Hetlioz - NC Standard

Restricted Product(s)

Restriction applies to brand and generic products

• Hetlioz® (tasimelteon capsule)
• Hetlioz LQTM (tasimelteon suspension)

FDA Approved Use

• Hetlioz capsules
  • For the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults.
  • For the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.
• Hetlioz LQ oral suspension
  • For the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in pediatric patients 3 years to 15 years of age.

Criteria for Approval of Restricted Product(s)

1. The patient has a diagnosis of Non-24-Hour Sleep-Wake Disorder (Non-24); AND; 
   1. The patient is 18 years of age or older; AND
   2. The patient is totally blind; OR 
2. The patient has a diagnosis of Smith-Magenis Syndrome (SMS); AND
   1. The patient is 3 years of age or older; AND
   2. The patient has a history of nighttime sleep disturbances; AND 
   3. The patient has a deletion of chromosome 17p11.2 or RAI1 gene mutation (medical record documentation required); AND
   4. If the request is for Hetlioz LQ suspension:
      1. The patient is between 3 years to 15 years of age; AND 
3. The patient has tried and had an inadequate response to a 3-month trial of melatonin (medical record documentation required); OR
   1. The patient has a clinical contraindication/intolerance to melatonin (medical record documentation required); AND
4. If the request is for brand Hetlioz capsules,
   1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic tasimelteon capsules (medical record documentation required); AND
5. The prescriber is a specialist in the area of the patient’s diagnosis or has consulted with a specialist in the area of the patient’s diagnosis; AND
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

January 2023: Criteria change: Criteria review and formatting changes. Added generic tasimelteon capsules to criteria and requirement of t/f of generic tasimelteon capsules.
July 2021: Criteria change: Specialist and three-month trial of melatonin required for all diagnoses Addition of quantity limit on tablets. Duration of approval decreased to 365 days.
March 2021: Criteria update: Added LQ suspension to the policy along with a quantity limit.
December 2020: Criteria update: Addition of expanded indication for sleep disturbances in Smith-Magenis Syndrome.
October 2019: Criteria update: Reformatted criteria. Changed duration of approval to 3 years.
October 2018: Annual review; No change.
October 2017: Annual review; No change.
October 2016: Annual review; No change.
October 2015: Annual review; No change.
October 2014: Original utilization management criteria issued.