Sodium oxybate — Blue Cross Blue Shield of Montana

Preferred products

• Authorized generic Sodium Oxybate

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. BOTH of the following:
• A. ONE of the following:
• 1. The patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR
• 2. The patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat an associated condition related to stage four advanced metastatic cancer AND
• B. The use of the requested agent is consistent with best practices for the treatment of stage four advanced, metastatic cancer, or an associated condition; supported by peer-reviewed, evidence-based literature; and approved by the United States Food and Drug Administration OR
• 2. The patient is currently being treated with the requested agent and the patient is currently stable on the requested agent OR
• 3. The patient has tried and had an inadequate response to modafinil OR armodafinil OR
• 4. Modafinil OR armodafinil was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event OR
• 5. The patient has an intolerance or hypersensitivity to modafinil OR armodafinil OR
• 6. The patient has an FDA labeled contraindication to BOTH modafinil AND armodafinil OR
• 7. Modafinil OR armodafinil is expected to be ineffective, cause a significant barrier to adherence, worsen a comorbid condition, decrease the ability to perform daily activities, or cause adverse reaction/harm OR
• 8. Modafinil OR armodafinil is not in the best interest of the patient based on medical necessity OR
• 9. The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as modafinil or armodafinil and that drug was discontinued due to lack of efficacy 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 have been 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 of administration AND
• The patient has been evaluated using polysomnography and/or a Multiple Sleep Latency Test AND
• If the patient has an FDA labeled indication, ONE of the following: age within FDA labeling OR supported off-label use for age AND
• If the request is for brand Xyrem, then ONE of the following:
• A. BOTH of the following: 1. stage 4 metastatic cancer use as described above AND 2. use supported by evidence-based literature OR
• B. The patient is currently treated and stable OR
• C. The patient has tried and had an inadequate response to authorized generic Sodium Oxybate OR
• D. Authorized generic Sodium Oxybate was discontinued due to lack of efficacy, diminished effect, or adverse event OR
• E. The patient has an intolerance or hypersensitivity to authorized generic Sodium Oxybate that is not expected with Xyrem OR
• F. The patient has an FDA labeled contraindication to authorized generic Sodium Oxybate that is not expected with Xyrem OR
• G. Authorized generic Sodium Oxybate is expected to be ineffective, cause adherence barrier, worsen comorbidity, decrease functional ability, or cause harm OR
• H. Authorized generic Sodium Oxybate is not in the best interest of the patient OR
• I. The patient has tried another drug in the same pharmacologic class or mechanism and discontinued due to lack of efficacy or adverse event OR
• J. There is support for use over authorized generic Sodium Oxybate AND
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., sleep specialist, neurologist, psychiatrist) or has consulted with such specialist AND
• The patient does NOT have any FDA labeled contraindications to the requested agent.
• Length of Approval: 12 months
• Ohio-specific condition: member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND criteria for off-label or compendia-supported use met.

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s prior authorization process AND
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., sleep specialist, neurologist, psychiatrist) or has consulted with a specialist AND
• The patient has shown clinical benefit with the requested agent AND
• The patient does NOT have any FDA labeled contraindications to the requested agent.
• Length of Approval: 12 months

Approval duration

12 months