BlueCross BlueShield of Tennessee Medical Policy Manual

Octreotide Suspension (Sandostatin® LAR Depot), Octreotide Acetate for Injectable Suspension

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY         

INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications

Sandostatin LAR Depot, octreotide acetate for injectable suspension

• Indicated in patients in whom initial treatment with Sandostatin Injection/octreotide acetate injection has been shown to be effective and tolerated for:

• Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal.
• Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
• Long-term treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors (VIPomas).

Limitations of Use:

In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin LAR Depot on tumor size, rate of growth and development of metastases, has not been determined.

Compendial Uses

• Neuroendocrine and adrenal tumors (NETs):

• Tumors of the gastrointestinal (GI) tract, lung, and thymus (carcinoid tumors)
• Tumors of the pancreas (islet cell tumors)
• Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
• Pheochromocytoma and paraganglioma

• Thymomas
• Meningiomas
• Merkel cell carcinoma
• Cancer-related diarrhea
• Inoperable malignant bowel obstruction
• Acquired immune deficiency syndrome (AIDS)-associated diarrhea
• Enterocutaneous fistula
• Pancreatic fistulas
• Gastroesophageal varices

• Pituitary adenoma
• Short bowel syndrome
• Zollinger-Ellison syndrome

All other indications are considered experimental/investigational and not medically necessary.

DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:

• For acromegaly:
  • For initial approval: Laboratory report indicating high pretreatment insulin-like growth factor-1 (IGF-1) level and chart notes indicating an inadequate or partial response to surgery or radiotherapy or that surgery or radiotherapy are not an option.

• • For continuation: Laboratory report indicating normal current IGF-1 levels or chart notes indicating that the member’s IGF-1 level has decreased or normalized since initiation of therapy.

• For cancer-related diarrhea: Chart notes indicating grade 3 or 4 diarrhea.

COVERAGE CRITERIA

Acromegaly

Authorization of 12 months may be granted for the treatment of acromegaly when all of the following criteria are met:

• Member has a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range.
• Member meets one of the following:
  • Member had an inadequate or partial response to surgery or radiotherapy.
  • Surgery or radiotherapy are not an option for the member.

Neuroendocrine Tumors (NETs)

• Authorization of 12 months may be granted for treatment of NETs of the gastrointestinal (GI) tract, lung, and thymus (carcinoid tumors).
• Authorization of 12 months may be granted for treatment of NETs of the pancreas (islet cell tumors), including gastrinomas, glucagonomas, and insulinomas.         
• Authorization of 12 months may be granted for treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
• Authorization of 12 months may be granted for treatment of pheochromocytoma and paraganglioma.

Carcinoid Syndrome

Authorization of 12 months may be granted for treatment of carcinoid syndrome.

Vasoactive Intestinal Peptide Tumors (VIPomas)

Authorization of 12 months may be granted for management of symptoms related to hormone hypersecretion of VIPomas.

Thymomas

Authorization of 12 months may be granted for treatment of thymomas.

Meningiomas

Authorization of 12 months may be granted for treatment of meningiomas when used in combination with everolimus for surgically inaccessible recurrent or progressive disease.

Merkel Cell Carcinoma

Authorization of 12 months may be granted for treatment of somatostatin receptor-positive Merkel cell carcinoma as a single agent when the member has a contraindication to anti-PD-L1 and anti-PD-1 therapy and one of the following criteria is met:

• The member has regional disease.
• The member has disease progression while on anti-PD-L1 or anti-PD-1 therapy.

Cancer-Related Diarrhea

Authorization of 12 months may be granted for treatment of cancer-related diarrhea when the member has grade 3 or greater diarrhea according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).

Inoperable Malignant Bowel Obstruction

Authorization of 12 months may be granted for management of GI symptoms (e.g., nausea, pain, vomiting) of inoperable bowel obstruction in members with cancer.

AIDS-Associated Diarrhea

Authorization of 12 months may be granted for treatment of AIDS-associated severe secretory diarrhea when anti-microbial (e.g., ciprofloxacin or metronidazole) or anti-motility agents (e.g., loperamide or diphenoxylate and atropine) have become ineffective.

Enterocutaneous Fistula

Authorization of 12 months may be granted for management of volume depletion from enterocutaneous fistula.

Pancreatic Fistulas

Authorization of 6 months may be granted for prevention and treatment of pancreatic fistulas following pancreatic surgery.

Gastroesophageal Varices

Authorization of 6 months may be granted for treatment of acute bleeding of gastroesophageal varices associated with cirrhosis.

Pituitary Adenoma

Authorization of 12 months may be granted for treatment of pituitary adenoma.

Short Bowel Syndrome

Authorization of 12 months may be granted for treatment of short bowel syndrome in members with large volume stool losses when fluid and electrolyte management is problematic.

Zollinger-Ellison Syndrome

Authorization of 12 months may be granted for treatment of Zollinger-Ellison syndrome.

CONTINUATION OF THERAPY

Acromegaly

Authorization of 12 months may be granted for continuation of therapy for acromegaly when the member’s IGF-1 level has decreased or normalized since initiation of therapy.

NETs, Carcinoid Syndrome, VIPomas, Thymomas, Meningiomas, Merkel Cell Carcinoma, Cancer-Related Diarrhea, Inoperable Malignant Bowel Obstruction, AIDS-Associated Diarrhea, and Zollinger-Ellison Syndrome

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when the member is experiencing clinical benefit as evidenced by improvement or stabilization in clinical signs and symptoms since initiation of therapy.

All Other Indications

All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria.

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

References

1. Sandostatin LAR Depot [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2024.
2. Octreotide acetate for injectable suspension. Parsippany, NJ: Teva Pharmaceuticals; July 2024.
3. Katznelson L, Laws ER, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99:3933-3951.
4. American Association of Clinical Endocrinologists Acromegaly Guidelines Task Force. Medical guidelines for clinical practice for the diagnosis and treatment of acromegaly – 2011 update. Endocr Pract. 2011;17(suppl 4):1-44.
5. The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 7, 2025.
6. Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; 2025. http://online.lexi.com. Accessed November 7, 2025.
7. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology®: Neuroendocrine and Adrenal Tumors. Version 3.2025. Available at: https://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Accessed November 7, 2025.
8. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology^®: Palliative Care Version 1.2026. Available at: https://www.nccn.org/professionals/physician_gls/pdf/palliative.pdf. Accessed November 17, 2025.
9. Fried M. Octreotide in the treatment of refractory diarrhea. Digestion. 1999,60:42‐46.
10. Thapar K, Kovacs K, Stefaneanu L, et al: Antiproliferative effect of the somatostatin analogue octreotide on growth hormone-producing pituitary tumors: Results of a multicenter randomized trial. Mayo Clin Proc 1997; 72:893-900.
11. Iyer K, DiBaise JK, Rubio-Tapia A. AGA Clinical Practice Update on Management of Short Bowel Syndrome: Expert Review. Clin Gastroenterol Hepatol. 2022;20(10):2185-2194.
12. Peeters M, Van den Brande J, Francque S. Diarrhea and the rationale to use Sandostatin. Acta Gastroenterol Belg. 2010;73(1):25-36.
13. Machado NO. Pancreatic fistula after pancreatectomy: Definitions, risk factors, preventive measures, and management – Review. Int J Surg Oncol. 2012;2012:602478.

ORIGINAL EFFECTIVE DATE: 12/1/2016

MOST RECENT REVIEW DATE: 7/31/2026

ID_CHS_2026

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.