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Date Printed: October 21, 2017: 11:36 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-J1000-20

Original Effective Date: 04/15/10

Revised: 06/15/17

Next Review: 05/09/18

Subject: Lanreotide (Somatuline® 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:

Lanreotide (Somatuline® Depot) is a somatostatin analogue structurally similar to octreotide (Sandostatin®). Somatostatin analogues were developed to improve upon the duration of action of natural somatostatin, which undergoes rapid proteolytic degradation and has a plasma half-life of only one minute. The predominant pharmacologic effect of lanreotide is a reduction in growth hormone and insulin-like growth factor-1 (IGF-1) concentrations. Lanreotide inhibits basal secretion of several gastric enzymes (e.g., motilin, gastric inhibitory peptide, pancreatic polypeptide) and postprandial secretion of pancreatic polypeptide, gastrin, and cholecystokinin.

Lanreotide is commercially available as a long-acting parenteral preparation. Lanreotide has been used extensively in Europe and several other countries for the treatment of acromegaly and for the symptomatic treatment of neuroendocrine carcinoid tumors. Similar to octreotide, lanreotide is used to minimize the symptoms associated with carcinoid tumors including diarrhea, abdominal pain, and flushing. In addition preliminary data indicate that lanreotide may exhibit antiproliferative effects on the tumor; however, more evidence is needed to confirm these findings. Lanreotide was designated as an orphan drug by the Food and Drug Administration (FDA) for the treatment of acromegaly in 2000, and was approved by the FDA for the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy in 2007. Lanreotide was also granted orphan designation for the treatment of neuroendocrine tumors and the symptoms associated with carcinoid syndrome in 2011. The FDA approved treatment of patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival in December 2014.

POSITION STATEMENT:

I. Initiation of lanreotide (Somatuline Depot) meets the definition of medical necessity when used to treat an indication listed in Table 1 below and all of the indication specific criteria are met:

Table 1

Indication

Specific Criteria

Acromegaly

ALL of the following:

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

2. 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.

3. The dosage will not exceed 120 mg every 4 weeks

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 120 mg every 4 weeks

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 120 mg every 4 weeks

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

ALL of the following:

1. The tumor has EITHER of the following features:

a. ALL of the following:

i. Unresectable

ii. Well- or moderately-differentiated

iii. Locally advanced

b. Metastatic

2. The dosage will not exceed 120 mg every 4 weeks

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 120 mg every 4 weeks

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 120 mg every 4 weeks

Approval duration: 1 year

II. Continuation of lanreotide (Somatuline 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 lanreotide

3. Dose does not exceed 120 mg every 4 weeks

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.

FDA-approved: lanreotide is indicated for (1) the long-term treatment of acromegaly in patients who have had an inadequate response to or cannot be treated with surgery and/or radiation, and (2) the treatment of patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. For GEP-NETs, the recommended dosage is 120 mg every 4 weeks via deep subcutaneous injection. For acromegaly, the goal of treatment is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal. Lanreotide should be initiated as a 90 mg deep subcutaneous injection at 4 week intervals for 3 months.

Dosage Adjustments (for acromegaly):

• After three months the dose may be adjusted as outlined in Table 1. Members who are controlled on lanreotide 60- or 90 mg may be considered for an extended dosing interval of 120 mg every 6 to 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of member response.

TABLE 1:

Dosage Adjustment

GH Level (ng/mL)

IGF-1

Symptoms

Dosage Adjustment

>1 to 2.5

Normal

Controlled

Maintain dose at 90 mg every 4 weeks

>2.5

Elevated

With or without uncontrolled symptoms

Increase dose to 120 mg every 4 weeks

≤1

Normal

Controlled

Decrease dose to 60 mg every 4 weeks

Renal and Hepatic Impairment: Members with moderate or severe renal impairment and moderate or severe hepatic impairment should receive a starting dose of 60 mg for the treatment of acromegaly. For the treatment of GEP-NETs, no adjustment is needed for mild or moderate renal impairment; however, there is insufficient information to recommend a dose for patients with severe renal impairment or with hepatic impairment of any severity. Caution should be exercised when considering members with moderate or severe renal impairment for an extended dosing interval.

Drug Availability: lanreotide is supplied as 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL sterile, single-use, pre-filled syringes. The syringes must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) and protected from light in its original package.

PRECAUTIONS:

CONTRAINDICATIONS

Hypersensitivity to lanreotide.

WARNINGS

Gallbladder: gallstones may occur due to reduced gallbladder motility; consider periodic monitoring.

Glucose metabolism: lanreotide inhibits secretion of insulin and glucagon; hypoglycemia and hyperglycemia may occur. Glucose monitoring is recommended and anti-diabetic treatment should be adjusted accordingly.

Thyroid Function: slight decreases in thyroid function have been seen during treatment; thyroid function tests are recommended when clinically indicated.

Drug Interactions: lanreotide may reduce the intestinal absorption of concomitant drugs (e.g., cyclosporine).

Cardiac function: bradycardia may occur; use with caution in at-risk patients (e.g., those on medications that cause bradycardia or pre-existing cardiac dysfunction).

Pregnancy and Lactation: Lanreotide is classified as pregnancy category C and it is unknown is lanreotide is distributed into human milk. Caution should be exercised when administered to women who are breastfeeding.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J1930

Injection, lanreotide, 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

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, other

D3A.8

Other benign neuroendocrine tumors

D13.7

Benign neoplasm of endocrine pancreas

D15.0

Benign neoplasm of thymus

D35.2

Benign neoplasm of pituitary gland

D35.3

Benign neoplasm of craniopharyngeal duct

D37.9

Neoplasm of uncertain behavior of digestive organ, unspecified

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) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

Medicare Part D: Florida Blue has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Capecitabine (Xeloda®) Tablets, 09-J1000-42
Carboplatin (Paraplatin ®) IV, 09-J0000-93

Docetaxel (Taxotere®) IV, 09-J0000-95

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

Octreotide Acetate (Sandostatin LAR Depot) Injection, 09-J0000-90

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

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

OTHER:

None applicable.

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2017. URL www.clinicalpharmacilogy-ip.com. Accessed 4/20/17.
  2. Lanreotide. In McEvoy GK, editor. AHFS drug information 2016 [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.
  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 2.2017 Neuroendocrine Tumors. Available at http://www.nccn.org/professionals/physicians_gls/PDF/neuroendocrine.pdf. Accessed 4/26/17.
  8. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 2017 Apr 20]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  9. Ronchi CL, Boschetti M, Degli Uberti EC, et al. Efficacy of a slow-release formulation of lanreotide (Autogel) 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study. Clin Endocrinol (Oxf). 2007 Oct;67(4):512-9. Epub 2007 Jun 7.
  10. Somatuline Depot (lanreotide acetate) [package insert]. Ipsen Biopharmaceuticals, Inc. Baskin Ridge (NJ): December 2014.

COMMITTEE APPROVAL:

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

GUIDELINE UPDATE INFORMATION:

04/15/10

New Medical Coverage Guideline.

01/15/11

Revision to guideline; consisting of adding ICD-10 codes.

12/15/11

Review and revision to guideline; consisting of updating dosage & administration, precautions and references.

12/15/12

Review and revision to guideline; consisting of revising and reformatting position statement; revising/updating description, dosage/administration, precautions, and reference sections.

06/15/13

Review and revision to guideline; consisting of revising position statement to include quantity limit and approval duration; updating coding and references.

10/15/13

Revision to guideline; consisting of adding QL.

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 the position statement, dosing/administration section, precautions 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 the position statement, coding and references.

10/01/16

Update to ICD-10 codes.

06/15/17

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

Date Printed: October 21, 2017: 11:36 AM