Subject: Dronabinol Limit Policy 137-H 01-2023

Drug

DRONABINOL PRODUCTS

MARINOL  (dronabinol)

SYNDROS  (dronabinol oral solution)

Policy:

FDA-approved Indications
Marinol and Syndros are indicated in adults for the treatment of:
     •   anorexia associated with weight loss in patients with Acquired
          Immune Deficiency Syndrome (AIDS).
     •    nausea and vomiting associated with cancer chemotherapy in
          patients who have failed to respond adequately to conventional
          antiemetic treatments.

 

INITIAL LIMIT QUANTITY
Limits do not accumulate together; patient is allowed the maximum limit for each drug   and strength
Drug	1 Month Limit*	3 Month Limit*
Marinol 2.5 mg, 5 mg, 10 mg   (dronabinol capsules)	60 capsules / 25 days	180 capsules / 75 days
Syndros   (dronabinol oral solution)	120 mL / 25 days	360 mL / 75 days
*The duration of 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period   to allow time for refill processing.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Marinol [package insert]. Parsippany, N J: The Pharma Network, LLC; October 2020.
2. Syndros [package insert]. Round Rock, TX: Benuvia Therapeutics LLC; September 2022.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed November 14, 2022.
4. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed November 11,2022.
5. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Antiemesis. Version 2.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed November 16, 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 15, 2023