Octreotide acetate is a somatostatin analogue indicated for treatment of acromegaly, severe diarrhea/flushing episodes associated with metastatic carcinoid tumors and profuse watery diarrhea associated with VIP-secreting tumors. Sandostatin can be given intravenously or subcutaneously, Sandostatin LAR depot formulation is given intramuscularly and Somatuline Depot is given via deep subcutaneous injection.

Octreotide acetate (Sandostatin®) may be considered medically necessary for ANY the following indications:

• Acromegaly for individuals who have had an inadequate response to or cannot be treated with:
  • Surgical resection; or
  • Pituitary irradiation; or
  • Bromocriptine mesylate at maximally tolerated doses; or
• Severe diarrhea and/or flushing episodes associated with metastatic carcinoid tumors; or
• Profuse watery diarrhea associated with vasoactive intestinal peptide (VIP) secreting tumors; or

Other Medically Accepted Non-FDA Approved Indications, Class IIb or Higher Grade Recommendation

• Poorly Differentiated (High Grade)/Large or Small Cell for symptom control if somatostatin scintigraphy positive; or
• Acquired immune deficiency syndrome (AIDS) - treatment of severe secretory diarrhea associated with AIDS when anti-microbial (e.g., ciprofloxacin or metronidazole) or anti-motility agents (eg. loperamide or diphenoxylate and atropine) have become ineffective; or
• Bowel obstruction - management of gastrointestinal (GI) symptoms (e.g., nausea, pain, vomiting) of inoperable bowel obstruction in persons with terminal cancer; or
• Amelioration of volume depletion from enterocutaneous fistula; or
• Prevention and treatment of pancreatic fistulas following pancreatic surgery; or
• Bleeding gastroesophageal (GE) varices when BOTH of the following are met:
  • GE varices are associated with liver disease; and
  • Octreotide acetate is used in combination with endoscopic therapy (that is, band ligation or sclerotherapy) or alone if endoscopic therapy is not immediately available; or
• Chemotherapy or radiation-induced diarrhea that is unresponsive to conventional antidiarrheal medications (e.g., diphenoxylate and atropine or loperamide); or
• Severe intractable diarrhea associated with graft versus host disease.

Compendia Sources

• Octreotide acetate (Sandostatin) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.

The use of Octreotide acetate (Sandostatin) not meeting the criteria as indicated in this policy is considered not covered.

Octreotide acetate (Sandostatin® LAR) may be considered medically necessary for ANY the following indications:

• In individuals for whom initial treatment with octreotide subcutaneous injection has been shown to be effective and tolerated of ANY of the following:
  • Acromegaly; or
  • Severe diarrhea and/or flushing episodes associated with metastatic carcinoid tumors; or
  • Profuse watery diarrhea associated with vasoactive intestinal peptide (VIP) secreting tumors; or

Other Medically Accepted Non-FDA Approved Indications, Class IIb or Higher Grade Recommendation

• Poorly Differentiated (High Grade)/Large or Small Cell for symptom control if somatostatin scintigraphy positive; or
• Acquired immune deficiency syndrome (AIDS) - treatment of severe secretory diarrhea associated with AIDS when anti-microbial (e.g., ciprofloxacin or metronidazole) or anti-motility agents (eg. loperamide or diphenoxylate and atropine) have become ineffective; or
• Bowel obstruction - management of gastrointestinal (GI) symptoms (e.g., nausea, pain, vomiting) of inoperable bowel obstruction in persons with terminal cancer; or
• Amelioration of volume depletion from enterocutaneous fistulae: or
• Prevention and treatment of pancreatic fistulas following pancreatic surgery; or
• Bleeding gastroesophageal (GE) varices when BOTH of the following are met:
  • GE varices are associated with liver disease; and
  • Octreotide acetate is used in combination with endoscopic therapy (that is, band ligation or sclerotherapy) or alone if endoscopic therapy is not immediately available; or
• Chemotherapy or radiation-induced diarrhea that is unresponsive to conventional antidiarrheal medications (e.g., diphenoxylate and atropine or loperamide); or
• Severe intractable diarrhea associated with graft versus host disease.

Compendia Sources

Octreotide acetate (Sandostatin LAR) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.

The use of Octreotide acetate (Sandostatin LAR) not meeting the criteria as indicated in this policy is considered not medically necessary.

Somatuline Depot may be considered medically necessary for ANY the following indications:

• The long-term treatment of acromegalic individuals who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy; or
• The treatment of adult individuals with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; or
• The treatment of adults with carcinoid syndrome.

Lanreotide may be considered medically necessary for ANY the following indications:

• The long-term treatment of acromegalic individuals who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy; or
• The treatment of adult individuals with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

Compendia Sources

Lanreotide and Somatuline Depot may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.

The use of lanreotide and Somatuline Depot not meeting the criteria as indicated in this policy is considered not medically necessary.

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits. 

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