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Date Printed: October 23, 2017: 07:26 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J0000-90

Original Effective Date: 03/15/09

Reviewed: 05/10/17

Revised: 06/15/17

Subject: Octreotide Acetate (Sandostatin LAR® Depot) Injection

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Octreotide acetate is a somatostatin analog that has similar effects in the body as those of the naturally occurring hormone. It inhibits the secretion of growth hormone, glucagon, insulin, gastrin, vasoactive intestinal peptide, secretin, motilin and pancreatic polypeptide. In addition, it suppresses the response of luteinizing hormone (LH) in response to gonadotropin releasing hormone (GnRH) and decreases splenic blood flow. Octreotide acetate is available as an immediate-release formulation, Sandostatin® (FDA-approved in 1988) and a long-acting formulation, Sandostatin LAR® Depot (FDA-approved in 1998). Octreotide acetate suppresses secretion of growth hormone (GH) and secondarily suppresses insulin-like growth factor-1 (IGF-1, somatomedin C) and is a treatment option for those with acromegaly. Studies have shown that after immediate-release octreotide acetate administration, growth hormone and IGF-1 levels are normalized in 50 to 60% of patients. Octreotide acetate also suppresses the release of the peptides and amines secreted from carcinoid tumors and vasoactive intestinal peptide tumors (VIPomas), which subsequently reduces the severe diarrhea and flushing associated with this disease. Sandostatin LAR was granted orphan designation by the FDA in 1998 for the treatment of severe diarrhea and flushing associated with malignant carcinoid tumors, acromegaly, and diarrhea associated with VIPoma; and, then in 2010, for the treatment of neuroendocrine tumors.

POSITION STATEMENT:

I. Initiation of octreotide acetate long-acting injection (Sandostatin LAR® Depot) meets the definition of medical necessity when administered for an indication listed in Table 1 below and ALL of the associated criteria are met:

Table 1

Indication

Specific Criteria

Acromegaly

ALL of the following:

1. Sandostatin LAR will be used as long-term therapy for the member’s acromegaly

2. The dosage will not exceed 40 mg per 28-day treatment cycle

3. EITHER of the following are met:

a. Member has had an inadequate response to surgery and/or radiotherapy.

b. Member is not a candidate for surgery and/or radiotherapy.

Adrenal gland neuroendocrine tumor

ALL of the following:

1. The tumor is somatostatin-receptor positive as determined by somatostatin receptor scintigraphy (a.k.a., octreotide scan) - documentation must be provided

2. Member is diagnosed with symptomatic, non-adrenocorticotropic hormone (non-ACTH) dependent Cushing's syndrome

3. Tumor is less than 4 cm

4. The dosage will not exceed 30 mg per 28-day treatment cycle.

Carcinoid Tumors (neuroendocrine tumors of the GI tract, lung, and thymus)

ALL of the following:

1. Treatment for ONE of the following:

a. Unresectable or metastatic disease AND tumor is somatostatin-receptor positive as determined by somatostatin receptor scintigraphy (a.k.a., octreotide scan) – documentation must be provided

b. Unresected primary gastrinoma

2. The dosage will not exceed 30 mg per 28-day treatment cycle.

Meningioma

ALL of the following:

a. The tumor is somatostatin-receptor positive as determined by somatostatin receptor scintigraphy (a.k.a., octreotide scan) (documentation must be provided).

b. The meningioma is surgically inaccessible (e.g., base-of-skull meningiomas)

c. The meningioma is refractory to radiation therapy

d. The dosage does not exceed 30 mg per 28-day treatment cycle.

Pancreatic neuroendocrine tumor

ALL of the following:

1. Use is for ONE of the following:

a. To treat symptoms associated with ONE of the following:

i. Gastrinoma

ii. Glucagonoma

iii. Vasoactive intestinal peptide tumors (VIPomas)

iv. Insulinoma when disease is metastatic AND tumor is somatostatin-receptor positive as determined by somatostatin receptor scintigraphy (a.k.a., octreotide scan) – documentation must be provided

b. For tumor control in member’s with unresectable and/or metastatic disease and ANY of the following:

i. Member is symptomatic

ii. Member has significant tumor burden

iii. Member has clinically significant progressive disease

2. The dosage will not exceed 30 mg per 28-day treatment cycle.

Poorly differentiated (high-grade) large cell or small cell neuroendocrine tumor

ALL of the following:

1. The tumor is somatostatin-receptor positive as determined by somatostatin receptor scintigraphy (a.k.a., octreotide scan) - documentation must be provided

2. The dosage will not exceed 30 mg per 28-day treatment cycle.

Thymomas and Thymic carcinomas

ALL of the following:

1. Sandostatin LAR is used as second-line therapy with or without prednisone

2. The dosage will not exceed 20 mg every two weeks

Approval duration: 1 year

II. Continuation of octreotide acetate long-acting injection (Sandostatin LAR Depot) meets the definition of medical necessity for members treated for an indication from Table 1 when the following criteria are met:

1. The member has been previously approved by Florida Blue or another healthplan in the past 2 years, OR the member has previously met all indication-specific criteria for coverage

2. Member has experienced a beneficial response to octreotide acetate long-acting injection

3. Dose does not exceed indication-specific dosing in Table 1

Approval duration: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

Members not currently receiving octreotide acetate injection subcutaneously:

Members currently receiving of octreotide acetate injection subcutaneously:

o GH ≤2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain Sandostatin LAR Depot dosage at 20 mg every 4 weeks.

o GH >2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled, increase Sandostatin LAR Depot dosage to 30 mg every 4 weeks.

o GH ≤1 ng/mL, IGF-1 normal, and clinical symptoms controlled, reduce Sandostatin LAR Depot dosage to 10 mg every 4 weeks.

o If GH, IGF-1, or symptoms are not adequately controlled at a dose of 30 mg, the dose may be increased to 40 mg every 4 weeks. Doses higher than 40 mg are not recommended.

o If symptoms are adequately controlled, consider a dose reduction to 10 mg for a trial period. If symptoms recur, dosage should then be increased to 20 mg every 4 weeks. Many patients can, however, be satisfactorily maintained at a 10-mg dose every 4 weeks.

o If symptoms are not adequately controlled, increase Sandostatin LAR Depot to 30 mg every 4 weeks. Dosages higher than 30 mg are not recommended.

Dosage Adjustments:

Product Availability: single-use kits containing a 6-mL vial of 10 mg, 20 mg or 30 mg strength; a syringe containing 2 mL of diluent; one vial adapter; and one sterile 1½” 20 gauge safety injection needle. For prolonged storage, stored at refrigerated temperatures between 2°C to 8°C (36°F to 46°F) and protected from light until the time of use.

PRECAUTIONS:

Contraindications:

None

Warnings:

Gallbladder effects: Gallbladder abnormalities may occur. Monitor periodically.

Blood glucose effects: hypoglycemia or hyperglycemia may occur. Glucose monitoring is recommended and antidiabetic treatment may need adjustment.

Thyroid effects: hypothyroidism may occur. Monitor thyroid levels periodically.

Cardiovascular effects: bradycardia, arrhythmia or conduction abnormalities may occur. Use with caution in at-risk members.

Nutritional effects: Octreotide may alter absorption of dietary fats. Depressed vitamin B12 levels and abnormal Schilling tests have been observed in some persons receiving octreotide therapy, and monitoring of vitamin B12 levels is recommended during therapy with octreotide.

Renal function impairment: In members with severe renal failure requiring dialysis, the half-life of octreotide may be increased, necessitating adjustment of the maintenance dosage.

Hepatic function impairment: In members with established liver cirrhosis, the starting dose of octreotide suspension should be 10 mg. Up-titrate the dose based on clinical response and speed of response as deemed necessary by the health care provider. Once at a higher dose, maintain the member or adjust the dose based on response and tolerability as in any noncirrhotic members.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J2353

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

ICD-10 Diagnoses Codes That Support Medical Necessity:

C7A.00

Malignant carcinoid tumor of unspecified site

C7A.010

Malignant carcinoid tumor of the duodenum

C7A.011

Malignant carcinoid tumor of the jejunum

C7A.012

Malignant carcinoid tumor of the ileum

C7A.019

Malignant carcinoid tumor of the small intestine, unspecified portion

C7A.020

Malignant carcinoid tumor of the appendix

C7A.021

Malignant carcinoid tumor of the cecum

C7A.022

Malignant carcinoid tumor of the ascending colon

C7A.023

Malignant carcinoid tumor of the transverse colon

C7A.024

Malignant carcinoid tumor of the descending colon

C7A.025

Malignant carcinoid tumor of the sigmoid colon

C7A.026

Malignant carcinoid tumor of the rectum

C7A.029

Malignant carcinoid tumor of the large intestine, unspecified portion

C7A.090

Malignant carcinoid tumor of the bronchus and lung

C7A.091

Malignant carcinoid tumor of the thymus

C7A.092

Malignant carcinoid tumor of the stomach

C7A.093

Malignant carcinoid tumor of the kidney

C7A.094

Malignant carcinoid tumor of the foregut, unspecified

C7A.095

Malignant carcinoid tumor of the midgut, unspecified

C7A.096

Malignant carcinoid tumor of the hindgut, unspecified

C7A.098

Malignant carcinoid tumors of other sites

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C7A.8

Other malignant neuroendocrine tumors

C7B.00 – C7B.04

Secondary carcinoid tumors of distant lymph nodes, liver, bone, peritoneum

C7B.09

Secondary carcinoid tumors of other sites

C7B.8

Other secondary neuroendocrine tumors

C25.0 – C25.9

Malignant neoplasm of pancreas

C37

Malignant neoplasm of thymus

C70.0 – C70.9

Malignant neoplasm of meninges

C74.00 – C74.92

Malignant neoplasm of adrenal gland

D3A.00

Benign carcinoid tumor of unspecified site

D3A.010 – D3A.012

Benign carcinoid tumor of the duodenum, jejunum, ileum

D3A.019 – D3A.029

Benign carcinoid tumor of the large intestine, unspecified portion, appendix, cecum, ascending colon, transverse colon, descending colon, sigmoid colon, rectum

D3A.090 – D3A.098

Benign carcinoid tumor of the bronchus and lung, thymus, stomach

D3A.8

Other benign neuroendocrine tumors

D13.7

Benign neoplasm of endocrine pancreas

D15.0

Benign neoplasm of thymus

D32.0

Benign neoplasm of cerebral meninges

D32.1

Benign neoplasm of spinal meninges

D32.9

Benign neoplasm of meninges, unspecified

D35.2

Benign neoplasm of pituitary gland

D35.3

Benign neoplasm of craniopharyngeal duct

D37.9

Neoplasm of uncertain behavior of digestive organ, unspecified

D42.0

Neoplasm of uncertain behavior of cerebral meninges

D42.1

Neoplasm of uncertain behavior of spinal meninges

D42.9

Neoplasm of uncertain behavior of meninges, unspecified

D43.0 – D43.9

Neoplasm of uncertain behavior of brain and central nervous system

E16.1

Other hypoglycemia

E16.3

Increased secretion of glucagon

E16.4

Abnormality of secretion of gastrin

E16.8

Other specified disorders of pancreatic internal secretion

E22.0

Acromegaly and pituitary gigantism

E24.8

Other Cushing’s syndrome

E34.0

Carcinoid syndrome

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Capecitabine (Xeloda®) Tablets, 09-J1000-42
Docetaxel (Taxotere®) IV, 09-J0000-95

Interferon alfa-n3 (Alferon N Injection®), 09-J0000-33

Lanreotide (Somatuline® Depot) Injection, 09-J1000-20

Paraplatin (Carboplatin®) IV, 09-J0000-93

Pasireotide (Signifor, Signifor LAR) Injection - 09-J1000-94

Temozolomide (Temodar®) Capsule and Injection, 09-J1000-52

OTHER:

None applicable.

REFERENCES:

  1. Chamberlain MC, Glantz MJ, Fadul CE. Recurrent meningioma: salvage therapy with long-acting somatostatin analogue. Neurology. 2007 Sep 4;69(10):969-73.
  2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc. ;2017. URL www.clinicalpharmacilogy-ip.com Accessed 4/20/17.
  3. Katznelson L, Atkinson JL, Cook DM, et al, American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of acromegaly--2011 update. Endocr Pract. 2011 Jul-Aug;17(Suppl 4):1-44.
  4. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Nov;99(11):3933-51. doi: 10.1210/jc.2014-2700. Epub 2014 Oct 30.
  5. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 4/20/17.
  6. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 4/26/17.
  7. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2016 Central Nervous System Cancers. Available at http://www.nccn.org/professionals/physicians_gls/PDF/cns.pdf. Accessed 4/26/17.
  8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2017 Neuroendocrine Tumors. Available at http://www.nccn.org/professionals/physicians_gls/PDF/neuroendocrine.pdf Accessed 4/26/17.
  9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2017 Thymomas and thymic carcinomas. Available at http://www.nccn.org/professionals/physicians_gls/PDF/thymic.pdf Accessed 4/26/17.
  10. Octreotide. In McEvoy GK, editor. AHFS drug information 2017 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2017 [cited 2017 Apr 20]. Available from http://online.statref.com. Subscription required to review.
  11. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/. Accessed 4/2017.
  12. Sandostatin LAR Depot (octreotide acetate) [package insert]. Novartis Pharmaceuticals Corp Inc. East Hanover (NJ): July 2016.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 05/10/17.

GUIDELINE UPDATE INFORMATION:

03/15/09

New Medical Coverage Guideline.

10/15/09

Revision to guideline; consisting of adding compendia supported indication and updating coding.

01/15/10

Revision to guideline; consisting of updating coding.

11/15/10

Review and revision to guideline; consisting of updating coding and references.

11/15/11

Review and revision to guideline; consisting of updating precautions, coding and references.

12/15/12

Review and revision to guideline; consisting of reformatting position statement, updating coding and references.

06/15/13

Review and revision to guideline; consisting of revising the position statement to include treatment of meningioma and approval duration; reformatting precautions section; updating references, coding, and program exceptions;

02/15/14

Revision to guideline; consisting of adding codes for neuroendocrine tumors.

06/15/14

Review and revision to guideline; consisting of revising position statement, updating references and coding.

06/15/15

Review and revision to guideline; consisting of updating position statement, dosage/administration section, and references.

10/01/15

Revision to guideline consisting of coding updates.

11/01/15

Revision: ICD-9 Codes deleted.

06/15/16

Review and revision to guideline consisting of updating position statement, coding and references.

10/01/16

Update to ICD-10 codes.

06/15/17

Review and revision to guideline consisting of updating position statement and references.

Date Printed: October 23, 2017: 07:26 AM