BlueCross BlueShield of Tennessee Medical Policy Manual

Octreotide Acetate Long-Acting Dosage Form

NDC CODE(S)

00078-0811-XX SandoSTATIN LAR Depot 10 MG KIT (NOVARTIS)

 

00078-0818- XX SandoSTATIN LAR Depot 20 MG KIT (NOVARTIS)

 

00078-0825- XX SandoSTATIN LAR Depot 30 MG KIT (NOVARTIS)

DESCRIPTION

Octreotide acetate is a synthetic analogue of the natural hormone somatostatin.  More potent than the natural hormone, it inhibits the release of growth hormone, glucagon, and insulin.  It also suppresses the response of luteinizing hormone (LH) to gonadal releasing hormone (GnRH), decreases splanchnic blood flow and inhibits the release of serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin and pancreatic polypeptide.

By confining octreotide in microspheres of the biodegradable glucose star polymer, D, L-lactic and glycolic acids copolymer, it maintains all of the pharmacological characteristics of immediate release octreotide but adds the feature of slow release as the polymer biodegrades, primarily through hydrolysis.  This allows less frequent administration, generally once every four weeks.  It is designed to be injected intramuscularly (intragluteally) for long-acting repeatable dosage. 

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Acromegaly

20 mg intramuscularly every 4 weeks

(after 3 months of therapy, doses may be titrated up if required with a maximum dose of 40 mg every 4 weeks)

Carcinoid Tumors and VIPomas

20 mg intramuscularly every 4 weeks

(after 2 months of therapy, doses may be titrated up if required with a maximum dose of 40 mg every 4 weeks)

All Other Indications

Up to 40 mg intramuscularly every 28 days

LENGTH OF AUTHORIZATION

Coverage is provided for six months and may be renewed.

Refer to DOSAGE LIMITS below

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.

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, the express terms of the health plan will govern.

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).

No controlled studies were found in the published literature that validate the use of octreotide acetate, long-acting dosage form, for the treatment or prevention of other conditions or diseases.  

SOURCES 

Lexi-Comp Online. (2018). AHFS Dl. Octreotide acetate. Retrieved June 7, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, February). Octreotide. Retrieved June 8, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium™. Octreotide acetate LAR. Retrieved July 18, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, July). Center for Drug Evaluation and Research. Sandostatin® LAR Depot (octreotide acetate) for injectable suspension). Retrieved June 7, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021008s035lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  9/11/2018

ID_MRx

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.

 

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

DIAGNOSIS

BILLABLE UNIT

MAXIMUM UNITS

All indications

1 mg = 1 billable unit

40 units every 28 days