Sodium Oxybate - Xywav Prior Authorization (with Quantity Limit) Criteria - Medicare Part D

Prior Authorization and Quantity Limit Criteria for Approval

Xywav will be approved when ALL of the following are met:

1. ONE of the following:

   1. The patient has a diagnosis of narcolepsy with cataplexy AND the patient is at least 7 years of age
      OR

   2. The patient has a diagnosis of narcolepsy with excessive daytime sleepiness AND ALL of the following:

      1. The patient is at least 7 years of age
         AND

      2. ONE of the following:

         1. The patient is under 18 years of age
            OR

         2. ONE of the following:

            1. The patient has tried and had an inadequate response to modafinil or armodafinil
               OR
            2. The patient has an intolerance or hypersensitivity to modafinil or armodafinil
               OR
            3. The patient has an FDA labeled contraindication to modafinil or armodafinil
               AND

      3. ONE of the following:

         1. The patient has tried and had an inadequate response to ONE standard stimulant medication (e.g., methylphenidate)
            OR
         2. The patient has an intolerance or hypersensitivity to ONE standard stimulant medication (e.g., methylphenidate)
            OR
         3. The patient has an FDA labeled contraindication to ONE standard stimulant medication (e.g., methylphenidate)
            OR

   3. The patient has a diagnosis of idiopathic hypersomnia AND the patient is at least 18 years of age
      AND

2. The patient does NOT have any FDA labeled contraindications to the requested medication
   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) does NOT exceed the maximum FDA labeled dose for the requested indication
         AND
      3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
         OR

   3. ALL of the following:

      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication
         AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months