Subject: Granisetron-Sancuso-Sustol Limit Policy 121-H 02-2022

Drug

ANTIEMETICS

granisetron hydrochloride (ALL PRODUCTS)

SANCUSO  (granisetron transdermal system)

SUSTOL  (granisetron extended-release injection)

Policy:

FDA-approved Indications          
Granisetron
Granisetron Tablets
Granisetron Hydrochloride Tablets are indicated for the prevention of:
•      Nausea and vomiting associated with initial and repeat courses of
        emetogenic cancer therapy, including high-dose cisplatin.
•      Nausea and vomiting associated with radiation, including total
        body irradiation and fractionated abdominal radiation.

Granisetron Injection:
Granisetron Hydrochloride Injection is indicated for:
•      Prevention of nausea and/or vomiting associated with initial and
        repeat courses of emetogenic cancer therapy, including high-dose
        cisplatin.
•      Prevention and treatment of postoperative nausea and vomiting in
        adults. As with other antiemetics, routine prophylaxis is not
        recommended in patients in whom there is little expectation that
        nausea and/or vomiting will occur postoperatively. In patients
        where nausea and/or vomiting must be avoided during the
        postoperative period, granisetron hydrochloride injection USP is
        recommended even where the incidence of postoperative nausea
        and/or vomiting is low.

Sancuso Transdermal System
Sancuso is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.

Sustol Extended-Release Injection
Sustol is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

LIMIT CRITERIA      Limits do not accumulate together, patient is allowed the maximum limit for each drug         and strength
Drug	4 Week Limit*	12 Week Limit*
Granisetron Tablets	12 tablets / 21 days	Does Not Apply*
Granisetron Injection 1 mg/mL or 4mg/4mL	2 mL / 21 days	Does Not Apply*
Sancuso Patches	2 patches / 21 days	Does Not Apply*
Sustol Extended-Release Injection  10 mg/0.4 ml	0.8 mL / 21 days	Does Not Apply*
* The duration of 21 days is used for a 28-day fill period to allow time for refill processing.
* These drugs are for short-term acute use; therefore, the mail limit will be the same as the retail limit. The intent is for prescriptions of the requested drug to be filled one month at a time, even if filled at mail order; there should be no 3 month supplies filled.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Granisetron Tablet [package insert]. Berlin, Connecticut: Breckenridge Pharmaceutical, Inc.; October 2019.
2. Granisetron Injection [package insert]. E. Windsor, New Jersey: AuroMedics Pharma LLC.; December
3. Sancuso Patch [package insert]. Bedminster, New Jersey: 3M Delivery Systems; April 2020.
4. Sustol Injection [package insert]. Chaska, Minnesota: Lifecore Biomedical; May 2017.
5. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, Ohio: UpToDate, Inc.; 2022; Accessed January 4, 2022.
6. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. https://www.micromedexsolutions.com/. Accessed December 22, 2022.
7. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Antiemesis. Version 1.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed December 28, 2022.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 12, 2022