Prior Auth Protocol

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.

Health Net Approved Indications and Usage Guidelines:

Treatment of acromegaly

For management of gastrointestinal neuroendocrine tumors (NETs), such as any of the following:
- Treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors
- Prophylactic treatment to prevent carcinoid crises prior to surgery for carcinoid tumor
- To reverse life-threatening hypotension due to carcinoid crisis during induction of anesthesia
- For the treatment of the profuse watery diarrhea associated with vasoactive intestinal polypeptide-secreting tumors (VIPomas)
- Prophylactic treatment prior to surgery for functioning gastrinoma (Zollinger Ellison syndrome)
- Prophylactic treatment prior to hepatic artery embolization for nonresectable multiple and hormone-secreting neuroendocrine tumors
- Stabilization of blood glucose levels in persons with functioning islet cell tumors (insulinomas or glucagonomas);

To reduce the incidence and severity of the postoperative complications of high-risk pancreatic surgery

Treatment of chemotherapy and/or radiation therapy-induced diarrhea

Treatment of severe secretory diarrhea associated with acquired immunodeficiency syndrome (AIDS)

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

Treatment of unresectable malignant thymoma that is refractory to standard chemotherapy

To reduce output from gastrointestinal (GI) or pancreatic fistulas

Management of gastrointestinal symptoms (e.g. nausea, vomiting, and pain) of inoperable bowel obstruction in persons with far advanced cancer

Thyroid stimulating hormone (TSH) hypersecretion due to TSH secreting adenoma

Dumping syndrome following gastric resection

Coverage is Not Authorized For:

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^R 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 during induction of 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.
DRUGDEX supports the use of Sandostatin with a Class IIb recommendation for the following:

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
diphenoxylate / atropine (Lomotil^R)	2.5 5 mg diphenoxylate component PO BID to QID	20mg/day of diphenoxylate
loperamide (Imodium^R) Note: Coverage of agents available without prescription (OTC) may vary with plan formulary and benefit design	4 mg PO initially then 2 mg after each loose stool	16 mg per day
Morphine, Anhydrous Oral solution (Opium Tincture 1%, 10 mg/ml)	6 mg (0.6 ml) PO QID	6 mg (0.6 ml) per dose 24 mg (2.4 ml) per day
Morphine, Anhydrous Oral solution (Paregoric 0.4 mg/ml)	2 4 mg (510 ml) PO QD to QID	4 mg (10 ml) per dose 16 mg (40 ml) per day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Sandostatin	Acromegaly 50 mcg SC/IV TID (Max 1500 mcg/day) Carcinoid tumor symptoms 100-600 mcg/day SC/IV in 2-4 divided doses (Max 1500 mcg/day) VIPomas 200-300 mcg SQ/IV in 2-4 divided doses Range (150-750 mcg/day) Secretory diarrhea, GI or pancreatic fistulas, TSH-secreting adenoma 50-100 mcg SC/IV QD to TID (Max 1500 mcg/day) All Other Indications Doses vary based on indication	NATL: 6 months or member's rerate date, whichever is later HNMC: 6 months
Sandostatin LAR	Acromegaly 20-40 mg IM q 4 weeks (Max 40 mg q 4 weeks) Carcinoid tumor symptoms 20-30 mg IM q 4 weeks (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 20-30 mg IM q 4 weeks (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 Secretory diarrhea, GI or pancreatic fistulas,TSH-secreting adenoma Patients may be titrated to response with the short-acting product then converted to LAR All Other Indications Doses vary based on indication Sandostatin LAR^RDepot should never be administered intravenously or subcutaneously.	NATL: 6 months or member's rerate date, whichever is later HNMC: 6 months

Product Availability:

Sandostatin Ampule: 50 mcg/mL, 100 mcg/mL, or 500 mcg/mL in 1 mL amps

Sandostatin Multi-dose Vial: 200 mcg/mL or 1000 mcg/mL in 5 mL vials

Sandostatin LAR Depot Kit: 10 mg, 20 mg, 30 mg in 6 mL vials (requires reconstitution)

References:

1. Sandostatin [Prescribing Information] East Hanover, NJ: Novartis Pharmaceuticals; March 2012.
2. Sandostatin LAR Depot [Prescribing Information] East Hanover, NJ: Novartis Pharmaceuticals; July 2014.
3. Octreotide acetate. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 3, 2015.
4. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. July 3, 2015.
5. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com. Accessed July 3, 2015.
6. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 25, 2015.
7. American Gastroenterological Association. American Gastroenterological Association medical position statement: short bowel syndrome and intestinal transplantation. Gastroenterology. 2003;124(4):1105-1110.
8. Ripamonti C, Mercadante S, Groff L, et.al. Role of octreotide, scopolamine, butylbromide, and hydration in symptom control of patients with inoperable bowel obstruction having a nasogastric tube- a prospective randomized clinical trial. J Pain Symptom Manage 2000;19(1):23-34.
9. 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):1187-1192.
10. 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):141-145.
11. 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 Endocrinol Metab 2001; 86:2849-2853.
12. Shimatsu A, Murabe H, Kamoi K, et.al. Treatment of thyrotropin-secreting pituitary adenomas with octreotide. Endocrine Journal 1999;46(1):113-123.