CurrentColorado Rocky Mountain Health PlansPolicy N/A

Brand Stelara (ustekinumab) coverage — prior authorization with biosimilar trial/intolerance criteria

Prior authorization policy governing coverage of brand Stelara for members; requires documentation that biosimilars are not appropriate or have failed. Affects providers submitting PA requests to UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBrand Stelara (ustekinumab) coverage — prior authorization with biosimilar trial/intolerance criteria

Policy CodePolicy N/A

Change TypeNew program / added

Effective DateNov 16, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit medical records showing either allergy/intolerance to all listed biosimilars or trials of two biosimilars (≥6 weeks each) with decreased effectiveness.

SourceLink

POLICY UPDATE CHANGES

New program requiring prior authorization for brand Stelara with specific biosimilar trial or intolerance criteria.

12 monthsAuthorization duration

6 weeksMinimum trial duration

2Biosimilars required tried/failed

3Biosimilars referenced

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Coverage Criteria

Brand Stelara may be approved when ONE of the following criterion sets is met:

ANY of the following

A. Brand Stelara
- - Steqeyma
  - Wezlana
  - Yesintek
- Authorization will be issued for 12 months.
B. Prior successful treatment plus loss of effectiveness on biosimilars
- Submission of medical records documenting patient has previously been successfully treated with brand Stelara
- - Steqeyma
  - Wezlana
  - Yesintek
- Authorization will be issued for 12 months.

Notwithstanding the coverage criteria above, UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic. Use of automated approval and re-approval processes varies by program and/or therapeutic class. Supply limits may be in place.

Authorization will be issued for 12 months.

Coding and Timelines

Minimum biosimilar trial duration

Minimum trial duration>= 6 weeks per biosimilar product

Applies toEach biosimilar product tried (Steqeyma, Wezlana, Yesintek)

ContextRequired as part of documentation that the member experienced decreased effectiveness on the biosimilar

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Brand Stelara requires prior authorization. Authorization will be issued for 12 months when criteria are met.

Step Therapy

Biosimilar Trial Requirement

Biosimilar trial requirement — Member must have tried and had decreased effectiveness on two of the listed biosimilars for at least 6 weeks per product unless there is documented allergy or demonstrated intolerance to inactive ingredients in all listed biosimilars.

Steqeyma
Wezlana
Yesintek

Documentation Required

Background

This program is administrative coverage guidance that requires providers to confirm a member is not an appropriate candidate for available ustekinumab biosimilars before approving brand Stelara. Approval is granted when one of two documented pathways is met: (1) medical records showing allergy or demonstrated intolerance to the inactive ingredients in all listed biosimilars (Steqeyma, Wezlana, Yesintek), or (2) medical records documenting prior successful treatment with brand Stelara plus trials of two of the listed biosimilars for at least 6 weeks per product with documented decreased effectiveness.

Providers should submit supporting medical records per the documentation requirements; requests that do not demonstrate the member is not an appropriate biosimilar candidate (either via documented intolerance to all biosimilars or the required biosimilar trial failures) may be denied.

Definitions

Biosimilar trial failure

DefinitionDocumentation that the member tried two of the biosimilars (Steqeyma, Wezlana, Yesintek) for at least 6 weeks per product and experienced a decrease in effectiveness.

Required elementsMedical records showing trials of two listed biosimilars, each ≥ 6 weeks, with documentation of decreased effectiveness

Biosimilars referencedSteqeyma; Wezlana; Yesintek

Initial Therapy Criteria

Initial authorization

Initial authorization requirements for brand Stelara

Initial approval: Approval granted if either documented allergy/intolerance to inactive ingredients in all three listed biosimilars OR prior successful treatment with brand Stelara plus documented trials and decreased effectiveness on two listed biosimilars for at least 6 weeks each

Re-authorization / Continuation Criteria

Re-authorization

Re-authorization considerations

Re-authorization: Authorizations may be re-approved for 12 months; UnitedHealthcare may rely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic for approval or re-approval

Step Therapy Requirements

Requirement	Details
Biosimilar trial requirement
Member must have tried two of the following biosimilars for at least 6 weeks per product and experienced a decrease in effectiveness: Steqeyma; Wezlana; Yesintek.

Quantity Limits

Brand Stelara — Supply/quantity notes

Quantity limitsSupply limits may be in place for Brand Stelara

Authorization durationAuthorizations are issued for 12 months when criteria are met (see authorization rules)

Program noteUnitedHealthcare may approve initial and re-authorization based on prior claim/medication history, ICD-10 codes, and/or claim logic

Biosimilar Trial Details

Billing Rule
Must trial Steqeyma (part of 2 biosimilar failures)
Member must have tried and failed two biosimilars including Steqeyma for at least 6 weeks each with decreased effectiveness unless allergy/intolerance to inactive ingredients in all three biosimilars is documented.
Steqeyma must be one of the biosimilars trialed unless allergy/intolerance pathway is met.

Billing Rule
Must trial Wezlana (part of 2 biosimilar failures)
Member must have tried and failed two biosimilars including Wezlana for at least 6 weeks each with decreased effectiveness unless allergy/intolerance to inactive ingredients in all three biosimilars is documented.
Wezlana must be one of the biosimilars trialed unless allergy/intolerance pathway is met.