diazoxide choline — Blue Cross Blue Shield of Alabama

other FDA labeled indications for the requested agent and route of administration

Initial criteria

ONE of the following:
• The patient has a diagnosis of Prader-Willi syndrome AND BOTH of the following:
– The patient has hyperphagia AND
– The patient's diagnosis has been confirmed by genetic testing indicating mutation on chromosome 15 (medical records required)
OR
• The patient has another FDA labeled indication for the requested agent and route of administration
AND for any FDA labeled indication ONE of the following:
– The patient’s age is within FDA labeling for the requested indication for the requested agent OR
– There is support for using the requested agent for the patient’s age for the requested indication
AND
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
AND
• The patient does NOT have any FDA labeled contraindications to the requested agent

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
AND
• The patient has had clinical benefit with the requested agent
AND
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
AND
• The patient does NOT have any FDA labeled contraindications to the requested agent

initial 4 months; renewal 12 months