Stelara (ustekinumab) — Blue Cross Blue Shield of Texas

Preferred products

• Ustekinumab
• Ustekinumab-aekn
• Ustekinumab-ttwe
• Wezlana (ustekinumab-auub)

Initial criteria

• Patient has stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR an associated condition AND use of the requested agent is consistent with best practices and supported by peer-reviewed evidence and FDA approval OR
• Patient is currently being treated with the requested agent and is stable on therapy [chart notes required] OR
• Patient has tried and had inadequate response to THREE preferred agents after at least a 3-month trial per agent [medical records required] OR
• THREE preferred agents were discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
• Patient has intolerance or hypersensitivity to THREE preferred agents not expected with the requested agent [medical records required] OR
• Patient has FDA labeled contraindication to ALL preferred agents not expected with requested agent [medical records required] OR
• THREE preferred agents expected to be ineffective based on clinical characteristics or would cause adherence barrier, worsen comorbidities, decrease function, or cause harm [chart notes required] OR
• THREE preferred agents not in the best interest of patient based on medical necessity [chart notes required] OR
• Patient has tried another drug in same pharmacologic class or mechanism as THREE preferred agents which was discontinued due to inefficacy, diminished effect, or adverse event [chart notes required] OR
• ALL preferred agents not clinically appropriate AND prescriber has provided complete list of previously tried agents for the indication [medical records required] AND
• Patient’s age is within FDA labeling for requested indication or supported by evidence AND
• Prescriber is specialist in patient's diagnosis area or has consulted with one AND
• Patient will NOT use requested agent with another immunomodulatory agent OR if combination use is planned, prescribing info does not limit and literature supports combination [documentation required] AND
• Patient has been tested for latent TB and, if positive, begun therapy for latent TB AND
• Patient has no FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient was previously approved for the requested agent through prior authorization AND
• Patient has had clinical benefit with the requested agent AND
• Requested agent is preferred OR SAME step therapy exceptions (THREE preferred agents, contraindications, intolerance, etc.) AND
• Prescriber is specialist or has consulted with one AND
• Combination use criteria met as in initial criteria AND
• Patient has no FDA labeled contraindications

Approval duration

12 months (UC: 12 weeks for some plans; BCBSIL/BCBSTX: 12 months)