Duvyzat — Blue Cross Blue Shield of Kansas

Initial criteria

• ONE of the following: (A) The requested agent is eligible for continuation of therapy AND ONE of the following: The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR 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 (B) BOTH of the following:
• 1. ONE of the following: (A) BOTH of the following: The patient has a diagnosis of Duchenne Muscular Dystrophy confirmed by genetic analysis (i.e., dystrophin deletion or duplication mutation) (genetic test required) AND ONE of the following: (A) BOTH of the following: The patient has been stable on corticosteroid therapy used to treat DMD for at least 6 months AND The patient will continue to be on corticosteroid therapy for DMD while taking the requested agent OR (B) The patient has an intolerance or hypersensitivity to a corticosteroid used to treat DMD OR (C) 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 AND If the patient has an FDA labeled indication, then ONE of the following: (A) The patient’s age is within FDA labeling for the requested indication for the requested agent 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 in the area of the patient’s diagnosis
• 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 in the area of the patient’s diagnosis
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months