Ztalmy Prior Authorization Criteria - Medicare Part D

Prior authorization criteria for approval

PA applies to new starts only

Initial Evaluation

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

1. BOTH of the following:

   1. The patient has a diagnosis of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
      AND
   2. The patient is within the FDA labeled age for the requested medication
      AND

2. ONE of the following:

   1. There is evidence of a claim that the patient is currently being treated with the requested medication within the past 180 days
      OR

   2. The prescriber states the patient is currently being treated with the requested medication
      OR

   3. BOTH of the following:

      1. The patient’s diagnosis has been confirmed with genetic testing indicating variant in CDKL5 gene
         AND
      2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist) 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. BOTH of the following:

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

Length of Approval: 12 months

Renewal Evaluation

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

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria
   AND

2. BOTH of the following:

   1. The patient has a diagnosis of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
      AND
   2. The patient is within the FDA labeled age for the requested medication
      AND

3. ONE of the following:

   1. There is evidence of a claim that the patient is currently being treated with the requested medication within the past 180 days
      OR

   2. The prescriber states the patient is currently being treated with the requested medication
      OR

   3. BOTH of the following:

      1. The patient has had clinical benefit with the requested medication
         AND
      2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
         AND

4. ONE of the following:

   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR

   2. BOTH of the following:

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

Length of Approval: 12 months