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)
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.
Octreotide acetate, long-acting dosage form, for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Neuroendocrine (i.e., carcinoid) tumors
Thymomas and thymic carcinomas
Octreotide acetate, long-acting dosage form for the treatment of diarrhea associated with vasoactive intestinal peptide tumors (VIPomas) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Octreotide acetate, long-acting dosage form for the treatment of other conditions/diseases is considered investigational.
Octreotide acetate, long-acting dosage form, is considered medically appropriate for individuals 18 years of age or older with ANY ONE of the following:
Diagnosis of acromegaly with ALL of the following:
Baseline growth hormone (GH) and IGF-I (somatomedin C) blood levels (renewal will require reporting of current levels)
Documentation of ANY ONE of the following:
Surgical resection with inadequate response
Pituitary irradiation with inadequate response
Surgery or radiation is not an option
Diagnosis of meningioma for surgically inaccessible, recurrent or progressive disease; radiation is not possible
Diagnosis of neuroendocrine/carcinoid tumors (e.g. GI tract, lung, thymus, pancreas and adrenal) tumors and ANY ONE of the following:
Symptoms of carcinoid syndrome (severe diarrhea/flushing episodes)
Used to treat symptoms related to hormone hypersecretion in pancreatic tumors
treatment of unresected
of primary gastrinoma
Used for the management of locoregional advanced or metastatic disease of the bronchopulmonary, thymic, gastrointestinal tract
Used for tumor control of unresectable and/or metastatic tumors of the pancreas
Diarrhea associated with vasoactive intestinal peptide tumors (VIPomas) [pancreatic neuroendocrine (islet cell) tumor, insulinoma, glucagonoma, somatostatinoma, and gastrinoma] and individual has profuse watery diarrhea
Thymomas and Thymic carcinomas as second-line therapy with or without prednisone
Octreotide acetate, long-acting dosage form, is considered medically appropriate for renewal if ALL of the following:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the agent, including, but not limited to, ANY ONE of the following:
Biliary tract abnormalities
Cardiac conduction abnormalities
Individual exhibits ANY ONE of the following:
Disease response with improvement in patient’s symptoms including reduction in symptomatic episodes (such as diarrhea, rapid gastric dumping, flushing, bleeding, etc) and/or stabilization of glucose levels or decrease in size of tumor or tumor spread
Diagnosis of acromegaly if disease response is indicated by ANY ONE of the following:
Reduction of growth hormone level from baseline
Reduction of IGF-I blood level from baseline
Diagnosis of neuroendocrine tumors of the pancreas (ONLY) and ALL of the following:
Individual has had disease progression
Therapy will be continued in patients with functional tumors in combination with systemic therapy.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
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.
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.
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.
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
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.
Maximum billable units per dose and over time by indication as a Medical Benefit