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Prior Authorization Protocol SANDOSTATIN®, SANDOSTATIN LAR® DEPOT (octreotide) NATL Coverage of drugs is first determined by the member’s pharmacy benefit. Please consult with or refer to the Evidence of Coverage document. I. FDA Approved Indications: Immediate-release Sandostatin • • • To reduce blood levels of growth hormone and insulin-like growth factor (IGF-I) (somatomedin C) in acromegaly patients who have had inadequate response to 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 treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide (VIP) secreting tumors. Sandostatin LAR For patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated. • Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. • Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors • Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors. II. Health Net Approved Indications and Usage Guidelines: • Treatment of acromegaly OR • For management of gastrointestinal neuroendocrine tumors (NETs), such as any of the following: o Treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors o Prophylactic treatment to prevent carcinoid crises prior to surgery for carcinoid tumor o To reverse life-threatening hypotension due to carcinoid crisis during induction of anesthesia o For the treatment of the profuse watery diarrhea associated with vasoactive intestinal polypeptide-secreting tumors (VIPomas) o Prophylactic treatment prior to surgery for functioning gastrinoma (Zollinger Ellison syndrome) o Prophylactic treatment prior to hepatic artery embolization for nonresectable multiple and hormone-secreting neuroendocrine tumors Confidential and Proprietary Page - 1 Draft Prepared: 08.03.05JK Approved by Health Net Pharmacy & Therapeutics Committee: 11.16.05, 11.18.09, 11.17.10, 11.9.11, 11.20.13, 11.19.14, 11.18.15 Updated: 08.09.05 MG, 09.09.05 RJL, 09.12.05 JK, 02.13.06 AG, 04.02.07 LR, 02.08.08 M McClusky, 07.10.08 MJMcClusky, 07.29.09 MJMcClusky, 06.28.10 MJMcClusky, 06.03.11 A Myong, 07.25.12 R. Gedey, 06.24.13 MJMcClusky, 11.19.13 S Redline, 09.09.14 A Myong, 07.03.15 M Vien, 01.11.16 L Borichevskiy, 12.15.16 A Sahota Prior Authorization Protocol SANDOSTATIN®, SANDOSTATIN LAR® DEPOT (octreotide) NATL o Stabilization of blood glucose levels in persons with functioning islet cell tumors (insulinomas or glucagonomas); OR • To reduce the incidence and severity of the postoperative complications of high-risk pancreatic surgery OR • Treatment of chemotherapy and/or radiation therapy-induced diarrhea OR • Treatment of severe secretory diarrhea associated with acquired immunodeficiency syndrome (AIDS) OR • Treatment of 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 OR • Treatment of unresectable malignant thymoma that is refractory to standard chemotherapy OR • To reduce output from gastrointestinal (GI) or pancreatic fistulas OR • Management of gastrointestinal symptoms (e.g. nausea, vomiting, and pain) of inoperable bowel obstruction in persons with far advanced cancer OR • Thyroid stimulating hormone (TSH) hypersecretion due to TSH secreting adenoma OR • III. Coverage is Not Authorized For: • IV. Dumping syndrome following gastric resection Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section unless there is sufficient documentation of efficacy and safety in the published literature. 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 Confidential and Proprietary Page - 2 Draft Prepared: 08.03.05JK Approved by Health Net Pharmacy & Therapeutics Committee: 11.16.05, 11.18.09, 11.17.10, 11.9.11, 11.20.13, 11.19.14, 11.18.15 Updated: 08.09.05 MG, 09.09.05 RJL, 09.12.05 JK, 02.13.06 AG, 04.02.07 LR, 02.08.08 M McClusky, 07.10.08 MJMcClusky, 07.29.09 MJMcClusky, 06.28.10 MJMcClusky, 06.03.11 A Myong, 07.25.12 R. Gedey, 06.24.13 MJMcClusky, 11.19.13 S Redline, 09.09.14 A Myong, 07.03.15 M Vien, 01.11.16 L Borichevskiy, 12.15.16 A Sahota Prior Authorization Protocol SANDOSTATIN®, SANDOSTATIN LAR® DEPOT (octreotide) NATL • • • • V. 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. i. Gastrinoma and Zollinger-Ellison syndrome ii. Insulinoma Therapeutic Alternatives: Drug diphenoxylate/ atropine (Lomotil) loperamide (Imodium)** Morphine, Anhydrous Oral solution (Opium Tincture 1%) Morphine, Anhydrous Oral solution (Paregoric) Dosing Regimen 2 tabs (5 mg) PO QID Dose Limit/Maximum Dose 8 tabs (20 mg) /day 4 mg PO initially, then 2 mg after each loose stool [50 mg/5 mL]: 6 mg (0.6 mL) PO QID 16 mg/day [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 6 mL/day * Requires prior authorization ** Coverage of agents available without prescription (OTC) may vary with plan formulary and benefit design VI. Recommended Dosing Regimen and Authorization Limit: Drug Sandostatin Dosing Regimen Acromegaly: Initial: 50 mcg SC/IV TID Maintenance: 100-500 mcg SC/IV TID (Max 1500 mcg/day) Carcinoid tumor symptoms: Initial: 100-600 mcg/day SC/IV in 2-4 divided doses for 2 weeks Authorization Limit NATL: 6 months or to member's renewal period, whichever is longer HNMC: 6 months Maintenance: 450 mcg/day SC/IV (Range 50-1500 Confidential and Proprietary Page - 3 Draft Prepared: 08.03.05JK Approved by Health Net Pharmacy & Therapeutics Committee: 11.16.05, 11.18.09, 11.17.10, 11.9.11, 11.20.13, 11.19.14, 11.18.15 Updated: 08.09.05 MG, 09.09.05 RJL, 09.12.05 JK, 02.13.06 AG, 04.02.07 LR, 02.08.08 M McClusky, 07.10.08 MJMcClusky, 07.29.09 MJMcClusky, 06.28.10 MJMcClusky, 06.03.11 A Myong, 07.25.12 R. Gedey, 06.24.13 MJMcClusky, 11.19.13 S Redline, 09.09.14 A Myong, 07.03.15 M Vien, 01.11.16 L Borichevskiy, 12.15.16 A Sahota Prior Authorization Protocol SANDOSTATIN®, SANDOSTATIN LAR® DEPOT (octreotide) NATL Drug Dosing Regimen Authorization Limit mcg/day) VIPomas: Initial: 200-300 mcg SC/IV in 2-4 divided doses for 2 weeks Maintenance: Not more than 450 mcg/day SC/IV Sandostatin LAR All Other Indications Doses vary based on indication Acromegaly: 20-40 mg IM q 4 weeks for 3 months (Max 40 mg Q 4 weeks) Carcinoid tumor symptoms: 20-30 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 NATL: 6 months or to member's renewal period, whichever is longer HNMC: 6 months VIPomas: 20-30 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 All Other Indication Doses vary based on indication Sandostatin LAR® Depot should never be administered intravenously or subcutaneously. VII. Product Availability: Sandostatin Ampule: 50 mcg, 100 mcg, or 500 mcg in 1 mL ampules and 200 mcg/mL or 1000 mcg/mL in 5 mL multi-dose vials Sandostatin LAR Depot Kit: 10 mg, 20 mg, 30 mg in 6 mL vials (requires reconstitution) VIII. References: 1. Sandostatin [package insert], East Hanover, NJ; Novartis: March 2012. 2. Sandostatin LAR Depot [package insert]. East Hanover, NJ; Novartis: June 2014. 3. American Gastroenterological Association. American Gastroenterological Association medical position statement: Short bowel syndrome and intestinal transplantation. Gastroenterology. 2003;124(4):1105-1110. 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):2334. 5. Mystakidou K, Tsilika E, Kalaidopoulou O, et al. Comparison of octreotide administration versus conservative treatment in the management of inoperable bowel obstruction in patients Confidential and Proprietary Page - 4 Draft Prepared: 08.03.05JK Approved by Health Net Pharmacy & Therapeutics Committee: 11.16.05, 11.18.09, 11.17.10, 11.9.11, 11.20.13, 11.19.14, 11.18.15 Updated: 08.09.05 MG, 09.09.05 RJL, 09.12.05 JK, 02.13.06 AG, 04.02.07 LR, 02.08.08 M McClusky, 07.10.08 MJMcClusky, 07.29.09 MJMcClusky, 06.28.10 MJMcClusky, 06.03.11 A Myong, 07.25.12 R. Gedey, 06.24.13 MJMcClusky, 11.19.13 S Redline, 09.09.14 A Myong, 07.03.15 M Vien, 01.11.16 L Borichevskiy, 12.15.16 A Sahota Prior Authorization Protocol SANDOSTATIN®, SANDOSTATIN LAR® DEPOT (octreotide) NATL 6. 7. 8. 9. 10. 11. with far advanced cancer: A randomized, double-blind, controlled clinical trial. Anticancer Res. 2002;22(2B):1187-1192. 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):141-5. 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):2849-53. Shimatsu A, Murabe H, Kamoi K, et.al. Treatment of thyrotropin-secreting pituitary adenomas with octreotide. Endocrine Journal. 1999, 46(1):113-23. Sandostatin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed January 11, 2016. Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed January 11, 2016. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed: January 11, 2016. The materials provided to you are guidelines used by this health plan to authorize, modify, or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual needs and the benefits covered under your contract. Confidential and Proprietary Page - 5 Draft Prepared: 08.03.05JK Approved by Health Net Pharmacy & Therapeutics Committee: 11.16.05, 11.18.09, 11.17.10, 11.9.11, 11.20.13, 11.19.14, 11.18.15 Updated: 08.09.05 MG, 09.09.05 RJL, 09.12.05 JK, 02.13.06 AG, 04.02.07 LR, 02.08.08 M McClusky, 07.10.08 MJMcClusky, 07.29.09 MJMcClusky, 06.28.10 MJMcClusky, 06.03.11 A Myong, 07.25.12 R. Gedey, 06.24.13 MJMcClusky, 11.19.13 S Redline, 09.09.14 A Myong, 07.03.15 M Vien, 01.11.16 L Borichevskiy, 12.15.16 A Sahota