UnitedHealthcare ustekinumab Coverage Update

Coverage / Medical Necessity Criteria

Preferred Product Criteria

Coverage for non-preferred ustekinumab products is medically necessary when ALL of the following are met:

Option 1: Both: (1) documentation of a trial of at least 14 weeks of Steqeyma or Yesintek resulting in minimal clinical response and residual disease activity; AND (2) provider attestation that, in their clinical opinion, the clinical response would be expected to be superior with the non-preferred ustekinumab product than experienced with Steqeyma or Yesintek.
Option 2: Both: (1) documentation of intolerance, contraindication, or adverse event to Steqeyma or Yesintek; AND (2) provider attestation that the same intolerance, contraindication, or adverse event would not be expected to occur with the non-preferred ustekinumab product.
Additional requirement: Patient has not had a loss of a favorable response after established maintenance therapy with Steqeyma, Yesintek, or other ustekinumab product.

Crohn's Disease

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

Initial therapy: Diagnosis of moderately to severely active Crohn's disease; AND one of the following: (a) history of failure to at least one conventional therapy (corticosteroids, 6-mercaptopurine, azathioprine, methotrexate) at up to maximally indicated doses unless contraindicated; OR (b) prior treatment with an FDA‑approved targeted immunomodulator for Crohn's disease. Ustekinumab must be administered as a single intravenous induction dose in accordance with FDA‑labeled dosing; patient must not be receiving ustekinumab in combination with a targeted immunomodulator; prescribed by or in consultation with a gastroenterologist; authorization will be for one induction dose.IV induction per FDA labeling

Initial induction limited to one IV dose; gastroenterology involvement required.

Continuation therapy: Documentation of positive clinical response; prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to self‑administer ustekinumab (with explanation); ustekinumab administered subcutaneously 8 weeks after the initial IV dose per FDA‑labeled dosing; patient must not be receiving ustekinumab in combination with a targeted immunomodulator; authorization for continuation is for no more than 12 months.

Plaque Psoriasis

Plaque psoriasis — Covered when ALL of the following are met

Initial therapy: Diagnosis of moderate to severe plaque psoriasis; AND one of the following: (A) ≥3% BSA involvement or palmoplantar/facial/genital/severe scalp disease plus history of failure to appropriate topical therapies; and history of failure to a 3‑month trial of methotrexate at the maximally indicated dose unless contraindicated; OR (B) prior treatment with an FDA‑approved targeted immunomodulator for plaque psoriasis; OR (C) patient is currently on ustekinumab. Prescriber must attest if patient/caregiver cannot self‑administer (with explanation); dosing initiated and titrated per FDA labeling; patient must not be receiving ustekinumab in combination with a targeted immunomodulator; prescribed by or in consultation with a dermatologist; initial authorization up to 12 months.

Continuation therapy: Documentation of positive clinical response; prescriber attestation regarding inability to self‑administer (with explanation) when requesting medical benefit administration; dosing continued per FDA labeling (weight‑based maintenance q12w or adjusted per inadequate response); patient must not be receiving ustekinumab in combination with a targeted immunomodulator; authorization for continuation is for no more than 12 months.

Psoriatic Arthritis

Psoriatic arthritis — Covered when ALL of the following are met

Initial therapy: Diagnosis of psoriatic arthritis; AND one of the following: history of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated; OR prior treatment with an FDA‑approved targeted immunomodulator for psoriatic arthritis; OR patient is currently on ustekinumab. Ustekinumab initiated and titrated per FDA labeling; prescriber attestation regarding inability to self‑administer (with explanation) when requesting medical benefit administration; patient must not be receiving ustekinumab in combination with a targeted immunomodulator; prescribed by or in consultation with a rheumatologist or dermatologist; initial authorization up to 12 months.

Continuation therapy: Documentation of positive clinical response; prescriber attestation regarding inability to self‑administer (with explanation); dosing per FDA labeling; patient must not be receiving ustekinumab in combination with a targeted immunomodulator; authorization up to 12 months.

Ulcerative Colitis

Ulcerative colitis — Covered when ALL of the following are met

Initial therapy: Diagnosis of moderately to severely active ulcerative colitis; AND one of the following: prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine); OR prior treatment with an FDA‑approved targeted immunomodulator for ulcerative colitis (document drug, date, duration); OR patient is currently on ustekinumab. Ustekinumab must be administered as a single intravenous induction dose in accordance with FDA‑labeled dosing; patient must not be receiving ustekinumab in combination with a targeted immunomodulator; prescribed by or in consultation with a gastroenterologist; authorization will be for one induction dose.

Continuation therapy: Documentation of positive clinical response; prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer ustekinumab (with explanation); ustekinumab administered subcutaneously 8 weeks after the initial intravenous dose per FDA‑labeled dosing; patient must not be receiving ustekinumab in combination with a targeted immunomodulator; authorization for continuation is for no more than 12 months.

Ulcerative Colitis - Medical Necessity

Ustekinumab is proven and medically necessary for ulcerative colitis when ALL of the following are met:

Diagnosis of moderately to severely active ulcerative colitis

Prior therapy: One of: prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine); OR prior treatment with an FDA‑approved targeted immunomodulator for ulcerative colitis (document drug, date, duration); OR patient is currently on ustekinumab

Examples of targeted immunomodulators listed in policy

Dosing pathway: One of initial therapy or continuation of therapy criteria must be met

Initial: single IV induction dose per FDA labeled dosing, not in combination with targeted immunomodulator, prescribed by or in consultation with gastroenterologist, authorization for one induction dose. Continuation: documentation of positive clinical response, prescriber attestation regarding inability to self‑administer with explanation, maintenance dosing 8 weeks after IV induction per FDA labeled dosing, not in combination with targeted immunomodulator, authorization up to 12 months.

Unproven / Not Medically Necessary Indications

Not medically necessary

Unproven indications: Ustekinumab is unproven and not medically necessary for ankylosing spondylitis and multiple sclerosis.

Clinical trials in axial spondyloarthritis and relapsing‑remitting multiple sclerosis did not demonstrate efficacy.

Plaque Psoriasis (adults and adolescents)

Covered for labeled dermatology indications when dosing matches recommended regimens

Plaque psoriasis (adults and adolescents) initiation and maintenance: Patient has moderate‑to‑severe plaque psoriasis and is a candidate for phototherapy or systemic therapy; dosing per weight: for patients ≤100 kg: 45 mg subcutaneously at week 0 and week 4 then every 12 weeks; for patients >100 kg: 90 mg subcutaneously at week 0 and week 4 then every 12 weeks. Alternate higher dose or increased frequency (e.g., every 8 weeks) may be used for inadequate response. Prescriber must follow FDA‑labeled dosing and specialty involvement (dermatologist) as required.weight‑based dosing

Applies to adult and adolescent (≥6 years) labeled indications per FDA.

Gastrointestinal indications

Covered for certain gastrointestinal indications consistent with guidelines and FDA labeling

Crohn's disease: Moderately to severely active Crohn's disease consistent with ACG guideline recommendations and FDA labeling; maintenance use supported for ustekinumab‑induced response. Initial induction requires a single IV dose per FDA labeling and gastroenterologist involvement.clinical diagnosis of moderate‑to‑severe Crohn's disease

ACG guidelines support ustekinumab for patients who failed prior therapies; maintenance supported for ustekinumab‑induced responders.

Ulcerative colitis: Moderately to severely active ulcerative colitis consistent with AGA/clinical guidance and FDA labeling for induction and maintenance; document prior therapies and rationale when applicable.clinical diagnosis of moderate‑to‑severe UC

AGA includes ustekinumab among biologic options for induction and maintenance.

Preferred Product Criteria / Non-preferred product approval

Coverage and product-preference logic for ustekinumab products

Preferred product baseline: Steqeyma and Yesintek are the preferred ustekinumab products; coverage for these is contingent on meeting the Diagnosis‑Specific Criteria.

Preferred products are Steqeyma (ustekinumab‑stba) and Yesintek (ustekinumab‑kfce).

Non‑preferred product approval: Treatment with non‑preferred ustekinumab products (Otulfi, Pyzchiva, Selarsdi, Stelara, Wezlana, or other non‑preferred biosimilars) will be provided contingent on meeting the Preferred Product Criteria and Diagnosis‑Specific Criteria.

Members on non‑preferred products must switch to preferred products unless Preferred Product Criteria are met.

Preferred Product Criteria exceptions: Approval of a non‑preferred product requires either: (a) documentation of at least 14 weeks trial of Steqeyma or Yesintek with minimal clinical response plus provider attestation of expected superiority with the non‑preferred product; OR (b) documentation of intolerance/contraindication/adverse event to Steqeyma or Yesintek plus provider attestation that the same would not be expected with the non‑preferred product. Additionally, patient must not have had loss of favorable response after established maintenance therapy with any ustekinumab product.

Diagnosis-specific targeted immunomodulator updates

Disease-specific combination and prior treatment restrictions were updated; these affect medical necessity determinations per diagnosis.

Crohn's disease updates: Policy updated to add Entyvio (vedolizumab), Omvoh (mirikizumab‑mrkz), and Tremfya (guselkumab) to the list of targeted immunomodulators the patient must not be receiving in combination with ustekinumab; prior treatment examples were correspondingly updated.

Combination exclusions and prior treatment examples for Crohn's disease revised.

Plaque psoriasis updates: Policy updated to add Bimzelx (bimekizumab‑bkzx) and Sotyktu (deucravacitinib) to the list of targeted immunomodulators referenced; some prior examples were removed (e.g., Orencia).

Modifies prior therapy examples for plaque psoriasis.

Psoriatic arthritis updates: Added Bimzelx and Xeljanz XR to the examples of targeted immunomodulators and removed selected agents (e.g., Olumiant) from examples.

Modifies prior therapy examples for psoriatic arthritis.

Administration timing (IV induction to SC maintenance)

IV to subcutaneous timing: Ustekinumab is to be administered subcutaneously 8 weeks after the initial intravenous induction dose for continuation/maintenance dosing.8 weeks

Policy language replaced specific brand reference with 'ustekinumab' to clarify timing across all ustekinumab products.

Ustekinumab must not be used concurrently with any other targeted immunomodulator in any indication-specific pathway. Each diagnosis section explicitly requires that the patient is not receiving ustekinumab in combination with a targeted immunomodulator (examples listed by indication) and authorization is contingent on that requirement being met.

Use of ustekinumab for ankylosing spondylitis and multiple sclerosis is designated as unproven and not medically necessary in this policy. Randomized controlled trials in axial spondyloarthritis did not demonstrate clinically meaningful benefit, and a randomized phase II trial in relapsing‑remitting multiple sclerosis failed to show efficacy on MRI lesion endpoints.

Clinical trial evidence in axial spondyloarthritis (radiographic and non‑radiographic axial SpA) did not show clinically meaningful improvement versus placebo across the randomized studies reviewed; therefore ustekinumab use for axial SpA is unsupported by demonstrated benefit and is not covered for this indication.

Per indication, the policy excludes patients who are receiving specified named targeted immunomodulators in combination with ustekinumab. The list of prohibited concomitant agents has been updated across disease sections (e.g., additions such as Entyvio/vedolizumab, Omvoh/mirikizumab, Tremfya/guselkumab, Bimzelx, Sotyktu and others; removals of certain older agents are noted), and examples are enumerated in each diagnosis-specific criterion.

Consistent with the evidence review and policy determination, use of ustekinumab for ankylosing spondylitis or multiple sclerosis is considered unproven and not medically necessary; requests for these indications do not meet the policy's medical necessity criteria.

Relapsing‑remitting multiple sclerosis and axial spondyloarthritis (axial SpA) were assessed in randomized studies that failed to demonstrate efficacy for ustekinumab. Because clinical studies did not show benefit for these indications, coverage for RRMS and axial SpA is unsupported under this policy.

Coverage of specific ustekinumab products is contingent on meeting both the Diagnosis‑Specific Criteria and the Preferred Product Criteria. Use of any ustekinumab product without satisfying those criteria (including preferred‑product step requirements and required documentation for non‑preferred product approval) may be considered not medically necessary and subject to denial.

Initial Therapy / Induction Requirements

Prior Authorization

Induction Constraints and Setting

Initial induction for Crohn's disease is limited to one intravenous induction dose (medical benefit); initial induction for ulcerative colitis is limited to one intravenous induction dose (medical benefit). Induction for both Crohn's disease and ulcerative colitis requires IV administration in an infusion center or hospital outpatient setting. Authorization for induction will be for one induction dose.

Initial induction authorization: one IV induction dose (Crohn's disease)
Initial induction authorization: one IV induction dose (Ulcerative colitis)
Setting: IV administration (medical benefit) — infusion center or hospital outpatient

Documentation Required

Policy History, Prior Authorization, and Administrative Notes

Prior authorization details and policy history notes — Prior authorization is required as per this policy; specific prior authorization form details are not specified in the excerpt. Policy history contains multiple revisions including updates to targeted immunomodulator lists, replacement of language to reference 'ustekinumab' for continuation dosing (previously referenced 'Stelara'), additions/removals of named agents across indications, and updates to applicable HCPCS/J-codes. Applicable HCPCS codes were updated to add J3490, J3590, Q5099*, Q5100*, Q5137, Q5138, Q9996, Q9997, Q9998, and Q9999 (*quarterly edit). Policy history entries indicate items were 'Added' or 'Removed' in prior revisions and note replacement of continuation-dosing language to reference ustekinumab. No explicit authorization denial triggers are specified in the cited chapters; no explicit denial triggers are present in this section. Prior therapy documentation and prescriber attestations (including self-administration attestation) are required where noted above. Preferred-product-first / preferred product step and preferred product override documentation: the section references preferred-product-first approach with defined exceptions in the planner; however, no step therapy rules are described in the excerpt. Continuation dosing name consistency: continuation dosing language was updated to reference 'ustekinumab' uniformly. Psoriatic arthritis sequencing considerations are noted in policy history updates to examples of previously treated targeted immunomodulators. Support for ustekinumab continuation dosing consistent with FDA-labeled schedules is required.

Continuation / Maintenance Therapy Criteria

Continuation Therapy

Continuation therapy requires documentation of response and other conditions specific to the indication.

General continuation requirements: Documentation of positive clinical response; prescriber attestation that the patient or caregiver cannot be trained or are physically unable to self‑administer (with explanation) when requesting medical benefit administration; dosing per FDA‑labeled continuation schedule; patient not receiving ustekinumab in combination with a targeted immunomodulator; authorization typically up to 12 months.

Continuation Therapy - Ulcerative Colitis

Continuation of therapy requirements for ulcerative colitis

Ulcerative colitis continuation: Documentation of positive clinical response; prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to self‑administer (with explanation); ustekinumab administered subcutaneously 8 weeks after the initial IV induction dose per FDA‑labeled dosing; patient not receiving ustekinumab in combination with a targeted immunomodulator; authorization for continuation up to 12 months.

Step Therapy / Sequencing Requirements

Requirement	Details
Must trial preferred ustekinumab products (Steqeyma or Yesintek)
Documentation of a trial of at least 14 weeks of Steqeyma or Yesintek resulting in minimal clinical response and residual disease activity is required prior to approval of a non-preferred ustekinumab product (or provider attestation per criteria).

Requirement	Documentation needed
Prior or concurrent inadequate response to conventional therapies (or prior targeted immunomodulator)
Document prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine), or prior treatment with an FDA‑approved targeted immunomodulator (document drug, date, and duration); not required if patient is currently on ustekinumab.

Consideration	Provider action / documentation
Follow guideline-based sequencing for psoriatic arthritis and related conditions
Document clinical rationale when selecting ustekinumab (e.g., prior biologic exposure, comorbidities such as IBD, contraindications to TNFi, patient preference for less frequent dosing) consistent with ACR/National Psoriasis Foundation guidance.

Override scenario	Required documentation / attestation
Provider attestation of expected superiority of non-preferred product
Either: (1) documentation of a ≥14‑week trial of Steqeyma or Yesintek with minimal clinical response plus provider attestation that clinical response would be superior with the non‑preferred product; OR (2) documentation of intolerance/contraindication/adverse event to Steqeyma or Yesintek plus provider attestation that the same intolerance/contraindication/adverse event would not be expected with the non‑preferred ustekinumab product. Also confirm patient has not had loss of favorable response after established maintenance therapy with any ustekinumab product.

Override scenario

Required documentation / attestation

Provider attestation of expected superiority of non-preferred product

Either: (1) documentation of a ≥14‑week trial of Steqeyma or Yesintek with minimal clinical response plus provider attestation that clinical response would be superior with the non‑preferred product; OR (2) documentation of intolerance/contraindication/adverse event to Steqeyma or Yesintek plus provider attestation that the same intolerance/contraindication/adverse event would not be expected with the non‑preferred ustekinumab product. Also confirm patient has not had loss of favorable response after established maintenance therapy with any ustekinumab product.

Provider Actions, Documentation & Billing Guidance

Prior Authorization

Prior authorization required for medical‑benefit ustekinumab (initial and continuation limits)

Prior authorization is required for administration of ustekinumab under the medical benefit; initial authorizations for IBD are limited to one IV induction dose and continuation authorizations are contingent on meeting continuation criteria (documentation of response, prescriber attestation, dosing per FDA label) and are typically authorized up to 12 months.

Prior authorization required for initial and continuation ustekinumab administration under the medical benefit.
Initial authorization for IBD is for one IV induction dose; continuation authorization requires documented response and is for no more than 12 months when criteria met.

Prior Authorization

Prior authorization: one IV induction dose; continuation requires stated documentation

Prior authorization is required and initial authorization for ustekinumab is limited to a single IV induction dose; continuation requires meeting the indication‑specific continuation criteria (e.g., documented positive clinical response, prescriber attestation regarding self‑administration) and dosing per FDA labeling.

Initial authorization limited to one IV induction dose.
Continuation requires documentation of positive clinical response and prescriber attestation if medical‑benefit administration is requested.

Applicable Billing & Diagnosis Codes

Applicable HCPCS/CodesHCPCS

J3357	Ustekinumab, for subcutaneous injection, 1 mg.
J3358	Ustekinumab for intravenous injection, 1 mg.
J3490	Unclassified drugs.
J3590	Unclassified biologics.
Q5099	Injection, ustekinumab-stba (Steqeyma), biosimilar, 1 mg.
Q5100	Injection, ustekinumab-kfce (Yesintek), biosimilar, 1 mg.
Q5137	Injection, ustekinumab-auub (wezlana), biosimilar, subcutaneous, 1 mg.
Q5138	Injection, ustekinumab-auub (wezlana), biosimilar, intravenous, 1 mg.
Q9996	Injection, ustekinumab-ttwe (pyzchiva), subcutaneous, 1 mg.
Q9997	Injection, ustekinumab-ttwe (pyzchiva), intravenous, 1 mg.

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Applicable ICD-10 Codes (selected list)ICD-10

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.
K50.019	Crohn's disease of small intestine with unspecified complications.
K50.10	Crohn's disease of large intestine without complications.
K50.90	Crohn's disease, unspecified, without complications.
K51.00	Ulcerative (chronic) pancolitis without complications.
K51.20	Ulcerative (chronic) proctitis without complications.

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Applicable HCPCS / J-codes added or updatedHCPCS

J3490	Unclassified drugs (added to applicable HCPCS list)
J3590	Unclassified biologics (added to applicable HCPCS list)
Q5099	Notation: added (quarterly edit)
Q5100	Notation: added (quarterly edit)
Q5137	Added to applicable HCPCS list
Q5138	Added to applicable HCPCS list
Q9996	Added to applicable HCPCS list
Q9997	Added to applicable HCPCS list
Q9998	Added to applicable HCPCS list
Q9999	Added to applicable HCPCS list

Updated Applicable HCPCS CodesHCPCS

J3490	Unclassified drugs (HCPCS) — added to applicable codes list
J3590	Unclassified biologics (HCPCS) — added to applicable codes list
Q5099	Temporary code (Q-code) — added to applicable codes list
Q5100	Temporary code (Q-code) — added to applicable codes list
Q5137	Temporary code (Q-code) — added to applicable codes list

CDAI clinical response — threshold (Crohn's disease)

DefinitionClinical response (Crohn's disease) defined in maintenance study as ≥ 100 point reduction in CDAI score at Week 8 of induction.

Biosimilar / Product Preference Information

Note

Preferred products: Steqeyma and Yesintek (coverage contingent on criteria)

Steqeyma and Yesintek are designated preferred ustekinumab products; coverage for these products is subject to meeting the Diagnosis‑Specific Criteria in the policy.

Steqeyma (ustekinumab‑stba) and Yesintek (ustekinumab‑kfce) are the preferred products.
Coverage for preferred products is contingent on meeting indication‑specific criteria.

Note

Preferred product reminder: non‑preferred use requires meeting policy criteria

Preferred‑product status and related coverage is reiterated: Steqeyma and Yesintek are preferred and coverage of non‑preferred ustekinumab requires meeting Diagnosis‑Specific and Preferred Product Criteria.

Non‑preferred ustekinumab products will be considered only if Preferred Product Criteria and Diagnosis‑Specific Criteria are satisfied.

Definitions and Background

Ustekinumab products are indicated for immune‑mediated conditions including Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. This policy treats all ustekinumab products collectively for coverage purposes while distinguishing preferred products (Steqeyma, Yesintek) and specifying indication‑specific medical necessity and dosing requirements.

Ustekinumab (definition)

DefinitionUstekinumab — term used herein to refer to all ustekinumab products (brand and biosimilar).

Clinical remission (ulcerative colitis)

DefinitionClinical remission (ulcerative colitis) — defined in trials as total Mayo score ≤ 2 with no subscore > 1 on any Mayo component.

Clinical response (Crohn's disease)

Definition

Policy Revision History & Material Changes

2025-07-01material_updateLatest

Preferred-product policy established: Steqeyma and Yesintek designated as preferred ustekinumab products and non-preferred products listed (Otulfi, Pyzchiva, Selarsdi, Stelara, Wezlana, others) with Preferred Product Criteria for continuation or initiation; applicable HCPCS codes updated and continuation language clarified to reference ustekinumab rather than brand name.

added_drugs

Policy history entries added listing Bimzelx (bimekizumab-bkzx) to the policy history.

OpenPayer

Ustekinumab products (medical benefit) — Coverage Criteria

Coverage / Medical Necessity Criteria

Initial Therapy / Induction Requirements

Continuation / Maintenance Therapy Criteria

Step Therapy / Sequencing Requirements

Provider Actions, Documentation & Billing Guidance

Applicable Billing & Diagnosis Codes

Biosimilar / Product Preference Information

Definitions and Background

Policy Revision History & Material Changes