Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Octreotide acetate (Sandostatin® LAR Depot)

Policy #:08.01.10d

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Octreotide acetate (Sandostatin® LAR Depot) is considered medically necessary and, therefore, covered for the long-term treatment of any of the following conditions in individuals who have already started therapy with octreotide acetate (Sandostatin®) immediate-release formulation, when any of the following conditions are present and the corresponding Dosing and Frequency Requirements are met:
  • Acromegaly
    • For the management of individuals who had inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy was not an option
    • Dosage and frequency up to 40 mg every 4 weeks
  • Central Nervous System (CNS) Cancers
    • Meningiomas
      • For the management of surgically inaccessible recurrent or progressive meningiomas when further radiation is not possible
      • Dosage and frequency up to 40 mg every 4 weeks
  • Metastatic Carcinoid Tumors
    • For the management of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors
    • Dosage and frequency up to 30 mg every 4 weeks
  • Neuroendocrine Tumors
    • Adrenal Gland Tumors
      • For symptom control if somatostatin scintigraphy positive in individuals with non-adrenocorticotropic hormone-dependent Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production
      • Dosage and frequency up to 30 mg every 4 weeks until disease progression or unacceptable toxicity
    • Neuroendocrine Tumors of the GI Tract, Lung, and Thymus
      • For the management of unresectable locoregional disease and/or distant metastases as a single agent or in combination with other systemic therapies
      • As symptom control in individuals with carcinoid syndrome as a single agent or in combination with telotristat or other systemic therapy
      • As primary treatment for unresected primary gastrinoma
      • Dosage and frequency up to 30 mg every 4 weeks until disease progression or unacceptable toxicity
    • Neuroendocrine Tumors of the Pancreas (Islet Cell Tumors)
      • For the management of symptoms related to hormone hypersecretion
      • For tumor control in individuals with unresectable locoregional disease and/or metastatic disease and clinically significant tumor burden or clinically significant progression if not already given
      • Dosage and frequency up to 30 mg every 4 weeks until disease progression or unacceptable toxicity
  • Thymomas and Thymic Carcinomas
    • As second-line therapy with or without prednisone
    • Dosage and frequency up to 30 mg every 4 weeks until disease progression or unacceptable toxicity for a maximum of 12 cycles
  • Vasoactive Intestinal Peptide (VIP)-secreting Tumors
    • For the management of profuse watery diarrhea associated with VIP-secreting tumors
    • Dosage and frequency up to 30 mg every 4 weeks

EXPERIMENTAL/INVESTIGATIONAL

All other uses for octreotide acetate (Sandostatin® LAR Depot), including dosage and frequency up to the covered amount specified, are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

DOSING AND FREQUENCY REQUIREMENTS

The Company reserves the right to modify the Dosing and Frequency Requirements listed in this policy to ensure consistency with the most recently published recommendations for the use of octreotide acetate (Sandostatin® LAR Depot). Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of octreotide acetate (Sandostatin® LAR Depot) outside of the Dosing and Frequency Requirements listed in this policy. For a list of Company-recognized pharmacology compendia, view the Company's policy on off-label coverage for prescription drugs and biologics.

Accurate member information is necessary for the Company to approve the requested dose and frequency of this drug. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the precertification process. The Company reserves the right to conduct post-payment review and audit procedures for any claims submitted for octreotide acetate (Sandostatin® LAR Depot).

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

When coverage of octreotide acetate (Sandostatin® LAR Depot) is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.
Guidelines

Octreotide acetate (Sandostatin® LAR Depot) is administered only intramuscularly.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, octreotide acetate (Sandostatin® LAR Depot) is covered under the medical benefits of the Company’s products when the medical necessity criteria and Dosing and Frequency Requirements listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS
  • Octreotide acetate (Sandostatin® LAR Depot) was approved by the FDA on November 25, 1998 for:
  • Long-term maintenance therapy in individuals with acromegaly who have had an inadequate response to surgery and/or radiotherapy, for whom surgery and/or radiotherapy is not an option and in whom initial treatment with Sandostatin® injection has been shown to be effective and tolerated
  • Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors in individuals in whom initial treatment with Sandostatin® injection has been shown to be effective and tolerated
  • Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors in individuals in whom initial treatment with Sandostatin® injection has been shown to be effective and tolerated

Description

Somatostatin is a naturally occurring hormone that has many biological actions because its receptors are found throughout the body. Some actions of somatostatin include inhibiting the secretion of growth hormones (GH), vasoactive intestinal peptide (VIP), gastrin, secretin, motilin, serotonin, pancreatic polypeptide, and insulin. Because somatostatin has a short half-life and targets many different hormones, somatostatin analogs were created, including octreotide acetate (Sandostatin®, Sandostatin® LAR Depot). Somatostatin analogs have a much longer half-life so they can be dosed less often, and have greater inhibitory selectivity of GH secretion over insulin secretion.

Octreotide acetate (Sandostatin®) is a fast-acting formulation with a short half-life, so it needs to be administered two to four times a day subcutaneously. In contrast, the long-acting formulation, octreotide acetate (Sandostatin® LAR Depot), is administered every four weeks, but it takes 10 to 14 days for the levels of the drug to achieve therapeutic levels in the body because it is not a fast-acting formulation. Hence, it is recommended that individuals with chronic conditions who require octreotide acetate initially receive octreotide acetate (Sandostatin®), followed by octreotide acetate (Sandostatin® LAR Depot) for continued therapy.

Because somatostatin receptors have been found throughout the whole gastrointestinal tract, octreotide acetate (Sandostatin® LAR Depot) aids in the long-term treatment of flushing and severe diarrhea associated with metastatic carcinoid tumors, as well as diarrhea associated with vasoactive intestinal peptide secreting tumors (VIPomas). These conditions cause the secretion of excessive amounts of vasoactive substances, such as histamine, bradykinin, serotonin, and prostaglandins. Octreotide acetate (Sandostatin® LAR Depot) works by blocking the release of serotonin and many of these other active peptides, as well as suppressing the secretion of gastrin, glucagon, and secretin.

Octreotide acetate (Sandostatin® LAR Depot) has been successful at reducing the signs and symptoms of acromegaly, a rare condition characterized by abnormal enlargement of bones in the extremities and head, as well as thickening of soft tissues, such as the heart, lips, and tongue. Acromegaly occurs when the pituitary gland produces too much GH, which in turn causes excess secretion of insulin-like growth factor-1 (IGF-1). The long-term use of this medication suppresses the secretion of GH and IGF-1 in individuals who have had inadequate response to, or cannot be treated with, other therapies, including surgery or radiotherapy.

Octreotide acetate (Sandostatin® LAR Depot) is approved by the US Food and Drug Administration (FDA) for long-term treatment in individuals with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option; long-term treatment for individuals with severe diarrhea and flushing episodes associated with metastatic carcinoid tumors; and long-term treatment of profuse watery diarrhea associated with VIP-secreting tumors.

CLINICAL STUDIES

ACROMEGALY
The efficacy of octreotide acetate (Sandostatin® LAR Depot) was evaluated in 101 individuals with acromegaly who achieved growth hormone (GH) levels less than 5 ng/mL while on subcutaneous octreotide acetate (Sandostatin®) injections in two clinical studies. Individuals were switched to 10 mg, 20 mg, 30 mg, or 40 mg of octreotide acetate (Sandostatin® LAR Depot) once every 4 weeks for up to 27 to 28 injections. Of the 101 individuals, only 88 individuals received all of the 27 to 28 injections. A mean GH level of less than 5.0 ng/mL was observed in 83% of the individuals that completed all 27 or 28 injections. GH and insulin-like growth factor-1 (IGF-1) levels were at least as well controlled with octreotide acetate (Sandostatin® LAR Depot) as they had been on octreotide acetate (Sandostatin®) injections and retained the level of control for the duration of the clinical trials.

The efficacy of octreotide acetate (Sandostatin® LAR Depot) was evaluated in a third study of 151 individuals with acromegaly, who achieved GH levels less than 10 ng/mL on octreotide acetate (Sandostatin®) injections. Individuals were switched to 10 mg, 20 mg, or 30 mg of octreotide acetate (Sandostatin® LAR Depot) once every 4 weeks for up to 12 injections. Only 122 individuals received all 12 injections; a mean GH level of less than 5.0 ng/mL was observed in 97% of the individuals. Growth hormone and IGF-1 levels were at least as well controlled with octreotide acetate (Sandostatin® LAR Depot) as they had been on octreotide acetate (Sandostatin®) injections and retained the level of control for the duration of the clinical trial.

CARCINOID SYNDROME
In a 6-month double-blind clinical study, the efficacy of octreotide acetate (Sandostatin® LAR Depot) was evaluated in 93 individuals with malignant carcinoid syndrome who had previously been responsive to octreotide acetate (Sandostatin®) injections. Sixty-seven individuals were randomized to receive 10 mg, 20 mg, or 30 mg of octreotide acetate (Sandostatin® LAR Depot) every 28 days, and 26 individuals remained on octreotide acetate (Sandostatin®) injections (100-300 mcg three times daily) unblinded. Over the 6-month period, approximately 50-70% of octreotide acetate (Sandostatin® LAR Depot) group required octreotide acetate (Sandostatin®) injections as supplemental therapy to control exacerbations of carcinoid symptoms, although steady-state serum octreotide acetate (Sandostatin® LAR Depot) levels had been reached. The mean daily stool frequency was as well controlled on octreotide acetate (Sandostatin® LAR Depot) as on octreotide acetate (Sandostatin®) injections.

Seventy-eight individuals with malignant carcinoid syndrome who participated in the 6-month study also participated in a 12-month extension study in which they received 12 injections of octreotide acetate (Sandostatin® LAR Depot) at 4-week intervals. During the extension study, diarrhea and flushing were as well controlled as during the 6-month study.

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References


American Hospital Formulary Service (AHFS). Drug Info 2015. Octreotide acetate. [LexiDrug Web site]. updated 03/08/2017. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed August 2, 2017.

Brunton LL, Lazo JS, Parker KL. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 11th ed. 2006;1496-98.

Chadha MK, Lombardo J, Mashtare T, et al. High-dose octreotide acetate for management of gastroenteropancreatic neuroendocrine tumors. Anticancer Res. 2009;29(10):4127-30.

Chamberlain MC, Glantz MJ, Fadul CE. Recurrent meningioma: salvage therapy with long-acting somatostatin analogue. Neurology. 2007;69(10):969-73.

Colao A, Faggiano A, Pivonello R. Somatostatin analogues: treatment of pituitary and neuroendocrine tumors. In: L. Martini, eds. Prog Brain Res. 2010;182:281-94.

Colao A, Pivonello R, Auriemma RS, Galdiero M, Savastano S, Lombardi G. Beneficial effect of dose escalation of octreotide-LAR as first-line therapy in patients with acromegaly. Eur J Endocrinol. 2007;157(5):579-87.

Dipiro JT, Talbert RL, Yee GC, et al. Pharmacotherapy: A Pathophysiologic Approach. 8th ed. 2011;626-27, 1349-50.

Elsevier’s Gold Standard Clinical Pharmacology Compendium. Octreotide acetate. [ClinicalKey Web site]. 07/25/2017. Available at: https://www.clinicalkey.com [via subscription only]. Accessed August 2, 2017.

Fleseriu M. Clinical efficacy and safety results for dose escalation of somatostatin receptor ligands in patients with acromegaly: a literature review. Pituitary. 2011;14(2):184-93.

Freda PU, Katznelson L, van der Lely AJ, et al. Long-acting somatostatin analog therapy of acromegaly: a meta-analysis. J Clin Endocrinol Metab. 2005;90(8):4465-73. Epub 2005 May 10.

Giustina A, Bonadonna S, Bugari G, et al. High-dose intramuscular octreotide in patients with acromegaly inadequately controlled on conventional somatostatin analogue therapy: a randomised controlled trial. Eur J Endocrinol. 2009;161(2):331-8. Epub 2009 May 22.

Goldfinger SE, Strosberg JR. Treatment of the carcinoid syndrome. 03/20/2017. Available at: http://www.uptodate.com/contents/treatment-of-the-carcinoid-syndrome [via subscription only]. Accessed August 2, 2017.

Lexi-Drugs Compendium. Octreotide acetate. [Lexicomp Online Web site]. 07/27/2017. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed August 2, 2017.

Ludlam WH, Anthony L. Safety review: dose optimization of somatostatin analogs in patients with acromegaly and neuroendocrine tumors. Adv Ther. 2011;28(10):825-41. Epub 2011 Sep 28.

Medscape Reference: Drugs, Diseases, and Procedures. octreotide (Rx) - Sandostatin, Sandostatin LAR. 2017. Available at: http://reference.medscape.com/drug/sandostatin-lar-octreotide-342836#10 . Accessed August 2, 2017.

Melmed S. Treatment of acromegaly. 05/31/2017. Available at: http://www.uptodate.com/contents/treatment-of-acromegaly [via subscription only]. Accessed August 2, 2017.

Melmed S, Casanueva F, Cavagnini F, et al. Consensus statement: medical management of acromegaly. Eur J Endocrinol. 2005;153(6):737-40.

Melmed S, Colao A, Barkan A, Acromegaly Consensus Group, et al. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009;94(5):1509-17. Epub 2009 Feb 10.

Micromedex Healthcare Series. DrugDex®. Octreotide. [Micromedex® 2.0 Web site]. updated 06/20/2017. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed August 1, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Central nervous system cancers. V1.2016. 07/25/16. [NCCN Web site]. Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site [via free subscription]. Accessed August 1, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Neuroendocrine Tumors. V3.2017. 06/13/17. [NCCN Web site]. Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site [via free subscription]. Accessed July 31, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Thymoma and Thymic Cancers.V1.2017. 03/02/2017. [NCCN Web site]. Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site [via free subscription]. Accessed August 1, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Octreotide acetate (LAR). [NCCN Web site]. 2017. Available at: http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=173 [via subscription only]. Accessed July 31, 2017.

Oberg K, Kvols L, Caplin M, et al. Consensus report on the use of somatostatin analogs for the management of neuroendocrine tumors of the gastroenteropancreatic system. Ann Oncol. 2004;15(6):966-73. Review.

Rinke A, Müller HH, Schade-Brittinger C, et al; PROMID Study Group. 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(28):4656-63.

Tritos N. Advances in medical therapies for Cushing's syndrome. Discov Med. 2012;13(9):171-179.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Octreotide (Sandostatin LAR® Depot) approval letter [FDA Web site]. 11/25/1998. Available at:http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21008ltr.pdf. Accessed August 1, 2017.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Octreotide (Sandostatin LAR® Depot) drug label [FDA Web site]. updated 07/22/2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021008s025lbl.pdf. Accessed July 31, 2017.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)

J2353 Injection, octreotide, depot form for intramuscular injection, 1 mg


Revenue Code Number(s)

N/A


Misc Code

N/A:

N/A


Coding and Billing Requirements


Cross References

Attachment A: Octreotide acetate (Sandostatin® LAR Depot)
Description: ICD-10 CODES AND NARRATIVES




Policy History

Effective 10/05/2017 this policy has been updated to the new policy template
format.
Version Effective Date: 09/20/2017
Version Issued Date: 09/20/2017
Version Reissued Date: N/A

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