Subject: Dihydroergotamine Nasal Spray Limit 145-H 07-2022

Drug

ERGOT DERIVATIVES

MIGRANAL NASAL SPRAY  (dihydroergotamine mesylate)

TRUDHESA NASAL SPRAY

Policy:

FDA-approved Indications
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.

 

LIMIT CRITERIA   Limits should accumulate across all drugs and strengths up to highest quantity listed   depending on the order the claims are processed.
Drug	1 Month Limit*	3 Month Limit*
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
*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.

RATIONALE

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.^1,3,4 Trudhesa (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults.²

For the acute treatment of migraine headaches with or without aura, one spray (0.5 mg) of Migranal Nasal Spray should be administered in each nostril. Fifteen minutes later, an additional one spray (0.5 mg) of Migranal Nasal Spray should be administered in each nostril, for a total dosage of four sprays (2 mg) of Migranal Nasal Spray. Studies have shown no additional benefit from acute doses greater than 2 mg for a single migraine administration. The safety of doses greater than 3 mg (six sprays) in a 24-hour period and 4 mg (eight sprays) in a 7-day period has not been established. Migranal Nasal Spray should not be used for chronic daily administration.¹

Migranal Nasal Spray is available in a 3.5 mL vial containing 4 mg of dihydroergotamine mesylate per vial. Packages are available in quantities of one unit or eight units. Each unit consists of one vial and one sprayer. Prior to administration, the pump must be primed (i.e., squeeze 4 times) before use. There is a sufficient quantity of medication in each unit to allow for priming and still allow for the full dose of Migranal to be administered. Once the nasal spray applicator has been prepared, it should be discarded (with any remaining drug in opened vial) after 8 hours.¹ 

The recommended dose of Trudhesa is 1.45 mg administered as two metered sprays into the nose (one spray of 0.725 mg into each nostril). The dose may be repeated, if needed, a minimum of 1 hour after the first dose. Do not use more than 2 doses of Trudhesa within a 24-hour period or 3 doses within a 7-day period. Trudhesa must be assembled prior to use. Use or discard Trudhesa within 8 hours once the vial has been opened or the product has been assembled. Trudhesa must be primed before initial use by releasing 4 sprays. Use Trudhesa immediately after priming. Discard Trudhesa immediately after use. Open and prepare a new Trudhesa if an additional dose is needed.²

Trudhesa nasal spray (0.725 mg per spray) is supplied as a package of 4 single-dose units. Each single-dose unit includes one vial containing 4 mg dihydroergotamine mesylate per 1 mL and one nasal spray device.²

Therefore, the quantity limit for Migranal (dihydroergotamine mesylate) Nasal Spray is set to eight units, which allows for treatment of up to eight headaches per month. The quantity limit for Trudhesa is set as 3 packages of 4 single-dose units per month, which allows for the maximum of 3 doses [3 single-dose units] within 7-day period. If the patient is requesting more than the initial quantity limit, the claim will reject with a message indicating that quantity limits are exceeded.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Migranal Nasal Spray [package insert]. Bridgewater, NJ: Bausch Health US LLC; April 2022.
2. Trudhesa [package insert]. Seattle, WA: Impel NeuroPharma Inc; September 2021.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed May 27, 2022.
4. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed May 27, 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.

December 10, 2022