Ustekinumab Products (Stelara and biosimilars) — Coverage and Prior Authorization Criteria
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Coverage and prior authorization criteria for ustekinumab products for FDA‑approved and compendial indications for Blue Cross Blue Shield of Tennessee members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Label-concordant use
Covered when dosing and indication match product labeling
Induction IV weight tiers and SC maintenance schedules are specified per product.
All uses of ustekinumab that are not specifically listed as FDA‑approved or accepted compendial indications are considered experimental/investigational and are not medically necessary. An explicit compendial exception is made for immune checkpoint inhibitor‑related toxicity where compendial support exists; otherwise, off‑label requests that lack support in recognized compendia or peer‑reviewed literature will generally be excluded from coverage.
Prior to initiation, document a negative tuberculosis (TB) screen within the prior 12 months for biologic‑naïve patients (TST or IGRA). If screening is positive, perform further evaluation to exclude active TB (for example, chest x‑ray). Do not administer ustekinumab to members with active tuberculosis; if latent TB is identified, start appropriate treatment before initiating therapy. Also document that the member will not receive concomitant therapy with another biologic or targeted synthetic agent for the same indication.
This policy follows Tennessee statutory requirements concerning off‑label drug coverage: off‑label uses of FDA‑approved drugs may be covered only when the use is supported by one of the statutorily recognized standard reference compendia or by published peer‑reviewed medical literature. Requests for off‑label indications must include citations or documentation demonstrating recognition by an accepted compendium or the peer‑reviewed literature to be considered for coverage.
Indications not listed as FDA‑approved or compendial uses (other than the specified immune checkpoint inhibitor‑related toxicity) are considered experimental/investigational and are not medically necessary. Such requests are subject to denial unless adequate compendial or peer‑reviewed support is provided per Tennessee mandate.
No additional coverage criteria are provided in this section.
Initial Authorization Requirements and Dosing
Initial therapy requirements — indication dependent
Initial authorization criteria are indication dependent and require prior therapy documentation or specific disease severity/age thresholds.
12-month authorization may be granted
12-month authorization may be granted
12-month authorization may be granted
12-month authorization may be granted
Initial dosing regimens — weight/age specific
Initial dosing is indication- and weight/age-specific per product labeling.
Applies to Crohn's disease, ulcerative colitis, and immune checkpoint inhibitor-related toxicity when IV induction indicated
Label induction — induction dosing per label
Induction dosing per label
Different brands list the same weight-tiered IV induction dosing.
Some indications (IBD) use SC 90 mg q8w with possible escalation.
Renewal and Maintenance Requirements
Continuation requirements — documentation of clinical improvement
Continuation of therapy requires documentation of clinical improvement appropriate to indication.
Authorization may be granted for 12 months
Authorization may be granted for 12 months
Maintenance dosing — maintenance regimens per label
Maintenance therapy regimens per product labeling
Follow product-specific weight/age rules.
Product Listing, Dosing Thresholds, and Codes
| Imuldosa IV / SC | Ustekinumab-srlf dosing regimens by indication and weight/age |
| Otulfi IV / SC | Ustekinumab-aauz dosing regimens by indication and weight/age |
| Pyzchiva IV / SC | Ustekinumab-ttwe dosing regimens by indication and weight/age |
| Selarsdi IV / SC | Ustekinumab-aekn dosing regimens by indication and weight/age |
| Starjemza | Ustekinumab-hmny dosing regimens by indication and weight/age |
Prior Authorization, Documentation, and Billing Guidance
Prior authorization required; typical durations
Prior authorization is required for ustekinumab products; authorizations are typically granted for 12 months for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, and 6 months for immune checkpoint inhibitor‑related diarrhea/colitis when coverage criteria are met.
Indication-specific authorization durations
Indication-specific authorization durations and conditions apply: 12-month authorizations may be granted for PsO, PsA, CD, and UC when criteria are met; 6-month authorizations may be granted for immune checkpoint inhibitor‑related diarrhea/colitis when there is inadequate response, intolerance, or contraindication to infliximab or vedolizumab.
Match product, indication, weight/age to labeled dosing
Coverage requires the requested ustekinumab product, route, and dose to match the indication- and age/weight-specific induction and maintenance regimens listed in the policy (e.g., IV induction: <56 kg = 260 mg; 56–<86 kg = 390 mg; ≥86 kg = 520 mg; SC maintenance: 45 mg or 90 mg schedules including 90 mg every 8 weeks for certain indications).
Prior Authorization: not specified in this segment
This document segment contains approval/implementation metadata but does not specify additional prior authorization code-level requirements beyond the policy criteria and effective date.
Step therapy may be required per external guide
Some agents covered by this policy may be subject to external step therapy requirements; refer to the 'Step Therapy Requirements for Provider Administered Specialty Medications' guide linked in the policy for any applicable step edits.
- External step therapy guide URL referenced in policy
Step therapy exceptions supported by clinical reasons
Documented clinical reasons may support bypassing step therapy (for example: pregnancy, breastfeeding, significant comorbidity, drug interactions, intolerance, hypersensitivity) when conventional systemic agents are inadvisable; provide chart notes explaining the clinical rationale.
- Examples include pregnancy, breastfeeding, significant liver/kidney disease, drug interaction, history of intolerance or adverse event.
No explicit step therapy rules present in policy text
No explicit step therapy sequences or internal step edits are described within this policy segment; step therapy application is determined by referenced external requirements and clinical rationale.
No internal step therapy rules in this segment
No step therapy rules are detailed in this document segment; providers should follow external step therapy guidance and document any clinical justification for exceptions.
Required documentation: diagnosis, BSA, prior meds, labs/imaging
Submit chart notes or medical record documentation supporting the diagnosis, affected area and body surface area (BSA) for psoriasis, prior medication history and response (or clinical reason to avoid prior therapies), and relevant labs/imaging as applicable to the indication.
- Affected area and BSA for psoriasis (initial requests)
- Prior medications tried and responses, or clinical reason to avoid them
- Relevant labs/imaging or endoscopy reports for IBD where applicable
Clinical response documentation required for continuation
For continuation/renewal requests, provide documentation of clinical response from baseline (e.g., decreased BSA or symptom improvement for psoriasis; joint counts or functional improvement for PsA; symptomatic improvement, laboratory markers, imaging/endoscopy findings, or disease activity scores for CD/UC).
- PsO: decreased BSA or improvement in signs/symptoms
- PsA: reduction in tender/swollen joints, dactylitis, enthesitis, or improved function
- CD/UC: improvement in symptoms, CRP/FC, endoscopic appearance, or disease activity scores
Document patient weight and age for dosing determination
Providers must document patient weight and age to support selection of the appropriate IV induction weight tier or SC maintenance regimen as specified by product labeling.
- IV induction weight tiers: <56 kg, 56–<86 kg, ≥86 kg
- Pediatric and adult weight/age thresholds for SC dosing (e.g., 0.75 mg/kg regimens, 45 mg vs 90 mg thresholds)
Required documentation for dosing and indication (medical record evidence)
Medical records must include evidence of the indication, patient age and weight, and that dosing follows product-specific induction and maintenance schedules (to support approval and adherence to quantity/dosing limits).
- Indication listed in chart notes
- Age and weight recorded to justify weight-tiered IV induction dose
- Dosing schedule documented (weeks 0 and 4 induction, maintenance interval)
Implementation approval and effective date noted
The document includes implementation approval language: 'Medical Policy Manual Approved Rev: Do Not Implement until 6/30/26' indicating the policy effective date and internal approval; this is informational and not a provider action requirement.
Non‑covered (experimental/investigational) indications may be denied
Indications not listed as FDA‑approved or compendial uses (other than the specified compendial use for immune checkpoint inhibitor‑related toxicity) are considered experimental/investigational and not medically necessary and may be denied.
Tuberculosis screening and exclusion of active TB required prior to initiation
Providers must document a negative tuberculosis (TB) test (TST or IGRA) within 12 months prior to initiating therapy for biologic‑naïve persons; if TB screening is positive, further testing to exclude active disease and treatment of latent TB prior to initiation are required—do not administer the medication to members with active TB.
- Negative TB test (TST or IGRA) within 12 months for biologic‑naïve individuals
- If positive: chest x-ray or other testing to exclude active disease; treat latent TB before initiating therapy
- Do not administer drug if active TB is present
Tennessee off‑label coverage mandate — compendia/literature required
Off‑label uses must comply with Tennessee statutory requirements: off‑label indications are covered only when recognized by a statutorily recognized compendium or supported by peer‑reviewed medical literature; failure to meet these requirements may result in denial.
No authorization criteria present in this segment (reference/approval only)
This small segment contains only reference and approval language (policy citations and effective date) and does not itself include actionable authorization criteria for providers.
Key Definitions and Clinical Measures
Step Therapy Expectations and Exceptions
| Step therapy applicability | Notes / source |
|---|---|
| Some agents on this policy may require step therapy per the external 'Step Therapy Requirements for Provider Administered Specialty Medications' guide. | |
| Reference: external step therapy guide URL provided in policy document. |
| Requirement | Supporting detail / examples |
|---|---|
| Documented failure, intolerance, or contraindication to prior therapies | |
| Examples of clinical reasons to avoid conventional systemic agents include drug interaction, pregnancy/breastfeeding, significant comorbidity, liver disease, history of intolerance; for immune checkpoint inhibitor‑related toxicity specifically, inadequate response/intolerance/contraindication to infliximab or vedolizumab is required. |
| Explicit step edits described? | Policy note |
|---|---|
| No — no explicit step therapy sequence or step edits are described in these document chunks. | |
| Off-label coverage is governed by Tennessee statutory compendia/literature rules per state mandate; specific step edits are not listed in this segment. |
| Dosing constraint | Specified regimen |
|---|---|
| Intravenous (IV) induction — weight‑tiered single dose | |
| <56 kg = 260 mg once; 56 to <86 kg = 390 mg once; ≥86 kg = 520 mg once (documented across listed products). | |
| Subcutaneous (SC) maintenance — adult and pediatric weight/age regimens | |
| Typical SC maintenance: 90 mg every 8 weeks; some indications/patients use 45 mg or weight/age‑based 0.75 mg/kg schedules with initial doses at weeks 0 and 4 and maintenance every 12 weeks; 90 mg every 4 weeks may be used for incomplete response where specified. |
Dosing Limits and Quantity Constraints
Administration Settings
IV induction requires infusion center or appropriate IV setting
IV induction doses are specified by weight tiers; IV induction implies administration in an infusion center or other appropriate intravenous setting.
- IV induction weight tiers: <56 kg = 260 mg once; 56–<86 kg = 390 mg once; ≥86 kg = 520 mg once [[chunk 28]].
- Administer IV induction in an infusion-capable setting.
SC maintenance may be given in clinic or at home per standard practice
Subcutaneous maintenance dosing is intended for clinic or home administration per usual practice; SC dosing schedules vary by product, weight, age, and indication.
- Typical SC maintenance: 90 mg every 8 weeks for certain indications; escalate to 90 mg every 4 weeks for incomplete response where specified [[chunk 31], [chunk 36]].
Reference Product and Biosimilar Information
Policy applies to Stelara and listed biosimilars
This policy applies to Stelara (ustekinumab) and the listed biosimilars; coverage and dosing rules in this policy apply to the reference product and the named biosimilars.
Named biosimilars have indication‑ and weight/age‑specific dosing
Named biosimilars and products (Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Steqeyma, Wezlana, Yesintek, etc.) have indication‑ and weight/age‑specific IV induction and SC maintenance dosing listed; coverage applies to these products per the same criteria and dosing schedules.
- Examples: IV induction weight tiers and SC maintenance schedules are provided per product for Crohn's disease, UC, PsO, and PsA [[chunks 28, 31, 36]].
Stelara (ustekinumab) listed with indication‑specific dosing
Stelara (ustekinumab) dosing is listed with indication‑ and weight/age‑specific induction and maintenance regimens for IV and SC routes and should be used as the reference dosing in authorization decisions.
Stelara dosing entries reference IV induction and SC maintenance
Additional Stelara product entries in the document list the same weight‑tiered IV induction and product‑specific SC maintenance regimens that must be followed for coverage.
Product entries reiterate weight‑based IV induction and SC maintenance
Further product entries reiterate weight‑based IV induction (260/390/520 mg) and SC maintenance schedules (45 mg or 90 mg regimens by weight/age and indication) applicable to listed ustekinumab products.
Additional product listings require label‑concordant dosing
Multiple additional product listings show the same indication‑ and weight/age‑based dosing patterns; ensure requested product dosing matches the listed regimen for that specific brand/biosimilar.
Confirm medical record aligns with product‑specific dosing table
Additional product rows in the policy further document IV induction and SC maintenance dosing by age/weight and indication; confirm the medical record aligns with the specific product dosing table used for the request.
Clinical Background
Ustekinumab is an interleukin‑12/23 inhibitor available as the reference product (Stelara®) and multiple biosimilars; it is indicated for moderate to severe plaque psoriasis (age ≥6 years), active psoriatic arthritis (age ≥6 years), and moderately to severely active Crohn's disease and ulcerative colitis in adults. Compendial use includes immune checkpoint inhibitor‑related diarrhea/colitis when alternative agents (e.g., infliximab or vedolizumab) are inadequate or contraindicated. Coverage requires meeting indication‑specific criteria and following product‑specific dosing and monitoring requirements.
Document History and References
Policy approved and scheduled for implementation effective 6/30/2026 (Medical Policy Manual Approved Rev: Do Not Implement until 6/30/26).
Clinical guideline and compendium sources cited or accessed (CDC TB testing; NCCN Management of Immunotherapy-related Toxicities; other guideline references listed).
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