BlueCross BlueShield of Tennessee Medical Policy Manual

Octreotide (Systemic)

DESCRIPTION

Octreotide is a long-acting analog of the natural hormone somatostatin. It inhibits the secretion of multiple hormones, including growth hormone (GH), glucagon, insulin, gastrin, vasoactive intestinal peptide, secretin, motilin and pancreatic polypeptide. Additionally, octreotide suppresses the response of luteinizing hormone (LH) to gonadotropin-releasing hormone (GnRH) and decreases splanchnic blood flow.

Examples of preparations of octreotide are: Sandostatin® and Sandostatin LAR® Depot.

REFER TO DECISION SUPPORT TREE

POLICY

Octreotide for the treatment of the following conditions is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

Acromegaly
Metastatic carcinoid tumors
Vasoactive intestinal polypeptide tumors (VIPomas)
Life-threatening hypotension
Glucagonomas
Insulinomas

Octreotide for the treatment of other conditions/diseases, including, but not limited to hepatocellular carcinoma is considered investigational. (See Applicable Tennessee State Mandate Requirements below.)

MEDICAL APPROPRIATENESS

Octreotide for the treatment of ANY ONE of the following is considered medically appropriate if criteria is met:

For the reduction of growth hormone, and IGF-I (insulin-like growth factor I or somatomedin C) blood levels associated with acromegaly with ANY ONE of the following:

Inadequate response to surgery, or surgical resection is not an option
Inability to tolerate or inadequate response to bromocriptine mesylate at maximum tolerable doses
Inadequate response to pituitary irradiation, or irradiation is not an option
For adjunctive therapy with irradiation to help relieve symptoms of acromegaly and possibly slow the rate of tumor growth

For severe diarrhea and facial flushing episodes associated with metastatic carcinoid tumors
For profuse watery diarrhea associated with vasoactive intestinal polypeptide tumors (VIPomas)
For the management of acute life-threatening hypotension associated with carcinoid crisis
For the prevention of carcinoid crisis precipitated by anesthesia, surgery, initiation of chemotherapy, or infection in individuals with metastatic carcinoid tumors
For preoperative management of insulinomas to stabilize glucose level
For preoperative treatment to stabilize glucagonomas

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.

Drugdex recognizes the use of octreotide in the treatment of:

Bleeding esophageal varices with an appropriate adjunctive therapeutic intervention such as sclerotherapy
Hyperinsulinemia from severe refractory metastatic insulinoma as palliative treatment
Secretory diarrhea in patients with AIDS (acquired immunodeficiency syndrome) that has failed antibiotic/anti-motility therapy
Non-infective diarrhea:

chemotherapy-induced diarrhea
acute radiation-induced diarrhea
persistent ileostomy diarrhea
refractory familial amyloidotic polyneuropathy-induced diarrhea

The NCCN Drugs & Biologics Compendium recognizes the use of octreotide for additional uses beyond the FDA-approved labeling in the treatment of the following conditions (Refer to the NCCN Drugs & Biologics Compendium or NCCN Clinical Practice Guidelines for detailed recommendations):

Neuroendocrine tumors
Thymic Malignancies

ADDITIONAL INFORMATION

For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of octreotide for the treatment of conditions/diseases including, but not limited to hepatocellular carcinoma.

SOURCES

Lexi-Comp Online. (2009). AHFS DI. Octreotide acetate. Retrieved September 30, 2009 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Octreotide. Retrieved September 30, 2009 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2009). NCCN Drugs & Biologics Compendium™. Ocetreotide acetate. Retrieved October 1, 2009 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2008, August). Center for Drug Evaluation and Research. FDA Labeling Information. Sandostatin® octreotide acetate injection. Retrieved September 30, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019667s054lbl.pdf.

U. S. Food and Drug Administration. (2008, March). Center for Drug Evaluation and Research. FDA Labeling Information. Sandostatin LAR® Depot (octreotide acetate for injectable suspension). Retrieved September 30, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021008s021lbl.pdf.

ORIGINAL EFFECTIVE DATE: 11/1/2004

MOST RECENT REVIEW DATE: 3/11/2010

ID_BT

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.

Pharmaceutical Decision Support Tree

Octreotide (Sandostatin® and Sandostatin LAR® Depot)

Is the requested medication being used to treat hepatocellular carcinoma?

If yes, this does not meet medical necessity and/or medical appropriateness criteria

If no, go to question #2

Is the agent being used for the reduction of growth hormone, and IGF-I (insulin-like growth factor I or somatomedin C) blood levels associated with acromegaly with ANY ONE of the following?

Inadequate response to surgery, or surgical resection is not an option
Inability to tolerate or inadequate response to bromocriptine mesylate at maximum tolerable doses
Inadequate response to pituitary irradiation, or irradiation is not an option
For adjunctive therapy with irradiation to help relieve symptoms of acromegaly and possibly slow the rate of tumor growth