givinostat hcl — Blue Cross Blue Shield of Illinois

Initial criteria

• ONE 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 ONE of the following: (1) The patient has been stable on corticosteroid therapy used to treat DMD for at least 6 months AND will continue corticosteroid therapy 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 (b) The patient has another FDA labeled indication for the requested agent and route of administration
• If the patient has an FDA labeled indication, ONE of the following: (a) The patient’s age is within FDA labeling for the requested indication OR (b) There is support for the use of the requested agent for the patient’s age for the requested indication
• If the requested agent is to be used to treat DMD, the patient is ambulatory
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., pediatric neurologist) or has consulted with a specialist
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• 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)
• If the requested agent is to be used to treat DMD, the patient is ambulatory
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., pediatric neurologist) or has consulted with a specialist
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months