Sunosi — Blue Cross Blue Shield of Oklahoma

Preferred products

• armodafinil
• modafinil

Initial criteria

• ONE of the following:
• A. Diagnosis of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) AND ALL of the following:
• 1. The underlying airway obstruction has been treated (e.g., CPAP) for at least 1 month prior to initiating therapy
• 2. The modalities to treat the underlying airway obstruction will be continued during treatment
• 3. ONE of the following:
• A. BOTH of the following:
• 1. The patient has stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR an associated condition
• 2. The use of the requested agent is consistent with best practices, supported by peer-reviewed evidence, and FDA approved
• OR B. The patient is currently being treated with the requested agent and is stable OR
• C. The patient has tried and had an inadequate response to armodafinil OR modafinil OR
• D. Armodafinil OR modafinil was discontinued due to lack of efficacy, effectiveness, diminished effect, or adverse event OR
• E. The patient has intolerance or hypersensitivity to armodafinil OR modafinil OR
• F. The patient has an FDA labeled contraindication to BOTH armodafinil AND modafinil OR
• G. Armodafinil OR modafinil is expected to be ineffective, cause adverse events, worsen comorbid condition, or reduce adherence OR function OR
• H. Armodafinil OR modafinil is not in the best interest of the patient based on medical necessity OR
• I. The patient has tried another agent in same pharmacologic class or mechanism as armodafinil OR modafinil and discontinued due to inadequate response
• B. Diagnosis of excessive daytime sleepiness associated with narcolepsy AND ONE of the following:
• 1. BOTH of the following:
• A. The patient has stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR an associated condition AND
• B. The use of the requested agent is consistent with best practices and FDA approved
• OR 2. Patient is currently being treated with and stable on the requested agent OR
• 3. Tried and had inadequate response to armodafinil OR modafinil OR
• 4. Armodafinil OR modafinil discontinued due to lack of efficacy, adverse events, or intolerance OR
• 5. Has intolerance or hypersensitivity to armodafinil OR modafinil OR
• 6. Has FDA labeled contraindication to BOTH armodafinil AND modafinil OR
• 7. Armodafinil/modafinil expected to be ineffective, reduce adherence, worsen comorbidity, or cause harm OR
• 8. Not in the best interest based on medical necessity OR
• 9. Tried another drug in same pharmacologic class or mechanism as armodafinil OR modafinil and discontinued due to inadequate response
• AND patient has been evaluated by polysomnography and/or Multiple Sleep Latency Test
• AND patient’s age is within FDA labeling or supported use for patient’s age and indication
• AND prescriber is a specialist in neurology, psychiatry, pulmonology, or sleep disorders, or has consulted one
• AND patient does NOT have any FDA labeled contraindications
• Additional approval pathway (Ohio): member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND BOTH of the following:
• A. No FDA labeled contraindications AND
• B. ONE of: another FDA labeled indication for requested agent, indication supported in compendia, OR two peer-reviewed journal articles supporting proposed use

Reauthorization criteria

• 1. Patient previously approved for the requested agent through plan’s PA process
• 2. Patient has had clinical benefit with the requested agent
• 3. If diagnosis is OSA, modalities to treat airway obstruction (e.g., CPAP) will be continued
• 4. Prescriber is specialist in neurology, psychiatry, pulmonology, or sleep disorders, or has consulted one
• 5. Patient does NOT have any FDA labeled contraindications

Approval duration

12 months