Anthem Blue Cross California Octreotide Agents Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of octreotide agents, Sandostatin and Sandostatin LAR. Octreotide exerts pharmacologic actions similar to the natural hormone somatostatin, but is a more potent inhibitor of GH, glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin-releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin, and pancreatic polypeptide. Acromegaly is a rare condition that occurs if a tumor causes excess growth hormone secretion, that in turn increases IGF-1 levels. The increase in the hormones causes the hands, feet, lips, nose, and tongue to become larger, bone changes, headaches, joint aches, and vision problems. Complications may develop such as type 2 diabetes, high blood pressure, heart disease, sleep apnea, and arthritis. Estimates are there are 3,000 new cases of acromegaly per year with a prevalence of about 25,000 patients in the US. Treatment includes surgery, radiation, and medications. Medications are used if surgery is impractical or not successful. Medications for acromegaly include somatostatin analogs, growth hormone receptor antagonist, and dopamine agonist. Dopamine agonist (e.g., cabergoline) has a limited role in the treatment of acromegaly for those with mild disease. The following table includes the somatostatin analogs and the growth hormone receptor antagonist. Table 1: Somatostatin Analogs and Growth Hormone Receptor Antagonist for Acromegaly Product Indications Somatostatin Analogs Mycapssa (octreotide) delayed-release capsules Octreotide (injection; immediate-release) Long-term maintenance treatment of acromegaly patients who have responded to and tolerated octreotide or lanreotide. Acromegaly in those who have inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. Route and frequency for Acromegaly Oral capsule used twice daily or daily; maximum daily dosage is 80 mg per day. Subcutaneous or intravenous injection three times a day Sandostatin LAR depot (octreotide, injection; long- acting release) Other indications: carcinoid tumors, vasoactive intestinal peptide tumors For patients in whom initial treatment with octreotide injection has been shown effective and tolerated. Long-term maintenance treatment of acromegaly patients who have had an inadequate response to surgery and/or radiotherapy or for whom surgery and/or radiotherapy is not an option Intramuscular injection every 4 weeks administered by a healthcare professional Signifor LAR (pasireotide, injection) Other indications: carcinoid tumors, vasoactive intestinal peptide tumors For patients with acromegaly who have had an inadequate response to surgery and/or whom surgery is not an option. Other indication: Cushing’s disease Intramuscular injection every 4 weeks administered by a healthcare professional 1 Product Indications Somatuline Depot (lanreotide, injection) For long-term treatment of acromegaly who have had an inadequate response to surgery and/or radiotherapy, or whom surgery and/or radiotherapy is not an option. Other indications: gastroenteropancreatic neuroendocrine tumors, carcinoid syndrome Growth Hormone Receptor Antagonist Somavert (pegvisomant, injection) For treatment of acromegaly in patients who have had an inadequate response to surgery or radiation, or for whom these therapies are not appropriate. Route and frequency for Acromegaly Deep subcutaneous injection every 4 weeks administered by a healthcare professional Subcutaneous injection daily The safety and/or efficacy of octreotide acetate have not been established for treating the following conditions. The peer-reviewed published medical literature consists of case reports, small case series, RCTs of small sample sizes, and non-randomized or uncontrolled trials which precludes drawing reliable conclusions on the safety and net health benefit of octreotide acetate for other conditions, including but not limited to: 1. AIDs-related diarrhea (Panel 2018); 2. Chyle fistula management following neck dissection surgery (Swanson, 2015); 3. Chylothorax in adults (Fujita, 2014; Ismail, 2015) and neonates (Das and Shah, 2010; Testoni, 2015); 4. Graves' ophthalmopathy (thyroid eye disease) (Stan, 2006); 5. Hypothalamic obesity (insulin hypersecretion) (Lustig, 2003; Michalsky, 2012); 6. Other carcinomas, such as: o Advanced, metastatic breast cancer (Bajetta, 2002; Chapman, 2015); o Hepatocellular cancer (Jia, 2010); o Prostate cancer (including castration-resistant) (Friedlander, 2012); 7. Other GI tract conditions, such as: o o o o o o bleeding from vascular malformations (such as, angiodysplasias, angioectasias, or/GI tract AVM (Brown, 2010; Junquera, 2007; Loyaga-Rendon, 2015, Szilagyi and Ghali, 2006); gastroparesis (Edmunds, 1998); non-variceal upper GI bleeding (Archimandritis, 2000); pancreatitis (Xu, 2013); short bowel syndrome (Nehra, 2001); small intestinal dysmotility associated with systemic sclerosis (scleroderma) (Nikou, 2007; Perlemuter, 1999; Soudah, 1991, Verne, 1995); 8. Polycystic kidney or liver disease (Caroli, 2013; Hogan, 2010; Ruggenenti, 2005). 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. Sandostatin, or Sandostatin LAR Depot (octreotide) Requests for Sandostatin, or Sandostatin LAR Depot (octreotide) may be approved if the following criteria are met: I. II. III. 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 Individual has had an inadequate response to any of the following: A. Surgical resection; OR B. Pituitary irradiation; OR C. Bromocriptine mesylate at maximally tolerated doses; IV. OR V. OR Surgery and/or radiotherapy is not an option; Individual has a diagnosis of carcinoid tumors and is using for any of the following: 2 OR VI. OR VII. OR VIII. OR IX. OR X. XI. XII. OR XIII. A. Metastatic carcinoid tumor to suppress or inhibit severe diarrhea and flushing episodes associated with the disease; Individual has a diagnosis of neuroendocrine and adrenal tumors and is using for any of the following: A. For the management of unresectable locoregional disease or distant metastasis (NCCN 2A); OR B. For the treatment of profuse watery diarrhea associated with VIPomas; OR C. Prophylactic treatment prior to surgery for gastrinoma (AHFS); Individual is using for bleeding Gastroesophagel (GE) varices and the following criteria are met: A. Gastroesophageal varices are associated with liver disease (Banares 2002, Corley 2001); AND B. Octreotide acetate is used in combination with endoscopic therapy or alone if endoscopic therapy is not immediately available (Garcia-Tsao 2007); Individual is using for malignant bowel obstruction to manage gastrointestinal symptoms (e.g. nausea, pain or vomiting) (AHFS); Individual is using for thymic carcinoma or thymoma with or without prednisone (NCCN 2A); Individual is using for meningiomas in central nervous system cancers (NCCN 2A); AND Individual has surgically inaccessible recurrent or progressive disease when radiation is not possible; AND Individual is using in combination with everolimus; Individual is requesting Sandostatin for rapid relief of symptoms or for breakthrough symptoms in individuals taking long-acting octreotide acetate when any of the criteria are met for the above uses (NCCN 2A). Requests for Sandostatin, or Sandostatin LAR (octreotide) may not be approved for any of the following: I. II. III. IV. V. VI. Individual is using for the treatment of chylothorax; OR Individual is using for the treatment of diarrhea associated with acquired immunodeficiency disease; OR Individual is using for the treatment of gastrointestinal diseases (e.g. bleeding from vascular malformations, gastroparesis, pancreatitis, prevention of postoperative complications following pancreatic surgery, short bowel syndrome, or upper GI bleeding); OR Individual is using for the treatment of Graves’ ophthalmopathy; OR Individual is using for the treatment of hypothalamic obesity; OR Individual is using for the treatment of other carcinomas (e.g. advanced breast cancer, hepatocellular cancer, or prostate cancer); OR Individual is using for the treatment of polycystic kidney disease; OR VII. VIII. When the above criteria are not met and for all other indications. Quantity Limits Quantity Limits Sandostatin LAR (octreotide) Depot Kit 20 mg Sandostatin LAR (octreotide) Depot Kit 10 mg, 30 mg 2 kits per 28 days 1 kit per 28 days Drug Limit 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 J2353 J2354 Injection, octreotide, depot form for intramuscular injection, 1 mg Injection, octreotide, nondepot form for subcutaneous or intravenous injection, 25 mcg [Sandostatin LAR] 3 ICD-10 Diagnosis C18.0-C18.9 Malignant neoplasm of colon [associated bowel obstruction] C25.0-C25.9 Malignant neoplasm of pancreas [related VIPoma syndrome] C37 C48.1-C48.8 C57.00-C57.4 C70.0-C70.9 C75.1 C7A.00-C7A.8 C7B.00-C7B.8 D01.7 D13.7 D15.0 D35.2 Malignant neoplasm of thymus Malignant neoplasm of peritoneum [associated bowel obstruction] Malignant neoplasm of other and unspecified female genital organs [associated bowel obstruction] Malignant neoplasm of meninges Malignant neoplasm of pituitary gland Malignant neuroendocrine tumors (carcinoid tumors) Secondary neuroendocrine tumors Carcinoma in situ of other specified digestive organs [pancreas] Benign neoplasm of endocrine pancreas Benign neoplasm of thymus Benign neoplasm of pituitary gland D3A.010-D3A.8 Benign neuroendocrine tumors E05.80-E05.81 Other thyrotoxicosis E22.0 Acromegaly and pituitary gigantism E31.20-E31.23 Multiple endocrine neoplasia [MEN] syndrome E34.0 H47.49 I85.11 Carcinoid syndrome Disorders of optic chiasm in (due to) other disorders Secondary esophageal varices with bleeding K56.690-K56.699 Other intestinal obstruction K59.1 Functional diarrhea K70.0-K75.9 Disease of liver [related bleeding esophageal varices] R19.7 Z85.841 Z85.845 Diarrhea, unspecified Personal history of malignant neoplasm of brain Personal history of malignant neoplasm of other parts of nervous tissue Document History Revised: 11/19/2023