Ustekinumab (brand and biosimilar products) — Coverage Criteria (IV/SC)
Clinical prior authorization and coverage criteria for ustekinumab (IV/SC) products for multiple labeled and compendia-supported indications, including dosing limits, initial and renewal criteria, and safety screening requirements for Viva Health members.
No material clinical or coverage changes in this revision.
Coverage Criteria and Indication-Specific Requirements
inv-01: Universal Initial Criteria
Covered when ALL of the following are met:
See indication-specific criteria for additional requirements.
inv-02: Plaque Psoriasis (PsO) Initial
Covered when ALL of the following are met:
Trials may be waived for members already established on biologic/targeted therapy or with >10% BSA involvement.
inv-03: Adult Psoriatic Arthritis (PsA) Initial
Covered when ALL of the following are met:
inv-04: Juvenile Psoriatic Arthritis (JPsA) Initial
Covered when ALL of the following are met:
inv-05: Adult Crohn's Disease (CD) Initial
Covered when ALL of the following are met:
Three months of corticosteroids not required if early non-response is confirmed.
inv-06: Pediatric Crohn's Disease (CD) Initial
Covered when ALL of the following are met:
Three months of corticosteroids not required if early non-response is confirmed.
inv-07: Ulcerative Colitis (UC) Initial
Covered when ALL of the following are met:
Three months of corticosteroids not required if early non-response is confirmed.
inv-08: Management of Immune Checkpoint Inhibitor-Related Toxicities
Covered when ALL of the following are met:
Induction IV dose plus up to 3 SC maintenance doses allowed; prior authorization for this indication may not be renewed.
inv-09: Supportive therapy in combination with marnetegragene autotemcel
Covered when ALL of the following are met:
Authorization provided for up to 3 total subcutaneous doses; retreatment with marnetegragene autotemcel is considered investigational.
inv-10: Dose escalation (CD & UC)
Dose escalation may be considered when ALL of the following are met:
Escalation must not exceed 90 mg subcutaneously every 4 weeks; prior authorization validity for escalation provided for 3 months with continued approval contingent on clinical improvement and ustekinumab levels.
inv-11: Indication-specific dosing
Dosing and maintenance schedules as specified for each indication and weight category:
Applies to listed products.
Applies to listed products.
Includes pediatric IV induction and subcutaneous maintenance dosing as detailed in document.
Applies to listed products.
inv-12: Route-specific ICD-10 code linkage
Coverage considerations reference the following ICD-10 diagnosis codes by administration route
Codes enumerated in chunks 54–60.
Codes enumerated in chunks 61–65.
The policy lists specific contraindications to phototherapy that may affect eligibility for therapies where phototherapy trials are required. Examples include xeroderma pigmentosum, other rare photosensitive genodermatoses (e.g., trichothiodystrophy, Cockayne, Bloom, Rothmund‑Thomson syndromes for UVB), pregnancy or lactation (PUVA), genetic disorders that increase skin cancer risk (e.g., Gorlin syndrome, oculocutaneous albinism for UVB), lupus erythematosus, prior history of photosensitivity diseases or prior melanoma/non‑melanoma skin cancer, extensive solar damage (PUVA), use of photosensitizing medications (PUVA), immunosuppression after organ transplant (UVB), severe liver, renal, or cardiac disease (PUVA), and young age (<12 years for PUVA). Members without access to phototherapy are reviewed on a case‑by‑case basis.
For members undergoing dose adjustment or re‑treatment, the policy states that members who do not regain response at a 4‑week interval should discontinue therapy. This guidance applies in the context of escalation or interval shortening decisions after documented loss of response.
Within this segment of the document there are no additional explicit exclusions specified beyond condition‑specific contraindications and the coverage criteria; utilization management and NQTL considerations are described separately.
This policy is written for non‑Medicare coverage determinations; however, Medicare Part B NCDs, LCDs, and LCAs may impose additional indications or exclusions that are not reflected here. Providers must comply with applicable CMS policies where Medicare Part B rules apply.
The policy does not support dose escalation that exceeds 90 mg subcutaneously every 4 weeks. Escalation requests must meet prerequisites including demonstration of an initial response, receipt of the specified IV loading dose and at least one subcutaneous maintenance dose, and clinical evidence of loss of response; requests failing to meet these prerequisites or seeking escalation beyond the 90 mg q4w limit may be denied.
No explicit statements labeling additional uses as not medically necessary are included in this document segment; the policy instead defines circumstances where requests (for example, unsupported dose escalation) may be denied under the listed criteria and prerequisites.
Billing Codes, Diagnosis Codes, and NDCs
| 57894-0060-xx | Stelara 45 mg/0.5 mL single-dose prefilled syringe (also listed as single-dose vial) |
| 57894-0061-xx | Stelara 90 mg/mL single-dose prefilled syringe |
| 84612-0076-xx | Wezlana 45 mg/0.5 mL single-dose prefilled syringe |
| 84612-0876-xx | Wezlana 45 mg/0.5 mL single-dose prefilled syringe (alternate) |
| 84612-0089-xx | Wezlana 90 mg/mL single-dose prefilled syringe |
| 84612-0889-xx | Wezlana 90 mg/mL single-dose prefilled syringe (alternate) |
| 84612-0055-xx | Wezlana 45 mg/0.5 mL single-dose vial |
| 84612-0855-xx | Wezlana 45 mg/0.5 mL single-dose vial (alternate) |
| 83257-0023-xx | Yesintek 45 mg/0.5 mL single-dose prefilled syringe |
| 83257-0025-xx | Yesintek 90 mg/mL single-dose prefilled syringe |
| 517590413-xx | Ustekinumab-aekn 45 mg/0.5 mL single-dose prefilled syringe (unbranded Selarsdi) |
| 51759-0414xx | Ustekinumab-aekn 90 mg/mL single-dose prefilled syringe (unbranded Selarsdi) |
| 82009-0160-xx | Ustekinumab-ttwe 45 mg/0.5 mL single-dose prefilled syringe (unbranded Pyzchiva) |
| 82009-0162-xx | Ustekinumab-ttwe 90 mg/mL single-dose prefilled syringe (unbranded Pyzchiva) |
| 65219-0862-xx | Ustekinumab-aauz 45 mg/0.5 mL single-dose prefilled syringe (unbranded Otulfi) |
| 65219-0866-xx | Ustekinumab-aauz 90 mg/mL single-dose prefilled syringe (unbranded Otulfi) |
| 65219-0864-xx | Ustekinumab-aauz 45 mg/0.5 mL single-dose vial (unbranded Otulfi) |
| 72606-0055-xx | Ustekinumab-stba 45 mg/0.5 mL single-dose prefilled syringe (unbranded Steqeyma) |
| 72606-0056-xx | Ustekinumab-stba 90 mg/mL single-dose prefilled syringe (unbranded Steqeyma) |
| 55513-0129-xx | Ustekinumab-auub 45 mg/0.5 mL single-dose prefilled syringe (unbranded Wezlana) |
| 57894-0054-xx | Stelara 130 mg/26 mL (5 mg/mL) single-dose vial |
| 84612-0066-xx | Wezlana 130 mg/26 mL (5 mg/mL) single-dose vial |
| 83257-0026-xx | Yesintek 130 mg/26 mL (5 mg/mL) single-dose vial |
| 72606-0029-xx | Steqeyma 130 mg/26 mL (5 mg/mL) single dose vial |
| 61314-0654-xx | Pyzchiva 130 mg/26 mL (5 mg/mL) single-dose vial |
| 65219-0828-xx | Otulfi 130 mg/26 mL (5 mg/mL) single-dose vial |
| 69448-0019-xx | Imuldosa 130 mg/26 mL (5 mg/mL) single-dose vial (also 51407-0931-xx) |
| 51407-0931-xx | Imuldosa 130 mg/26 mL (5 mg/mL) single-dose vial (alternate) |
| 51759-0708-xx | Selarsdi 130 mg/26 mL (5 mg/mL) single-dose vial |
| 51759-0711-xx | Selarsdi 130 mg/26 mL (5 mg/mL) single-dose vial (alternate / also listed for aekn) |
Authorization, Documentation, and Denial Risk
Prior Authorization Duration and Dose Escalation
Initial prior authorizations are generally granted for 6 months (180 days) unless otherwise specified; Crohn's disease and ulcerative colitis have specific shorter initial validity and dose-escalation approvals are time-limited. Dose escalation requests for Crohn's disease and ulcerative colitis will be reviewed only if the member has met induction requirements and shown initial response; requests that do not meet these criteria (for example, no IV loading dose, no minimum one subcutaneous maintenance dose, no initial response by treatment week 16) may be denied. Prior authorization validity for dose escalation will be provided for 3 months (90 days) with continued renewal contingent upon demonstration of clinical improvement and documentation of ustekinumab trough levels when available.
- Initial PA validity: generally 6 months (180 days); Crohn's/Ulcerative Colitis — indication-specific durations apply
- Dose escalation PA validity: 3 months (90 days) with continued approval contingent on clinical improvement and trough levels
Documentation and Clinical Prerequisites for Authorization
Prior authorization must include documentation that the provider has obtained and submitted: evidence of prior failure, intolerance, or contraindication to specified reference biologics when applicable; documentation of trials of required therapies (topicals, phototherapy, non-biologic systemic agents, corticosteroids or immunomodulators, or TNF inhibitors where specified); objective baseline disease severity assessment; and appropriate ICD-10 diagnosis code(s) supporting the requested indication and route of administration. For dose-escalation requests, include clinical rationale for escalation and documentation that induction and maintenance dosing prerequisites were met.
- Required documentation: prior failure/intolerance/contraindication to listed reference biologics when applicable
- Therapy trials: topical (≥4 weeks), phototherapy (≥3 months), non-biologic systemic agent (≥3 months) unless exemptions apply (established biologic users, >10% BSA, or other specified exceptions)
- For IBD: documented minimum 3-month trials of corticosteroids/immunomodulators or TNF modifier unless contraindicated or early non-response
- Include objective baseline severity measure (e.g., PASI, BSA, validated disease activity scores)
- Include appropriate ICD-10 diagnosis code(s) from the route-specific lists on the claim
Trough Level Documentation
Ustekinumab trough levels should be obtained and submitted when available and covered by the benefit; a trough <4.5 µg/mL supports consideration of interval shortening or escalation, while a trough >4.5 µg/mL may support interval extension with monitored reassessment. Trough testing is required for continued dose-escalation approval when applicable.
- Obtain and document ustekinumab trough level if test is covered by benefit
- Trough interpretation: <4.5 µg/mL supports interval shortening/escalation; >4.5 µg/mL may support interval extension with follow-up assessment
Utilization Management and Cost Consideration
Utilization management (e.g., prior authorization, dose limits, step therapy) has been applied with consideration of clinical indications and comparably across MH/SUD and M/S drug benefits. One explicit factor driving PA for this drug/group is drug cost; cost considerations may trigger PA or other utilization controls.
- NQTL consideration: utilization management methods applied comparably across benefit categories
- Cost of drug identified as a reason for applying PA or utilization controls
CMS Policy Adherence and Medicare Coverage Consistency
Medicare beneficiaries may be subject to Centers for Medicare & Medicaid Services (CMS) policies (Medicare Benefit Policy Manual, relevant NCDs, LCDs, and LCAs) for outpatient (Part B) drugs. Where applicable, compliance with NCDs/LCDs/LCAs is required; noncompliance with those CMS policies may result in denial for Medicare Part B claims. Use the CMS Medicare Coverage Database to identify applicable documents.
- Medicare Part B outpatient drugs: follow Medicare Benefit Policy Manual Chapter 15 §50 and applicable NCDs/LCDs/LCAs
- Search NCD/LCD/LCA: https://www.cms.gov/medicare-coverage-database/search.aspx
- Noncompliance with applicable CMS policies may trigger denial for Medicare Part B claims
Dose Escalation Denial Triggers
Requests for dose escalation that lack required prerequisites or documentation (no initial response, missing IV loading dose when required, no minimum one subcutaneous maintenance dose, absence of trough level data when indicated) are at high risk for denial. Providers should ensure all induction/maintenance dosing and clinical response criteria are documented before submitting an escalation request.
- Denial triggers for dose escalation: absence of initial response by treatment week 16, no documented IV loading dose (when required), no documented minimum one subcutaneous maintenance dose, missing trough level data when test is available/covered
Initial Dosing and Induction Requirements
inv-56: Initial Dosing
Dosing for induction and maintenance varies by indication
See Section V for exact HCPCS unit limits per dose and indication.
inv-57: Initial therapy dosing
Initial IV induction and subcutaneous loading dosing per indication and weight
Renewal and Ongoing Therapy Requirements
inv-58: Renewal/Continuation Therapy
Renewal criteria and duration
Renewals are generally for 12 months (365 days) unless specified otherwise; certain indications (ICI-related toxicities, supportive therapy with Kresladi) have limited or non-renewable authorizations.
inv-59: Continuation therapy monitoring
Continuation and monitoring requirements for members after dose escalation or maintenance:
Prior Trials and Step Therapy Requirements
| Coverage requirement | Details |
|---|---|
| Prior therapy requirement | Prior trials required before approval unless contraindicated, not tolerated, or member already established on biologic or targeted synthetic therapy. Required prior therapies vary by indication (e.g., topical agents, phototherapy, non-biologic systemic agents for plaque psoriasis; corticosteroids/immunomodulators or TNF modifiers for Crohn's disease and ulcerative colitis). |
| Age and baseline assessment | Member must meet indication-specific minimum age and have physician-assessed baseline disease severity using an objective measure/tool. (Examples: Psoriasis ≥6 years; Pediatric Crohn's ≥2 years.) |
| Exception to prior trial requirement | Trials may be waived for members already established on biologic/targeted therapy or for certain severe/extensive disease (e.g., >10% BSA in plaque psoriasis) or when contraindications/intolerance exist. |
| Coverage requirement | Details |
|---|---|
| Initial induction and maintenance before escalation | Dose escalation for Crohn's disease and ulcerative colitis requires that the member: has shown an initial response; received the initial IV loading dose; and received at least one subcutaneous maintenance dose. Escalation requests prior to week 16 are evaluated case-by-case. |
| Role of ustekinumab trough levels | If available and covered, ustekinumab trough levels should be obtained and documented; a trough <4.5 µg/mL supports interval shortening or escalation, and levels >4.5 µg/mL may support interval extension with reassessment. Trough testing must be covered by the benefit to be used. |
| Escalation limits and authorization period | Dose escalation must not exceed 90 mg subcutaneously every 4 weeks. Prior authorization for escalation is provided for 3 months with continued approval contingent on demonstration of clinical improvement and ustekinumab levels (if available). Members not regaining response at a 4-week interval should discontinue therapy. |
| NQTL implication | Details |
|---|---|
| NQTL checklist | The NQTL factor checklist identifies utilization management methods (such as prior authorization or step therapy) as applied comparably across benefits; cost of the drug is specifically noted as a factor to consider for PA. |
| Specific application | This document segment indicates possible application of utilization management (PA/step therapy) but does not provide additional specifics on step sequences or automated rules in the NQTL section. |
Quantity, Units, and Billing Limits
Site of Care and Administration Settings
Site-of-care: IV induction possible; SC maintenance outpatient/home
Induction dosing may be intravenous in an appropriate outpatient infusion or hospital outpatient setting for certain indications; maintenance is primarily subcutaneous and may be administered in office, infusion center, or at home per product labeling and payer rules.
- Use IV (facility/infusion) settings for weight-based induction doses (e.g., 260–520 mg as specified).
- SC maintenance (90 mg or weight-based pediatric dosing) can be given in office or at home where allowed.
IV induction in infusion setting; SC maintenance in office or home
Administer IV induction in an appropriate outpatient infusion setting (hospital outpatient/infusion center); subcutaneous maintenance dosing may be administered in office or at home per policy and labeling.
- Bill IV induction with the appropriate J/Q HCPCS code and modifier (JA for IV, JB for SC) as noted in billing guidance.
- Confirm site-of-care billing rules with payer prior to administration.
SC maintenance may be administered in outpatient or home settings
Policy references subcutaneous administration, implying that subcutaneous maintenance dosing may be provided in outpatient or home settings where permitted.
- Document site of administration consistent with payer site-of-care rules.
Biosimilars, Brands, and Substitution Guidance
Biosimilar listing and PA prerequisite to reference products
Biosimilar and multiple brand names of ustekinumab are listed; prior authorization requires documentation of failure, intolerance, or contraindication to the specified reference products before consideration of alternate ustekinumab products.
- Include prior-failure documentation to Selarsdi™, Stelara®, Ustekinumab, and Yesintek™ when applicable.
- Specify the exact product requested and appropriate NDC/HCPCS codes in the PA.
Use listed billing codes and NDCs for branded products/biosimilars
Multiple branded products and biosimilars are enumerated with dosing and NDC/HCPCS billing codes; use the listed billing codes for submission and follow payer billing guidance (JA modifier for IV, JB modifier for SC) as noted.
Clinical Background and Drug Information
Ustekinumab is described as a human monoclonal antibody available in multiple branded and biosimilar forms and is administered intravenously for induction (in some indications) and subcutaneously for maintenance. The policy covers FDA‑approved and compendia‑recommended uses across dermatology, rheumatology, gastroenterology, and select supportive/oncology‑related toxicities, and lists multiple brand and biosimilar product names.
Definitions and Clinical Terms
Policy Revision History
Policy last reviewed on 2026-05-05 with confirmation of prior authorization rules for dose escalation and reiteration of limits (90 mg SC every 4 weeks) and requirements for initial IV loading and at least one SC maintenance dose.
Prior authorization for dose escalation procedures updated to require demonstration of initial response, IV loading dose, a minimum of one SC maintenance dose, and consideration of ustekinumab trough levels (<4.5 µg/mL) to support escalation; escalation limited to 90 mg SC every 4 weeks and PA validity provided for 3 months pending demonstration of clinical improvement.
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.