Imuldosa (ustekinumab-srlf) — Blue Cross Blue Shield of Texas

Preferred products

• Stelara (ustekinumab)
• Selarsdi (ustekinumab-aekn)
• Steqeyma (ustekinumab-stba)
• Pyzchiva (ustekinumab-ttwe)
• Yesintek (ustekinumab-kfce)
• Wezlana (ustekinumab-auub)

Initial criteria

• For HS: The patient has tried and had an inadequate response to at least one conventional agent (e.g., doxycycline, minocycline, tetracycline, oral contraceptives [females only], metformin [females only], finasteride [females only], spironolactone [females only], intralesional corticosteroids [triamcinolone], clindamycin with rifampin, rifampin-moxifloxacin-metronidazole, cyclosporine, oral retinoids) after at least 3 months of therapy OR has intolerance/hypersensitivity to one conventional agent OR has an FDA labeled contraindication to all conventional agents OR has prior use of another biologic immunomodulator for HS.
• For diagnoses not previously mentioned: The requested agent is a preferred agent OR if non-preferred, the patient must meet ONE of the following: (A) has stage four advanced metastatic cancer treated with the requested agent for cancer or associated condition AND use is consistent with FDA approval and supported by evidence-based literature; OR (B) is currently stable on the requested agent; OR (C) tried and had inadequate response to three preferred agents after ≥3-month trial per agent; OR (D) discontinued three preferred agents due to lack of efficacy or adverse event; OR (E) has intolerance or hypersensitivity to three preferred agents; OR (F) has FDA labeled contraindication to all preferred agents; OR (G) three preferred agents expected to be ineffective, worsen condition, or cause harm; OR (H) three preferred agents not in best interest based on medical necessity; OR (I) has tried another drug in same class as three preferred agents discontinued due to ineffectiveness; OR (J) all preferred agents are not clinically appropriate and prescriber provided complete list of previously tried agents.
• If FDA labeled indication: patient's age within labeling or supported use AND prescriber is a specialist or has consulted specialist AND patient will not use agent concurrently with another immunomodulator unless prescribing information allows and evidence supports use AND patient does not have FDA labeled contraindications AND patient tested for latent tuberculosis and treated if positive.
• Compendia support allowed from AHFS, DrugDex (1, 2a, 2b), or NCCN (1, 2a, 2b) recommended uses.

Reauthorization criteria

• Patient previously approved for requested agent through prior authorization AND has had clinical benefit AND meets one of the following referencing preferred agents table: is a preferred agent OR meets non-preferred substitution criteria similar to initial approval (advanced cancer, stability, or multiple preferred agents tried/intolerant/contraindicated/not appropriate) AND prescriber is or has consulted with relevant specialist AND patient not using prohibited concomitant immunomodulators unless supported by evidence AND patient has no FDA labeled contraindications.

Approval duration

12 months