STELARA (ustekinumab) Prior Authorization Coverage Criteria
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Defines prior authorization requirements for STELARA (ustekinumab) for Mississippi Division of Medicaid members, including initial and re-authorization criteria, dosing reference, and formulation details.
No material clinical or coverage changes in this revision.
Coverage Criteria for STELARA (ustekinumab)
Initial Authorization
Covered when ALL of the following are met for initial authorization:
Biosimilar justification required prior to approval.
Re-Authorization
Covered when ALL of the following are met for re-authorization:
Re-authorization duration: 1 year.
There are no explicit non-covered indications or exclusions listed in this policy beyond the requirement that therapy align with the FDA‑approved indication and the dosing recommended in the manufacturer’s package insert. Coverage decisions rely on meeting the package insert age/weight criteria and having an FDA‑approved diagnosis for use of STELARA (ustekinumab).
Therapy that departs from the manufacturer’s guidance will not meet criteria. Specifically, requests for dosing that exceed the manufacturer's recommended dose based on the patient’s age, weight, and diagnosis, or requests for use when the patient does not meet the package insert age/weight or FDA‑approved indication, will not be approved. In addition, for both initial and re‑authorization requests, the prescriber must provide a documented clinical justification explaining why all preferred ustekinumab biosimilars cannot be utilized; failure to provide this justification (or to meet age/weight/indication requirements) is a basis for denial.
Initial Therapy
Initial Therapy
Initial authorization criteria for STELARA (ustekinumab):
Prescriber justification is required prior to approval.
Continuation / Re-Authorization
Continuation / Re-authorization
Re-authorization requirements to continue STELARA:
Re-authorization period: 1 year.
Provider Actions and Documentation Requirements
Prior authorization required; approval based on meeting criteria
Prior authorization is required for STELARA (ustekinumab). Approval will be considered only when the member meets the policy's initial or re-authorization criteria and supporting documentation is provided.
Documented justification required for not using preferred biosimilars
Prescriber must provide a documented clinical justification explaining why all preferred ustekinumab biosimilars cannot be used; for re-authorization, ‘stabilized on brand’ alone is not adequate justification.
- Initial authorization requires documented justification why preferred biosimilars must not be utilized.
- Re-authorization requires documented justification why the member could not be switched to any preferred biosimilars; being stabilized on brand alone is insufficient.
Required documentation: Universal PA Form plus clinical evidence
Submit the Universal PA Form with all supporting clinical documentation, including diagnosis, patient age/weight, dosing rationale, and the prescriber's clinical justification for not using preferred biosimilars; for re-authorization include documentation of positive clinical response.
- Universal PA Form must be included with the request.
- Attach clinical records showing diagnosis, age/weight per package insert, dosing calculations, and biosimilar justification.
- For re-authorization, include evidence of positive clinical response to therapy.
Common triggers for denial
Requests are likely to be denied if the member fails to meet package-insert age/weight, lacks an FDA‑approved diagnosis, does not provide prescriber justification for not using preferred biosimilars, or if the prescribed dose exceeds manufacturer recommendations.
- Patient does not meet minimum age or weight per package insert.
- Diagnosis is not an FDA‑approved indication for ustekinumab.
- No prescriber justification for not using preferred biosimilars (or insufficient justification on re‑auth, e.g., 'stabilized on brand' alone).
- Prescribed dose exceeds manufacturer's recommended dose based on age, weight, and diagnosis.
Biosimilar Requirements
Document why preferred ustekinumab biosimilars cannot be used (initial & re‑auth)
For both initial authorization and re-authorization, the prescriber must document why all preferred ustekinumab biosimilars cannot be utilized; for re-authorization, ‘stabilized on brand’ alone is not an adequate justification.
- Initial: documented clinical justification why preferred biosimilars must not be utilized.
- Re-authorization: documented justification that the member could not be switched to any preferred biosimilar — stabilization on brand alone is insufficient.
Step Therapy / Prescriber Justification
| Step | Requirement / Prescriber action | Coverage status |
|---|---|---|
| 1 | ||
| Prescriber must provide a documented clinical justification explaining why all preferred ustekinumab biosimilars cannot be utilized prior to approval (required for initial authorization). | ||
| Covered with criteria | ||
| Re-authorization | ||
| Prescriber must document why the member could not be switched to any preferred ustekinumab biosimilars (stabilization on brand alone is not sufficient); continuation of initial criteria, dose within manufacturer's recommendations, and documentation of positive clinical response are also required. | ||
| Covered with criteria |
Background
Ustekinumab (STELARA®) is a human interleukin‑12 and ‑23 antagonist used to treat certain autoimmune inflammatory diseases. Per the manufacturer’s labeling cited in this policy, approved indications include moderate to severe plaque psoriasis (age ≥6 years), active psoriatic arthritis (age ≥6 years), moderately to severely active Crohn’s disease (age ≥2 years), and moderately to severely active ulcerative colitis (adults).
Definitions
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