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givinostat hcl oral suspension 8.86 MG/ML — Blue Cross Blue Shield of Montana

compendia-supported indications

Initial criteria

  • ALL of the following:
  • 1. BOTH of the following:
  • A. ONE of the following:
  • 1. BOTH of the following:
  • A. The patient has a diagnosis of Duchenne Muscular Dystrophy confirmed by genetic analysis (dystrophin deletion or duplication mutation) (genetic test required) AND
  • B. ONE of the following:
  • 1. BOTH of the following:
  • A. The patient has been stable on corticosteroid therapy used to treat DMD for at least 6 months AND
  • B. The patient will continue to be on corticosteroid therapy for DMD while taking the requested agent OR
  • 2. The patient has an intolerance or hypersensitivity to a corticosteroid used to treat DMD OR
  • 3. The patient has an FDA labeled contraindication to all corticosteroids used to treat DMD OR
  • 2. The patient has another FDA labeled indication for the requested agent and route of administration 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 the use of the requested agent for the patient's age for the requested indication AND
  • 2. If the requested agent is to be used to treat DMD, the patient is ambulatory AND
  • 3. The prescriber is a specialist in the area of the patient's diagnosis (e.g., pediatric neurologist) or the prescriber has consulted with such a specialist AND
  • 4. The patient does NOT have any FDA labeled contraindications to the requested agent
  • OR, for members in Ohio:
  • 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 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 supporting the proposed use as generally safe and effective (case studies not acceptable)

Reauthorization criteria

  • ALL of the following:
  • 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  • 2. The patient has had improvements or stabilization with the requested agent (e.g., slowed disease progression, improved strength, timed motor function, pulmonary function, reduced need for scoliosis surgery) AND
  • 3. If the requested agent is to be used to treat DMD, the patient is ambulatory AND
  • 4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., pediatric neurologist) or has consulted with such a specialist AND
  • 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months