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Winlevi — Blue Cross Blue Shield of Montana

other FDA labeled indication

Initial criteria

  • ONE of the following:
  • 1. The requested agent is eligible for continuation of therapy AND the following:
  • • The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed
  • OR
  • 2. BOTH of the following:
  • A. The patient has a diagnosis of acne vulgaris AND ONE of the following:
  • 1. The patient has tried and had an inadequate response to at least ONE generic topical antibiotic agent used in the treatment of acne OR
  • 2. The patient has tried and had an inadequate response to at least ONE generic topical retinoid agent used in the treatment of acne OR
  • 3. The patient has an intolerance or hypersensitivity to a generic topical antibiotic agent OR a generic topical retinoid therapy used in the treatment of acne OR
  • 4. The patient has an FDA labeled contraindication to ALL generic topical antibiotic agents AND generic topical retinoid agents used in the treatment of acne AND
  • B. If the patient has an FDA labeled indication, then ONE of the following:
  • 1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
  • 2. There is support for using the requested agent for the patient’s age for the requested indication
  • OR
  • The requested agent will also be approved when the following are met:
  • 1. The member resides in Ohio AND
  • 2. The plan is Fully Insured or HIM Shop (SG) AND BOTH of the following:
  • A. The patient does NOT have any FDA labeled contraindications to the requested agent AND
  • B. ONE of the following:
  • 1. The patient has another FDA labeled indication for the requested agent and route of administration OR
  • 2. The patient has another indication that is supported in compendia for the requested agent and route of administration OR
  • 3. The prescriber has submitted TWO articles from major peer-reviewed professional medical journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use(s) as generally safe and effective (affirmative study designs required)

Reauthorization criteria

  • Continuation of therapy: patient has been treated with the requested agent within the past 90 days and is at risk if therapy is changed

Approval duration

12 months