Viva Health ustekinumab Coverage & Prior Auth

Coverage Criteria

Universal Initial Criteria

Covered when ALL of the following universal and initial criteria are met:

Universal initial requirements: Patient has a documented contraindication, intolerance, or prior failure to listed ustekinumab products (Selarsdi™, Stelara®, Ustekinumab §, Yesintek™); AND patient meets age requirement (18 years unless otherwise specified for the indication); AND provider confirms patient is up to date with age-appropriate vaccinations prior to initiating therapy; AND patient has been screened for latent tuberculosis and will receive ongoing monitoring; AND patient does not have an active infection and will not receive live vaccines during therapy; AND patient is not on concurrent biologic or targeted synthetic therapy.

Plaque Psoriasis Initial Therapy

Plaque Psoriasis — Covered when ALL of the following are met:

Age and disease severity: Member is at least 6 years of age; AND physician-assessed baseline disease severity using an objective measure; AND documented moderate to severe plaque psoriasis for ≥6 months with one of: BSA ≥3% OR PASI ≥10 OR incapacitating/serious emotional consequences due to plaque location or intractable pruritus.

Prior therapy trials: Member did not respond to or is not a candidate for: a minimum 4-week trial of topical agents; AND a minimum 3-month trial of at least one non-biologic systemic agent; AND a minimum 3-month trial of phototherapy (PUVA or UVB), unless exempt. Note: members already established on biologic/targeted therapy or with >10% BSA are exempt from these step requirements.

Adult Psoriatic Arthritis Initial Therapy

Adult Psoriatic Arthritis — Covered when ALL of the following are met:

Baseline assessment: Physician has assessed baseline disease severity using an objective measure and documented moderate to severe active disease.

Prior therapy requirements by phenotype: For predominantly axial disease or enthesitis: failure of at least a 4-week trial of one NSAID unless contraindicated; OR for peripheral arthritis or dactylitis: failure of at least a 3-month trial of one conventional synthetic DMARD (e.g., methotrexate, azathioprine, sulfasalazine, leflunomide, hydroxychloroquine); OR patient is already established on biologic or targeted synthetic therapy for PsA.

Juvenile Psoriatic Arthritis Initial Therapy

Juvenile Psoriatic Arthritis — Covered when ALL of the following are met:

Age and assessment: Member is at least 6 years of age; AND physician-assessed baseline disease severity using an objective measure; AND documented moderate to severe active polyarticular disease.

Prior therapy: Member has had at least a 1-month trial and failure of either an oral NSAID OR a conventional synthetic DMARD (e.g., methotrexate, leflunomide, sulfasalazine) unless contraindicated or intolerant; OR member is already established on biologic or targeted synthetic therapy. May be used as single agent or in combination with methotrexate.

Crohn's Disease Initial Therapy

Crohn's Disease (Adult and Pediatric) — Covered when ALL of the following are met:

Assessment and severity: Physician-assessed baseline disease severity using an objective measure and documented moderate to severe active disease.

Prior therapy requirements: Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6‑mercaptopurine, methotrexate) OR a minimum 3-month trial of a TNF inhibitor (e.g., adalimumab, certolizumab, infliximab); OR evidence of high-risk disease for which these agents are inadequate and biologic therapy is necessary; OR patient is already established on biologic or targeted synthetic therapy. Note: three months of corticosteroids are not required if early non-response is confirmed. For adults, IV induction dosing per weight bands is required prior to SC maintenance (see dosing criteria).

Ulcerative Colitis Initial Therapy

Ulcerative Colitis — Covered when ALL of the following are met:

Assessment and severity: Physician-assessed baseline disease severity using an objective measure and documented moderate to severe active disease.

Prior therapy requirements: Documented failure or ineffective response to a minimum 3-month trial of conventional therapy (aminosalicylates, corticosteroids, or immunomodulators) at maximum tolerated doses OR a minimum 3-month trial of a TNF inhibitor (e.g., adalimumab, golimumab, infliximab); OR patient is already established on biologic or targeted synthetic therapy. Note: three months of corticosteroids are not required if early non-response is confirmed. For adults, IV induction dosing per weight bands is required prior to SC maintenance (see dosing criteria).

ICI-Related Toxicities

Management of Immune Checkpoint Inhibitor-Related Toxicities — Covered when ALL of the following are met:

Prior therapy and condition: Member has been receiving an immune checkpoint inhibitor; AND has diarrhea or colitis refractory to infliximab and/or vedolizumab; AND either has mild (G1) persistent or progressive symptoms with positive lactoferrin/calprotectin OR has moderate (G2) to severe (G3‑G4) diarrhea or colitis. Prior authorization initial validity is for a one-time IV induction dose with up to three SC maintenance doses as specified in authorization rules.

Supportive therapy for LAD-I

Supportive therapy with marnetegragene autotemcel — Covered when ALL of the following are met:

Supportive use for LAD-I: Member is scheduled to receive marnetegragene autotemcel for severe leukocyte adhesion deficiency‑I (LAD‑I); AND therapy is intended to prevent a hyperinflammatory bone marrow microenvironment. Coverage is limited to a total of 3 subcutaneous 90 mg doses per the prior authorization rules and initial prior authorization validity as specified for supportive therapy.

Dosing and escalation (by indication)

Covered when the following dosing/administration and response criteria are met for respective indications (select per indication):

Plaque psoriasis (adult) dosing: Loading: ≤100 kg: 45 mg at weeks 0 & 4; >100 kg: 90 mg at weeks 0 & 4. Maintenance: ≤100 kg: 45 mg every 12 weeks; >100 kg: 90 mg every 12 weeks.

Plaque psoriasis (pediatric) dosing (products listed): Pediatric loading and maintenance weight-based dosing applies to listed products only: <60 kg: 0.75 mg/kg at weeks 0 & 4 then q12w; 60–100 kg: 45 mg at weeks 0 & 4 then q12w; >100 kg: 90 mg at weeks 0 & 4 then q12w.

Psoriatic arthritis dosing: Adult: 45 mg at weeks 0 & 4 then 45 mg every 12 weeks; if coexisting moderate‑severe plaque psoriasis and >100 kg: 90 mg loading and 90 mg maintenance. Pediatric dosing per weight bands as specified for listed products.

Crohn's disease dosing: Adult IV weight‑based induction (one‑time): ≤55 kg: 260 mg; >55–85 kg: 390 mg; >85 kg: 520 mg. Maintenance: 90 mg SC given 8 weeks after the initial IV dose then every 8 weeks thereafter. Pediatric IV induction and SC maintenance dosing specified by weight bands.

Phototherapy (PUVA or UVB) may be clinically inappropriate for some members. Examples of contraindications to phototherapy include: xeroderma pigmentosum, other rare photosensitive genodermatoses (e.g., trichothiodystrophy, Cockayne syndrome, Bloom syndrome, Rothmund‑Thomson syndrome for UVB), pregnancy or lactation (PUVA only), genetic disorders associated with increased skin cancer risk (e.g., Gorlin syndrome, oculocutaneous albinism for UVB), lupus erythematosus, a history of photosensitivity disorders or prior melanoma/non‑melanoma skin cancer, immunosuppression after organ transplant (UVB only), use of photosensitizing medications (PUVA only), or severe hepatic, renal, or cardiac disease (PUVA only). Anatomical locations such as face, genitalia, scalp, or nails may be considered ineligible for phototherapy. Members without access to phototherapy will be reviewed on a case‑by‑case basis.

For dose escalation scenarios, the policy requires that members who do not regain clinical response after escalation to a 4‑week subcutaneous interval should discontinue therapy. Prior authorization for escalation is time‑limited and contingent on demonstration of clinical improvement and ustekinumab levels (if available).

The policy documents an NQTL (Non‑Quantitative Treatment Limitation) assessment and checklist describing utilization management methods (e.g., prior authorization) used to limit benefit duration or extent. The NQTL checklist summarizes factors considered (indication, safety/efficacy, potential for misuse, cost) and supports applying prior authorization comparably across benefit categories.

Medicare Part B coverage rules may differ from this non‑Medicare guidance. Where applicable, providers and claims must comply with CMS policy (Medicare Benefit Policy Manual Chapter 15 §50) and any relevant National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs), which can supersede the plan’s non‑Medicare criteria.

Dose escalation is permitted only within the limits specified by the policy. Specifically, escalation must not exceed 90 mg subcutaneously every 4 weeks; escalation beyond this maximum is not allowed.

Not stated in this portion of the document.

Coding and Diagnosis Codes

Primary HCPCS / J-codesHCPCSCovered

J3357	Ustekinumab, for subcutaneous injection, 1 mg; 1 billable unit = 1 mg (Stelara SQ Only; Includes unbranded biologic)
J3358	Ustekinumab, for intravenous injection, 1 mg; 1 billable unit = 1 mg (Stelara IV Only; Includes unbranded biologic)
J3590	Unclassified biologics (Discontinue use on 07/01/2026)
C9399	Unclassified drugs or biologicals (Discontinue use on 07/01/2026)

Q-code biosimilar / product-specific codesHCPCSCovered

Q5137	Injection, ustekinumab-auub (wezlana), biosimilar, subcutaneous, 1 mg; 1 billable unit = 1 mg
Q5138	Injection, ustekinumab-auub (wezlana), biosimilar, intravenous, 1 mg; 1 billable unit = 1 mg
Q9996	Injection, ustekinumab-ttwe (pyzchiva), subcutaneous, 1 mg; 1 billable unit = 1 mg
Q9997	Injection, ustekinumab-ttwe (pyzchiva), intravenous, 1 mg; 1 billable unit = 1 mg
Q9998	Injection, ustekinumab-aekn (selarsdi), biosimilar, 1 mg; 1 billable unit = 1 mg
Q9999	Injection, ustekinumab-aauz (otulfi), biosimilar, 1 mg; 1 billable unit = 1 mg
Q5098	Injection, ustekinumab-srlf (imuldosa), biosimilar, 1 mg; 1 billable unit = 1 mg
Q5100	Injection, ustekinumab-kfce (yesintek), biosimilar, 1 mg; 1 billable unit = 1 mg
Q5099	Injection, ustekinumab-stba (steqeyma), biosimilar, 1 mg; 1 billable unit = 1 mg
Q5164	Injection, ustekinumab-hmny (starjemza), biosimilar, 1 mg; 1 billable unit = 1 mg (Effective 07/01/2026)

Billing modifiers notemixed

JA / JB

When product-level Q-code does not specify route, bill with JA modifier for IV infusion or JB modifier for subcutaneous injection as appropriate.

Subcutaneous NDCs by product and presentationNDCCovered

57894-0060-xx	Stelara 45 mg/0.5 mL prefilled syringe (also listed as single-dose vial)
57894-0061-xx	Stelara 90 mg/mL prefilled syringe
84612-0076-xx	Wezlana 45 mg/0.5 mL prefilled syringe
84612-0876-xx	Wezlana 45 mg/0.5 mL prefilled syringe (alternate)
84612-0089-xx	Wezlana 90 mg/mL prefilled syringe
84612-0889-xx	Wezlana 90 mg/mL prefilled syringe (alternate)
84612-0055-xx	Wezlana 45 mg/0.5 mL single-dose vial
83257-0023-xx	Yesintek 45 mg/0.5 mL prefilled syringe
83257-0025-xx	Yesintek 90 mg/mL prefilled syringe
83257-0024-xx	Yesintek 45 mg/0.5 mL single-dose vial

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Intravenous NDCs by productNDCCovered

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 single-dose vial
72606-0029-xx	Steqeyma 130 mg/26 mL single-dose vial
61314-0654-xx	Pyzchiva 130 mg/26 mL single-dose vial
65219-0828-xx	Otulfi 130 mg/26 mL single-dose vial
69448-0019-xx	Imuldosa 130 mg/26 mL single-dose vial (also 51407-0931-xx)
51759-0708-xx	Selarsdi 130 mg/26 mL single-dose vial (also 51759-0711-xx)
00143-9171-xx	Starjemza 130 mg/26 mL single-dose vial
57894-0444-xx	Ustekinumab 130 mg/26 mL single-dose vial (unbranded Stelara)

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ICD-10 codes — Crohn's disease (partial list)ICD-10Covered

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
K50.018	Crohn's disease of small intestine with other complication
K50.019	Crohn's disease of small intestine with unspecified complications
K50.10	Crohn's disease of large intestine without complications
K50.111	Crohn's disease of large intestine with rectal bleeding
K50.112	Crohn's disease of large intestine with intestinal obstruction

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ICD-10 codes — Ulcerative colitis and relatedICD-10Covered

K51.00	Ulcerative (chronic) pancolitis without complications
K51.011	Ulcerative (chronic) pancolitis with rectal bleeding
K51.012	Ulcerative (chronic) pancolitis with intestinal obstruction
K51.013	Ulcerative (chronic) pancolitis with fistula
K51.014	Ulcerative (chronic) pancolitis with abscess
K51.018	Ulcerative (chronic) pancolitis with other complication
K51.019	Ulcerative (chronic) pancolitis with unspecified complications
K51.20	Ulcerative (chronic) proctitis without complications

ICD-10 codes — Psoriasis, Juvenile arthritis, symptomsICD-10Covered

L40.0	Psoriasis vulgaris
L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis
L40.59	Other psoriatic arthropathy
M08.80	Other juvenile arthritis, unspecified site
R19.7	Diarrhea, unspecified

ICD-10 codes — Symptom or supportive codesICD-10Covered

D71.1

Leukocyte adhesion deficiency

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization for Dosing and Escalation

Prior authorization is required for initial dosing and for requests to escalate dose or shorten dosing interval; typical initial approval is 6 months (180 days) unless otherwise specified (see exceptions for Crohn's disease and ulcerative colitis, immune checkpoint inhibitor–related toxicities, and supportive therapy with marnetegragene autotemcel). Dose-escalation requests for Crohn's disease/ulcerative colitis will be reviewed case-by-case and, when approved, PA validity is provided for 3 months with continued renewal contingent on demonstration of clinical improvement and, if available, ustekinumab trough levels.

Initial prior authorization validity: 6 months (180 days) unless specified otherwise.
Crohn's disease & ulcerative colitis dose-escalation PA validity: 3 months (90 days) with continued renewal every 12 months upon meeting continuation criteria.
Dose-escalation requests prior to week 16 are evaluated case-by-case.

Prior Authorization

Prior Authorization May Be Required

Prior authorization may be required based on utilization management and non-quantitative treatment limitation (NQTL) factors such as drug cost and plan-designed review methods. PA consideration applies to subcutaneous and intravenous administrations where clinically appropriate.

Background

Ustekinumab is an interleukin‑12/23 inhibitor available as intravenous and subcutaneous formulations and is indicated for multiple inflammatory conditions including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Intravenous weight‑based induction dosing is used for Crohn’s disease and ulcerative colitis with subsequent subcutaneous maintenance; subcutaneous fixed dosing (e.g., 45 mg or 90 mg) is used for psoriasis and psoriatic arthritis per weight and indication. Baseline assessment and appropriate screening (including TB screening and vaccination review) are required prior to initiation.

Definitions and Terms

Contraindications to phototherapy — list of conditions that make phototherapy inappropriate

Xeroderma pigmentosumAbsolute contraindication to PUVA/UVB phototherapy

Pregnancy or lactation (PUVA only)PUVA contraindicated during pregnancy or lactation

History of melanoma or photosensitivity diseasesPrior melanoma, chronic actinic dermatitis, solar urticaria or non‑melanoma skin cancer contraindicate phototherapy

Severe organ dysfunction or immunosuppressionSevere liver, renal, or cardiac disease (PUVA) and organ transplant immunosuppression (UVB) are contraindications

Photosensitizing medications and genetic cancer‑risk disordersPhotosensitizing drugs (PUVA) and genetic disorders increasing skin cancer risk (e.g., Gorlin syndrome, oculocutaneous albinism) are contraindications

Dosing Limits and Initial Therapy

Dosing and initial therapy rules:

Dosing limits summary: Plaque Psoriasis: SC loading and maintenance per weight (see dosing): typical max units 90 mg loading and 90 mg maintenance q12w; Psoriatic Arthritis: 45 mg loading and 45 mg q12w (90 mg if indicated by weight/psoriasis severity). Crohn's Disease & Ulcerative Colitis: IV one‑time induction (weight‑based up to 520 mg) then SC maintenance 90 mg at 8 weeks and every 8 weeks thereafter. Immune checkpoint‑related toxicity: IV 520 mg x1 then up to three 90 mg SC maintenance doses. Supportive therapy with marnetegragene autotemcel: up to three 90 mg SC doses total.

Initial therapy dosing

Initial therapy dosing — IV induction required for Crohn's disease/UC with SC maintenance; other dosing varies by indication and weight:

Initial IV induction for CD/UC (adult): IV one‑time induction by weight bands: ≤55 kg: 260 mg; >55–85 kg: 390 mg; >85 kg: 520 mg.

Renewal and Continuation Criteria

Renewal Criteria

Renewal/continuation requirements:

Renewal criteria: Member must continue to meet the universal and indication‑specific criteria; duration of prior authorization has not been exceeded; AND there is absence of unacceptable toxicity (examples: serious infections, malignancy, severe hypersensitivity, PRES/RPLS, non‑infectious pneumonia).

Continuation criteria

Continuation depends on maintained response and trough levels where applicable:

Continuation after escalation: Prior authorization validity for dose escalation is provided for 3 months with continued approval contingent on demonstration of clinical improvement and ustekinumab trough levels (if available). Members who are responding may continue current dosing; those who do not regain response at a 4‑week escalated interval should discontinue therapy.

Step Therapy Requirements

Indication	Required prior therapies / trial	Notes
Plaque psoriasis (≥6 years)	Documented inadequate response, intolerance, or contraindication to: 1) ≥4‑week trial of topical agents; AND 2) ≥3‑month trial of at least one non‑biologic systemic agent; AND 3) ≥3‑month trial of phototherapy (PUVA or UVB), unless exempt (e.g., already established on biologic/targeted therapy or >10% BSA)	Physician‑assessed moderate‑to‑severe disease for ≥6 months with BSA ≥3% OR PASI ≥10 OR disabling location; exemptions noted for members already on biologic/targeted therapy or >10% BSA
Adult Crohn's disease	Documented failure, contraindication, or inadequate response to: a minimum 3‑month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6‑mercaptopurine, methotrexate) OR a minimum 3‑month trial of a TNF modifier (e.g., adalimumab, certolizumab, infliximab); OR high‑risk disease requiring biologic; OR already established on biologic/targeted therapy	Three months of corticosteroids not required if early non‑response is confirmed; baseline objective severity assessment required
Ulcerative colitis	Documented failure or ineffective response to: a minimum 3‑month trial of conventional therapy (aminosalicylates, corticosteroids, or immunomodulators) OR a minimum 3‑month trial of a TNF modifier (e.g., adalimumab, golimumab, infliximab); OR already established on biologic/targeted therapy	Three months of corticosteroids not required if early non‑response is confirmed; baseline objective severity assessment required

Requirement	Details	Prior auth / escalation notes
IV induction required before escalation (CD/UC and certain indications)	Member must receive the initial intravenous loading dose as specified for the indication (weight‑based IV induction for Crohn's/UC) and at least one subsequent subcutaneous maintenance dose	Dose escalation allowed only after documented initial response and subsequent loss of response by week 16; prior authorization for escalation is time‑limited and contingent on clinical improvement and trough levels if available
Minimum SC maintenance exposure before escalation	At least one subcutaneous maintenance dose administered following the IV induction (i.e., 90 mg SC given 8 weeks after IV induction for CD/UC) is required prior to consideration of escalation	Requests for escalation prior to week 16 will be evaluated case‑by‑case considering clinical picture (severity, hypoalbuminemia, prior TNF‑I failure, perianal disease) and ustekinumab trough if available
Escalation limits	Maximum permitted escalation: 90 mg subcutaneously every 4 weeks (members may benefit from smaller interval reductions in select cases)	Prior authorization validity for escalation is provided for 3 months with continued approval contingent on demonstration of clinical improvement and ustekinumab levels (if available); members who do not regain response at a 4‑week interval should discontinue therapy

Quantity Limits

ustekinumab — 90 or 520 billable units per specified dose schedule

Subcutaneous maintenance/typical dose90 billable units = 90 mg for maintenance or per‑dose subcutaneous administration

Intravenous induction dose520 billable units = 520 mg single IV induction dose (used for CD/UC and certain ICI‑toxicity protocols)

Billing unit mappingHCPCS billing units correspond to mg (1 billable unit = 1 mg) — typical billable units used: 90 or 520

Site of Care and Product Availability

Billing Rule

Use IV (infusion center) and SC (office/home) product codes and NDCs per policy

IV formulations are billed for clinic/infusion center administration (130 mg single‑dose vials available); SC formulations are available for office or home administration — see NDC/Q‑code listings for product and vial/syringe details.

IV vial product examples and NDCs are listed in the policy for infusion‑center billing.
SC product NDCs for prefilled syringes and vials are listed for office or home use.

Billing Rule

Bill SC administrations using the listed NDCs for outpatient/home use

Subcutaneous formulations (prefilled syringes/vials) may be used for outpatient, office, or self‑administration; include the listed NDC(s) for the product supplied when billing.

Supply the appropriate SC NDC (product and strength) as listed in the policy when submitting claims.

Biosimilar and Unbranded Product Guidance

Billing Rule

Bill using J‑ or Q‑codes listed for Stelara and biosimilars

Stelara (ustekinumab) and listed biosimilars/unbranded alternatives are assigned specific HCPCS and Q‑codes (e.g., J3357, J3358 and multiple Q‑codes); use the appropriate J‑ or Q‑code per route/brand as specified in the policy when billing.

J3357 for subcutaneous ustekinumab (1 mg/unit) and J3358 for intravenous ustekinumab (1 mg/unit).
Multiple Q‑codes for biosimilar/unbranded products are provided; select the correct code per product.

Billing Rule

Confirm specific Q‑code/NDC pairings for billing of Stelara and biosimilars

Additional listing of Stelara and biosimilar Q‑codes/NDCs is provided in the policy appendix; confirm the correct code (Q‑code or J‑code) and NDC for billing per the product dispensed.

Refer to the policy’s billing section for the full list of Q‑codes and associated product NDCs when preparing claims.

OpenPayer

Ustekinumab (IV/SC) — Coverage Criteria

Coverage Criteria

Coding and Diagnosis Codes

Provider Actions and Prior Authorization

Background

Definitions and Terms

Dosing Limits and Initial Therapy

Renewal and Continuation Criteria

Step Therapy Requirements

Quantity Limits

Site of Care and Product Availability

Biosimilar and Unbranded Product Guidance