Intravenous ustekinumab (all brands) — Medical Benefit Medication Utilization Policy
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This medical benefit medication utilization policy governs prior authorization and coverage criteria for intravenous ustekinumab products (originator and biosimilars) for Crohn's disease and ulcerative colitis for Community-Care members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Intravenous Ustekinumab
Initial Therapy - Crohn's disease
Covered when ALL of the following are met for Crohn's disease:
Crohn's initial IV dose criteria
- Dose options: 260 mg (2 of the 130 mg vials) — weight ≤ 55 kg and weight provided.
- Dose options: 390 mg (3 of the 130 mg vials) — weight > 55 kg and ≤ 85 kg and weight provided.
- Dose options: 520 mg (4 of the 130 mg vials) — weight > 85 kg and weight provided.
Initial Therapy - Ulcerative colitis
Covered when ALL of the following are met for Ulcerative Colitis:
Ulcerative colitis initial IV dose criteria
- Dose options: 260 mg (2 of the 130 mg vials) — weight ≤ 55 kg and weight provided.
- Dose options: 390 mg (3 of the 130 mg vials) — weight > 55 kg and ≤ 85 kg and weight provided.
- Dose options: 520 mg (4 of the 130 mg vials) — weight > 85 kg and weight provided.
Authorization is limited to a single intravenous (IV) induction dose of ustekinumab for Crohn's disease or ulcerative colitis. This policy does not address ongoing or maintenance dosing—requests for repeat or maintenance infusions should not be submitted under this authorization and will require separate review or a different policy pathway. If approved, the single authorized dose must be dispensed within 1 month of approval.
Billing and Coding
| 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. |
| Q5138 | Injection, ustekinumab-auub (wezlana), biosimilar, intravenous, 1 mg. |
| Q9997 | Injection, ustekinumab-ttwe (pyzchiva), intravenous, 1 mg. |
| Q9998 | Injection, ustekinumab-aekn (selarsdi), biosimilar, 1 mg. |
| Q9999 | Injection, ustekinumab-aauz (otulfi), biosimilar, 1 mg. |
Provider Actions and Requirements
Prior authorization required for initial IV ustekinumab
Prior authorization is required for the initial intravenous ustekinumab induction dose. The request must be submitted by a gastroenterology specialist and include the diagnosis, patient weight, the requested dose expressed as the appropriate vial quantity (2, 3, or 4 vials per weight-based dosing), and confirmation that the patient is not currently established on ustekinumab.
- Requested dose must match weight-based dosing: 2 vials (≤55 kg), 3 vials (>55–85 kg), 4 vials (>85 kg).
- Authorization is for a single IV induction dose (single fill within 1 month if approved).
Step therapy: preferred product (Selarsdi IV) required first
The policy requires use of the preferred product (Selarsdi IV) first; other IV ustekinumab products will be considered only if the patient has a contraindication, intolerance, or has tried and failed the preferred product.
- Provider must document reason (contraindication, intolerance, or treatment failure) to request a non-preferred IV ustekinumab product.
Document gastroenterology specialty, diagnosis, weight, and not currently established
When requesting the initial IV dose, the provider must document that the prescriber is a gastroenterology specialist, specify the diagnosis (moderately to severely active Crohn's disease or ulcerative colitis), provide the patients weight, and confirm the patient is not currently established on ustekinumab.
- Include requested vial quantity corresponding to weight-based dosing (2 vials for ≤55 kg; 3 vials for >55–85 kg; 4 vials for >85 kg).
- Authorization is for a single IV induction dose only.
Denial risk for non-preferred ustekinumab IV products
Requests for non-preferred intravenous ustekinumab products may be denied if the patient has not demonstrated a contraindication, intolerance, or treatment failure with the preferred product (Selarsdi IV).
- Ensure documentation of contraindication, intolerance, or prior treatment failure with Selarsdi IV to avoid denial.
Background
Ustekinumab IV is indicated for use in patients with moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. The initial IV induction dose is weight-based and must match one of the specified vial quantities: 260 mg (2 x 130 mg vials) for patients ≤55 kg, 390 mg (3 vials) for patients >55–85 kg, or 520 mg (4 vials) for patients >85 kg. Initial IV dosing must be prescribed by a gastroenterology specialist and is intended for patients who are not currently established on ustekinumab.
Definitions
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