ModifiedmhnPolicy CP.PHAR.264

Ustekinumab (Stelara) and biosimilars — coverage criteria

Defines medical necessity, prior authorization, dosing, and coverage criteria for ustekinumab (Stelara) and listed biosimilars for Medicaid members across Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

Policy Summary

Payermhn

PolicyUstekinumab (Stelara) and biosimilars — coverage criteria

Policy CodePolicy CP.PHAR.264

Change TypeBiosimilars & coding additionsclinical sequencing and UC severity updates

Effective Date08.16

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating indication-specific criteria, dosing, and preferred biosimilar use or justification for non-preferred product.

SourceLink

POLICY UPDATE CHANGES

Added newly approved biosimilars and formulations (examples: Wezlana, Selarsdi, Pyzchiva, Otulfi, Imuldosa, Yesintek, Steqeyma, Starjemza, Pyzchiva autoinjector) and corresponding HCPCS/Q-codes to criteria and appendices.

Removed redirection to preferred adalimumab products for several indications and revised redirection to Zeposia with bypass allowance based on biologic/JAKi failure.

Added options for documenting UC severity including modified Mayo Score >= 5 and Mayo Endoscopic Score > 2.

Extended initial approval durations to 12 months for chronic conditions.

4Covered FDA indications listed

12 monthsInitial approval duration

Mayo ≥5 / MES >2

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.

UC severity scores allowed

multiplePreferred biosimilars

HCPCS/Q addedNew billing codes

Coverage Criteria

Initial Therapy - Crohn's Disease

Covered when ALL of the following are met

CD Initial: 2. Prescribed by or in consultation with a gastroenterologist.

CD Initial: 3. Age ≥ 18 years.

ONE of

a: Failure of a ≥ 3 consecutive month trial of at least ONE immunomodulator (e.g., azathioprine, 6-mercaptopurine [6-MP], methotrexate) at up to maximally indicated doses unless clinically significant adverse effects or contraindication or previous biologic failure.
b: Medical justification supports inability to use immunomodulators (see Appendix E).

CD Initial: 5. For requests for non-preferred product, member must use all preferred biosimilars (Otulfi, Pyzchiva [branded], Selarsdi/ustekinumab-aekn, Steqeyma, Yesintek) unless clinically significant adverse effects are experienced or all are contraindicated.

CD Initial: 6. No combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase (JAK) inhibitors.

See Section III for diagnoses/indications not authorized.

CD Initial: 7. Dose does not exceed both initial IV weight-based induction AND maintenance SC limits: (a) Initial IV induction — weight ≤ 55 kg: 260 mg once; weight > 55 kg to 85 kg: 390 mg once; weight > 85 kg: 520 mg once; AND (b) Maintenance SC — 90 mg given 8 weeks after the initial IV dose, then 90 mg every 8 weeks.Weight thresholds as specified

Approval duration: 12 months

Initial Therapy - Plaque Psoriasis

Covered when ALL of the following are met

PsO Initial: 1. Diagnosis of moderate-to-severe plaque psoriasis (PsO) evidenced by either ≥ 3% total body surface area OR involvement of hands, feet, scalp, face, or genital area.

PsO Initial: 2. Request is for subcutaneous (SC) formulation.

PsO Initial: 3. Prescribed by or in consultation with a dermatologist or rheumatologist.

PsO Initial: 4. Age ≥ 6 years.

ONE of

Initial Therapy - Psoriatic Arthritis

Covered when ALL of the following are met

PsA Initial: 1. Diagnosis of psoriatic arthritis (PsA).

PsA Initial: 2. Request is for subcutaneous (SC) formulation.

PsA Initial: 3. Prescribed by or in consultation with a dermatologist or rheumatologist.

PsA Initial: 4. Age ≥ 6 years.

PsA Initial: 5. For requests for non-preferred product, member must use all preferred biosimilars (Otulfi, Pyzchiva [branded], Selarsdi/ustekinumab-aekn, Steqeyma, Yesintek) unless clinically significant adverse effects are experienced or all are contraindicated.

Initial Therapy - Ulcerative Colitis

Covered when ALL of the following are met

UC Initial: 1. Diagnosis of ulcerative colitis (UC).

UC Initial: 2. Prescribed by or in consultation with a gastroenterologist.

UC Initial: 3. Age ≥ 18 years.

UC Initial: 4. Documentation of disease activity using one of: Mayo Score ≥ 6, modified Mayo Score ≥ 5, or Mayo Endoscopic Score ≥ 2 (see Appendix F).

UC Initial: 5. Failure of an 8‑week trial of systemic corticosteroids unless contraindicated, clinically significant adverse effects are experienced, or previously failed a biologic agent for UC.

Continuation Therapy

Covered when ALL of the following are met

Continued Therapy: 1. Member meets one of the following: (a) currently receiving medication via the Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and continuity-of-care regulations apply.

Continued Therapy: 2. Member is responding positively to therapy.

Continued Therapy: 3. Request is for subcutaneous (SC) formulation.

Continued Therapy: 4. For requests for non-preferred product, member must use all preferred biosimilars (Otulfi, Pyzchiva [branded], Selarsdi/ustekinumab-aekn, Steqeyma, Yesintek) unless clinically significant adverse effects are experienced or all are contraindicated.

Indication-specific dosing (Initial and maintenance)

Covered when dosing follows FDA/label-specified induction and maintenance regimens for the indicated diagnosis

Psoriasis and Psoriatic Arthritis dosing: For plaque psoriasis and psoriatic arthritis: SC dosing at weeks 0 and 4 followed by maintenance every 12 weeks. Adult dosing: weight ≤ 100 kg: 45 mg; weight > 100 kg: 90 mg. Pediatric dosing per product‑specific guidance (e.g., 0.75 mg/kg for certain biosimilars for weight < 60 kg).Weight 100 kg

See Appendix G for dose rounding guidelines.

Initial / Continuation Therapy (high-level)

Coverage is permitted when indication-specific clinical criteria and prior therapy sequencing are met, with allowance for biosimilar selection per policy

General: 1. Member must meet the indication‑specific clinical criteria outlined in the respective initial or continuation sections (diagnosis, prescriber specialty, age, prior therapy or medical justification, and dosing limits).

Includes pediatric dosing considerations and recently added biosimilars/formulations.

General: 2. Use of preferred biosimilars may be required; for non‑preferred products, member must trial preferred biosimilars (Otulfi, Pyzchiva [branded], Selarsdi/ustekinumab-aekn, Steqeyma, Yesintek) unless contraindicated or clinically significant adverse effects occur.

General: 3. Evidence of prior therapies or documented biologic/JAKi failure may be required to support bypass of conventional therapy sequencing per indication (e.g., bypass conventional therapies if member has failed a biologic agent).

Documentation requirements per Appendix E/F/G and prior authorization guidance.

Requests for ustekinumab (or listed biosimilars) used in combination with other biological disease-modifying antirheumatic drugs (bDMARDs) or other potent immunosuppressants are not authorized. The policy explicitly lists examples (e.g., TNF antagonists, interleukin agents, JAK inhibitors, anti‑CD20 agents, selective co‑stimulation modulators, integrin receptor antagonists, TYK2 inhibitors, sphingosine‑1‑phosphate receptor modulators) and cites the increased risk of additive immunosuppression, neutropenia, and serious infections as the rationale for denial.

Uses of ustekinumab for indications that are not FDA‑approved and not specifically addressed in this policy are excluded unless the request includes sufficient supporting documentation per the applicable off‑label use policy (Medicaid: CP.PMN.53) or other evidence of coverage. The policy instructs providers to follow the off‑label policy when an indication, age, or dosing regimen is not listed in the policy.

Ustekinumab (and listed biosimilars) is contraindicated in patients with a history of clinically significant hypersensitivity to ustekinumab products or any of the excipients. The policy notes there are no boxed warnings reported for these products.

The policy has removed several prior redirection requirements to preferred agents (for example, certain adalimumab products) for specific indications. Operational updates and appendix revisions over 2023–2025 clarified preferred product lists and removed some redirection criteria; see the detailed appendices and the updated indication‑specific sections for exceptions and the current therapeutic redirection rules.

Use of ustekinumab in combination with other bDMARDs, JAK inhibitors, anti‑CD20 monoclonal antibodies, or other specified potent immunosuppressants is considered not authorized (not medically necessary) because of the risk of additive immunosuppression and related hematologic and infectious adverse events. Requests proposing combination regimens should be expected to be denied.

The policy notes coding guidance for informational purposes and states that inclusion or exclusion of procedure/billing codes does not guarantee coverage. Absence of an explicit not‑medically‑necessary statement in a code listing does not imply authorization; providers must follow the clinical criteria and documentation requirements in the policy.

The policy reflects that redirection to preferred adalimumab products for ulcerative colitis was removed based on guideline updates (AGA 2024) and subsequent policy revisions. Operational changes documented in the review history indicate removal of adalimumab redirection for UC and related adjustments to step‑therapy language.

Coding and Scoring

Covered products (brand and biosimilars)mixedCovered

NDC/HPC/other not listed

Policy lists multiple brand and biosimilar ustekinumab products (Stelara, Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Steqeyma, Wezlana, Yesintek, others)

HCPCS codes referencedHCPCS

C9399	Unclassified drugs or biologicals.
J3590	Unclassified drugs or biologicals.
J3357	Ustekinumab, for subcutaneous injection, 1 mg.
J3358	Ustekinumab, for intravenous injection, 1 mg.
Q5098	Injection, ustekinumab-srlf (imuldosa), biosimilar, 1 mg.
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.

1–10 of 13

1/2

HCPCS / Q codes addedHCPCS

Q5137	HCPCS code added (listed in document)
Q5138	HCPCS code added (listed in document)
Q9996	HCPCS code added (listed in document)
Q9997	HCPCS code added (listed in document)
Q9998	HCPCS code added (listed in document)
Q9999	HCPCS code added (listed in document)
C9399	HCPCS code added (listed in document)
J3590	HCPCS code added (listed in document)
Q5098	HCPCS code added (listed in document)
Q5099	HCPCS code added (listed in document)

1–10 of 11

1/2

Disease activity score thresholds

Mayo Score (UC)Mayo Score ≥ 6

Modified Mayo Score (UC)Modified Mayo Score ≥ 5

Mayo Endoscopic Score (UC)Mayo Endoscopic Score ≥ 2

Weight-based induction doses

Weight ≤ 55 kg260 mg IV (single initial dose)

Weight > 55 kg to 85 kg390 mg IV (single initial dose)

Weight > 85 kg

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests must document indication-specific dosing and use preferred biosimilars unless contraindicated; prior authorization may be required for ustekinumab products.

Preferred biosimilars: Otulfi, Pyzchiva (branded), Selarsdi (or unbranded ustekinumab-aekn), Steqeyma, Yesintek.
Prior authorization may be required for ustekinumab products.

Prior Authorization

Prior Authorization Dosing Requirements

Prior authorization approvals will reflect indication-specific dosing regimens. For Crohn's disease and ulcerative colitis initial dosing is weight‑based IV induction followed by SC maintenance; Psoriatic arthritis and psoriasis have specified SC induction and maintenance schedules.

CD/UC initial IV induction dosing: ≤55 kg = 260 mg once; >55 to 85 kg = 390 mg once; >85 kg = 520 mg once.
CD/UC maintenance: 90 mg SC 8 weeks after the IV dose, then 90 mg every 8 weeks (maximum 90 mg every 8 weeks).

Background

Background: Ustekinumab and listed biosimilars are human interleukin‑12/23 antagonists indicated for multiple immune‑mediated diseases including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The policy establishes indication‑specific diagnostic, prescriber, age, prior‑therapy, and dosing requirements to determine medical necessity for ustekinumab products and enumerates covered brands and biosimilars.

Definitions and Abbreviations

6-mercaptopurine (6-MP)

Term6-MP

Definition6-mercaptopurine (abbreviated in appendices)

Use in policyListed as an example immunomodulator alternative in Appendix B

Methotrexate (MTX)

TermMTX

DefinitionMethotrexate (abbreviated in appendices)

Use in policyRequired trial of MTX may be required for PsO initial therapy unless contraindicated

Policy Summary

Payermhn

PolicyUstekinumab (Stelara) and biosimilars — coverage criteria

Policy CodePolicy CP.PHAR.264

Change TypeBiosimilars & coding additionsclinical sequencing and UC severity updates

Effective Date08.16

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating indication-specific criteria, dosing, and preferred biosimilar use or justification for non-preferred product.

SourceLink

On This Page

a: Failure of a ≥ 3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses.

b: Intolerance/contraindication to MTX AND failure of a ≥ 3 consecutive month trial of cyclosporine or acitretin at up to maximally indicated doses unless adverse effects or contraindicated.

c: Intolerance/contraindication to MTX, cyclosporine, and acitretin AND failure of phototherapy unless contraindicated or clinically significant adverse effects are experienced.

PsO Initial: 6. For requests for non-preferred product, member must use all preferred biosimilars (Otulfi, Pyzchiva [branded], Selarsdi/ustekinumab-aekn, Steqeyma, Yesintek) unless clinically significant adverse effects are experienced or all are contraindicated.

PsO Initial: 7. No combination use with bDMARDs or JAK inhibitors.

PsO Initial: 8. Dose does not exceed specified adult or pediatric weight-based regimens per product labeling and Appendix G (see dosing tables).

See Appendix G for dose rounding guidelines

PsA Initial: 6. No combination use with bDMARDs or JAK inhibitors.

Dose limits

a - Adult: Adult: weight-based dosing initially and 4 weeks later, followed by maintenance every 12 weeks — 45 mg per dose or 90 mg per dose if co-existent PsO and weight > 100 kg.
b - Pediatric: Pediatric: weight-based dosing initially and 4 weeks later, followed by maintenance every 12 weeks — options include 0.75 mg/kg (< 60 kg) or 45 mg (≥ 60 kg) or 90 mg if co-existent PsO and weight > 100 kg per product-specific guidance.

UC Initial: 6. For requests for non-preferred product, member must use all preferred biosimilars (Otulfi, Pyzchiva [branded], Selarsdi/ustekinumab-aekn, Steqeyma, Yesintek) unless clinically significant adverse effects are experienced or all are contraindicated.

UC Initial: 7. No combination use with bDMARDs or JAK inhibitors.

UC Initial: 8. Dose does not exceed both initial IV weight‑based induction AND maintenance SC limits: (a) Initial IV induction — weight ≤ 55 kg: 260 mg once; weight > 55 kg to 85 kg: 390 mg once; weight > 85 kg: 520 mg once; AND (b) Maintenance SC — 90 mg given 8 weeks after the initial IV dose, then 90 mg every 8 weeks.Weight thresholds as specified

Approval duration: 12 months

Continued Therapy: 5. No combination use with bDMARDs or JAK inhibitors.

Continued Therapy: 6. If request is for a dose increase, new dose must not exceed indication‑specific maximums (PsO/PsA: weight‑based regimens every 12 weeks per Appendix G; CD/UC: 90 mg every 8 weeks).

Approval duration: 12 months

General: 4. Requests for combination therapy with other bDMARDs or JAK inhibitors are not authorized.

See Section III for diagnoses/indications not authorized.

General: 5. Initial approval durations for chronic conditions have been extended to 12 months; prior authorization may require evidence and dosing consistent with product labeling and policy dosing tables.

Operational updates include newly added biosimilars and HCPCS/Q codes.

520 mg IV (single initial dose)

Modified Mayo Score

Modified Mayo Score threshold>= 5

ContextUsed to document disease activity for Ulcerative Colitis per Appendix F

Policy useAcceptable alternative to Mayo Score or Mayo Endoscopic Score for UC initial criteria

Mayo Endoscopic Score

Mayo Endoscopic Score threshold> 2

ContextOption to define moderate-to-severe UC for initial criteria

Policy noteMay be used in lieu of full Mayo Score or modified Mayo for UC severity documentation

PsO/PsA adult SC: weight-based at weeks 0 and 4, then every 12 weeks — typical adult: ≤100 kg = 45 mg, >100 kg = 90 mg.

Pediatric dosing: per indication (e.g., 0.75 mg/kg for weight <60 kg in certain products); follow Appendix G and product-specific pediatric criteria.

Denial Risk

Documentation, Sequencing, and Coding Risks

Providers must submit supporting documentation and ensure therapy sequencing and prior‑therapy requirements are clearly documented. Requests missing required evidence of prior therapies, disease severity, or appropriate sequencing may be denied.

Required documentation: office chart notes, lab results, endoscopy reports, and other clinical information supporting criteria.
Sequencing risk: lack of documentation that conventional agents, immunomodulators, or required biologics/JAKi were tried and failed (or that clinical justification for bypass exists) can result in denial.
Coding-related denial risk: inclusion or exclusion of codes in the request does not guarantee coverage — inconsistent billing or incomplete coding may lead to claims denial. Providers should reference up-to-date coding guidance prior to claim submission.

Step Therapy

Step Therapy and Therapeutic Alternatives

Step therapy / therapeutic alternative requirements vary by indication. Initial therapy generally requires failure of specified conventional immunomodulators or systemic agents unless medical justification for inability to use them is provided. Bypass of conventional therapies is allowed if the member previously failed a biologic agent for the indication.

Crohn's Disease: failure of ≥3 consecutive months of at least one immunomodulator (e.g., azathioprine, 6‑MP, methotrexate) at maximally indicated doses, unless contraindicated or medically justified.
Psoriasis: failure of ≥3 months of methotrexate (or intolerance/contraindication plus failure of cyclosporine or acitretin; phototherapy allowed if systemic agents contraindicated) before biologic use unless previously failed a biologic agent.
Psoriatic Arthritis: follow specified step requirements per indication and age; conventional therapy failure required unless prior biologic failure documented.

Documentation Required

Immunomodulator Medical Justification

Medical justification for inability to use immunomodulators (supporting bypass of step therapy) must be documented. Appendix E lists acceptable clinical scenarios that may constitute medical justification.

Examples of acceptable justification: inability to induce short‑term symptomatic remission with a 3‑month trial of systemic glucocorticoids; high‑risk disease features (extensive ileal/ileocolonic disease, perianal/severe rectal disease, fistulizing disease, deep ulcerations, penetrating/stricturing phenotype, intestinal obstruction or abscess).
Postoperative recurrence risk factors (e.g., prior resection, ileum and colon location, perianal fistula, diagnosis‑to‑surgery <10 years) may also support immunomodulator avoidance.

Documentation Required

Required Disease Severity Documentation

Required disease severity documentation must accompany requests for UC and other indications where specified. Use validated scoring systems and include component or overall scores per appendices.

For UC initial therapy: document Mayo Score ≥6, modified Mayo Score ≥5, or Mayo Endoscopic Score ≥2 (see Appendix F for score definitions and component interpretation).
Requests lacking endoscopic or clinical scoring to demonstrate moderate‑to‑severe disease may be denied.

Plaque psoriasis (PsO)

TermPsO

DefinitionPlaque psoriasis (abbreviated PsO in appendices)

Severity criteriaModerate-to-severe PsO includes ≥3% BSA or involvement of hands/feet/scalp/face/genital area

Psoriatic arthritis (PsA)

TermPsA

DefinitionPsoriatic arthritis (abbreviated PsA in appendices)

Policy noteRequests for PsA should be prescribed by or in consultation with a dermatologist or rheumatologist

Crohn's disease (CD)

TermCD

DefinitionCrohn's disease (abbreviated CD in appendices)

Dosing noteInitial weight-based IV induction dosing applies for CD per Dosage and Administration

Ulcerative colitis (UC)

TermUC

DefinitionUlcerative colitis (abbreviated UC in appendices)

Severity documentationDisease activity may be documented using Mayo, modified Mayo, or Mayo Endoscopic scores

Methotrexate (duplicate entry)

TermMTX

DefinitionMethotrexate (duplicate entry; abbreviation appears in Appendix A)

Clinical roleUsed as step therapy requirement for PsO when applicable

Janus kinase inhibitors (JAKi)

TermJAKi

DefinitionJanus kinase inhibitors (abbreviated JAKi in appendices)

Policy roleCombination use with ustekinumab is not authorized; JAKi failure may be part of sequencing considerations

Moderate-to-severe UC

DefinitionModerate-to-severe UC may be documented using modified Mayo Score ≥ 5

Alternative definitionOr Mayo Endoscopic Score > 2

Policy actionable thresholdModified Mayo Score ≥ 5 or Mayo Endoscopic Score > 2 can be used to define moderate-to-severe UC for coverage determinations