ANTIEMETICS [Akynzeo®, Anzemet®, Cesamet®, Emend®, Sancuso®, Varubi™, Zuplenz®] UTILIZATION MANAGEMENT CRITERIA DRUG CLASS: 5-HT3 Receptor Antagonists 5-HT3 Receptor Antagonist and Substance P/Neurokinin (NK1) Receptor Antagonist Combination Substance P/Neurokinin (NK1) Receptor Antagonist Synthetic cannabinoid BRAND (generic) NAMES: Akynzeo (netupitant/palonosetron): 300 mg netupitant/0.5 mg palonosetron capsule Anzemet (dolasetron mesylate): 50 mg, 100 mg strength tablet Cesamet (nabilone): 1 mg strength capsule Emend (aprepitant): 40 mg, 80 mg, 125 mg strength capsules, 125 mg oral suspension Sancuso (granisetron transdermal system): 52 cm2 patch containing 34.3 mg of granisetron delivering 3.1 mg per 24 hours Varubi (rolapitant): 90 mg strength tablet Zuplenz (ondansetron): 4 mg and 8 mg oral soluble film FDA-APPROVED INDICATIONS Akynzeo is a fixed combination of netupitant, a substance P/neurokinin 1 (NK1) receptor antagonist, and palonosetron, a serotonin-3 (5-HT3) receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Oral palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. Anzemet is indicated for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, including initial and repeat courses in adults and children 2 years and older. ® and SM Marks of the Blue Cross and Blue Shield Association. ®1 and ™ Trade names are the intellectual property of their respective owners. Blue Cross and Blue Shield of North Carolina is an independent licensee of the Blue Cross and Blue Shield Association Last Reviewed: October 2016 Page 1 Cesamet is indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents. Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments. Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days). Cesamet capsules are not intended to be used on as needed basis or as a first antiemetic product prescribed for a patient. As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness. Emend capsules are indicated: In combination with other antiemetic agents in patients 12 years of age and older and patients less than 12 years of age who weigh at least 30 kg for prevention of: o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) For prevention of postoperative nausea and vomiting (PONV) in adults. EMEND for oral suspension is indicated in combination with other antiemetic agents, in patients 6 months of age and older for prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) (1.1) Sancuso is indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days. Varubi is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Zuplenz is indicated for: Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction to abdomen, or daily fractions to the abdomen. Prevention of postoperative nausea and/or vomiting. ® and SM Marks of the Blue Cross and Blue Shield Association. ®1 and ™ Trade names are the intellectual property of their respective owners. Blue Cross and Blue Shield of North Carolina is an independent licensee of the Blue Cross and Blue Shield Association Last Reviewed: October 2016 Page 2 COVERAGE AUTHORIZATION CRITERIA Non-formulary medications included in this criterion are subject to a trial and failure of up to 2 formulary alternatives that are clinically appropriate to treat the same condition. Akynzeo may be eligible for coverage when the following criteria are met: 1. The patient is ≥18 years of age; AND 2. Akynzeo is being prescribed for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy; AND a. There is documented use of an emetogenic cancer chemotherapy agent listed in the most recent NCCN guidelines (refer to guidelines on pages 8-9); AND b. If prescribing highly and/or moderately emetogenic intravenous chemotherapy and a neurokinin-1 (NK1) antagonist, i. The patient has experienced a therapeutic failure or inadequate response to Emend; OR ii. The patient has a contraindication to Emend; AND i. The patient has experienced a therapeutic failure or inadequate response to generic oral ondansetron or generic oral granisetron; OR ii. The patient has a contraindication to generic oral ondansetron or generic oral granisetron. b. If prescribing low and/or minimal emetogenic intravenous chemotherapy and/or emetogenic oral chemotherapy, i. The patient has experienced a therapeutic failure or inadequate response to generic oral ondansetron or generic oral granisetron; OR ii. The patient has a contraindication to generic oral ondansetron or generic oral granisetron. Anzemet may be eligible for coverage when the following criteria are met: 1. The patient is ≥2 years of age; AND 2. Anzemet is being prescribed for nausea and vomiting secondary to pregnancy; OR 3. Anzemet is being prescribed for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy; AND 4. There is documented use of a moderately emetogenic cancer chemotherapy agent listed in the most recent NCCN guidelines (refer to guidelines on pages 8-9); AND 5. The patient has experienced a therapeutic failure or inadequate response to generic oral ondansetron or generic oral granisetron; OR 6. The patient has a contraindication to generic oral ondansetron or generic oral granisetron. ® and SM Marks of the Blue Cross and Blue Shield Association. ®1 and ™ Trade names are the intellectual property of their respective owners. Blue Cross and Blue Shield of North Carolina is an independent licensee of the Blue Cross and Blue Shield Association Last Reviewed: October 2016 Page 3 Cesamet may be eligible for coverage when the following criteria are met: 1. The patient is ≥18 years of age; AND 2. Cesamet is being prescribed for the treatment of nausea and vomiting associated with cancer chemotherapy; AND 3. There is documented use of an emetogenic cancer chemotherapy agent listed in the most recent NCCN guidelines (refer to guidelines on pages 8-9); AND 4. The patient has experienced a therapeutic failure or inadequate response to generic oral ondansetron or generic oral granisetron; OR 5. The patient has a contraindication to generic oral ondansetron or generic oral granisetron. Emend may be eligible for coverage when the following criteria are met: 1. Emend is being prescribed for at least one of the following (a, b, c, or d): a. Emend is being prescribed in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high dose-cisplatin; AND i. For Emend capsules, the patient is ≥ 12 years of age or < 12 years of age who weigh at least 30kg; AND ii. For Emend suspension, the patient is 6 months of age or older; AND iii. There is documented use of a highly emetogenic cancer chemotherapy agent listed in the most recent NCCN guidelines (refer to guidelines on pages 8-9); AND iv. If prescribing highly emetogenic oral chemotherapy, the patient has experienced a therapeutic failure or inadequate response to generic oral ondansetron or generic oral granisetron; OR v. The patient has a contraindication