Sunosi — Blue Cross Blue Shield of Texas

Preferred products

• armodafinil
• modafinil

Initial criteria

• Patient has a diagnosis of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) AND ALL of the following:
• - The underlying airway obstruction has been treated (e.g., continuous positive airway pressure [CPAP]) for at least 1 month prior to initiating therapy with the requested agent
• - The modalities to treat the underlying airway obstruction (e.g., CPAP) will be continued during treatment with the requested agent
• - ONE of the following:
• - The patient has been diagnosed with stage IV advanced metastatic cancer and the requested agent is being used to treat the cancer or an associated condition, AND the use is consistent with best practices, supported by evidence-based literature, and FDA approved
• - The patient is currently being treated with and stable on the requested agent
• - The patient has tried and had an inadequate response to armodafinil OR modafinil
• - Armodafinil OR modafinil was discontinued due to lack of efficacy, effectiveness, diminished effect, or adverse event
• - The patient has an intolerance or hypersensitivity to armodafinil OR modafinil
• - The patient has an FDA labeled contraindication to BOTH armodafinil AND modafinil
• - Armodafinil OR modafinil is expected to be ineffective, cause significant adherence barriers, worsen a comorbid condition, impair functional ability, cause adverse reaction or harm
• - Armodafinil OR modafinil not in best interest of the patient based on medical necessity
• - The patient has tried another prescription drug in the same pharmacologic class or with same mechanism of action as armodafinil OR modafinil and that drug was discontinued due to lack of efficacy, diminished effect, or adverse event
• OR The patient has a diagnosis of excessive daytime sleepiness associated with narcolepsy AND ONE of the following:
• - The patient has stage IV advanced metastatic cancer and the requested agent is used for the cancer or associated condition, consistent with best practices, supported by evidence, and FDA approved
• - The patient is currently treated and stable on the requested agent
• - The patient has tried and had inadequate response to armodafinil OR modafinil
• - Armodafinil OR modafinil was discontinued due to lack of efficacy, effectiveness, diminished effect, or adverse event
• - The patient has intolerance or hypersensitivity to armodafinil OR modafinil
• - The patient has FDA labeled contraindication to BOTH armodafinil AND modafinil
• - Armodafinil OR modafinil ineffective, causes barriers, worsens comorbidities, impairs function, or causes harm
• - Armodafinil OR modafinil not in best interest due to medical necessity concerns
• - The patient has tried another prescription drug in same pharmacologic class or mechanism and discontinued due to lack of efficacy, diminished effect, or adverse event
• AND The patient has been evaluated by polysomnography and/or Multiple Sleep Latency Test
• AND If requested for FDA labeled indication, patient’s age is within or supported for use by evidence for requested indication
• AND Prescriber is a specialist (neurologist, psychiatrist, pulmonologist, sleep disorder specialist) or has consulted with a specialist
• AND Patient does not have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• The patient has had clinical benefit with the requested agent
• If diagnosis is excessive daytime sleepiness associated with OSA, underlying airway obstruction therapy (e.g., CPAP) continues during treatment
• Prescriber is a specialist or has consulted with a specialist in the area of patient’s diagnosis
• The patient does not have any FDA labeled contraindications to the requested agent

Approval duration

12 months