Austedo/Austedo XR Prior Authorization (with Quantity Limit) Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Austedo/Austedo XR will be approved when ALL of the following are met:

1. ONE of the following:
   1. The patient has a diagnosis of chorea associated with Huntington’s disease AND BOTH of the following:
      1. ONE of the following:
         1. The patient does NOT have a current diagnosis of depression
            OR
         2. The patient has a current diagnosis of depression and is being treated for depression
            AND
      2. ONE of the following:
         1. The patient does NOT have a diagnosis of passive suicidal ideation and/or behavior
            OR
         2. The patient has a diagnosis of passive suicidal ideation and/or behavior and must NOT be actively suicidal
            OR
   2. The patient has a diagnosis of tardive dyskinesia AND ONE of the following:
      1. The prescriber has reduced the dose of or discontinued any medications known to cause tardive dyskinesia (i.e., dopamine receptor blocking medications)
         OR
      2. The prescriber has provided clinical rationale indicating that a reduced dose or discontinuation of any medications known to cause tardive dyskinesia is not appropriate
         AND
2. The patient will NOT be using the requested medication in combination with a monoamine oxidase inhibitor (MAOI)
   AND
3. The patient will NOT be using the requested medication in combination with reserpine
   AND
4. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND
5. 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