Somatostatin Analogs - Somatuline Depot Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

PA applies to new starts only

Initial Evaluation

Somatuline Depot will be approved when BOTH of the following are met:

1. ONE of the following:

   1. The patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested medication AND 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

   2. ONE of the following:

      1. The patient has a diagnosis of acromegaly AND ONE of the following:

         1. The patient is NOT a candidate for surgical resection or pituitary radiation therapy
            OR
         2. The requested medication is for adjunctive therapy with pituitary radiation therapy
            OR
         3. The patient had an inadequate response to surgery or pituitary radiation therapy as indicated by growth hormone levels or serum IGF-1 levels that are above the reference range
            OR

      2. The patient has a diagnosis of gastroenteropancreatic neuroendocrine tumors AND BOTH of the following:

         1. The tumors are well or moderately differentiated
            AND

         2. ONE of the following:

            1. The tumors are unresectable, locally advanced
               OR
            2. The patient has metastatic disease
               OR

      3. The patient has a diagnosis of carcinoid syndrome
         OR

      4. The patient has another indication that is supported in CMS approved compendia for the requested medication
         AND

2. The requested dose is within FDA labeled dosing or supported in CMS approved compendia dosing for the requested indication

Length of Approval: 6 months

Renewal Evaluation

Somatuline Depot 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 an FDA labeled indication or an indication that is supported in CMS approved compendia 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. ONE of the following:

         1. The patient has a diagnosis of acromegaly
            OR
         2. The patient has a diagnosis of metastatic OR unresectable, locally advanced, well or moderately differentiated gastroenteropancreatic neuroendocrine tumors
            OR
         3. The patient has a diagnosis of carcinoid syndrome
            OR
         4. The patient has another indication that is supported in CMS approved compendia for the requested medication
            AND

      2. The patient has had clinical benefit with the requested medication
         AND

4. The requested dose is within FDA labeled dosing or supported in CMS approved compendia dosing for the requested indication

Length of Approval: 12 months