See Important Reminder at the end of this policy for important regulatory and legal information.

Transcription

1 Clinical Policy: (Sandostatin, Sandostatin LAR) Reference Number: CP.CPA.149 Effective Date: Last Review Date: Line of Business: Medicaid Medi-Cal Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Octreotide acetate (Sandostatin and Sandostatin LAR ) is a somatostatin analog. FDA approved indication Sandostatin is indicated: To reduce blood levels of growth hormone and insulin-like growth factor (IGF-I (somatomedin C) in acromegaly patients who have had inadequate response or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease For the treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors. Sandostatin LAR is indicated: For treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for: o Acromegaly o Severe diarrhea/flushing episodes associated with metastatic carcinoid tumors o Profuse watery diarrhea associated with VIP-secreting tumors Limitation of use: In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and development of metastases, has not been determined. Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Centene Corporation that Sandostatin and Sandostatin LAR are medically necessary when the following criteria are met: I. Initial Approval Criteria A. All Indications (must meet all): 1. Prescribed for the treatment of one of the following (a - k): a. Acromegaly; b. Gastrointestinal neuroendocrine tumors (NETs), such as any of the following: Page 1 of 7

2 i. Treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors; ii. Prophylactic treatment to prevent carcinoid crises prior to surgery for carcinoid tumor; iii. To reverse life-threatening hypotension due to carcinoid crisis during induction of anesthesia; iv. For the treatment of the profuse watery diarrhea associated with vasoactive intestinal polypeptide-secreting tumors (VIPomas); v. Prophylactic treatment prior to surgery for functioning gastrinoma (Zollinger Ellison syndrome); vi. Prophylactic treatment prior to hepatic artery embolization for nonresectable multiple and hormone-secreting neuroendocrine tumors; vii. Stabilization of blood glucose levels in persons with functioning islet cell tumors (insulinomas or glucagonomas); c. To reduce the incidence and severity of the postoperative complications of highrisk pancreatic surgery; d. Chemotherapy and/or radiation therapy-induced diarrhea; e. Severe secretory diarrhea associated with acquired immunodeficiency syndrome (AIDS); f. Acute bleeding and early rebleeding of gastroesophageal varices associated with cirrhosis when used in conjunction with endoscopic band ligation or sclerotherapy or alone, if ligation/sclerotherapy is not immediately available; g. Unresectable malignant thymoma that is refractory to standard chemotherapy; h. To reduce output from gastrointestinal (GI) or pancreatic fistulas; i. Gastrointestinal symptoms (e.g. nausea, vomiting, and pain) of inoperable bowel obstruction in persons with far advanced cancer; j. Thyroid stimulating hormone (TSH) hypersecretion due to TSH secreting adenoma; k. Dumping syndrome following gastric resection; 2. Dose does not exceed the maximum recommended dose for the relevant indication. Approval duration: 6 months or member s renewal period, whichever is longer B. Other diagnoses/indications 1. Refer to CP.PMN.53 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) II. Continued Therapy A. All Indications in Section I (must meet all): 1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; 2. Documentation of positive response to therapy; 3. Dose does not exceed the maximum recommended dose for the relevant indication. Approval duration: 6 months or member s renewal period, whichever is longer B. Other diagnoses/indications (must meet 1 or 2): Page 2 of 7

3 1. Currently receiving medication via Centene benefit and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to CP.PMN.53 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy CP.PMN.53 or evidence of coverage documents IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AHFS: American Hospital Formulary Service NCCN: National Comprehensive Cancer Network VIP: vasoactive intestinal peptide Appendix B: General Information Sandostatin LAR Depot is used for long-term maintenance therapy after the patient has successfully been titrated on Sandostatin for a minimum of 2 weeks. Two open label clinical studies investigated a 48-week treatment with Sandostatin LAR Depot in 143 untreated (de novo) acromegalic patients. The median reduction in tumor volume was 20.6 % in Study 1 (49 patients) at 24 weeks and 24.5% in Study 2 (94 patients) at 24 weeks and 36.2% at 48 weeks. Use of Sandostatin to manage persons with short bowel syndrome if daily intravenous fluid requirements are greater than 3 liters is not supported by literature. Sandostatin reduces fluid losses but also diminishes splanchnic protein synthesis, which can interfere with the process of adaptation. Sandostatin increases small bowel transit time but tachyphylaxis often develops. In addition, Sandostatin predisposes patients to the development of gallstones for which they are already at high risk. AHFS states Sandostatin is effective for the acute management of potentially life threatening hypotension associated with carcinoid crisis or to prevent carcinoid crisis that might be precipitated by anesthesia surgery, initiation of chemotherapy, or infection. NCCN practice compendium guidelines recommend Sandostatin and Sandostatin LAR with a category 2A for unresectable malignant thymoma that is refractory to standard chemotherapy NCCN practice compendium guidelines recommend Sandostatin and Sandostatin LAR with a category 2A for recurrent of progressive meningiomas when further radiation is not possible. Appendix C: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/Maximum Dose diphenoxylate/ atropine 2 tabs (5 mg) PO QID 8 tabs (20 mg) /day (Lomotil ) Page 3 of 7

4 Drug Dosing Regimen Dose Limit/Maximum Dose loperamide 4 mg PO initially, then 2 mg after 16 mg/day (Imodium )** each loose stool Morphine, Anhydrous Oral solution (Opium Tincture 1%) [50 mg/5 ml]: 6 mg (0.6 ml) PO QID 6 ml/day Morphine, Anhydrous Oral solution (Paregoric) [2 mg/5 ml]: 2 to 4 mg (5 to 10 ml) PO QID PRN 5 10 ml PO QD to QID 40 ml/day Therapeutic alternatives are listed as Brand name (generic) when the drug is available by brand name only and generic (Brand name ) when the drug is available by both brand and generic. V. Dosage and Administration Sandostatin Indication Dosing Regimen Maximum Dose Acromegaly Initial: 50 mcg SC/IV TID Max 1500 mcg/day) Carcinoid tumor symptoms VIPomas All Other Indications Maintenance: mcg SC/IV TID Initial: mcg/day SC/IV in 2-4 divided doses for 2 weeks Maintenance: 450 mcg/day SC/IV Initial: mcg SC/IV in 2-4 divided doses for 2 weeks Maintenance: Not more than 450 mcg/day SC/IV Doses vary based on indication Range mcg/day) 450 mcg/day SC/IV Varies Sandostatin LAR Indication Dosing Regimen Maximum Dose Acromegaly mg IM q 4 weeks for 3 months Max 40 mg Q 4 weeks) Carcinoid tumor symptoms mg IM q 4 weeks for 2 months (Max 30 mg Q 4 weeks); may decrease to 10 mg q 4 weeks after a period of 2 months on 20 mg q 4 weeks VIPomas mg IM q 4 weeks for 2 months (Max 30 mg Q 4 Max 30 mg Q 4 weeks Max 30 mg Q 4 weeks Page 4 of 7

5 All Other Indication weeks); may decrease to 10 mg q 4 weeks after a period of 2 months on 20 mg q 4 weeks Doses vary based on indication Sandostatin LAR Depot should never be administered IV or SC Varies VI. Product Availability Drug Sandostatin Sandostatin LAR Availability Ampule: 50 mcg, 100 mcg, or 500 mcg in 1 ml ampule and 200 mcg/ml or 1000 mcg/ml in multidose vial Depot Kit :10 mg, 20 mg, 30 mg in 6 ml vial (requires reconstitution) VII. References 1. Sandostatin [package insert], East Hanover, NJ; Novartis: Feburary Available at: Accessed January 24, Sandostatin LAR Depot [package insert]. East Hanover, NJ; Novartis:. July Available at: Accessed January 24, American Gastroenterological Association. American Gastroenterological Association medical position statement: Short bowel syndrome and intestinal transplantation. Gastroenterology. 2003;124(4): Ripamonti C, Mercadante S, Groff L, et.al. Role of octreotide, scopolamine, butylbromide, and hydration in symptom control of patients with inoperable bowel obstruction and nasogastric tubes: A prospective randomized trial. J Pain Symptom Manage. 2000;19(1): Mystakidou K, Tsilika E, Kalaidopoulou O, et al. Comparison of octreotide administration versus conservative treatment in the management of inoperable bowel obstruction in patients with far advanced cancer: A randomized, double-blind, controlled clinical trial. Anticancer Res. 2002;22(2B): Erem C, Hacihasanoglu A, Sari A, et.al. A rare case and a rapid tumor response to therapy: Dramatic reduction in tumor size during octreotide treatment in a patient with TSH-secreting pituitary macroadenoma. Endocrine. 2004, 25(2): Caron P, Arlot S, Bauters C, et.al. Efficacy of the long-acting octreotide formulation (octreotide-lar) in patients with thyrotropin-secreting pituitary adenomas. J Clin Endocrinology & Metabolism. 2001, 86(6): Shimatsu A, Murabe H, Kamoi K, et.al. Treatment of thyrotropin-secreting pituitary adenomas with octreotide. Endocrine Journal. 1999, 46(1): Sandostatin. American Hospital Formulary Service Drug Information. Available at: Accessed January 11, Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed January 24, Page 5 of 7

6 11. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: Accessed: January 11, Reviews, Revisions, and Approvals Date P&T Approval Date Converted to new template. Minor changes to verbiage and grammar. References updated Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Page 6 of 7

7 Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services. Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 7 of 7