CurrentColorado Rocky Mountain Health PlansPolicy 2026D0045Z

Ustekinumab (medical benefit products)

Medical benefit drug policy for ustekinumab products (including listed biosimilars) governing medical necessity criteria, preferred vs non-preferred product rules, diagnosis-specific coverage (Crohn's disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis), administration route constraints, and applicable procedure/diagnosis codes for UnitedHealthcare Commercial plans (Policy 2026D0045Z effective Jan 1, 2026).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyUstekinumab (medical benefit products)

Policy CodePolicy 2026D0045Z

Change TypeProduct additions; HCPCS/J-code additions; Preferred product and switching rules added

Effective DateJan 1, 2026

Next Review Date

Key ActionAuthorization required per diagnosis-specific criteria; document diagnosis, prior therapy history (drug, date, duration), positive clinical response for continuation, and prescriber attestation when pediatric/self-administration inability is claimed.

POLICY UPDATE CHANGES

Revised list of applicable ustekinumab products for injection by a healthcare professional; added Imuldosa and Starjemza.

Added HCPCS/J-codes C9399, J3490, J3590, and Q5098 to Applicable Codes.

Updated CMS and References sections to reflect most current information.

4Covered indications listed

4Applicable HCPCS/J/Q codes added

2Not medically necessary indications

Coverage Summary

Policy 2026D0045Z (effective January 1, 2026) covers ustekinumab products under a medical benefit with coverage_with_criteria. Scope: medical-benefit ustekinumab products and listed biosimilars (provider-administered IV/SC formulations); self-administered ustekinumab products are generally pharmacy benefit per member plan. Preferred products are Steqeyma, Wezlana, and Yesintek; non-preferred products (including newly added Imuldosa and Starjemza) may be covered only when Preferred Product Criteria and Diagnosis-Specific Criteria are met and members already on non-preferred products must switch to a preferred product unless meeting exception criteria. Covered (proven/medically necessary) indications include Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis; not medically necessary/unproven indications include ankylosing spondylitis and multiple sclerosis.

Coverage thresholds & preferences

Preferred product trial duration>= 14 weeks of Steqeyma, Wezlana, or Yesintek

Authorization durationAuthorization for continuation or initial authorizations typically no more than 12 months

Administration interval after IV inductionUstekinumab to be administered 8 weeks after the initial intravenous dose

Topical BSA threshold (psoriasis)>= 3% body surface area involvement (or palmoplantar, facial, genital, severe scalp) to meet criteria

Methotrexate trial (psoriasis/psoriatic arthritis)3 month trial of methotrexate at maximally indicated dose required for certain medically necessary pathways

Steqeyma/Wezlana/Yesintek trial requirementAt least 14 weeks trial of preferred products required before non-preferred unless intolerance/contraindication documented

Preferred productsSteqeyma, Wezlana, Yesintek

New products addedImuldosa and Starjemza added to applicable ustekinumab products list (2 new products)

Billing/code additionsHCPCS/J-codes added including C9399, J3490, J3590, Q5098

Preferred Product Criteria & Product-Preference Rules

Prior Authorization

Product-preference and continuation requirements for Imuldosa or Starjemza

Members currently receiving Imuldosa or Starjemza must be transitioned to preferred products (Steqeyma, Wezlana, or Yesintek) to continue coverage unless they meet specified exception criteria. Exceptions are allowed when the member has either: (1) documentation of a trial of at least 14 weeks of a preferred product (Steqeyma, Wezlana, or Yesintek) with minimal clinical response and residual disease activity plus a provider attestation that the requested non-preferred product (Imuldosa or Starjemza) would be expected to produce superior clinical benefit; or (2) documentation of intolerance, contraindication, or adverse event to preferred products plus a provider attestation that the same issue would not be expected with the requested non-preferred product. In all cases the patient must not have had a loss of a favorable response after established maintenance therapy with a preferred or other ustekinumab product.

Billing Rule

Applicable HCPCS/J-code reporting

Diagnosis-Specific Criteria (Initial and Continuation Therapy)

Diagnosis-Specific Criteria: Crohn's Disease (Medically Necessary alternative pathway)

Alternative/medically necessary criteria for Crohn's disease when specified prior therapies failed or other conditions met.

ALL of the following

Diagnosis of moderately to severely active Crohn's disease
One of the following
- Initial therapy with conventional therapy failure or prior targeted immunomodulator
  - One of
    Conventional therapy failure
    History of failure to one of the following conventional therapies at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced: Corticosteroids (e.g., prednisone, methylprednisolone, budesonide); 6-mercaptopurine (Purinethol); Azathioprine (Imuran); Methotrexate (Rheumatrex, Trexall)

Not Medically Necessary / Unproven Indications

Evidence cited in the policy supports exclusion for axial spondyloarthritis/ankylosing spondylitis and multiple sclerosis: three randomized trials in axial SpA did not demonstrate clinically meaningful improvement versus placebo and were discontinued/failed to meet primary endpoints; phase I/II MS trials showed no efficacy signal and larger/longer studies were recommended, supporting the policy position that these indications are unproven and not medically necessary.

Criteria for Imuldosa (ustekinumab-srlf) and Starjemza (ustekinumab-hmny)

Prior Authorization

Product-preference and continuation requirements for Imuldosa or Starjemza

Members on Imuldosa or Starjemza will generally be required to switch to preferred products (Steqeyma, Wezlana, or Yesintek) to continue coverage unless they meet the defined exception criteria (14-week preferred-product trial with minimal response plus clinician attestation, or documented intolerance/contraindication/adverse event with clinician attestation). Coverage for these non-preferred products is contingent on meeting the Preferred Product Criteria and the Diagnosis-Specific Criteria; ensure billing uses the applicable HCPCS/J/Q codes when reporting.

Applicable Codes

HCPCS - Ustekinumab specific J-codes and unclassified codesHCPCS

J3357	Ustekinumab, for subcutaneous injection, 1 mg
J3358	Ustekinumab for intravenous injection, 1 mg
J3490	Unclassified drugs
J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

HCPCS - Q-codes for specific ustekinumab products (biosimilars and brands)HCPCS

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
Q9997	Injection, ustekinumab-ttwe (Pyzchiva), intravenous, 1 mg
Q9998	Injection, ustekinumab-aekn (Selarsdi), 1 mg
Q9999	Injection, ustekinumab-aauz (Otulfi), biosimilar, 1 mg

Applicable HCPCS / J-codes addedHCPCS

C9399	Unclassified drugs or biologicals
J3490	Unclassified drugs
J3590	Unclassified biologics
Q5098	Injection, ustekinumab-srlf (Imuldosa), biosimilar, 1 mg

ICD-10 - Crohn's disease codesICD-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
K50.018	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

1–10 of 28

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ICD-10 - Ulcerative colitis codesICD-10

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
K51.211	Ulcerative (chronic) proctitis with rectal bleeding
K51.212	Ulcerative (chronic) proctitis with intestinal obstruction

1–10 of 42

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ICD-10 - Psoriasis and related codesICD-10

L40.0	Psoriasis vulgaris
L40.1	Generalized pustular psoriasis
L40.2	Acrodermatitis continua
L40.3	Pustulosis palmaris et plantaris
L40.4	Guttate psoriasis
L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis motilins
L40.53	Psoriatic spondylitis
L40.54	Psoriatic juvenile arthropathy

1–10 of 13

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Clinical Evidence & Trial Results

69.4%Pediatric plaque psoriasis PGA 0/1 (Week 12) SD dosing vs placebo 5.4% (p<0.001)

67.6%Pediatric plaque psoriasis PGA 0/1 (Week 12) HSD dosing vs placebo 5.4% (p<0.001)

Key evidence summaries: Cochrane (2019) moderate-certainty evidence indicates ustekinumab is probably effective for maintenance of remission in Crohn's disease. In ulcerative colitis (NEJM induction/maintenance program), IV induction showed clinical remission at Week 8 (~15.5%–15.6% vs placebo 5.3%, p<0.001) and maintenance at Week 44 favored ustekinumab (90 mg SC q12w 38.4%; q8w 43.8% vs placebo 24.0%). For plaque psoriasis (PHOENIX/Griffiths and pediatric trials), ustekinumab produced high PASI75/PASI90 and PGA 0/1 rates (e.g., PASI75 ~67.5%–73.8% vs etanercept 56.8% at week 12; pediatric PGA 0/1 ~67.6%–69.4% vs placebo 5.4%). Axial SpA trials (three RCTs) failed to show clinically meaningful benefit over placebo. Multiple sclerosis studies (phase I and phase II) did not show efficacy signals, supporting lack of benefit; safety in MS requires further study. Guideline recommendations align with these data: AGA recommends ustekinumab among biologic options for moderate–severe UC, and professional society guidance supports ustekinumab use in Crohn's disease and psoriasis with specified positioning relative to other agents.

Background

Background: Ustekinumab is a human IgG1κ monoclonal antibody that binds the shared p40 subunit of interleukin-12 and interleukin-23. The policy distinguishes benefit routing by administration: provider-administered IV or subcutaneous ustekinumab formulations are managed under the medical benefit, whereas self-administered subcutaneous ustekinumab products are generally obtained through the pharmacy benefit per the member's plan. The policy scope covers medical benefit ustekinumab products and biosimilars (including recently added Imuldosa and Starjemza) and specifies preferred versus non-preferred product rules and medical necessity criteria for covered indications.

Definitions

UstekinumabRefers to all ustekinumab products (listed brands and biosimilars) covered under this policy

Targeted immunomodulatorExamples include adalimumab, certolizumab, vedolizumab, mirikizumab, upadacitinib, risankizumab, guselkumab and others listed per indication

Preferred Product CriteriaPolicy section defining preferred ustekinumab products (Steqeyma, Wezlana, Yesintek) and the conditions under which non-preferred products may be covered (trial of preferred products or intolerance/contraindication plus no prior loss of favorable response)

Diagnosis-Specific Criteria

Revision History

2026-01-01added (is_material: true)Latest

Revised list of applicable ustekinumab products for injection by a healthcare professional; added Imuldosa (ustekinumab-srlf) and Starjemza (ustekinumab-hmny).

2026-01-01added (is_material: true)Latest

Added HCPCS/J-codes C9399, J3490, J3590, and Q5098 to Applicable Codes.

2026-01-01revised (is_material: true)

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyUstekinumab (medical benefit products)

Policy CodePolicy 2026D0045Z

Change TypeProduct additions; HCPCS/J-code additions; Preferred product and switching rules added

Effective DateJan 1, 2026

Next Review Date

On This Page

Newly added HCPCS/J-code options for billing these ustekinumab products include C9399, J3490, J3590, and Q5098. Use these codes as appropriate when reporting administration or the specific ustekinumab biosimilar product.

Documentation Required

Clinical attestation required for exceptions

To support exceptions for non-preferred products, providers must supply documentation of the clinical rationale and an attestation. Required documentation includes results of the preferred-product trial or documentation of intolerance/contraindication/adverse event, and a provider attestation that, in their clinical opinion, the requested non-preferred product is clinically warranted (e.g., that superior response is expected or that the prior intolerance would not recur). The policy also requires confirmation that the patient has not had loss of a favorable response after established maintenance therapy where applicable.

Prior targeted immunomodulator

Patient has been previously treated with a targeted immunomodulator FDA-approved for Crohn's disease (examples listed in policy)

Ustekinumab is to be administered as a single intravenous induction dose

Ustekinumab induction dosing is in accordance with the US FDA labeled dosing for Crohn's disease

Patient is not receiving ustekinumab in combination with a targeted immunomodulator (examples listed in policy)

Prescribed by or in consultation with a gastroenterologist

Continuation of therapy

Documentation of positive clinical response
Pediatric/self-administration attestation
- Patient is under the age of 18 years old
- Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer ustekinumab FDA labeled for self-administration; prescriber must submit explanation
Ustekinumab is to be administered 8 weeks after the initial intravenous dose
Ustekinumab continuation dosing is in accordance with the US FDA labeled dosing for Crohn's disease
Patient is not receiving ustekinumab in combination with a targeted immunomodulator (examples listed in policy)

Diagnosis-Specific Criteria: Plaque Psoriasis (Medically Necessary pathway)

Alternate medically necessary criteria for initial therapy in plaque psoriasis.

ALL of the following

Diagnosis of moderate to severe plaque psoriasis
One of the following
- Topical + methotrexate failure path
  - Greater than or equal to 3% body surface area involvement, palmoplantar, facial, genital involvement, or severe scalp psoriasis
  - History of failure to one of the following topical therapies, unless contraindicated or clinically significant adverse effects are experienced: Corticosteroids; Vitamin D analogs; Tazarotene; Calcineurin inhibitors; Anthralin; Coal tar
  - History of failure to a 3 month trial of methotrexate at the maximally indicated dose, unless contraindicated or clinically significant adverse effects are experienced
- Patient has been previously treated with a targeted immunomodulator FDA-approved for plaque psoriasis
- Patient is currently on ustekinumab
Pediatric/self-administration attestation
- Patient is under the age of 18 years old
- Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer ustekinumab FDA labeled for self-administration; prescriber must submit explanation
Ustekinumab is initiated and titrated according to US FDA labeled dosing for plaque psoriasis
Patient is not receiving ustekinumab in combination with a targeted immunomodulator (examples listed in policy)
Prescribed by or in consultation with a dermatologist
Initial authorization is for no more than 12 months
Continuation
- Documentation of positive clinical response
- Pediatric/self-administration attestation
  - Patient is under the age of 18 years old
  - Prescriber attestation that the patient or caregiver are not able to be trained or are physically unable to administer ustekinumab FDA labeled for self-administration; prescriber must submit explanation
- Ustekinumab is initiated and titrated according to US FDA labeled dosing for plaque psoriasis
- Patient is not receiving ustekinumab in combination with a targeted immunomodulator (examples listed in policy)

Prior Authorization

Prior authorization required with documentation

Prior authorization is required. Initial induction authorizations are generally limited to a single IV induction dose; continuation authorizations may be approved for up to 12 months. Documentation required with authorization requests includes the diagnosis, prior therapy history (drug name, dates, duration), evidence of positive clinical response for continuation, and prescriber attestation when pediatric patients or inability to self-administer is claimed.

Billing Rule

Induction authorization is single IV dose

When an induction dose is authorized as a single intravenous administration, report the IV induction with J3358 (ustekinumab for intravenous injection, 1 mg) as indicated for the single IV induction authorization.

Documentation Required

Prescriber attestation for pediatric/self-administration

For pediatric patients or when a patient or caregiver cannot be trained or is physically unable to self-administer FDA-labeled ustekinumab, the prescriber must submit an attestation explaining the inability to self-administer. This attestation should accompany supporting documentation and is required for medical-benefit administered dosing in lieu of self-administration.

Documentation Required

Prior therapy documentation for biologic/immunomodulator history

Acceptable evidence of prior biologic or immunomodulator therapy includes claims history or submission of medical records. Documentation should specify the drug, dates, and duration of therapy to show prior exposure or failure as required by the diagnosis-specific criteria.

Policy section that lists clinical criteria for coverage by diagnosis (e.g., Crohn's disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis) including induction/continuation requirements

Added language that coverage for Imuldosa or Starjemza will be provided contingent on Preferred Product Criteria and Diagnosis-Specific Criteria and required switching rules for members already on these products (members must change to preferred products Steqeyma, Wezlana, or Yesintek unless meeting exception criteria).

2026-01-01updated (is_material: false)Latest

Updated CMS and References sections to reflect most current information.

Authorization is for no more than 12 months