Overview

This document addresses the use of Somatuline Depot (lanreotide) for acromegaly. Somatuline Depot is also FDA approved for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression free survival and carcinoid syndrome to reduce the frequency of short-acting somastatin analog rescue therapy. Somatuline Depot may reduce gallbladder motility and lead to gallstone formation. Some may also experience hypoglycemia or hyperglycemia as a result of inhibition of the secretion of insulin and glucagon. The most common overall cardiac adverse reactions observed included sinus bradycardia, bradycardia, and hypertension. Somatuline Depot is provided as a single dose, prefilled syringe and administered as a deep subcutaneous injection.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Somatuline Depot (lanreotide)

1. Requests for Somatuline Depot (lanreotide) may be approved if the following criteria are met:
• Individual has a diagnosis of acromegaly; AND
• Diagnosis of acromegaly has been verified by, or in consultation with, a board-certified endocrinologist who has reviewed and verified the test results (including but not limited to: Insulin-like Growth Factor 1 levels; Oral Glucose Tolerance Test with associated Growth Hormone (GH) levels) that are indicative of a positive test; AND
• Either of the following:
  • A. Individual has had an inadequate response to surgery and/or radiotherapy; OR
  • B. Surgery and/or radiotherapy are not an option (such as but not limited to, individual is an inappropriate candidate for surgical- or radiation-based therapy); OR
2. IV. Individual has a diagnosis of unresectable, well-or moderately-differentiated, locally advanced or metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (Label, NCCN 2A); OR
3. V. Individual has a diagnosis of carcinoid syndrome.
• Individual has a diagnosis of Neuroendocrine Tumors, including GI Tract, Lung, Thymus, Pancreas, and Pheochromocytoma/Paraganglioma (NCCN 2A) and used in one of the following ways:
  • A. To treat unresectable primary gastrinoma; OR
  • B. For symptomatic treatment of insulinoma tumors expressing somatostatin receptors; OR
  • C. For symptomatic treatment of glucagonoma; OR
  • D. For symptomatic treatment of tumors secreting vasoactive intestinal polypeptide (VIPoma); OR
  • E. For treatment of symptoms related to hormone hypersecretion and/or carcinoid syndrome; OR
  • F. For tumor control in patients with unresectable, locally advanced, and/or metastatic disease; OR
  • G. Individual is diagnosed with diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNECH).
4. Somatuline Depot (lanreotide) may not be approved when the above criteria are not met and for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

• J1930
• J1931
• Injection, lanreotide, 1 mg [Somatuline Depot]
• J1932-Injection, lanreotide, (cipla), 1 mg

ICD-10 Diagnosis

• C7A.00-C7A.8
  • Malignant neuroendocrine tumors (carcinoid tumors)
• C7B.00-C7B.8
  • Secondary neuroendocrine tumors
• D3A.010-D3A.8
  • Benign neuroendocrine tumors
• D13.7
• D37.9
• E16.8
• E22.0
• E34.0
  • Benign neoplasm of endocrine pancreas
  • Neoplasm of uncertain behavior of digestive organ, unspecified
  • Other specified disorders of pancreatic internal secretion
  • Acromegaly and pituitary gigantism
  • Carcinoid syndrome
• J84.841
  • Neuroendocrine cell hyperplasia of infancy

Document History

Reviewed: 09/11/2023