Medical Policy Manual
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Medical Policy Manual
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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

Compendial Uses

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

DOCUMENATION

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

Coverage Criteria

Acromegaly

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

Neuroendocrine Tumors (NETs)

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.

Pheochromocytoma and Paraganglioma

Authorization of 12 months may be granted for treatment of pheochromocytoma and paraganglioma.

Thymomas and Thymic Carcinomas

Authorization of 12 months may be granted for treatment of thymomas and thymic carcinomas.

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.

Inoperable Bowel Obstruction in Cancer

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.

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 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

Enterocutaneous Fistula

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

Gastroesophageal Varices

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

Pancreatic Fistulas

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

Pituitary Adenoma

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

Short Bowel Syndrome

Authorization of 12 months may be grated for treatment of short bowel syndrome when the daily intravenous fluid requirement is greater than 3 liters.

Zollinger-Ellison Syndrome

Authorization of 12 months may be grated 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, Pheochromocytoma/Paraganglioma, Thymomas/Thymic Carcinomas, AIDS-Associated Diarrhea, Bowel Obstruction, Cancer-Related 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 2023.
  2. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 14, 2023.
  3. Clinical Consult. CVS Caremark Clinical Programs Review: Focus on Pediatric Endocrinology. September 2007.
  4. Katznelson L, Laws ER, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99:3933-3951.
  5. 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.
  6. The NCCN Clinical Practice Guidelines in Oncology® Neuroendocrine and Adrenal Tumors (Version 1.2023). © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed Novermber 14, 2023.
  7. Rinke A, Muller H, Schade-Brittinger C, et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID study group. J Clin Oncol. 2009;27:4656-4663.
  8. 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.
  9. The NCCN Clinical Practice Guidelines in Oncology® Thymomas and Thymic Carcinomas. (Version 1.2023). © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 14, 2023.
  10. The NCCN Clinical Practice Guidelines in Oncology® Palliative Care (Version 2.2023). © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 14, 2023.
  11. Harris AG, O'Dorisio TM, Woltering EA, et al. Consensus statement: Octreotide dose titration in secretory diarrhea. Diarrhea Management Consensus Development Panel. Dig Dis Sci. 1995;40(7):1464-1473.
  12. Fried M. Octreotide in the treatment of refractory diarrhea. Digestion. 1999,60:42‐46.
  13. Edmunds MC, Chen JD, Soykan I, et al. Effect of octreotide on gastric and small bowel motility in patients with gastroparesis. Aliment Pharmacol Ther. 1998;12(2):167-174.
  14. Ripamonti C, Mercadante S, Groff L, et al. Role of octreotide, scopolamine butylbromide, and hydration in symptom control of patients with inoperable bowel obstruction and nasogastric tubes: A prospective randomized trial. J Pain Symptom Manage. 2000;19(1):23-34.
  15. Mercadante S, Ripamonti C, Casuccio A, et al. Comparison of octreotide and hyoscine butylbromide in controlling gastrointestinal symptoms due to malignant inoperable bowel obstruction. Support Care Cancer. 2000;8(3):188-191.
  16. Dorta G. Role of octreotide and somatostatin in the treatment of intestinal fistulae. Digestion. 1999;60 Suppl 2:53-56.
  17. Jamil M, Ahmed U, Sobia H. Role of somatostatin analogues in the management of enterocutaneous fistulae. J Coll Physicians Surg Pak. 2004;14(4):237-240.
  18. Rahbour G, Siddiqui MR, Ullah MR, et al. A meta-analysis of outcomes following use of somatostatin and its analogues for the management of enterocutaneous fistulas. Ann Surg. 2012;256(6):946-954.
  19. Freitas DS, Sofia C, Pontes JM, et al. Octreotide in acute bleeding esophageal varices: A prospective randomized study. Hepatogastroenterology. 2000;47(35):1310-1314.
  20. Imperiale TF, Teran JC, McCullough AJ. A meta-analysis of somatostatin versus vasopressin in the management of acute esophageal variceal hemorrhage. Gastroenterology. 1995;109(4):1289-1294.
  21. Gøtzsche PC, Hróbjartsson A. Somatostatin analogues for acute bleeding oesophageal varices. Cochrane Database Syst Rev. 2008;(3):CD000193.
  22. Erstad BL. Octreotide for acute variceal bleeding. Ann Pharmacother. 2001;35(5):618-626.
  23. Corley DA, Cello JP, Adkisson W, et al. Octreotide for acute esophageal variceal bleeding: A meta-analysis. Gastroenterology. 2001;120(4):946-954.
  24. Gross M, Schiemann U, Muhlhofer A, Zoller WG. Meta-analysis: Efficacy of therapeutic regimens in ongoing variceal bleeding. Endoscopy. 2001;33(9):737-746.
  25. Li-Ling J, Irving M. Somatostatin and octreotide in the prevention of postoperative pancreatic complications and the treatment of enterocutaneous pancreatic fistulas: A systematic review of randomized controlled trials. Br J Surg. 2001;88(2):190-199.
  26. Machado NO. Pancreatic fistula after pancreatectomy: Definitions, risk factors, preventive measures, and management – Review. Int J Surg Oncol. 2012;2012:602478.
  27. Adachi T, Kuroki T, Kitasato A, et al.  Safety and efficacy of early drain removal and triple-drug therapy to prevent pancreatic fistula after distal pancreatectomy. Pancreatology 2015;15:411-416.
  28. Gurusamy KS, Koti R, Fusai G, Davidson BR. Somatostatin analogues for pancreatic surgery. Cochrane Database Syst Rev. 2013;4:CD008370.
  29. Alberta Provincial CNS Tumour Team. Pituitary adenomas. Clinical Practice Guideline No. CNS-006 Edmonton, AB: Alberta Health Services, Cancer Care; August 2012.
  30. Peeters M, Van den Brande J, Francque S. Diarrhea and the rationale to use Sandostatin. Acta Gastroenterol Belg. 2010;73(1):25-36.
  31. Mystakidou K, Tsilika E, Kalaidopoulou O, et al. Comparison of octreotide administration vs conservative treatment in the management of inoperable bowel obstruction in patients with far advanced cancer: A randomized, double- blind, controlled clinical trial. Anticancer Res. 2002;22(2B):1187-1192.
  32. American Gastroenterological Association. American Gastroenterological Association medical position statement: Short bowel syndrome and intestinal transplantation. Gastroenterology. 2003;124(4):1105-1110.
  33. Loehrer PJ Sr, Wang W, Johnson DH, et al. Octreotide alone or with prednisone in patients with advanced thymoma and thymic carcinoma: An Eastern Cooperative Oncology Group Phase II Trial. J Clin Oncol. 2004;22(2):293-299.
  34. Leandros E, Antonakis PT, Albanopoulos K, et al. Somatostatin versus octreotide in the treatment of patients with gastrointestinal and pancreatic fistulas. Can J Gastroenterol. 2004;18(5):303-306.
  35. Allen PJ, Gonen M, Brennan MF, et al. Pasireotide for postoperative pancreatic fistula. N Engl J Med. 2014;370(21):2014-2022.
  36. Lexicomp Online®, Lexi-Drugs. Waltham, MA: UpToDate, Inc.; Updated November 1, 2023. http://online.lexi.com [available with subscription]. Accessed November 10, 2023.
  37. Octreotide acetate for injectable suspension. Parsippany, NJ: Teva Pharmaceuticals; January 2024.

ORIGINAL EFFECTIVE DATE: 12/1/2016

MOST RECENT REVIEW DATE: 1/14/2025

ID_CHS

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.

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