ANTIEMETICS UTILIZATION MANAGEMENT CRITERIA

Transcription

1 ANTIEMETICS [Akynzeo, Anzemet, Cesamet, Emend, Sancuso, Varubi, Zuplenz ] DRUG CLASS: UTILIZATION MANAGEMENT CRITERIA 5-HT 3 Receptor Antagonists 5-HT 3 Receptor Antagonist and Substance P/Neurokinin (NK 1) Receptor Antagonist Combination Substance P/Neurokinin (NK 1) 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 cm 2 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. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 1

2 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. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 2

3 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. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 3

4 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 to generic oral ondansetron or generic oral granisetron. b. Emend is being prescribed in combination with other antiemetic agents, for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC); 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 to generic oral ondansetron or generic oral granisetron. c. Emend is being prescribed as capsules for the prevention of postoperative nausea and vomiting (PONV) in adults 18 years of age; 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. and SM Marks of the Blue Cross and Blue Shield. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 4

5 Sancuso may be eligible for coverage when the following criteria are met: 1. The patient is 18 years of age; AND 2. Sancuso is being prescribed for nausea and vomiting secondary to pregnancy; OR 3. Sancuso is being prescribed for the prevention of nausea and vomiting in a patient receiving moderately and/or highly emetogenic chemotherapy; AND a. There is documented use of a moderately and/or highly emetogenic cancer chemotherapy agent, as listed in the most recent NCCN guidelines (refer to guidelines on pages 8-9), for up to 5 consecutive days; 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 Varubi may be eligible for coverage when the following criteria are met: 1. The patient is 18 years of age; AND 2. Varubi is being prescribed, in combination with other antiemetic agents, 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 cancer chemotherapy (HEC); 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 c. 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. Zuplenz may be eligible for coverage when the following criteria are met: 1. The patient is 18 years of age; AND 2. Zuplenz is being prescribed for at least one of the following: a. Nausea and vomiting secondary to pregnancy b. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy and 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) c. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy and 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 SM Marks of the Blue Cross and Blue Shield. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 5

6 d. 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 e. Prevention of postoperative nausea and/or vomiting; AND 3. The patient has experienced a therapeutic failure or inadequate response to generic oral ondansetron or generic oral granisetron; OR 4. The patient has a contraindication to generic oral ondansetron or generic oral granisetron. Length of Approval: 12 months QUANTITY LIMIT EXCEPTION CRITERIA (listed on page 7) Quantities above the program quantity limit for Anzemet may be eligible for coverage when ONE of the following is met: 1. The patient has cancer chemotherapy related nausea and vomiting and will be receiving chemotherapy more than 7 days per month OR 2. The patient has hyperemesis gravidarum OR 3. The prescriber has submitted documentation in support of the requested therapeutic use and quantity for the requested medication. Quantities above the program quantity limit for Sancuso or Varubi may be eligible for coverage when ONE of the following is met: 1. The patient has cancer chemotherapy related nausea and vomiting and will be receiving chemotherapy more than 7 days per month OR 2. The patient has delayed emesis in highly emetogenic chemotherapy OR 3. The patient has hyperemesis gravidarum OR 4. The prescriber has submitted documentation in support of the requested therapeutic use and quantity for the requested medication. Quantities above the program quantity limit for Akynzeo or Emend may be eligible for coverage when ONE of the following is met: 1. The patient has cancer chemotherapy related nausea and vomiting and will be receiving chemotherapy more than 7 days per month OR 2. The patient has delayed emesis in highly emetogenic chemotherapy OR 3. The prescriber has submitted documentation in support of the requested therapeutic use and quantity for the requested medication. Quantities above the program quantity limit for Cesamet may be eligible for coverage when: 1. BOTH of the following are met: a. The patient has a documented history of failure to respond adequately to one conventional antiemetic treatment (Akynzeo, Anzemet, Emend, granisetron, Sancuso, or Zofran/Zofran ODT/ondansetron); AND b. The patient has cancer chemotherapy related nausea and vomiting and will be receiving chemotherapy more than 7 days per month OR 2. The prescriber has submitted documentation in support of the requested therapeutic use and quantity for the requested medication. Quantities above the program quantity limit for Zuplenz may be eligible for coverage when ONE of the following is met: and SM Marks of the Blue Cross and Blue Shield. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 6

7 1. The patient has cancer chemotherapy related nausea and vomiting and will be receiving chemotherapy more than 7 days per month OR 2. The patient has delayed emesis in highly emetogenic chemotherapy OR 3. The patient has hyperemesis gravidarum OR 4. The patient has radiation therapy induced nausea and vomiting and radiation treatment that extends beyond 7 days per month OR 5. The prescriber has submitted documentation in support of the requested therapeutic use and quantity for the requested medication. Length of Approval: 12 months Program Quantity Limit Brand (Generic) Akynzeo (netupitant/palonosetron) 300 mg netupitant/0.5 mg palonosetron capsule Anzemet (dolasetron mesylate) 50 mg, 100mg strength tablet Quantity Per 30 Day Limit 2 capsules 7 tablets Cesamet (nabilone) 1 mg strength capsule 42 capsules Emend (aprepitant) 40 mg strength capsule 4 capsules Emend (aprepitant) 80 mg strength capsule 4 capsules Emend (aprepitant) 125 mg strength capsule 2 capsules Emend (aprepitant) 2 therapy packs Emend Therapy Pack (1 x 125mg capsule; 2 x 80mg capsules) Emend (aprepitant) 125mg suspension 6 suspension packets Sancuso (granisetron transdermal system) 52 cm 2 patch containing 34.3 mg of granisetron delivering 3.1 mg per 24 hours Varubi (rolapitant) Zuplenz (ondansetron) 4 mg and 8 mg oral soluble film 1 patch 4 tablets 20 films (2 boxes of 10) and SM Marks of the Blue Cross and Blue Shield. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 7

8 Emetogenic Potential of Intravenous and Oral Antineoplastic Agents Table based on NCCN Clinical Practice Guidelines in Oncology Version Antiemesis AC Combination defined as either doxorubicin or epirubicin with cyclophosphamide Dacarbazine Mechlorethamine Intravenous Agents High Emetic Risk (>90% frequency of emesis) Carmustine Cisplatin >250 mg/m 2 Doxorubicin 60 mg/m 2 Streptozocin Cyclophosphaminde >1500 mg/m 2 Epirubicin >90mg/m 2 Ifosfamide 2 g/m 2 per dose Intravenous Agents Moderate Emetic Risk (30-90% frequency of emesis) Aldesleukin Amifostine >300 Arsenic trioxide Azacitidine >12-15 million IU/m 2 mg/m 2 Bendamustine Busulfan Carboplatin v Carmustine v 250 mg/m 2 Clofarabine Cyclophosphaminde Cytarabine >200 mg/m 2 Dactinomycin v 1500 mg/m 2 Danuorubicin v Doxorubicin v Epirubicinv 90 mg/m 2 Idarubicin <60mg/m 2 Ifosfamide Interferon alfa Irinotecan v Melphalan <2 g/m 2 per dose 10 million IU/m 2 Methotrexate v 250 mg/m 2 Oxaliplatin Temozolomide Intravenous Agents Low Emetic Risk (10-30% frequency of emesis) Ado-trastuzumab Amifostine 300mg Aldesleukin Belinostat emtansine 12 million IU/m 2 Blinatumomab Brentuximab vedotin Cabazitaxel Carfilzomib Cytarabine (low dose) Docetaxel Doxorubicin (liposomal) Eribulin mg/m 2 Etoposide 5-FU Floxuridine Gemcitabine Interferon alfa Ixabepilone Methotrexate Mitomycin >5 <10 million IU/m 2 >50 mg/m 2 <250 mg/m 2 Mitoxantrone Omacetaxine Paclitaxel Paclitaxel-albumin Pemetrexed Pentostatin Prelatrexate Romidepsin Thiotepa Topotecan Ziv-afilbercept Intravenous Agents Minimal Emetic Risk (<10% frequency of emesis) Alemtuzumab Asparaginase Bevacizumab Bleomycin and SM Marks of the Blue Cross and Blue Shield. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 8

9 Bortezomib Cetuximab Cladribine(2- chlorodeoxyadenosine) Cytarabine <100 mg/m 2 Decitabine Denileukin dftitox Dexrazoxane Fludarabine Interferon alfa Ipilimumab Methotrexate Nelarabine 5 million IU/m 2 50 mg/m 2 Nivolumab Obinutuzumab Ofatumumab Panitumumab Pegaspargase Peginterferon Pembrolizumab Pertuzumab Ramucirumab Rituximab Siltuximab Temsirolimus Trastuzumab Valrubicin Vinblastine Vincristine Vincristine (liposomal) Vinorelbine Oral Agents Moderate to High Emetic Risk Altretamine Busulfan ( 4 mg/day) Ceritinib Crizotinib Cyclophosphamide Estramustine Etoposide Lenvatinib ( 100 mg/m 2 /day) Lomustine (single day) Mitotane Olaparib Panobinostat Procarbazine Temozolomide (>75 mg/m 2 /day) Vismodegib Oral Agents Minimal to Low Emetic Risk Afatinib Axitinib Bexarotene Bosutinib Busulfan (<4 mg/day) Cabozantinib Capecitabine Chlorambucil Cyclophosphamide (<100 Dasatinib Dabrafenib Erlotinib mg/m 2 /day) Everolimus Fludarabine Gefitinib Hydroxyurea Ibrutinib Idelalisib Imatinib Lapatinib Lenalidomide Melphalan Mercaptopurine Methotrexate Nilotinib Palbociclib Pazopanib Pomalidomide Ponatinib Regorafenib Ruxolitinib Sorafenib Sunitinib Temozolomide ( 75 Thalidomide Thioguanine mg/m 2 /day) Topotecan Trametinib Tretinoin Vandetanib Vemurafenib Vorinostat CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS Akynzeo Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron with or without known hypersensitivity to other 5-HT3 receptor antagonists. Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Anzemet Anzemet is contraindicated in patients known to have hypersensitivity to the drug. Anzemet prolongs the QT interval in a dose dependent fashion. Torsade de Pointes has been reported during post-marketing experience. Avoid Anzemet in patients with congenital long QT syndrome, hypomagnesemia, or hypokalemia. Hypokalemia and hypomagnesemia and SM Marks of the Blue Cross and Blue Shield. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 9

10 must be corrected prior to Anzemet administration. Monitor these electrolytes after administration as clinically indicated. Use ECG monitoring in patients with congestive heart failure, bradycardia, renal impairment, and elderly patients. Anzemet has been shown to cause dose dependent prolongation of the PR and QRS interval and reports of second or third degree atrioventricular block, cardiac arrest and serious ventricular arrhythmias including fatalities in both adult and pediatric patients. At particular risk are patients with underlying structural heart disease and preexisting conduction system abnormalities, elderly, patients with sick sinus syndrome, patients with atrial fibrillation with slow ventricular response, patients with myocardial ischemia or patients receiving drugs known to prolong the PR interval (such as verapamil) and QRS interval (e.g., flecainide or quinidine). Anzemet should be used with caution and with ECG monitoring in these patients. Anzemet should be avoided in patients with complete heart block or at risk for complete heart block, unless they have an implanted pacemaker. Cesamet Contraindications: Cesamet is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid. The effects of Cesamet may persist for a variable and unpredictable period of time following its oral administration. Adverse psychiatric reactions can persist for 48 to 72 hours following cessation of treatment. Cesamet has the potential to affect the CNS, which might manifest itself in dizziness, drowsiness, euphoria high, ataxia, anxiety, disorientation, depression, hallucinations and psychosis. Cesamet can cause tachycardia and orthostatic hypotension. Because of individual variation in response and tolerance to the effects of Cesamet, patients should remain under supervision of a responsible adult especially during initial use of Cesamet and during dose adjustments. Patients receiving treatment with Cesamet should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while receiving Cesamet. Cesamet should not be taken with alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system effects of nabilone. Emend Contraindications: Hypersensitivity to any component of this medication and Emend should not be used concurrently with pimozide, terfenadine, astemizole, or cisapride, since inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions. Coadministration of aprepitant with warfarin (a CYP2C9 substrate) may result in a clinically significant decrease in International Normalized Ratio (INR) of prothrombin time. The efficacy of hormonal contraceptives during and for 28 days following the last dose of Emend may be reduced. Alternative or back-up methods of contraception should be used. Emend is a dose-dependent inhibitor of CYP3A4, and should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4. Caution should be exercised when administered in patients with severe hepatic impairment. Sancuso Contraindications: Known hypersensitivity to granisetron or to any of the components of the patch. and SM Marks of the Blue Cross and Blue Shield. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 10

11 Varubi Contraindications: Concurrent use with thioridazine, a CYP2D6 substrate. Interaction with CYP2D6 Substrates with a Narrow Therapeutic Index: The inhibitory effect of a single dose of Varubi on CYP2D6 lasts at least 7 days and may last longer. Avoid use of pimozide; monitor for adverse reactions if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Zuplenz Contraindications: Concomitant use of apomorphine. Hypersensitivity to ondansetron. Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. ZUPLENZ in patients with congenital long QT syndrome. Monitor ECG in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation. The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension. Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. DOSAGE AND ADMINISTRATION Akynzeo One Akynzeo capsule administered approximately 1 hour prior to the start of chemotherapy. Akynzeo can be taken with or without food. Anzemet Adults: The recommended oral dosage of Anzemet is 100 mg given within one hour before chemotherapy. Pediatrics: The recommended oral dosage in pediatric patients 2 to 16 years of age is 1.8 mg/kg given within one hour before chemotherapy, up to a maximum of 100 mg. Safety and effectiveness in pediatric patients under 2 years of age have not been established. In children for whom the 100 mg tablet is not appropriate based on their weight or ability to swallow tablets, the Anzemet Injection solution may be mixed into apple or apple-grape juice for oral dosing in pediatric patients. The diluted product may be kept up to 2 hours at room temperature before use. Cesamet The usual adult dosage is 1 or 2 mg 2 times a day. On the day of chemotherapy, the initial dose should be given 1 to 3 hours before the chemotherapeutic agent is administered. To minimize side effects, it is recommended that the lower starting dose be used and that the dose be increased as necessary. A dose of 1 or 2 mg the night before may be useful. The maximum recommended daily dose is 6 mg given in divided doses 3 times a day. Cesamet may be administered 2 or 3 times a day during the entire course of each cycle of chemotherapy and, if needed, for 48 hours after the last dose of each cycle of chemotherapy. and SM Marks of the Blue Cross and Blue Shield. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 11

12 Emend Prevention of Chemotherapy Induced Nausea and Vomiting (CINV): 125 mg 1 hr before chemo, day 1 and 80 mg once daily on days 2 and 3, in a regimen with a corticosteroid and a 5-HT3 antagonist. Prevention of Postoperative Nausea and Vomiting (PONV): The recommended oral dosage of Emend is 40 mg within 3 hours prior to induction of anesthesia. Emend may be taken with or without food. Sancuso Apply a single patch to the upper outer arm a minimum of 24 hours before chemotherapy. The patch may be applied up to a maximum of 48 hours before chemotherapy as appropriate. Remove the patch a minimum of 24 hours after completion of chemotherapy. The patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen. Varubi The recommended dosage is 180 mg rolapitant administered approximately 1 to 2 hours prior to the start of chemotherapy. Administer in combination with dexamethasone and a 5- HT3 receptor antagonist; see full prescribing information for dosing information. Zuplenz Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy: The adult oral dosage is 24 mg given successively as three 8 mg films administered 30 minutes before the start of chemotherapy. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy: Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy. Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy. Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day. Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia. *See full prescribing information for complete dosage and administration information* REFERENCES Akynzeo (netupitant and palonosetron) Prescribing Information. Eisai Inc., Woodcliff Lake, NJ and SM Marks of the Blue Cross and Blue Shield. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 12

13 Anzemet (dolasetron mesylate) Prescribing Information. Sanofi-aventis U.S. LLC, Bridgewater, NJ Cesamet (nabilone) Prescribing Information. MEDA Pharmaceuticals. Quebec, Canada Emend (nabilone) Prescribing Information. Merck 7 Co., Inc. Whitehouse Stations, NJ Sancuso (granisetron) Prescribing Information. ProStrakan, Inc. Bridgewater, NJ Varubi (rolapitant) Prescribing Information. Tesaro, Inc. Waltham, MA. September Zuplenz (ondansetron) Prescribing Information. Galena Biopharma, Inc., Portland, OR NCCN Clinical Practice Guidelines in Oncology. Antiemesis Version POLICY IMPLEMENTATION/UPDATE INFORMATION October 2016: Reviewed for ASO Net Results and Essential formularies. Clarified verbiage in points 3 and 3a of Sancuso. Removed verbiage in regard to restricted access for Enhanced and Basic Open formularies. Non-formulary verbiage added. July 2016: Added new to market Emend Suspension. January 2016: Original utilization management criteria issued. and SM Marks of the Blue Cross and Blue Shield. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 13

14 and SM Marks of the Blue Cross and Blue Shield. 1 and Trade names are the intellectual property of their Last Reviewed: October 2016 Page 14