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Drug Therapy Guidelines: Anti-emetic/Anti-ver tigo Agents

Zofran® (ondansetron)F,Kytril® (granisetron)NF, Anzemet® (dolasetron)NF, Emend® 

(aprepitant)NF

 Effective Date: 11/20/07

Committee Review Date: 4/1/99, 10/17/00,

9/18/01, 9/24/02, 10/21/03, 9/28/04, 8/16/05,

8/29/06, 11/5/07

Policy Statements:

Non-Formulary or Prior Authorization drugs will require an appropriate trial of aFormulary agent(s) based on clinical criteria. Members wi th a closed Formulary (2 Tier)prescription benefit are limited to use of Formulary agents only. A therapeutic trial ofsamples of a Non-Formulary or Prior Author ization agent w ill no t be accepted asappropriate.

Please be sure to list all therapies that have been previously tried on the request form sothat your request can be processed in a timely manner.

What they Do and How they are Used:

•  Ondansetron, granisetron and dolasetron are selective serotonin 5-HT(3)-type receptor

antagonists. These medications are used for the prevention and treatment of nauseaand vomiting in select situations. Indications for each product are listed below.

•  Zofran®:a) Prevention of nausea and vomiting associated with initial and repeat courses of

emetogenic cancer chemotherapyb) Prevention of post operative nausea or vomitingc) Prevention of nausea and vomiting associated with radiotherapy in patients

receiving either total body irradiation, single high dose fraction to the abdomenor daily fractions to the abdomen (oral)

d) Prevention of nausea and vomiting associated with highly emetogenic cancer

chemotherapy, including cisplatin ≥ 50mg/m2 (oral)

•  Kytril® NF*

a) Prevention of nausea and vomiting associated with initial and repeat courses ofemetogenic cancer therapy, including high dose cisplatin

b) Nausea and vomiting associated with radiation including total body irradiationand fractional abdominal irradiation (oral only)

c) Prevention and treatment of post-operative nausea and vomiting (injection only)

•  Anzemet® NF* a) Prevention of nausea and vomiting associated with initial and repeat courses of

emetogenic cancer chemotherapy, including high dose cisplatin (injection only)b) Prevention of post-operative nausea and vomitingc) Treatment of post-operative nausea and vomiting (injection only)

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•  Emend®) NF* is a selective high-affinity antagonist of human substance P/neurokinin 1(NK1) receptors, that is used as an anti-emetic in combination with other anti-emeticagents for the prevention of acute and delayed nausea and vomiting associated withinitial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin.

Rationale for Prior Author ization:To provide coverage for anti-emetic/anti-vertigo agents for conditions where they are FDAapproved or an established effective/standard practice.

Benefit Design:Coverage is determined through a prior authorization process for every claim, with the followingexceptions:

•  Prescriptions written by the following providers will not require prior authorization:therapeutic radiology, hematology, radiation oncology, oncology, pediatric hematology-oncology, surgical oncology, hematology-oncology, gynecology-oncology, nursepractitioner – hematology, nurse practitioner – oncology.

Prior Authorization Criteria:Indications having to do with the treatment of cancer are not covered within this guideline.Zofran®, Emend®, Kytril® and Anzemet® treatments will be covered for these indications whenprescribed by certain specialists identified above. Quantity limits also apply.

Coverage for Zofran® is provided in accord with the following:

•  Post-operative nausea and vomiting in patients who have failed a first line agent:meclizine or dimenhydrinate and a second line agent: prochlorperazine, promethazineor chlorpromazine or who have had adverse events or contraindications to theseconventional antiemetic therapies.

•  As third line treatment in pregnant patients with hyperemesis gravidarum who have

failed pyridoxine as a first line agent, AND three agents from the following five:promethazine, meclizine, dimenhydrinate, metoclopramide, or prochlorperazine.Patients treated less than the 10th gestational week has not been documented in theclinical literature and is therefore not recommended.

Pregnancy Category B Pregnancy Category C

dimenhydrinatemeclizine

metoclopramidepyridoxine (30-75mg daily)

prochlorperazinepromethazine

•  Zofran® is used off label for various gastrointestinal disorders: There is not good clinical or

long term safety data to satisfy the FDA for indications in the treatment of DiabeticGastroparesis, Dumping Syndrome or Irritable Bowel Syndrome. Therefore, consideration oftherapy will be based on supporting clinical evidence provided by the prescribing physician.

Coverage Duration:Length of therapy approved will vary depending on patient’s diagnosis and medicationrequested. Recommended dosages for Zofran® are as follows:

•  Prevention of postoperative nausea or vomiting (oral):a) Adults: 16 mg given as a single dose 1 hour before induction of anesthesia.b) Children: There is no experience in children with the use of tablets or oral

solution in the prevention of postoperative nausea and vomiting.

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•  Hyperemesis Gravidarum; Doses of 4—8 mg PO given 2—3 times per day have beenadministered as early as 10 weeks gestation in a small number of pregnant women.

Quantity limits apply to all medications in this category. There is a quantity limit of 7 days supplyper prescription on ondansetron, granisetron and dolasetron and a quantity limit of 5 dayssupply per prescription per copay on aprepitant. The number of tablets/capsules or packs that

may be received at a time are outlined below:

Medication Quantity Limit

 Anzemet® 50mg, 100mg tablets #7

Emend® 125mg capsule #2

Emend® 80mg #8Emend® trifold packs containing one 125 mgcapsule and two 80 mg capsules

#2 packs

Kytril® 1mg tablet #14

Zofran® 24mg tablet #7

Zofran®/ODT 4mg, 8mg tablets #21

Note: Patients may receive more than one 3-5 day supply per month if appropriate. One copaywould apply to each 3-5 day supply.

References:1. Anzemet® [Prescribing Information], Aventis, Kansas City, MO. October 20032. Emend® [Prescribing Information], Merck. 20033. Mattes CL. Management of hyperemesis in pregnant women. Lancet 1999 Jan 23,

353;9149:3254. Johnson L. Interventions for nausea and vomiting in early pregnancy. Cochrane

Database Syst Rev. 2000;(2):CD000145.5. Kytril® [Prescribing Information], RTP, NC; Glaxo Smith Kline. June 20056. Levichek, Z, Atanachovic, G, Oepkes, D, et al. Nausea and vomiting of pregnancy.

Evidence-based treatment algorithim. Can Fam Physician 2002; 48:2677. UpToDate online, Hyperemesis Gravidarum, http://www.utdol.com (accessed July 18,

2005).8. Zofran® [Prescribing Information], RTP, NC; Glaxo Smith Kline. June 2005.