Xywav — Blue Cross Blue Shield of Kansas
narcolepsy with cataplexy
Initial criteria
- ONE of the following:
- A. The patient has a diagnosis of narcolepsy with cataplexy OR narcolepsy with excessive daytime sleepiness AND ONE of the following:
- 1. The patient has tried and had an inadequate response to modafinil OR armodafinil OR
- 2. The patient has an intolerance or hypersensitivity to modafinil OR armodafinil OR
- 3. The patient has an FDA labeled contraindication to BOTH modafinil AND armodafinil OR
- B. The patient has a diagnosis of idiopathic hypersomnia AND ALL of the following:
- 1. The requested agent is Xywav AND
- 2. The patient has completed a sleep study AND
- 3. All other causes of hypersomnia have been ruled out AND
- 4. ONE of the following:
- A. The patient has tried and had an inadequate response to modafinil OR
- B. The patient has an intolerance or hypersensitivity to modafinil OR
- C. The patient has an FDA labeled contraindication to modafinil OR
- C. The patient has another FDA approved indication for the requested agent and route of administration AND
- 2. 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 for the requested agent OR
- B. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
- 3. If the request is for brand Xyrem, then ONE of the following:
- A. The patient has an intolerance or hypersensitivity to authorized generic Sodium Oxybate that is not expected to occur with the requested agent OR
- B. The patient has an FDA labeled contraindication to authorized generic Sodium Oxybate that is not expected to occur with the requested agent OR
- C. There is support for the use of the requested agent over authorized generic Sodium Oxybate AND
- 4. The patient will NOT be using the requested agent in combination with another oxybate agent, Sunosi, OR Wakix for the requested indication AND
- 5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., sleep specialist, neurologist, psychiatrist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
- 6. The patient does NOT have any FDA labeled contraindications to the requested agent
Approval duration
12 months