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

Prior Authorization and Quantity Limit Criteria for Approval

Sodium oxybate solution will be approved when ALL of the following are met:

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

2. ONE of the following:

   1. The patient has a diagnosis of narcolepsy with cataplexy
      OR

   2. BOTH of the following:

      1. The patient has a diagnosis of narcolepsy with excessive daytime sleepiness
         AND

      2. ONE of the following:

         1. The patient is 7-17 years of age
            OR

         2. ALL of the following:

            1. The patient is 18 years of age or over
               AND

            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 another indication that is supported in CMS approved compendia for the requested medication
      AND

3. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND

4. 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