Subject: Cesamet Limit Policy 47-H 02-2022
Policy:
FDA-approved Indications
Cesamet capsules are 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 Substance 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 an as needed basis or as a first antiemetic product prescribed for a patient.
As with all controlled drugs, prescribers should monitor patients receiving Cesamet for signs of excessive use, abuse and misuse. Patients who may be at an increased risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness.
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LIMIT CRITERIA
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Drug
Cesamet 1 mg capsule
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4 Week Limit*
18 capsules / 21 days
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12 Week Limit*
Does Not Apply*
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* 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.
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Place of Service:
Outpatient
The above policy is based on the following references:
- Cesamet [package insert]. Bridgewater, NJ: Bausch Health US LLC; March 2020.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, OH: Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com/. Accessed January 2021.
- Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed January 2021.
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
