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Prior Authorization Protocol
SANDOSTATINR, SANDOSTATIN LARR DEPOT (octreotide)


HNMC
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    Immediate-release Sandostatin
    • To reduce growth hormone and 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 severe diarrhea and flushing episodes associated with the disease.
    • For treatment of profuse watery diarrhea associated with vasoactive intestinal peptide (VIP) secreting tumors.
    Sandostatin LAR
    Sandostatin LAR is a somatostatin analogue indicated in 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.
  2. Health Net Approved Indications and Usage Guidelines:
    • Treatment of acromegaly
    OR
    • 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);
    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

    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
    OR
    • Thyroid stimulating hormone (TSH) hypersecretion due to TSH secreting adenoma
    OR
    • Dumping syndrome following gastric resection
  3. 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.
  4. 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 LARR 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 to reverse life threatening hypotension due to carcinoid crisis during induction of anesthesia surgery, initiation of chemotherapy, or infection.
    • NCCN practice guidelines shows Sandostatin with a category 2A for unresectable malignant thymoma that is refractory to standard chemotherapy
    • DRUGDEX supports the use of Sandostatin with a Class IIb recommendation for the following:
      i. chemotherapy and/or radiation therapy-induced diarrhea
      ii. severe secretory diarrhea associated with AIDS
      iii. acute bleeding and early rebleeding of gastroesophageal varices associated with cirrhosis
      iv. inoperable symptomatic bowel obstruction
      v. reduce the incidence and severity of the postoperative complications of high-risk pancreatic surgery
      vi. symptoms associated with severe dumping syndrome (early and/or late) after gastric surgery
      vii. TSH hypersecretion due to TSH-secreting adenoma (thyrotropin overproduction)
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    diphenoxylate / atropine (LomotilR)

    2 tabs PO QID

    8 tabs per day

    loperamide (ImodiumR)**

    **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%)

    0.6 mL PO QID

    6 ml per day

    Morphine, Anhydrous Oral solution (Paregoric)

    5 - 10 ml PO QD to QID

    40 ml/day
    * Requires Prior Authorization
  6. 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)
    Secretory diarrhea, GI or pancreatic fistulas, TSH-secreting adenoma
    50-100 mcg SC/IV QD - TID (Max 1500 mcg/day)

    All Other Indications
    Doses vary based on indication

    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 LARR Depot should never be administered intravenously or subcutaneously.

    6 months

  7. Product Availability:
    Sandostatin Ampule: 50 mcg/mL, 100 mcg/mL, or 500 mcg/mL in 1 mL amps
    Vial: 200 mcg/mL or 1000 mcg/mL in 5 mL vials
    Sandostatin LAR Depot Kit: 10 mg, 20 mg, 30 mg in 5 mL vials (requires reconstitution)
  8. References:
    1. Sandostatin [package insert], East Hanover, NJ; Novartis: March 2012.
    2. Sandostatin LAR Depot [package insert]. East Hanover, NJ; Novartis: May 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):23-34.
    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 with far advanced cancer: A randomized, double-blind, controlled clinical trial. Anticancer Res. 2002;22(2B):1187-1192.
    6. 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.
    7. 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.
    8. Shimatsu A, Murabe H, Kamoi K, et.al. Treatment of thyrotropin-secreting pituitary adenomas with octreotide. Endocrine Journal. 1999, 46(1):113-23.
    9. Sandostatin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 3, 2014.
    10. DRUGDEXR System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 3, 2014
    11. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed July 3, 2014.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.