Anthem ustekinumab Coverage & Prior Auth Update

Coverage Criteria

Initial Therapy

Covered when ANY of the indication-specific groups below are met

I. Crohn's disease (CD): Individual is 18 years of age or older with moderate to severe Crohn's disease.age >= 18

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II. Psoriatic arthritis (PsA): Individual is 6 years of age or older with moderate to severe PsA AND has had an inadequate response to or is intolerant of conventional nonbiologic DMARDs (e.g., methotrexate, sulfasalazine, cyclosporine, leflunomide) OR has a contraindication to those agents.age >= 6

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III. Plaque psoriasis (Ps): Individual is 6 years of age or older with chronic moderate to severe plaque psoriasis meeting either: (1) plaque psoriasis involving >= 3% body surface area (BSA), OR (2) plaque psoriasis involving < 3% BSA when involving sensitive areas or areas that significantly impact daily function; AND the individual has had an inadequate response to or is intolerant of phototherapy or other systemic therapy (e.g., acitretin, cyclosporine, methotrexate) OR has a contraindication to those therapies.age >= 6; BSA >= 3% or sensitive area involvement

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IV. Ulcerative colitis (UC): Individual is 18 years of age or older with moderate to severe ulcerative colitis.age >= 18

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V. Immunotherapy-related toxicities: Individual is receiving immune checkpoint inhibitor therapy and is experiencing moderate to severe diarrhea or colitis that persists despite treatment with steroids and biologics (infliximab and/or vedolizumab).

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Continuation Therapy

Covered when ALL of the following are met

Continuation criteria: 1) Individual has been receiving and is maintained on a stable dose of the requested ustekinumab product; AND 2) There is confirmation of clinically significant improvement or stabilization in clinical signs and symptoms of the disease.

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Increased dosing (CD/UC) criteria

Increased maintenance dosing (up to 90 mg every 4 weeks or two 45 mg units every 4 weeks) may be approved when ALL of the following are met:

Escalated dosing initial requirements: 1) Individual has been treated with standard maintenance dosing (every 8 weeks) for at least 2 doses or 16 weeks; 2) Increased dosing is prescribed by or in consultation with a gastroenterologist; 3) Individual initially achieved an adequate response to standard maintenance dosing but subsequently lost response OR partially responded with inadequate response to standard maintenance dosing as determined by the prescriber; 4) Symptoms, if present, are not due to active infections or other gastrointestinal disorders; 5) Requested dosing does not exceed 1 x 90 mg every 4 weeks or 2 x 45 mg every 4 weeks.up to 90 mg every 4 weeks

Initial approval duration 16 weeks; continued approval 1 year if regained/adequate response and no unacceptable adverse effects; regular assessment for de-escalation required.

Quantity limit overrides

Specific override allowances for initiation and maintenance by indication and weight:

Initiation overrides: - For plaque psoriasis or psoriatic arthritis in individuals <= 100 kg (220 lbs.): may approve 1 additional 45 mg syringe/autoinjector or vial (45 mg/0.5 mL) in the first 84 days (12 weeks) of treatment. - For psoriatic arthritis in individuals > 100 kg: may approve 1 additional 45 mg syringe/autoinjector (45 mg/0.5 mL) in the first 84 days. - For plaque psoriasis or concomitant PsA in individuals > 100 kg: may approve 1 additional 90 mg syringe/autoinjector (90 mg/1 mL) in the first 84 days.

Overrides limited to first 84 days (12 weeks).

Maintenance override for IBD: For adult Crohn's disease and ulcerative colitis maintenance: may approve 1 x 90 mg syringe/autoinjector or 2 x 45 mg vials/syringes/autoinjectors every 8 weeks (56 days). Escalated dosing to every 4 weeks allowed per escalated dosing criteria.

See escalated dosing criteria for initiation and continuation requirements.

Requests for ustekinumab will be denied when the agent is used in combinations or situations that increase safety risk or conflict with policy criteria. Examples include use in combination with phototherapy for psoriasis or psoriatic arthritis, concomitant use with oral or topical JAK inhibitors, apremilast, ozanimod, etrasimod, deucravacitinib, or with other listed biologic immunomodulators (other TNF antagonists, IL‑23 inhibitors, IL‑17 inhibitors, IL‑6 inhibitors, IL‑1 inhibitors, vedolizumab, abatacept, rituximab, or natalizumab). Coverage is also excluded for members with a history of posterior reversible encephalopathy syndrome, with active tuberculosis or other serious infections or recurrent infections, or when initiating therapy without documentation of a tuberculin skin test or CDC‑equivalent test for latent tuberculosis (unless switching from another targeted immune modulator with no new TB risk factors).

The policy clarifies that the phototherapy exclusion specifically applies to both psoriasis and psoriatic arthritis, such that ustekinumab will not be approved when used in combination with phototherapy for those indications.

Ustekinumab is not medically necessary for uses that are not listed in the coverage criteria or when the specified indication‑specific criteria are not met. Examples include the scenarios and combinations listed under exclusions (see combination with JAK inhibitors, listed biologics, active serious infections, lack of required TB testing when initiating, history of posterior reversible encephalopathy syndrome, and other policy exceptions).

Escalation of ustekinumab dosing for Crohn's disease or ulcerative colitis is not medically necessary if the individual had no response to ustekinumab at standard maintenance dosing (every 8 weeks). Escalated dosing is also not appropriate when the request is based solely on therapeutic drug level or anti‑drug antibody testing in the absence of clinical signs or symptoms of disease.

Initial Therapy Criteria (Indication-specific)

Initial therapy criteria

Initial approval is indication-specific and includes age and prior therapy requirements where specified.

Initial CD: Age >=18 with moderate to severe Crohn's disease.age >= 18

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Initial PsA: Age >=6 with moderate to severe psoriatic arthritis AND inadequate response to or intolerance of conventional nonbiologic DMARDs OR contraindication to those agents.age >= 6

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Initial Plaque Psoriasis: Age >=6 with chronic moderate to severe plaque psoriasis meeting BSA (>=3%) or sensitive-area criteria AND inadequate response to or intolerance of phototherapy or other systemic therapy OR contraindication to those therapies.

Continuation and Continued Therapy

Continuation requirements

Continuation approvals require ongoing stable dosing and documented clinical benefit.

Continuation: Member is on a stable dose of the requested ustekinumab product AND there is confirmation of clinically significant improvement or stabilization of signs and symptoms.

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Continued therapy for escalated dosing (CD/UC)

Continued approval rules for escalated dosing in Crohn's disease and ulcerative colitis

Continued escalated dosing: 1) Requested dosing does not exceed 1 x 90 mg every 4 weeks or 2 x 45 mg every 4 weeks; 2) Individual has subsequently regained response or achieved adequate response following increased dosing as shown by clinical improvement; 3) Individual is not experiencing unacceptable adverse effects from increased dosing; 4) Individual will be assessed regularly for dose de-escalation.

Continued approval duration: 1 year.

Coding and Dosing Details

Drug strengths and product entriesNDC | mixed

Stelara 130 mg/26 mL (5 mg/mL) vial	specified vial strength and limits
Stelara 45 mg/0.5 mL	specified syringe/vial strength and limits
Stelara 90 mg/1 mL	specified syringe strength and limits
Imuldosa 130 mg/26 mL	specified vial strength and limits
Pyzchiva 130 mg/26 mL	specified vial strength and limits
Otulfi 130 mg/26 mL	specified vial strength and limits
Selarsdi 45 mg/0.5 mL	specified strength and limits
Starjemza 130 mg/26 mL	specified vial strength and limits
Steqeyma 130 mg/26 mL	specified vial strength and limits
Wezlana 130 mg/26 mL	specified vial strength and limits

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HCPCS (intravenous)HCPCS

C9399	Unclassified drugs or biologicals [when specified as Starjemza (ustekinumab-hmny) vial for intravenous use]
J3358	Ustekinumab, for intravenous injection, 1 mg [Stelara intravenous]
J3590	Unclassified biologics [when specified as Starjemza (ustekinumab-hmny) vial for intravenous use]
Q5098	Injection, ustekinumab-srlf (Imuldosa), biosimilar, 1 mg [when specified as vial for intravenous use]
Q5099	Injection, ustekinumab-stba (Steqeyma), biosimilar, 1 mg [when specified as vial for intravenous use]
Q5100	Injection, ustekinumab-kfce (Yesintek), biosimilar, 1 mg [when specified as vial for intravenous use]
Q5138	Injection, ustekinumab-auub (Wezlana), biosimilar, intravenous, 1 mg
Q9997	Injection, ustekinumab-ttwe (Pyzchiva), intravenous, 1 mg
Q9998	Injection, ustekinumab-aekn (Selarsdi), biosimilar, 1 mg [when specified as vial for intravenous use]
Q9999	Injection, ustekinumab-aauz (Otulfi), biosimilar, 1 mg [when specified as vial for intravenous use]

HCPCS (subcutaneous)HCPCS

C9399	Unclassified drugs or biologicals [when specified as Starjemza (ustekinumab-hmny) single-use prefilled syringe]
J3357	Ustekinumab, for subcutaneous injection, 1 mg [Stelara subcutaneous]
J3590	Unclassified biologics [when specified as Starjemza (ustekinumab-hmny) single-use prefilled syringe]
Q5098	Injection, ustekinumab-srlf (Imuldosa), biosimilar, 1 mg [when specified as single-use prefilled syringe]
Q5099	Injection, ustekinumab-stba (Steqeyma), biosimilar, 1 mg [when specified as single-use prefilled syringe]
Q5100	Injection, ustekinumab-kfce (Yesintek), biosimilar, 1 mg [when specified as single-use prefilled syringe]
Q5137	Injection, ustekinumab-auub (Wezlana), biosimilar, subcutaneous, 1 mg
Q9996	Injection, ustekinumab-ttwe (Pyzchiva), subcutaneous, 1 mg
Q9998	Injection, ustekinumab-aekn (Selarsdi), biosimilar, 1 mg [when specified as single-use prefilled syringe]
Q9999	Injection, ustekinumab-aauz (Otulfi), biosimilar, 1 mg [when specified as single-use prefilled syringe]

DiagnosisICD-10

K50.00-K50.919	Crohn's disease [regional enteritis]
K51.00-K51.919	Ulcerative colitis
K52.1	Toxic gastroenteritis and colitis [immunotherapy-related toxicity]
L40.0-L40.9	Psoriasis
R19.7	Diarrhea, unspecified [immunotherapy-related toxicity]

Plaque psoriasis BSA

Plaque psoriasis BSA threshold>= 3% body surface area (or <3% when involving sensitive areas impacting function)

Applicable age for plaque psoriasis coverageIndividual is >= 6 years of age

Clinical requirementChronic moderate to severe plaque psoriasis with inadequate response or intolerance to phototherapy or other systemic therapy, or contraindication to those therapies

Maintenance dosing interval

Standard maintenance intervalEvery 84 days (12 weeks)

Per-product maintenance limit example

Quantity Limits and Dosing Rules

Stelara, Ustekinumab and biosimilars — Initial vial limits & maintenance

Initial vial limits — <= 55 kg2 vials (one-time fill)

Initial vial limits — >55 kg to 85 kg3 vials (one-time fill)

Initial vial limits — >85 kg4 vials (one-time fill)

Maintenance dosing general ruleGenerally 1 syringe/vial per 84 days (12 weeks) for single-use formulations

ustekinumab (all formulations) — Maintenance and escalated dosing

Standard maintenance dosing1 x 90 mg every 8 weeks OR 2 x 45 mg every 8 weeks

Escalated (increased) dosing allowance

Step Therapy and Preferred Agents

Requirement	Details
Documentation of trials of preferred agents	For commercial Crohn's disease or ulcerative colitis requests, provide documentation of a trial with and inadequate response or intolerance to TWO preferred agents (a trial of multiple products with the same active ingredient counts as a trial of ONE preferred agent).
Reason preferred agents cannot be used	If trials of preferred agents are not feasible, provide clinical rationale why the individual is unable to use ALL preferred agents (examples: contraindication/warning present in all preferred product labeling but not the non-preferred product; preferred products lack activity against a concomitant condition covered by the non-preferred product; prior exposure to TNF antagonists limits ability to use remaining preferred agents).
Current use exception	Requests may be approved if the individual is currently on the requested non‑preferred agent (continuation of therapy).
Medicaid exception for inactive ingredient intolerance	For Medicaid, a non‑preferred ustekinumab agent may be approved if the individual has an allergy or severe intolerance to an inactive ingredient in the preferred agent that interferes with use and the same intolerance is not expected with the non‑preferred product. Convenience reasons alone do not justify approval.

Benefit / Setting	Preferred products (examples)	Non‑preferred products (examples)
Commercial — Crohn's disease (10/01/2025)	Avsola; Remicade; Unbranded Infliximab; Entyvio; Selarsdi IV; Stelara IV; Unbranded Ustekinumab IV; Skyrizi IV; Tremfya IV	Imuldosa; Otulfi; Pyzchiva; Steqeyma; Wezlana; Yesintek
Commercial — Crohn's disease (02/01/2026)	Avsola; Remicade; Unbranded Infliximab; Entyvio; Selarsdi IV; Stelara IV; Unbranded Ustekinumab IV; Skyrizi IV; Tremfya IV	Imuldosa; Otulfi; Pyzchiva; Starjemza; Steqeyma; Wezlana; Yesintek
Step therapy tables and updates	Step therapy table updates and convenience notes noted in document history (02/01/2025, 10/01/2025, 12/01/2025); preferred lists may vary by effective date and benefit configuration.	Non‑preferred lists updated over time; refer to benefit-specific lists for current non‑preferred ustekinumab biosimilars and products (document history includes multiple step therapy updates).

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required per clinical criteria. Initial requests must meet indication-specific criteria including age and disease severity, and prior therapy requirements where applicable. For Crohn's disease and ulcerative colitis, prior authorization decisions may also depend on step therapy and preferred-agent status described elsewhere in this policy.

Applies to Stelara, Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Steqeyma, Ustekinumab (unbranded), Wezlana, Yesintek.

Documentation Required

Continuation Request Documentation Required

For continuation (renewal) requests, submit documentation confirming the member has been receiving and is maintained on a stable dose and there is clinically significant improvement or stabilization in clinical signs and symptoms of the disease. Include objective and/or clinician-assessed measures of response (for example, reduction in stool frequency or bloody stools, improvement in abdominal pain, endoscopic response, or other relevant clinical documentation).

Site of Care and Administration Notes

Billing Rule

Site‑of‑care and preferred agent requirements

When approved, site of care may be infusion center, office, or home depending on product, and the plan may require use of preferred agent(s) per the member’s benefit design.

Background

Ustekinumab is a monoclonal antibody that targets the p40 subunit shared by interleukin‑12 and interleukin‑23, thereby inhibiting downstream release of proinflammatory cytokines. It is indicated for multiple immune‑mediated conditions including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Several biosimilar and interchangeable products to the reference agent Stelara are listed in the policy.

Definitions

Biosimilar / Interchangeable

Designated biosimilars/interchangeablesWezlana, Selarsdi, Otulfi, Pyzchiva, Starjemza, Steqeyma, Yesintek, Imuldosa

Reference productStelara (ustekinumab)

Added interchangeable biosimilar notedStarjemza (ustekinumab-hmny) added as interchangeable in clinical criteria, step therapy, and quantity limits

Moderate to severe plaque psoriasis — definition

Definition — moderate to severe plaque psoriasis>=3% body surface area OR <3% BSA when involving sensitive areas or areas that significantly impact daily function

Age thresholdApplies to individuals >= 6 years of age for plaque psoriasis coverage

Biosimilar and Interchangeable Notes

Billing Rule

Biosimilars and preferred product use

Stelara (ustekinumab) and multiple biosimilars/interchangeables are listed; step therapy and quantity limits may require use of preferred agent(s) prior to non‑preferred products per benefit configuration.

Billing Rule

Starjemza added — coding and criteria updates

Starjemza (ustekinumab‑hmny) was added as an interchangeable biosimilar in clinical criteria, step therapy, and quantity limits; HCPCS NOC (C9399) and J3590 entries were added for vial and single‑use syringe forms and should be used where applicable.

HCPCS entries include C9399 and J3590 for Starjemza vial and prefilled syringe

Revision History

2025-02-01step_therapy_update

Step therapy table updates were made to the policy.

2025-08-15biosimilar_addition

Select Review added the interchangeable biosimilar Starjemza (ustekinumab-hmny) to clinical criteria, step therapy, and quantity limits and added HCPCS NOC C9399 and J3590 coding for vial and single‑use prefilled syringe forms.

2025-10-01step_therapy_update

OpenPayer

Ustekinumab Agents — Clinical Coverage and Prior Authorization Criteria

Coverage Criteria

Initial Therapy Criteria (Indication-specific)

Continuation and Continued Therapy

Coding and Dosing Details

Quantity Limits and Dosing Rules

Step Therapy and Preferred Agents

Provider Actions and Documentation Requirements

Site of Care and Administration Notes

Background

Definitions

Biosimilar and Interchangeable Notes

Revision History