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

Preferred products

• Ustekinumab
• Ustekinumab-aekn
• Wezlana (ustekinumab-auub)
• Steqeyma (ustekinumab-stba)
• Yesintek (ustekinumab-kfce)

Initial criteria

• For PJIA: patient's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for PJIA.
• For HS: Must meet ONE of the following: (A) Tried and had an inadequate response to ONE conventional agent (oral tetracyclines, oral contraceptives [females], metformin [females], finasteride [females], spironolactone [females], intralesional corticosteroids [triamcinolone], clindamycin + rifampin, rifampin + moxifloxacin + metronidazole, cyclosporine, or oral retinoids) after ≥3 months of therapy; OR (B) Has intolerance or hypersensitivity to ONE conventional agent used in treatment of HS; OR (C) Has FDA labeled contraindication to ALL conventional agents used in HS; OR (D) Medication history indicates use of another biologic immunomodulator that is FDA labeled or supported in compendia for HS.
• For other diagnoses: Must meet ONE of the following (reference preferred agents table): (A) Requested agent is a preferred agent; OR (B) Meets cancer exception criteria for stage 4 advanced metastatic cancer; OR (C) Patient currently stable on requested agent; OR (D) Tried and had inadequate response to THREE preferred agents after at least 3‑month trials; OR (E) THREE preferred agents discontinued due to lack of efficacy/adverse events; OR (F) Intolerance or hypersensitivity to THREE preferred agents not expected with requested agent; OR (G) FDA labeled contraindication to ALL preferred agents not expected with requested agent; OR (H) THREE preferred agents expected ineffective or cause significant barrier to adherence, comorbidity worsening, or adverse reaction; OR (I) THREE preferred agents not in best interest (medical necessity); OR (J) Tried another prescription drug in same pharmacologic class or mechanism as THREE preferred agents with discontinuation due to lack of efficacy or adverse event; OR (K) ALL preferred agents not clinically appropriate AND prescriber provided complete list of prior agents. Additional requirements: patient age appropriate per FDA labeling (or supported compendia use); prescriber is or has consulted a specialist appropriate to diagnosis; patient not using requested agent concomitantly with another immunomodulatory agent unless supported by prescribing information and clinical evidence; no FDA labeled contraindications; and screened for latent tuberculosis with treatment initiated if positive.

Reauthorization criteria

• Patient previously approved for requested agent through plan's prior authorization process.
• Patient has had clinical benefit with requested agent.
• Must meet ONE of: requested agent is preferred OR meets same step logic for stage 4 cancer, stability, or trial/intolerance/contraindication/inefficacy of at least THREE preferred agents as outlined in initial criteria.
• Prescriber is a specialist or has consulted specialist in diagnosis area.
• Patient will not use requested agent with another immunomodulatory agent unless prescribing information and evidence support combination.
• Patient has no FDA labeled contraindications to requested agent.

Approval duration

12 months (except ulcerative colitis 12 weeks)