Sunosi — Blue Cross Blue Shield of Montana

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. Underlying airway obstruction has been treated (e.g., CPAP) for at least 1 month prior to initiating therapy
• 2. Modalities to treat airway obstruction (e.g., CPAP) will be continued during treatment
• 3. ONE of the following:
• A. Patient has stage IV advanced metastatic cancer and requested agent is being used to treat the cancer or an associated condition AND use is consistent with best practices and FDA approval OR
• B. Patient is currently being treated and stable on the requested agent OR
• C. Patient has tried and had inadequate response to armodafinil OR modafinil OR
• D. Armodafinil OR modafinil discontinued due to lack of efficacy, diminished effect, or adverse event OR
• E. Patient has intolerance or hypersensitivity to armodafinil OR modafinil OR
• F. Patient has FDA labeled contraindication to BOTH armodafinil AND modafinil OR
• G. Armodafinil OR modafinil expected to be ineffective, cause significant barrier to adherence, worsen comorbid condition, decrease functional ability, or cause harm OR
• H. Armodafinil OR modafinil not in patient's best interest based on medical necessity OR
• I. Tried another prescription drug in the same pharmacologic class or with similar mechanism as armodafinil/modafinil, discontinued due to lack of efficacy or intolerance OR
• B. Diagnosis of excessive daytime sleepiness associated with narcolepsy AND ONE of the following:
• 1. Patient has stage IV advanced metastatic cancer and use is consistent with best practices and FDA approval OR
• 2. Patient currently 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 or adverse event OR
• 5. Intolerance or hypersensitivity to armodafinil OR modafinil OR
• 6. FDA labeled contraindication to BOTH armodafinil AND modafinil OR
• 7. Armodafinil OR modafinil expected to be ineffective, cause significant barrier to adherence, worsen comorbid condition, decrease functional ability, or cause harm OR
• 8. Armodafinil OR modafinil not in best interest based on medical necessity OR
• 9. Tried another prescription in same pharmacologic class as armodafinil/modafinil, discontinued due to lack of efficacy or intolerance
• AND the following additional conditions are met:
• 2. Patient has been evaluated by polysomnography and/or Multiple Sleep Latency Test
• 3. If patient has FDA labeled indication, ONE of the following:
• A. Patient’s age is within FDA labeling for the indication OR
• B. There is supportive evidence for patient’s age for that indication
• 4. Prescriber is or has consulted with a specialist (neurologist, psychiatrist, pulmonologist, sleep disorder specialist)
• 5. Patient has no FDA labeled contraindications to the requested agent
• For members residing in Ohio and plan is Fully Insured or HIM Shop (SG), BOTH of the following:
• A. Patient has no FDA labeled contraindications to requested agent AND
• B. ONE of the following:
• 1. Patient has another FDA labeled indication for requested agent
• 2. Patient has another indication supported in compendia (DrugDex, AHFS-DI, NCCN, LexiDrugs, etc.)
• 3. Prescriber submitted two peer-reviewed journal articles supporting proposed use

Reauthorization criteria

• 1. Patient has been previously approved for requested agent through plan’s PA process
• 2. Patient has had clinical benefit with requested agent
• 3. If diagnosis is OSA, airway obstruction treatment (e.g., CPAP) will be continued
• 4. Prescriber is or has consulted with appropriate specialist (neurologist, psychiatrist, pulmonologist, or sleep disorder specialist)
• 5. Patient has no FDA labeled contraindications to requested agent

Approval duration

12 months