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Antiemetic Injection Therapy AHM (PDF) Antiemetic Injection Therapy AHM Clinical Indications • Aloxi (palonosetron) is considered medically necessary for 1 or more of the following • Prevention of acute nausea and/or vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, including high-dose cisplatin and for breakthrough treatment of chemotherapy induced nausea and/or vomiting of low emetogenic cancer chemotherapy in persons who have an inadequate response or contraindication to intravenous granisetron (Kytril) or ondansetron (Zofran) at the Food and Drug Administration (FDA) recommended dose • Prevention or treatment of post-operative nausea or vomiting when intravenous Kytril (Granisetron) or ondansetron (Zofran) at the FDA recommended dose has failed or is contraindicated. • Severe, intractable, persistent nausea or vomiting during pregnancy when ALL of the following have been met . Clinical signs of dehydration are present or nausea and vomiting have persisted for more than 3 weeks . Intravenous Kytril (Granisetron) or Zofran (ondansetron) at the FDA recommended dose has failed or is contraindicated. • Refractory cases of nausea or vomiting for other indications (e.g., bulimia nervosa, cyclic vomiting syndrome, HIV) when intravenous Kytril (Granisetron)or Zofran (ondansetron) at the FDA recommended dose has failed or is contraindicated • Kytril (Granisetron) is considered medically necessary for 1 or more of the following • Prevention of acute and delayed nausea and/or vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy including high-dose displatin and for treatment of chemotherapy-induced nausea and/or vomiting of low or minimally emetogenic cancer chemotherapy in persons who have an inadequate response or contraindication to intravenous granisetron (Kytril) or ondansetron (Zofran) at the Food and Drug Administration (FDA) recommended dose • Prevention of radiation-induced nausea and/or vomiting secondary to total body irradiation when oral antiemetic therapy (e.g., Zofran or Kytril) has failed or is contraindicated. to intravenous Kytril (Granisetron) or Zofran (ondansetron) at the Food and Drug Administration (FDA) recommended dose AC-AEANT0820112 Page 1 of 12 Copyright 2016 No part of this document may be reproduced without permission ActiveHealth Management Medical Management Guidelines • Prevention or treatment of post-operative nausea or vomiting when oral Kytril (Granisetron) or Zofran (ondansetron) has failed or is contraindicated. • Severe, intractable, persistent nausea or vomiting during pregnancy when clinical signs of dehydration are present or nausea and vomiting have persisted for more than 3 weeks and ALL of the following conditions are met: . Conservative treatment has failed (e.g., dietary changes, ginger, multi-vitamin, vitamin B6 (pyridoxine) with or without doxylamine (Unisom) . Oral, sublingual, or rectal antiemetics have failed or are contraindicated including 2 or more of the following : • Dimenhydrinate (Dramamine) • Zofran (ondansetron) or Kytril (Granisetron) • Promethazine (Phenergan) • Trimethobenzamide (Tigan) . Other injectable/intravenous antiemetics have failed or are contraindicated including ALL of the following • Dimenhydrinate (Dramamine) • Promethazine (Phenergan) • Refractory cases of nausea or vomiting for other indications (e.g., bulimia nervosa, cyclic vomiting syndrome, HIV) when oral Kytril (Granisetron) or Zofran (ondansetron) has failed or is contraindicated. • Emend (fosaprepitant dimeglumine) is considered medically necessary for 1 or more of the following • Prevention of acute nausea and/or vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, including high-dose cisplatin and for breakthrough treatment of chemotherapy induced nausea and/or vomiting of low emetogenic cancer chemotherapy in persons who have an inadequate response or contraindication to intravenous granisetron (Kytril) or ondansetron (Zofran) at the Food and Drug Administration (FDA) recommended dose • Prevention or treatment of post-operative nausea or vomiting when intravenous Kytril (Granisetron) or ondansetron (Zofran) at the FDA recommended dose has failed or is contraindicated. • Refractory cases of nausea or vomiting for other indications (e.g., bulimia nervosa, cyclic vomiting syndrome, HIV) when intravenous Kytril (Granisetron) or Zofran (ondansetron) at the FDA recommended dose has failed or is contraindicated • Zofran (ondansetron) is considered medically necessary for 1 or more of the following • Prevention of acute and delayed nausea and/or vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy including high-dose displatin and for treatment of chemotherapy-induced nausea and/or vomiting of low or minimally emetogenic cancer chemotherapy in persons who have AC-AEANT0820112 Page 2 of 12 Copyright 2016 No part of this document may be reproduced without permission ActiveHealth Management Medical Management Guidelines an inadequate response or contraindication to intravenous granisetron (Kytril) or ondansetron (Zofran) at the Food and Drug Administration (FDA) recommended dose • Prevention of radiation-induced nausea and/or vomiting secondary to total body irradiation when oral antiemetic therapy (e.g., Zofran or Kytril) has failed or is contraindicated. to intravenous Kytril (Granisetron) or Zofran (ondansetron) at the Food and Drug Administration (FDA) recommended dose • Prevention of radiation-induced nausea and/or vomiting secondary to TBI when oral Kytril (Granisetron) or Zofran (ondansetron) at the FDA recommended dose has failed or is contraindicated • Prevention or treatment of post-operative nausea or vomiting when oral Kytril (Granisetron) or Zofran (ondansetron)has failed or is contraindicated. • Severe, intractable, persistent nausea or vomiting during pregnancy when clinical signs of dehydration are present or nausea and vomiting have persisted for more than 3 weeks and ALL of the following conditions are met: . Conservative treatment has failed (e.g., dietary changes, ginger, multi-vitamin, vitamin B6 (pyridoxine) with or without doxylamine (Unisom) . Oral, sublingual, or rectal antiemetics have failed or are contraindicated including 2 or more of the following • Dimenhydrinate (Dramamine) • Zofran (ondansetron) or Kytril (Granisetron) • Promethazine (Phenergan) • Trimethobenzamide (Tigan) . Other injectable/intravenous antiemetics have failed or are contraindicated including ALL of the following • Dimenhydrinate (Dramamine) • Promethazine (Phenergan) • Anzemet (dolasetron) is considered medically necessary for 1 or more of the following • Prevention of radiation-induced nausea or vomiting secondary to total body irradiation (TBI) when intravenous antiemetic therapy with Kytril (Granisetron) or Zofran (ondansetron) at the FDA recommended dose has failed or is contraindicated. • Prevention or treatment of post-operative nausea or vomiting when intravenous Kytril (Granisetron) or Zofran (ondansetron) at the FDA recommended dose has failed or is contraindicated. • Refractory cases of nausea or vomiting for other indications (e.g., bulimia nervosa, cyclic vomiting syndrome, HIV) when intravenous Kytril (Granisetron) or Zofran (ondansetron) at the FDA recommended dose has failed or is contraindicated. Indications considered Not Medically Necessary AC-AEANT0820112 Page 3 of 12 Copyright 2016 No part of this document may be reproduced without permission ActiveHealth Management Medical Management Guidelines • Aloxi (palonosetron) is considered experimental and investigational for the prevention of radiation-induced nausea and vomiting because there is insufficient evidence of their effectiveness for this indication. • Emend (fosaprepitant dimeglumine) is considered experimental and investigational for the prevention of radiation-induced nausea and vomiting because there is insufficient evidence of their effectiveness for this indication. • Anzemet (dolasetron) is considered experimental and investigational for prevention of nausea or vomiting from cancer chemotherapy. • Note: 5-HT3 receptor antagonist antiemetic intravenous therapy is considered experimental and investigational for motion-induced nausea and vomiting (motion- sickness). • Note: As with other antiemetics, routine prophylaxis is not recommended for individuals in whom there is little expectation that nausea and/or vomiting will occur post-operatively. • Note: This policy does not address the use of 5-HT3 receptor antagonists in the emergency room. Serotonin 3 receptor antagonists have been used in the management of acute toxicities (e.g., acetaminophen, theophylline). Evidence Summary Background • Serotonin 3 (5-HT3) receptor antagonists [(i.e., palonosetron (Aloxi), dolasetron mesylate (Anzemet), granisetron (Kytril), and ondansetron (Zofran)] are used for the treatment and prevention of post-operative nausea and vomiting as well as nausea and vomiting caused by cancer chemotherapy, radiotherapy, and pregnancy. 5-HT3 receptor antagonists work by blocking serotonin binding at vagal afferents in the gut and in regions of the central nervous system (CNS) involved in emesis. • Antiemetic practice guidelines from the National Comprehensive Cancer Network (NCCN, 2008) recommend antiemetic regimens based upon the emetogenic potential of the chemotherapy drug as well as individual risk factors. The antiemetic regimen for highly emetogenic drugs includes
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