Bcbs Prov Guid Zofran

Drug Therapy Guidelines:
Anti-emetic/Anti-vertigo 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 a
Formulary agent(s) based on clinical criteria. Members with a closed Formulary (2 Tier)
prescription benefit are limited to use of Formulary agents only. A therapeutic trial of
samples of a Non-Formulary or Prior Authorization agent will not be accepted as
appropriate.
Please be sure to list all therapies that have been previously tried on the request form so
that 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 nausea
and 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 chemotherapy
b) Prevention of post operative nausea or vomiting
c) Prevention of nausea and vomiting associated with radiotherapy in patients
receiving either total body irradiation, single high dose fraction to the abdomen
or 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*
emetogenic cancer therapy, including high dose cisplatin
b) Nausea and vomiting associated with radiation including total body irradiation
and fractional abdominal irradiation (oral only)
c) Prevention and treatment of post-operative nausea and vomiting (injection only)
Anzemet NF*
emetogenic cancer chemotherapy, including high dose cisplatin (injection only)
b) Prevention of post-operative nausea and vomiting
c) Treatment of post-operative nausea and vomiting (injection only)
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-emetic
agents for the prevention of acute and delayed nausea and vomiting associated with
initial and repeat courses of highly emetogenic cancer chemotherapy, including highdose cisplatin.
Rationale for Prior Authorization:

To provide coverage for anti-emetic/anti-vertigo agents for conditions where they are FDA
approved or an established effective/standard practice.
Benefit Design:
Coverage is determined through a prior authorization process for every claim, with the following
exceptions:
Prescriptions written by the following providers will not require prior authorization:
therapeutic radiology, hematology, radiation oncology, oncology, pediatric hematologyoncology, surgical oncology, hematology-oncology, gynecology-oncology, nurse
practitioner 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 when
prescribed 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, promethazine
or chlorpromazine or who have had adverse events or contraindications to these
conventional 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 the
clinical literature and is therefore not recommended.
Pregnancy Category B
dimenhydrinate
meclizine
metoclopramide
pyridoxine (30-75mg daily)
Pregnancy Category C
prochlorperazine
promethazine
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 Diabetic
Gastroparesis, Dumping Syndrome or Irritable Bowel Syndrome. Therefore, consideration of
therapy will be based on supporting clinical evidence provided by the prescribing physician.
Coverage Duration:
Length of therapy approved will vary depending on patients diagnosis and medication
requested. 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.
Hyperemesis Gravidarum; Doses of 48 mg PO given 23 times per day have been

administered 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 supply
per prescription on ondansetron, granisetron and dolasetron and a quantity limit of 5 days
supply per prescription per copay on aprepitant. The number of tablets/capsules or packs that
may be received at a time are outlined below:
Medication
Anzemet 50mg, 100mg tablets
Emend 125mg capsule
Emend 80mg
Emend trifold packs containing one 125 mg
capsule and two 80 mg capsules
Kytril 1mg tablet
Zofran 24mg tablet
Zofran/ODT 4mg, 8mg tablets
Quantity Limit
#7
#2
#8
#2 packs
#14
#7
#21
Note: Patients may receive more than one 3-5 day supply per month if appropriate. One copay
would apply to each 3-5 day supply.
References:
1. Anzemet [Prescribing Information], Aventis, Kansas City, MO. October 2003
2. Emend [Prescribing Information], Merck. 2003
3. Mattes CL. Management of hyperemesis in pregnant women. Lancet 1999 Jan 23,
353;9149:325
4. 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 2005
6. Levichek, Z, Atanachovic, G, Oepkes, D, et al. Nausea and vomiting of pregnancy.
Evidence-based treatment algorithim. Can Fam Physician 2002; 48:267
7. UpToDate online, Hyperemesis Gravidarum, http://www.utdol.com (accessed July 18,
2005).
8. Zofran [Prescribing Information], RTP, NC; Glaxo Smith Kline. June 2005.

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Drug Therapy Guidelines:

What they Do and How they are Used:

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

Emend) NF* is a selective high-affinity antagonist of human substance P/neurokinin 1

Rationale for Prior Authorization:

Prevention of postoperative nausea or vomiting (oral):

Hyperemesis Gravidarum; Doses of 48 mg PO given 23 times per day have been

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