Somatostatin Analogs - Octreotide Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Initial Evaluation

Octreotide acetate will be approved when ALL 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 90 days
         OR
      2. The prescriber states the patient is currently being treated with the requested medication AND provided clinical justification to support that the patient is at risk if therapy is changed
         OR

   2. ONE of the following:

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

         1. 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 severe diarrhea and/or flushing episodes associated with metastatic carcinoid tumors
         OR

      3. The patient has profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors
         OR

      4. The patient has a diagnosis of dumping syndrome AND ONE of the following:

         1. The patient has tried and had an inadequate response to acarbose
            OR
         2. The patient has an intolerance or hypersensitivity to acarbose
            OR
         3. The patient has an FDA labeled contraindication to acarbose
            OR

      5. 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

Octreotide acetate 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. ONE of the following:

   1. The patient has a diagnosis of acromegaly
      OR
   2. The patient has severe diarrhea and/or flushing episodes associated with metastatic carcinoid tumors
      OR
   3. The patient has profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors
      OR
   4. The patient has a diagnosis of dumping syndrome
      OR
   5. The patient has another indication that is supported in CMS approved compendia for the requested medication
      AND

3. 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