Hetlioz — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ONE of the following:
• A. If the requested agent is Hetlioz capsules, then ONE of the following:
• 1. The patient has BOTH of the following:
• A. Diagnosis of Non-24-hour sleep-wake disorder AND B. Patient is totally blind (no light perception)
• OR 2. BOTH of the following:
• A. Diagnosis of Smith-Magenis Syndrome confirmed by ONE of the following genetic mutations: 1. Heterozygous deletion of 17p11.2 OR 2. Heterozygous pathogenic variant involving RAI1 AND B. Requested agent used to treat nighttime sleep disturbances associated with SMS
• B. If the requested agent is Hetlioz LQ suspension, then BOTH of the following:
• 1. Diagnosis of Smith-Magenis Syndrome confirmed by ONE of the following genetic mutations: A. Heterozygous deletion of 17p11.2 OR B. Heterozygous pathogenic variant involving RAI1 AND 2. Used to treat nighttime sleep disturbances associated with SMS
• OR C. Patient has another FDA labeled indication for the requested agent and route of administration
• OR D. Patient has another indication that is supported in compendia for the requested agent and route of administration
• AND if the patient has an FDA labeled indication, then ONE of the following:
• A. Patient’s age is within FDA labeling for the requested indication OR B. There is support for using the requested agent for the patient’s age for the requested indication
• 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 does NOT have any FDA labeled contraindications to the requested agent
• Compendia allowed: AHFS or DrugDex 1, 2a, or 2b level of evidence
• Approval also applies for members residing in Ohio with Fully Insured or HIM Shop (SG) plan when:
• A. No FDA labeled contraindications AND ONE of the following:
• 1. Another FDA labeled indication for the requested agent and route of administration OR
• 2. Another indication supported in compendia for the requested agent and route of administration OR
• 3. Two peer-reviewed medical journal articles supporting proposed use as generally safe and effective (no case studies)

Reauthorization criteria

• 1. Patient previously approved for the requested agent through the plan’s Prior Authorization process
• 2. Patient has had clinical benefit with the requested agent
• 3. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., sleep specialist, neurologist, psychiatrist) or has consulted with a specialist
• 4. Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months