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The Policy VaultThe Policy Vault

Tirbanibulin ointment 1% — Blue Cross Blue Shield of Montana

external genital and/or perianal warts (EGW)/condyloma acuminata

Preferred products

  • generic imiquimod 5% cream
  • fluorouracil solution

Initial criteria

  • If the patient has an FDA labeled indication, then ONE of the following: (A) age is within FDA labeling for the requested indication, OR (B) there is support for using the requested agent for the patient’s age for the requested indication.
  • Diagnosis-based criteria: ONE of the following:
  • A. BOTH of the following: (1) diagnosis of actinic keratoses of the face/scalp AND (2) requested agent is diclofenac 3% gel, Carac 0.5% cream, Efudex 5% cream, Fluoroplex, Tolak, imiquimod 5%, Zyclara 3.75%, Zyclara 2.5%, or Klisyri.
  • B. BOTH of the following: (1) diagnosis of actinic keratoses of trunk/extremities AND (2) requested agent is diclofenac 3% gel, Efudex 5% cream, or Fluoroplex.
  • C. BOTH of the following: (1) diagnosis of superficial basal cell carcinoma AND (2) requested agent is imiquimod 5% or Efudex 5% cream.
  • D. BOTH of the following: (1) diagnosis of external genital/perianal warts AND (2) requested agent is imiquimod 5% or Zyclara 3.75% cream.
  • For actinic keratoses or superficial basal cell carcinoma, ONE of: (1) currently stable on requested agent, OR (2) tried and inadequate response to generic imiquimod 5% cream or fluorouracil solution, OR (3) discontinued due to lack of efficacy or adverse event, OR (4) intolerance or hypersensitivity, OR (5) FDA labeled contraindication to both, OR (6) expected to be ineffective, adherence barrier, worsen comorbid condition, decrease functional ability, or cause harm, OR (7) not in patient’s best interest based on medical necessity, OR (8) tried another agent in same class with failure or adverse event.
  • For external genital or perianal warts, ONE of: (1) stable on requested agent, OR (2) tried and inadequate response to generic imiquimod 5% cream.