Subject: Dronabinol PA with Limit 392-C P01-2025

Drug

Dronabinol Products

MARINOL  (dronabinol)

SYNDROS  (dronabinol)

Policy:

Indications

FDA-approved Indications

Marinol

Marinol is 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.

Syndros

Syndros is 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.

Coverage Criteria

Anorexia Associated with Weight Loss Due to Acquired Immune Deficiency Syndrome (AIDS)

Authorization may be granted when the requested drug is being prescribed for anorexia associated with weight loss due to Acquired Immune Deficiency Syndrome (AIDS).

Nausea and Vomiting Associated with Cancer Chemotherapy

Authorization may be granted when the requested drug is being prescribed for nausea and vomiting associated with cancer chemotherapy when the following criteria is met:

• The patient has failed to respond adequately to a conventional antiemetic treatment [NOTE: Examples of conventional antiemetic treatments include dexamethasone, metoclopramide, olanzapine, prochlorperazine, and 5-HT3 receptor antagonists (e.g., Anzemet [dolasetron], granisetron, ondansetron)].

Quantity Limits Apply

Marinol (dronabinol) 120 capsules per 25 days, 360 capsules per 75 days or Syndros (dronabinol) oral solution 240 mL per 25 days, 720 mL per 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.

Duration of Approval (DOA)

• 392-C: DOA: 6 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Marinol [package insert]. Parsippany, NJ: ThePharmaNetwork LLC; January 2023.
2. Syndros [package insert]. Round Rock, TX: Benuvia Therapeutics LLC; October 2022.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed November 29,
4. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/29/2024).
5. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Antiemesis. Version 2.2024. Available at: https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed November 29, 2024.
6. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2020; 38:2782-2797.
7. American Cancer Society. How is Chemotherapy Used to Treat Cancer? https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/chemotherapy/how-is-chemotherapy-used-to-treat-cancer.html. November 2019. Accessed November 27, 2024.

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 06, 2025