Xermelo Prior Authorization (with Quantity Limit) Criteria – Medicare Part D

Prior authorization criteria for approval

Initial Evaluation

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

1. The patient has a diagnosis of carcinoid syndrome diarrhea
   AND

2. The patient has tried and had an inadequate response to treatment with a somatostatin analog [e.g., Sandostatin (octreotide), Sandostatin LAR (octreotide), Somatuline Depot (lanreotide)]
   AND

3. The requested medication will be used in combination with a somatostatin analog [e.g., Sandostatin (octreotide), Sandostatin LAR (octreotide), Somatuline Depot (lanreotide)]
   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

Renewal Evaluation

Xermelo 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. The patient has a diagnosis of carcinoid syndrome diarrhea
   AND

3. The patient has had clinical benefit with the requested medication (e.g., reduction in the average number of daily bowel movements)
   AND

4. The requested medication will be used in combination with a somatostatin analog [e.g., Sandostatin (octreotide), Sandostatin LAR (octreotide), Somatuline Depot (lanreotide)]
   AND

5. 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