Xyrem — Blue Cross Blue Shield of Oklahoma

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 is currently being treated with the requested agent and is stable on it OR
• 2. The patient has tried and had an inadequate response to modafinil OR armodafinil OR
• 3. Modafinil OR armodafinil was discontinued due to lack of efficacy, diminished effect, or an adverse event OR
• 4. The patient has an intolerance, hypersensitivity, or contraindication to modafinil OR armodafinil OR
• 5. Modafinil OR armodafinil is expected to be ineffective, or not in the patient’s best interest due to clinical characteristics, medical necessity reasons, or would cause a significant barrier to adherence, worsen comorbid condition, decrease daily functioning, or cause harm OR
• 6. The patient has tried another prescription drug in same pharmacologic class or mechanism as modafinil OR armodafinil and was discontinued due to ineffectiveness or adverse event OR
• B. The patient has a diagnosis of idiopathic hypersomnia AND ALL of the following:
• 1. The requested agent is Xywav AND
• 2. All other causes of hypersomnia ruled out AND
• 3. ONE of the following: inadequate response, intolerance, or contraindication to modafinil
• C. The patient has another FDA labeled indication for the requested agent and route AND has been evaluated by polysomnography and/or Multiple Sleep Latency Test AND age within or supported for labeling AND specialist involvement required AND patient has no contraindications
• If the request is for brand Xyrem, then ONE of the following: patient currently stable on requested agent OR tried authorized generic Sodium Oxybate with inadequate response or adverse event/intolerance/contraindication OR authorized generic expected to be ineffective, not in best interest, or another similar drug failed OR support exists for use over authorized generic
• Prescriber must be a specialist in area of diagnosis or must have consulted with one
• Patient must not have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. Patient previously approved for requested agent through plan’s PA process AND
• 2. Prescriber is or consulted with a relevant specialist AND
• 3. Patient has shown clinical benefit with requested agent AND
• 4. Patient has no FDA labeled contraindications

Approval duration

12 months