CMS Octreotide Acetate for Injectable Suspension (Sandostatin® LAR Depot) Form

Summary Of Evidence

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Analysis of Evidence

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Octreotide acetate is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone, somatostatin. Octreotide acetate for injectable suspension is a long-acting dosage form containing octreotide. It maintains all of the clinical and pharmacological characteristics of the immediate-release dosage form, octreotide acetate, with the added feature of slow release of octreotide from the site of injection, reducing the need for frequent administration.

Octreotide exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of growth hormone, glucagon, and insulin than somatostatin. By virtue of these pharmacological actions, octreotide has been used to treat the symptoms associated with metastatic carcinoid tumors (severe diarrhea and flushing) and vasoactive intestinal peptide (VIP) secreting adenomas (profuse watery diarrhea).

Octreotide substantially reduces, and in many cases, can normalize growth hormone and/or IGF-1 (somatomedin C) levels in patients with acromegaly.

• Octreotide acetate for injectable suspension is Food and Drug Administration (FDA) approved for the reduction of growth hormone and IGF-1 in patients with acromegaly, for whom medical treatment is appropriate, and who have been shown to respond to and can tolerate short-acting subcutaneous octreotide acetate. The goal of treatment is to reduce growth hormone and IGF-1 levels to normal. It is also used in patients who have had an inadequate response to surgery or in those for whom surgical resection is not an option. It is also used in patients who have received radiation and have had an inadequate therapeutic response.

• It is FDA approved for the suppression of severe diarrhea and flushing associated with malignant carcinoid syndrome in patients in whom initial treatment with short-acting, subcutaneous octreotide acetate has been effective and tolerated.
  
  
• It is FDA approved for long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors in patients in whom initial treatment with short-acting, subcutaneous octreotide acetate has been shown to be effective.
  
  
• The approved route of administration of octreotide acetate for injectable suspension is intragluteally, and it must be administered under the direct supervision of a physician.
  
  
• Octreotide acetate for injectable suspension is covered only when it is used according to FDA guidelines.
  
  
• A trial of therapy using the short-acting, subcutaneous form of octreotide acetate is a prerequisite prior to administering the long-acting octreotide acetate suspension. However, the short-acting, subcutaneous form of octreotide is noncovered by Palmetto Government Benefit Administrators (GBA), because it is self-administrable.
  
  
• Octreotide is covered for chemotherapy-induced diarrhea (CID) when oral antidiarrheal medications, such as loperamide, have become ineffective.