Prior Authorization and Quantity Limit Criteria for Approval

Tasimelteon capsules will be approved when ALL of the following are met:

1. ONE of the following:
   1. ALL of the following:
      1. The patient has a diagnosis of Non-24-hour sleep-wake disorder
         AND
      2. The patient is totally blind (i.e., no light perception)
         AND
      3. The patient is at least 18 years of age
         OR
   2. ALL of the following:
      1. The patient has a diagnosis of Smith-Magenis Syndrome (SMS) confirmed by the presence of ONE of the following genetic mutations:
         1. A heterozygous deletion of 17p11.2
            OR
         2. A heterozygous pathogenic variant involving RAI1
            AND
      2. The requested medication is being used to treat nighttime sleep disturbances associated with SMS
         AND
      3. The patient is at least 16 years of age
         AND
2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, sleep specialist, psychiatrist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
3. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR
   2. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
         AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months