Subject: Dihydroergotamine Nasal Limit 145-H P06-2024 v2

Drug

Dihydroergotamine Nasal

ATZUMI  (dihydroergotamine mesylate)

MIGRANAL  (dihydroergotamine mesylate)

TRUDHESA  (dihydroergotamine mesylate)

Policy:

Indications

FDA-approved Indications

Atzumi

Atzumi is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use

Atzumi is not indicated for the preventive treatment of migraine.

Atzumi is not indicated for the management of hemiplegic migraine or migraine with brainstem aura.

Migranal

Migranal (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura.

Migranal (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.

Trudhesa

Trudhesa is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use

Trudhesa is not indicated for the preventive treatment of migraine.

Trudhesa is not indicated for the management of hemiplegic or basilar migraine.

Initial Limit Quantity

Please Note: Since manufacturer package sizes may vary, it is the discretion of the dispensing pharmacy to fill quantities per package size up to these quantity limits. In such cases the filling limit and day supply may be less than what is indicated.

Limits should accumulate across all drugs and strengths up to highest quantity listed depending on the order the claims are processed.

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.

Drug	1 Month Limit	3 Month Limit
Atzumi (dihydroergotamine mesylate)	12 nasal devices  / 25 days	40 nasal devices / 75 days
Migranal (dihydroergotamine mesylate)	8 nasal units / 25 days	24 nasal units / 75 days
Trudhesa (dihydroergotamine mesylate)	12 units (3 packages) / 25 days	36 units (9 packages) / 75 days

Place of Service:

Outpatient

The above policy is based on the following references:

1. Atzumi [package insert]. Durham, NC: Satsuma Pharmaceuticals, Inc.; April 2025.
2. Migranal Nasal Spray [package insert]. Bridgewater, NJ: Bausch Health US, LLC; September 2022.
3. Trudhesa [package insert]. Seattle, WA: Impel NeuroPharma Inc; August
4. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed April 1, 2024.
5. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 04/1/2024).

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 21, 2025