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.

Delaware Mandate:

Effective September 1, 2017, 18 Delaware Code §§3338B and 3555B, require that no individual policy or contract of health insurance, or certificate issued thereunder, which is delivered, issued for delivery, renewed, modified, altered, or amended in this State by any health insurer, health service corporation or health maintenance organization that directly or indirectly covers the treatment of cancer shall limit or exclude coverage for a drug approved by the United States Food and Drug Administration by mandating that the insured shall first be required to fail to successfully respond to a different drug or drugs or prove a history of failure of such drug or drugs; provided, however that the use of such drug or drugs is consistent with best practices for the treatment of stage 4 advanced, metastatic cancer or, in the case of other cancers, the use of the drug is supported by national clinical guidelines, national standards of care, or peer reviewed medical literature for the treatment of the cancer, or in the case of targeted therapy, the target at issue.

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:

o    Surgical resection; or

o    Pituitary irradiation; or

o    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

·         Central Nervous System Cancers – Meningiomas when used as:

o    Treatment for surgically inaccessible recurrent or progressive meningiomas when further radiation is not possible; or

• Neuroendocrine Tumors - Adrenal Gland Tumors:

o    For symptom control if somatostatin receptor scintigraphy is positive in individuals with non-adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production; or

• Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, and Thymus when used as:

o    Primary treatment for unresected primary gastrinoma; or

o    Management of locoregional unresectable disease and/or distant metastases as a single agent or in combination with other systemic therapies; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or

o    Treatment of underlying Zollinger-Ellison syndrome; or

o    Prophylactic treatment prior to surgery for gastrinoma; or

• Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas when used as:

o    Treatment of symptoms related to hormone hypersecretion; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or

• Thymomas and Thymic Carcinomas when used as second-line therapy with or without prednisone; or
• 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). 

Octreotide acetate (Sandostatin) is considered experimental/investigational for all other indications and therefore non-covered.  Scientific evidence does not support its use for any other indications. 

Octreotide acetate (Sandostatin® LAR) 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:

o    Surgical resection; or

o    Pituitary irradiation; or

o    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
• Central Nervous System Cancers – Meningiomas when used as:

o    Treatment for surgically inaccessible recurrent or progressive meningiomas when further radiation is not possible; or

• Neuroendocrine Tumors - Adrenal Gland Tumors:

o    For symptom control if somatostatin receptor scintigraphy is positive in patientsindividuals with non-adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production; or

• Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, and Thymus when used as:

o    Primary treatment for unresected primary gastrinoma; or

o    Management of locoregional unresectable disease and/or distant metastases as a single agent or in combination with other systemic therapies; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or

o    Treatment of underlying Zollinger-Ellison syndrome; or

o    Prophylactic treatment prior to surgery for gastrinoma; or

o    Treatment of carcinoid syndrome when used as:

§  As a single agent; or

§  In combination with telotristat for persistent diarrhea due to poorly controlled carcinoid syndrome; or

§  In combination with subsequent treatment options for persistent symptoms such as flushing or diarrhea; or

• Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas when used as:

o    Treatment of symptoms related to hormone hypersecretion; if disease progression, treatment with octreotide may be continued in combination with any of the subsequent treatment options; or

o   For tumor control in individuals with unresectable locoregional disease and/or metastatic disease and clinically significant tumor burden or clinically significant progression if not already given; or

• Thymomas and Thymic Carcinomas when used as second-line therapy with or without prednisone; or
• 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).

Octreotide acetate (Sandostatin LAR) is considered experimental/investigational for all other indications and therefore non-covered.  Scientific evidence does not support its use for any other indications.

Lanreotide (Somatuline® Depot) may be considered medically necessary for ANY the following indications:

• Neuroendocrine Tumors - Adrenal Gland Tumors for:

• Symptom control if somatostatin receptor scintigraphy is positive in individuals with non-adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production; or

• Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, and Thymus as:
  • Primary treatment for unresected primary gastrinoma; or
  • Management of locoregional unresectable disease and/or distant metastases as a single agent or in combination with other systemic therapies; if disease progression, treatment with lanreotide may be continued in combination with any of the subsequent treatment options; or
  • Treatment of carcinoid syndrome:
    • As a single agent; or
    • In combination with telotristat for persistent diarrhea due to poorly controlled carcinoid syndrome; or
    • In combination with subsequent treatment options for persistent symptoms such as flushing or diarrhea; or
• Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas for:
  • Treatment of symptoms related to hormone hypersecretion; if disease progression, treatment with lanreotide may be continued in combination with any of the subsequent treatment options; or
  • For tumor control in individuals with unresectable locoregional disease and/or metastatic disease and clinically significant tumor burden or clinically significant progression if not already given; or

• Treatment of individuals with unresectable, well-or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; or

• For the long-term treatment of acromegaly in individuals who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.

 Lanreotide (Somatuline Depot) is considered experimental/investigational for all other indications and therefore non-covered.  Scientific evidence does not support its use for any other indications.

NOTE: Dosage recommendations per the FDA label.