=18

Diagnosis: Documented hidradenitis suppurativa

Prescriber: Prescribed by, or in consultation with, a specialist in dermatology

Prior antibiotics: Inadequate response to oral antibiotics for at least 90 days OR intolerance/contraindication to oral antibiotics90 days

Continuation Therapy

Authorization of 6 months may be granted for continuation when ALL of the following are met:

Paid claim requirement: Formulary ustekinumab biosimilar will continue to pay within the quantity limit after the initial approval if there is at least one paid claim of at least a 30-day supply within the last 365 days for formulary ustekinumab30-day claim within 365 days

Psoriasis response: Reduction in BSA from baseline OR improvement in signs/symptoms (e.g., itching, redness, flaking, scaling, burning, cracking, pain)

PsA response: Improvement in number of swollen/tender joints, dactylitis, enthesitis, or skin/nail involvement from baseline

CD response: Remission or improvement in abdominal pain, diarrhea, body weight, abdominal mass, hematocrit, endoscopic mucosa, or improvement on a disease activity scoring tool (e.g., CDAI) from baseline

Maintenance and Quantity Limit Criteria

Covered when dosing and quantity limits align with policy:

Maintenance dosing: Maintenance subcutaneous dose of ustekinumab 90 mg must be administered 8 weeks after the initial intravenous dose8 weeks after IV load

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Quantity limit: Ustekinumab 45 mg or 90 mg is limited to 1 injection per 6 weeks; a post-limit loading dose allowance of 2 injections per 35 days is permitted1 injection/6 weeks; 2 injections/35 days

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All indications for ustekinumab that are not listed as FDA-approved indications in this policy or the single compendial use (hidradenitis suppurativa in adults) are considered experimental/investigational and are not a covered benefit.

This policy and its coverage criteria apply to the Medicaid population as specified in the document's scope.

Use of ustekinumab for any indication not listed among the FDA-approved indications or the compendial use for hidradenitis suppurativa is considered not medically necessary / investigational under this policy and will not be covered.

Product Coding, Dosing Limits, and Weight-based Rules

Product listing (no codes provided)mixed

NDC/CPT/HCPCS not listed

Document lists product names Otulfi, Selarsdi, Steqeyma, Yesintek but does not provide billing codes in this section.

Quantity-limited dosesmixedCovered

45 mg or 90 mg

Ustekinumab single injection dose strengths as referenced in quantity limit - 1 injection per 6 weeks; post-limit loading dose allowance of 2 injections per 35 days.

Weight-based dosing thresholds

Pediatric weight bands (PsO loading/maintenance)<60 kg; 60-100 kg; >100 kg (pediatric loading and maintenance dosing per policy)

Adult loading threshold<100 kg and >100 kg (adult subcutaneous loading: <100 kg = 45 mg; >100 kg = 90 mg)

IV induction weight cutoffs (IBD)≤55 kg; >55 to 85 kg; >85 kg (single IV dose: 260 mg; 390 mg; 520 mg respectively)

Maintenance weight-based noteMaintenance dosing for subcutaneous therapy follows the weight bands above for pediatrics and adults as specified in policy

Injection frequency

Routine quantity limit

Prescriber Requirements, Prior Authorization, and Documentation

Billing Rule

Quantity limit requirement and dosing constraints

Quantity limits apply to ustekinumab dosing. Maintenance dosing and quantity constraints: the recommended subcutaneous maintenance dose for Crohn's disease and ulcerative colitis is 90 mg administered 8 weeks after the initial intravenous dose. For plaque psoriasis and psoriatic arthritis, maintenance dosing generally begins 12 weeks after the loading doses per FDA guidelines (see dosing tables). The plan limits 45 mg or 90 mg doses to 1 injection per 6 weeks. A loading dose allowance permits up to 2 injections within a 35-day period.

Maintenance: 90 mg SC at 8 weeks after IV load for CD/UC
PsO/PsA maintenance generally every 12 weeks after loading per FDA guidance
Quantity limit: 45 mg or 90 mg — 1 injection per 6 weeks
Loading dose allowance: up to 2 injections per 35 days

Background on Ustekinumab and Indications

Ustekinumab is indicated in this policy for treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and for adults with moderately to severely active Crohn's disease or ulcerative colitis; the policy also includes select compendial use for hidradenitis suppurativa. Dosing and administration pathways differ by indication: Crohn's disease and ulcerative colitis allow FDA‑approved intravenous induction with weight‑based IV doses followed by a subcutaneous maintenance dose of 90 mg administered 8 weeks after the initial IV dose, while plaque psoriasis and psoriatic arthritis follow the FDA weight‑based loading and maintenance schedules described in the policy. Specialist involvement, objective baseline assessment, and appropriate infection screening (including TB testing unless exempt) are required prior to and during therapy.

Definitions and Screening Requirements

Moderate to severe plaque psoriasis

DefinitionModerate to severe plaque psoriasis: at least 10% body surface area (BSA) affected OR involvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

Age criterionPolicy applies to members 6 years of age or older for PsO indication

Assessment requirementPhysician must assess baseline disease severity using an objective measure/tool

TB screening

Screening requirementPretreatment tuberculosis (TB) screening with a TB skin test or an interferon gamma release assay (e.g., QFT-GIT, T-SPOT.TB) is required

ExemptionMembers who have received ustekinumab or any other biologic DMARD or targeted synthetic DMARD are exempt from TB screening requirements

OpenPayer

Ustekinumab biosimilar (subcutaneous) coverage

Coverage Criteria for Ustekinumab (SC biosimilars)

Product Coding, Dosing Limits, and Weight-based Rules

Prescriber Requirements, Prior Authorization, and Documentation

Background on Ustekinumab and Indications

Definitions and Screening Requirements