Duvyzat (givinostat hcl oral suspension 8.86 MG/ML) — Blue Cross Blue Shield of Oklahoma

Duchenne Muscular Dystrophy (DMD)

Initial criteria

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 (i.e., 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

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 the prescriber has consulted with such a specialist AND
5. The patient does NOT have any FDA labeled contraindications to the requested agent

12 months