Subject: metyrosine-Demser SGM 6346-A P2025

Drug

DEMSER  (metyrosine)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications^1,2

Demser (metyrosine) is indicated in the treatment of patients with pheochromocytoma for:

• Preoperative preparation of patients for surgery
• Management of patients when surgery is contraindicated
• Chronic treatment of patients with malignant pheochromocytoma

Demser (metyrosine) is not recommended for the control of essential hypertension.

Compendial Use^3,4

For pheochromocytoma/paraganglioma: may be used in combination with alpha blockade with or without dihydropyridine calcium channel blockade and/or beta blockade as medical preparation for primary treatment.

All other indications are considered experimental/investigational and not medically necessary.

Coverage Criteria

Pheochromocytoma/Paraganglioma^1-4

Authorization of 12 months may be granted for treatment of pheochromocytoma/paraganglioma when the member has experienced an inadequate treatment response, intolerance, or has a contraindication to an alpha-adrenergic antagonist (e.g., terazosin, doxazosin, prazosin, phenoxybenzamine) and any of the following criteria are met:

• The requested agent will be used for preoperative preparation for surgery
• The requested agent will be used for management when surgery is contraindicated
• The requested agent will be used for chronic treatment for malignant pheochromocytoma

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section who have improvement in symptoms (e.g., blood pressure, heart rate, headaches, sweating, anxiety) and no unacceptable toxicity while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Demser [package insert]. Bridgewater, NJ: Bausch Health US, LLC.; July 2021.
2. metyrosine [package insert]. Bridgewater, NJ. Amneal Pharmaceuticals LLC.; November 2020.
3. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed December 3, 2024.
4. The NCCN Clinical Practice Guidelines in Oncology® Neuroendocrine and Adrenal Tumors Version 2.2024. National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed December 3, 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 02, 2025