Subject: Dibenzyline PA with Limit 3673-C P07-2025

Drug

DIBENZYLINE  (phenoxybenzamine)

Policy:

Indications

FDA-approved Indications

Dibenzyline is indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta-blocking agent concomitantly.

Compendial Uses

Paraganglioma.^5,6

Coverage Criteria

Pheochromocytoma, Paraganglioma

Authorization may be granted when the requested drug is being prescribed for the treatment of pheochromocytoma or paraganglioma to control episodes of hypertension and sweating when ONE of the following criteria is met:

• The patient has experienced an inadequate treatment response to an alpha 1 selective adrenergic receptor blocker (e.g., doxazosin, prazosin, terazosin).
• The patient has experienced an intolerance to an alpha 1 selective adrenergic receptor blocker (e.g., doxazosin, prazosin, terazosin).
• The patient has a contraindication that would prohibit a trial of an alpha 1 selective adrenergic receptor blocker (e.g., doxazosin, prazosin, terazosin).

Quantity Limits Apply

360 capsules per 25 days or 1,080 capsules 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)

• 3673-C: DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Dibenzyline [package insert]. Bannockburn, IL: Advanz Pharma (US) Corp.; Novmber 2023.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed June 4, 2025.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 06/04/2025).
4. Neumann HPH, Young WF, Eng C. Pheochromocytoma and Paraganglioma. The New England Journal of Medicine 2019; 381:552-65.
5. Lenders JWM, Duh QY, Eisenhofer G, et al. Pheochromocytoma and Paraganglioma: An Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology and Metabolism 2014;99(6):1915-1942.
6. Neuroendocrine and Adrenal Tumors. NCCN Guidelines version 2.2025. Available at: https://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Accessed June 4, 2025.

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.

December 13, 2025