Wakix — Blue Cross Blue Shield of Texas

Initial criteria

• 1. The patient has ONE of the following: A. Has a diagnosis of excessive daytime sleepiness associated with narcolepsy OR B. Has a diagnosis of cataplexy associated with narcolepsy AND
• 2. ONE of the following: A. BOTH of the following: 1. ONE of the following: A. The patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR B. 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 2. 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 B. ONE of the following: 1. The request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member 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 armodafinil OR modafinil OR 4. Armodafinil OR modafinil 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 armodafinil OR modafinil OR 6. The patient has an FDA labeled contraindication to BOTH armodafinil AND modafinil OR 7. Armodafinil OR modafinil is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug; OR cause a significant barrier to the patient’s adherence of care; OR worsen a comorbid condition; OR decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities; OR cause an adverse reaction or cause physical or mental harm OR 8. Armodafinil OR modafinil 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 armodafinil OR modafinil and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event OR 10. The patient has been prescribed the requested non-controlled agent due to comorbid conditions OR concerns about controlled substance use
• 3. The patient has been evaluated using polysomnography and/or a Multiple Sleep Latency Test
• 4. If the patient has an FDA labeled indication, then ONE of the following: 1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR 2. There is support for using the requested agent for the patient’s age for the requested indication
• 5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, psychiatrist, sleep disorder specialist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
• 6. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review]
• 2. The patient has had clinical benefit with the requested agent
• 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, psychiatrist, sleep disorder specialist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
• 4. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months