Sodium oxybate — Blue Cross Blue Shield of Illinois

Initial criteria

• Diagnosis of narcolepsy with cataplexy OR narcolepsy with excessive daytime sleepiness AND ONE of the following: (1) Patient has stage 4 advanced metastatic cancer and requested agent used to treat the cancer or an associated condition consistent with best practices and FDA approval; OR (2) Patient currently being treated with and stable on the requested agent; OR (3) Patient has tried and had an inadequate response to modafinil OR armodafinil; OR (4) Modafinil OR armodafinil discontinued due to lack of efficacy or adverse event; OR (5) Patient has intolerance or hypersensitivity to modafinil OR armodafinil; OR (6) Patient has FDA labeled contraindication to BOTH modafinil AND armodafinil; OR (7) Modafinil OR armodafinil expected to be ineffective or cause harm; OR (8) Modafinil OR armodafinil not in best interest based on medical necessity; OR (9) Patient has tried another prescription drug in same pharmacologic class as modafinil or armodafinil and discontinued due to lack of efficacy or adverse event
• OR Diagnosis of idiopathic hypersomnia AND (1) Requested agent is Xywav AND (2) All other causes of hypersomnia ruled out AND (3) ONE of the following: tried and had inadequate response to modafinil OR intolerance/hypersensitivity to modafinil OR FDA labeled contraindication to modafinil
• OR Patient has another FDA labeled indication for the requested agent and route of administration AND patient evaluated using polysomnography and/or Multiple Sleep Latency Test AND patient's age within or supported for FDA labeling for the indication
• If the request is for brand Xyrem, ONE of the following: (A) Patient has stage 4 advanced metastatic cancer and requested agent used to treat the cancer or an associated condition consistent with best practices and FDA approval; OR (B) Patient currently treated and stable on requested agent; OR (C) Tried and had inadequate response to authorized generic Sodium Oxybate; OR (D) Authorized generic Sodium Oxybate discontinued due to lack of efficacy or adverse event; OR (E) Patient has intolerance/hypersensitivity to authorized generic Sodium Oxybate not expected with requested agent; OR (F) Patient has FDA labeled contraindication to authorized generic Sodium Oxybate not expected with requested agent; OR (G) Authorized generic Sodium Oxybate expected to be ineffective or cause harm; OR (H) Authorized generic Sodium Oxybate not in best interest based on medical necessity; OR (I) Patient tried another prescription drug in same pharmacologic class as authorized generic Sodium Oxybate and discontinued due to lack of efficacy or adverse event; OR (J) Support for use of requested agent over authorized generic Sodium Oxybate
• Prescriber is a sleep specialist, neurologist, psychiatrist, or has consulted a specialist
• Patient does NOT have any FDA labeled contraindication to the requested agent

Reauthorization criteria

• Patient previously approved for the requested agent through plan’s Prior Authorization Review process
• Prescriber is a sleep specialist, neurologist, psychiatrist, or has consulted a specialist
• Patient has shown clinical benefit with the requested agent
• Patient does NOT have any FDA labeled contraindication to the requested agent

Approval duration

12 months