Q5164, Injection, ustekinumab-hmny (starjemza), biosimilar, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Documentation Required
- Documentation of intolerance, contraindication, or adverse event to Steqeyma, Wezlana, or Yesintek when relying on intolerance/contraindication pathway for non-preferred product coverage.
- Documentation of positive clinical response is required for continuation of therapy (per indication-specific continuation criteria).
- When prior targeted immunomodulator therapy is cited as meeting criteria, documentation is required (policy: 'Document drug, date, and duration of therapy').
- Documentation of a trial of at least 14 weeks of Steqeyma, Wezlana, or Yesintek resulting in minimal clinical response to therapy and residual disease activity (required for Preferred Product Criteria exception to use non-preferred product).
- Provider attestation (required in Preferred Product Criteria) that in their clinical opinion the clinical response would be expected to be superior with the requested non-preferred ustekinumab product than experienced with the preferred product (or attestation that the same intolerance/contraindication/adverse event would not be expected with the requested product).
- For initial Crohn's disease and ulcerative colitis therapy: documentation that ustekinumab will be administered as a single intravenous induction dose consistent with FDA labeled dosing (and authorization will be for one induction dose).
Key Coverage Criteria
- Moderately to severely active Crohn's disease (treatment proven) when all specified criteria in the Diagnosis-Specific Criteria are met.
- Moderately to severely active ulcerative colitis (treatment proven) when all specified criteria in the Diagnosis-Specific Criteria are met.
- Moderate to severe plaque psoriasis (treatment proven) when all specified criteria in the Diagnosis-Specific Criteria are met.
- Psoriatic arthritis (treatment proven) when all specified criteria in the Diagnosis-Specific Criteria are met.
- Adolescent patients (6 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy (per FDA labeling; referenced in Clinical Evidence / FDA section).
- Maintenance therapy for Crohn's disease and ulcerative colitis following an appropriate intravenous induction dose (per Diagnosis-Specific Criteria and FDA-labeled dosing).
3 Active Policies
UHC-POL-ustekinumab, Ustekinumab
UMR-POL-UMR-ustekinumab, Ustekinumab
SUREST-POL-SUREST-ustekinumab, Ustekinumab
Related Codes
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