Medical Drug Criteria (MDC)                                           

Policy Num:       M5.001.007
Policy Name:     Somatuline® Depot; Lanreotide
Policy ID:          [M5.001.007]  [Ac / Mg / M+ / P+]  [PI]

Last Review:       May 10, 2024
Next Review:      May 20, 2025
 

Related MDC: None

Somatuline® Depot; Lanreotide

Summary

Somatuline® Depot; Lanreotide is used to treat people with acromegaly (condition in which the body produces too much growth hormone, causing enlargement of the hands, feet, and facial features; joint pain; and other symptoms) who have not successfully, or cannot be treated with surgery or radiation. Lanreotide injection is also used to treat people with neuroendocrine tumors in the gastrointestinal (GI) tract or the pancreas (GEP-NETs) that have spread or cannot be removed by surgery. Lanreotide injection is in a class of medications called somatostatin agonists. It works by decreasing the amounts of certain natural substances produced by the body.

Policy Statements

Somatuline® Depot; Lanreotide may be considered medically necessary in patients 18 years of age or older and patient has not received a long-acting somatostatin analogue (e.g., Octreotide LAR depot, Lanreotide SR, Lanreotide auto-gel, pasireotide LAR depot, etc.) within the last 4 weeks; AND

Acromegaly^1,2,5,6

• Patient’s diagnosis is confirmed by elevated (age-adjusted) or equivocal serum IGF-1 as well as inadequate suppression of growth hormone (GH) after a glucose load; AND
• Patient has documented inadequate response to surgery and/or radiotherapy or it is not an option for the patient; AND
• Patient’s tumor has been visualized on imaging studies (i.e., MRI or CT-scan); AND
• Baseline GH and IGF-1 blood levels (renewal will require reporting of current levels); AND
• Will not be used in combination with oral octreotide

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) ^1,2

• Patient has unresectable, locally advanced or metastatic disease; AND
• Patient has non-functioning tumors without hormone-related symptoms; AND
• Patient has well or moderately differentiated disease

Carcinoid Syndrome^1,2,3

Patient has documented neuroendocrine tumors with a history of carcinoid syndrome
(flushing and/or diarrhea); AND

• Used to reduce the frequency of short-acting somatostatin analog rescue therapy; OR
• Used for treatment and/or control of symptoms

Neuroendocrine and Adrenal Tumors (e.g., GI Tract, Lung, Thymus, Pancreas, and
Pheochromocytoma/Paraganglioma) ^1,2,3,8

• Used as primary treatment for unresected primary gastrinoma; OR
• Used for locoregional unresectable bronchopulmonary or thymic disease as primary therapy or as subsequent therapy if progression on first-line therapy (including disease progression on prior treatment with lanreotide in patients with functional tumors); AND
  • Used for management of hormone symptoms and/or somatostatin receptor positivedisease determined by imaging (i.e., 68Ga-dotatate imaging PET/CT or PET/MRI or somatostatin receptor scintigraphy); OR
• Patient has distant metastatic bronchopulmonary or thymic disease; AND
  • Used for somatostatin receptor positive disease and/or symptomatic hormonal disease if clinically significant tumor burden and low grade (typical) histology OR evidence of progression OR intermediate grade (atypical histology); AND
    • Used as primary therapy or as subsequent therapy if progression on first-line therapy (including disease progression on prior treatment with lanreotide in patients with functional tumors); OR
  • Used for somatostatin receptor positive disease and/or hormonal symptoms if asymptomatic with low tumor burden and low grade (typical) histology; OR
  • Used for somatostatin receptor positive disease and/or chronic cough/dyspnea that is notresponsive to inhalers with multiple lung nodules or tumorlets and evidence of diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNECH); OR
• Used for the management of locoregional advanced or distant metastatic disease of the gastrointestinal tract; AND
  • Patient is asymptomatic with a low tumor burden; OR
  • Patient with a clinically significant tumor burden; OR
  • Patient has disease progression and is not already receiving lanreotide; OR
  • Patient has disease progression with functional tumors and will be continuing treatment with lanreotide; OR
• Used to manage symptoms related to hormone hypersecretion of locoregional neuroendocrine tumors of the pancreas (well differentiated grade 1/2); AND
  • Patient has gastrinoma, glucagonoma, or VIPoma; OR
• Used for tumor control of locoregional advanced and/or distant metastatic neuroendocrine tumors of the pancreas (well differentiated grade 1/2 – Gastrinoma, Glucagonoma, Insulinoma, VIPoma ) [***NOTE: for insulinoma ONLY, patient must have somatostatin-receptor positive disease]; AND
  • Patient is asymptomatic with a low tumor burden and stable disease; OR
  • Patient is symptomatic; OR
  • Patient has a clinically significant tumor burden; OR
  • Patient has clinically significant progression and is not already receiving lanreotide; OR
• Patient has unresectable locally advanced or metastatic neuroendocrine tumors (well differentiated grade 3); AND
  • Patient has favorable biology (e.g., relatively low Ki-67 [<55%], somatostatin receptorpositive
    disease); OR
• Patient has pheochromocytoma or paraganglioma; AND
  • Patient has symptomatic locally unresectable somatostatin receptor-positive disease; OR
  • Patient has distant metastatic disease

Policy Guidelines

Renewal Criteria ^1,2,3,8

Coverage can be renewed based upon the following criteria:

• Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: formation of gallstones, cardiovascular abnormalities (bradycardia, sinus bradycardia, and hypertension), uncontrolled blood glucose abnormalities (hyperglycemia or hypoglycemia), thyroid disorders (hypothyroidism), etc.; AND

Acromegaly

• Disease response as indicated by an improvement in signs and symptoms compared to baseline; AND

  • Reduction of growth hormone (GH) by random testing to < 1.0 mcg/L; OR

  • Age-adjusted normalization of serum IGF-1

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

• Disease response with treatment as indicated by an improvement in symptoms including reduction in symptomatic episodes (such as diarrhea, rapid gastric dumping, flushing, bleeding, etc.) and/or stabilization of glucose levels and/or decrease in size of tumor or tumor spread

Carcinoid Syndrome

• Disease response with treatment as indicated by reduction in use of short-acting somatostatin analog rescue medication (e.g., octreotide) and a decrease in the frequency of diarrhea and flushing events, when compared to baseline

Neuroendocrine and Adrenal Tumors (e.g., GI Tract, Lung, Thymus, Pancreas, and Pheochromocytoma/Paraganglioma)

• Disease response with treatment as indicated by an improvement in symptoms including reduction in symptomatic episodes (such as diarrhea, rapid gastric dumping, flushing, bleeding, etc.) and/or stabilization of glucose levels and/or decrease in size of tumor or tumor spread; OR
• Patient has had disease progression and therapy will be continued in patients with functional tumors

DOSAGE/ADMINISTRATION

Acromegaly

• Recommended starting dose is 90 mg by deep subcutaneous injection every 4 weeks for 3 months, adjusted thereafter based on GH and/or IGF-1 levels:
  • GH >1 to ≤ 2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: maintain Somatuline Depot dose at 90 mg every 4 weeks
  • GH > 2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled, increase Somatuline Depot dose to 120 mg every 4 weeks
  • GH ≤ 1 ng/mL, IGF-1 normal and clinical symptoms controlled: reduce Somatuline Depot dose to 60 mg every 4 weeks
• Renal and Hepatic Impairment: Initial dose is 60 mg every 4 weeks for 3 months in moderate and severe renal or hepatic impairment, then adjust thereafter based on GH and/or IGF-1 levels.

GEP-NETs; Carcinoid Syndrome

• 120 mg administered every 4 weeks by deep subcutaneous injection

Neuroendocrine & Adrenal Tumors (GI Tract, Lung, Thymus, Pancreas, & Pheochromocytoma/ Paraganglioma)

• Dose range of 90 mg to 120 mg every 4 weeks

REQUIRED MEDICAL INFORMATION

As established above.

EXCLUSION CRITERIA

None

BENEFIT APPLICATION

As established in policy. Initial coverage will be for three months and is eligible for renewal for six months.

Medicare Coverage Criteria

There was no LCD, NDC identified for PR region

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

References

1. Somatuline Depot [package insert]. Signes, France; Ipsen Pharma Biotech; June 2019. Accessed March 2022.
2. Lanreotide [package insert]. Warren, NJ; Cipla, Inc.; March 2022. Accessed March 2022.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for lanreotide. National Comprehensive Cancer Network, 2022. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2022.
4. Giustina A, Chanson P, Kleinberg D, et al. Expert consensus document: A consensus on the medical treatment of acromegaly. Nat Rev Endocrinol. 2014 Apr; 10(4):243-8. doi: 10.1038/nrendo.2014.21. Epub 2014 Feb 25.

5. 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.
6. Fleseriu M, Biller BMK, Freda PU, et al. A Pituitary Society update to acromegaly management guidelines. Pituitary 24, 1–13 (2021). https://doi.org/10.1007/s11102-020-01091-7.
7. Giustina A, Barkhoudarian G, Beckers A et al. Multidisciplinary management of acromegaly: A consensus. Rev Endocr Metab Disord 21, 667–678 (2020). https://doi.org/10.1007/s11154-020-09588-z.
8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Neuroendocrine and Adrenal Tumors. Version 4.2021. National Comprehensive Cancer Network, 2022. The NCCN Compendium® is a derivative work of the
NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2022.

Codes

Applicable Modifiers

Some modifiers.

Policy History