Modifiedculinary health fundPolicy N/A

Ustekinumab subcutaneous prior authorization for inflammatory conditions

This policy governs prior authorization requirements and coverage criteria for ustekinumab subcutaneous products for inflammatory conditions (Crohn's disease, plaque psoriasis, psoriatic arthritis, ulcerative colitis) for members of Culinary Health Fund.

Policy Summary

Payerculinary health fund

PolicyUstekinumab subcutaneous prior authorization for inflammatory conditions

Policy CodePolicy N/A

Change TypeMultiple product additions and material criteria revisions

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and ensure specialist prescribing/consultation with documentation of required IV induction timing and prior therapy trials per indication.

SourceLink

POLICY UPDATE CHANGES

Multiple unbranded and branded ustekinumab subcutaneous products (including several biosimilars) were added to the policy.

Age requirements were added for initial approvals for Crohn's disease (>=18), psoriatic arthritis (>=6), and ulcerative colitis (>=18).

Plaque psoriasis initial-therapy exceptions updated to include prior intolerance or trial of apremilast (Otezla/Otezla XR) or deucravacitinib (Sotyktu) as alternatives to traditional systemic agent trial.

For ulcerative colitis initial therapy, specific options of approval (e.g., trial of one systemic therapy; pouchitis-related criteria) were removed.

For Crohn's Disease initial therapy, approval options requiring prior systemic corticosteroid use, one conventional systemic therapy plus note, enterocutaneous or rectovaginal fistulas, or ileocolonic resection were removed.

Starjemza subcutaneous injection was added to the policy; the same criteria apply as the other ustekinumab subcutaneous products.

Ustekinumab-aauz subcutaneous injection was added to the policy; the same criteria apply as the other ustekinumab subcutaneous products.

Review dates noted/updated: 11/05/2025 and 02/11/2026.

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Coverage and Indication Criteria

inv-01: Indication-specific authorization criteria — Crohn's Disease (Initial Therapy)

Covered when ALL of the following Crohn's Disease initial therapy criteria are met:

ALL of the following

Patient is > 18 years of age.
According to the prescriber, the patient will receive a single induction dose with ustekinumab intravenous within 2 months of initiating therapy with ustekinumab subcutaneous.
The medication is prescribed by or in consultation with a gastroenterologist.

inv-21: Initial therapy — indication-specific initial therapy criteria and authorization durations

Initial therapy — authorization duration and removed options note: Approve for 6 months when initial therapy criteria are met. Historical options related to prior trials and surgical or fistula conditions have been removed from initial therapy criteria.

ALL of the following

Approve for 6 months when the patient meets ALL initial therapy criteria (age > 18 years; planned IV induction within 2 months; prescribed by or in consultation with a gastroenterologist).
If patient has received < 6 months of therapy or is restarting therapy, review under Initial Therapy criteria (not continuation).
Note: Options removed from initial therapy criteria — the following are no longer required or considered as separate approval options: prior or current systemic corticosteroid use or corticosteroid contraindication; trial of one conventional systemic therapy for Crohn's disease (and its associated note); presence of enterocutaneous (perianal or abdominal) or rectovaginal fistulas; history of ileocolonic resection.

inv-22: Crohn's Disease initial therapy changes

Crohn's Disease — continuation/established therapy criteria (reference to initial therapy for patients with <6 months or restarting therapy):

ALL of the following

Patient is currently receiving ustekinumab subcutaneous and has been established on the requested drug for at least 6 months.
Approve for 1 year if the patient meets at least ONE of the following: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal markers such as fecal lactoferrin or fecal calprotectin; serum markers such as C-reactive protein; imaging studies such as MRE or CT enterography; endoscopic assessment; and/or reduced dose of corticosteroids). (b) Compared with baseline prior to initiating the requested drug, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool).

CONDITIONS NOT RECOMMENDED FOR APPROVAL: Coverage of ustekinumab subcutaneous is not recommended for Ankylosing Spondylitis (AS) due to limited efficacy data. Concurrent use with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition is not recommended; this does not exclude use of conventional synthetic disease-modifying antirheumatic drugs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) in combination. Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria; criteria will be updated as new published data are available.

HISTORY: Revision summary notes that certain ustekinumab subcutaneous products were added to the policy and that for Crohn's Disease initial therapy, specific approval option requirements were removed (see Initial Therapy changes above). Selected Revision, Review Date = 02/11/2026.

Use in combination with another biologic or targeted synthetic oral small molecule drug for an inflammatory condition is considered not recommended due to potential for higher adverse events and lack of supportive controlled data.

No explicit 'not medically necessary' statements are present in the provided excerpts; see Conditions Not Recommended for Approval for coverage exclusions and rationale.

Initial Therapy Authorization Requirements

Initial therapy

Indication-specific initial therapy criteria and authorization durations

Crohn's initial: Patient >18 years of age; according to the prescriber, the patient will receive a single induction dose with ustekinumab intravenous within 2 months of initiating ustekinumab subcutaneous; and medication is prescribed by or in consultation with a gastroenterologist

Approve for 6 months

Psoriasis initial: Patient ≥6 years of age; patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant OR prescriber documents a contraindication to methotrexate; and medication is prescribed by or in consultation with a dermatologist

Approve for 3 months; exception: 3-month trial or intolerance to a prior biologic (other than requested), apremilast, or deucravacitinib may substitute

PsA initial: Patient >6 years of age; medication is prescribed by or in consultation with a rheumatologist or dermatologist

Criteria for Members Currently Receiving Therapy

Currently receiving therapy

Criteria for patients currently receiving ustekinumab subcutaneous

Continuation general: Patient has been established on the requested drug for the specified prior duration (at least 6 months for Crohn's disease and ulcerative colitis; at least 3 months for plaque psoriasis; at least 6 months for psoriatic arthritis) AND patient has demonstrated clinical benefit defined as either improvement by at least one objective measure (examples vary by condition) OR improvement in symptoms compared with baselineestablished ≥3 or ≥6 months depending on indication

Approve for 1 year

Prescriber Requirements and Provider-Facing Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for ustekinumab subcutaneous products, including newly added products Starjemza and ustekinumab-aauz. Initial approvals require the medication to be prescribed by or in consultation with a specialist who manages the treated condition. All approvals are provided for the durations specified in the policy (months counted as 30 days).

Applies to all ustekinumab SC products (including Starjemza and ustekinumab-aauz).
Initial approvals: prescriber must be the specialist or consult with one.
Approval durations follow policy table (1 month = 30 days).

Note

Dosing / Induction Expectations

Weight-based dosing and induction expectations vary by indication. For Crohn's disease and ulcerative colitis, an initial IV induction dose is required with SC maintenance starting 8 weeks after the IV dose (maintenance: 90 mg SC every 8 weeks). For plaque psoriasis and psoriatic arthritis, dosing is weight-based with induction at Week 0 and Week 4, then maintenance every 12 weeks; pediatric dosing tiers are specified by weight.

Step Therapy and Prior Treatment Requirements

Step	Requirement	Duration / notes
1
Trial of at least one traditional systemic agent for ≥3 months unless the patient is intolerant or meets an exception (prior trial of a biologic other than the requested agent, a 3‑month trial or intolerance to apremilast [Otezla/Otezla XR], or a 3‑month trial or intolerance to deucravacitinib [Sotyktu]). A biosimilar of the requested biologic does not count.
Approve for 3 months for plaque psoriasis initial therapy when criteria met. Examples of traditional systemic agents include methotrexate, cyclosporine, acitretin, or PUVA (3‑month trial).

Step	Requirement	Notes
0
Specific step therapy sequencing and additional step requirements are not detailed in the available excerpt; policy revisions removed several Crohn's disease initial‑therapy approval options (prior systemic corticosteroid use or contraindication; trial of one conventional systemic therapy with associated note; presence of enterocutaneous or rectovaginal fistulas; history of ileocolonic resection).
Removal of those initial‑therapy options implies the step/sequence criteria for Crohn's disease were revised; refer to full policy for the retained/updated Crohn's disease initial‑therapy requirements.

Dosing Thresholds and Codes

Weight-based dosing thresholds

Adult plaque psoriasis weight thresholdAdults ≤100 kg: 45 mg SC; Adults >100 kg: 90 mg SC

Pediatric plaque psoriasis cutoffsPediatrics ≥6 years: <60 kg = 0.75 mg/kg SC; 60–100 kg = 45 mg SC; >100 kg = 90 mg SC

Psoriatic arthritis weight-based ruleAdults >100 kg with co‑existent moderate–severe plaque psoriasis: 90 mg SC; all other adults: 45 mg SC

Maintenance dosing context for GI indicationsFor Crohn's disease and ulcerative colitis maintenance SC dosing is 90 mg Q8W, following IV induction

Administration Setting

Billing Rule

Site of care: SC dosing may be given at home or under physician supervision

Per site-of-care guidance, dosing may be administered under physician supervision or by the patient/caregiver at home; subcutaneous dosing is weight-based per the product labeling.

Policy dosing section: SC injection under supervision of a physician or by patient/caregiver.
Weight-based dosing schedules and pediatric cutoffs are specified in the dosing section.

Branded and Biosimilar Product Guidance

Billing Rule

Same PA criteria apply to Stelara and listed biosimilars/brands

All branded and biosimilar ustekinumab subcutaneous products listed in the policy (including Stelara and the various biosimilars/brands added) are subject to the same prior authorization criteria.

Policy history and product list show multiple branded and biosimilar ustekinumab SC products were added with the statement that the same criteria apply.
Examples include Stelara, Starjemza, ustekinumab-aauz, and others named in the policy.

Definitions and Administration Notes

IV induction dose (Crohn's disease & ulcerative colitis)

Timing expectationPolicy expects the IV induction to occur within 2 months of initiating subcutaneous therapy

Maintenance follow-upMaintenance SC dosing begins 8 weeks after the IV induction dose (90 mg SC Q8W)

Subcutaneous — definition

TermSubcutaneous (SC)

Usage noteRefers to administration by injection under the skin (SC) per prescribing information

Context in policySC denotes the maintenance route for ustekinumab after any required IV induction for certain GI indications

Clinical Background

Ustekinumab subcutaneous is an interleukin-12/23 inhibitor approved for multiple inflammatory conditions. The policy lists FDA‑approved indications including moderate to severe plaque psoriasis (≥6 years), psoriatic arthritis (≥6 years), and inflammatory bowel disease indications — Crohn's disease (adults ≥18) and ulcerative colitis (adults ≥18). The document history also notes the addition of multiple branded and biosimilar ustekinumab subcutaneous products to the policy (e.g., Starjemza, ustekinumab-aauz) which are subject to the same coverage criteria.

Policy Summary

Payerculinary health fund

PolicyUstekinumab subcutaneous prior authorization for inflammatory conditions

Policy CodePolicy N/A

Change TypeMultiple product additions and material criteria revisions

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and ensure specialist prescribing/consultation with documentation of required IV induction timing and prior therapy trials per indication.

SourceLink

On This Page

Crohn's Disease — initial therapy (removed options)

Modifications to Crohn's Disease initial therapy approval options (removals noted)

Crohn's Disease initial therapy - removed options: For Crohn's Disease initial therapy, the policy removed approval options that had allowed authorization based on prior systemic corticosteroid use or corticosteroid contraindication; trial of one conventional systemic therapy with its accompanying Note; presence of enterocutaneous (perianal or abdominal) or rectovaginal fistulas; or history of ileocolonic resection.

These prior-therapy and clinical-state options were eliminated from the initial therapy pathways.

Step Therapy

Plaque Psoriasis Step Requirement

For plaque psoriasis initial therapy, the patient must have tried at least one traditional systemic agent for ≥3 months unless intolerant. An exception exists if the patient has already had a 3-month trial of, or intolerance to, at least one prior biologic (other than the requested medication), apremilast (Otezla), or deucravacitinib (Sotyktu). A prior biologic does not require stepping back to a traditional systemic agent.

Traditional systemic agents include methotrexate, cyclosporine, or acitretin; a 3-month PUVA trial counts.
A biosimilar of the requested biologic does not count toward the biologic exception.
If requesting 90 mg syringe, approval allowed when patient >100 kg, currently on 90 mg, or inadequate response to 45 mg after ≥3 months.

Documentation Required

Documentation Requirements

No additional specific documentation requirements were provided in the excerpt. Standard supporting documentation (e.g., specialist consultation notes, prior therapy trials, objective measures of response) should be submitted with PA requests per usual practice.

Submit documentation of specialist prescribing/consultation for initial approvals.
For continuation approvals, provide objective measures of benefit (e.g., fecal calprotectin, CRP, imaging, endoscopy) or symptom improvement compared with baseline when applicable.