Hetlioz LQ — Blue Cross Blue Shield of Montana

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: heterozygous deletion of 17p11.2 OR heterozygous pathogenic variant involving RAI1 AND B. The requested agent is used to treat nighttime sleep disturbances associated with SMS OR 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: heterozygous deletion of 17p11.2 OR heterozygous pathogenic variant involving RAI1 AND 2. The requested agent is 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 supported in compendia for the requested agent and route of administration
• 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 and agent OR B. There is support for use at the patient’s age for the requested indication
• Prescriber is a specialist in area of diagnosis (e.g., sleep specialist, neurologist, psychiatrist) or has consulted with one
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Compendia allowed: AHFS, DrugDex 1, 2a, or 2b level of evidence
• Alternative additional pathway: Member resides in Ohio AND Plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: A. No FDA labeled contraindications to the requested agent AND B. ONE of the following: 1. Patient has another FDA labeled indication OR 2. Patient has another compendia supported indication OR 3. Prescriber has submitted TWO peer-reviewed articles supporting the proposed use (acceptable: randomized, double blind, placebo controlled clinical trials; case studies not accepted)

Reauthorization criteria

• 1. Patient previously approved through plan’s Prior Authorization process
• 2. Patient has had clinical benefit with the requested agent
• 3. Prescriber is a specialist in area of diagnosis or has consulted with one
• 4. Patient does NOT have any FDA labeled contraindications

Approval duration

12 months