Dihydroergotamine – NC Standard

Restricted Product(s):

Restriction applies to brand and generic products

• dihydroergotamine mesylate inj (generic D.H.E. 45®)
• Migranal® (dihydroergotamine mesylate nasal spray)
• Trudhesa® (dihydroergotamine mesylate nasal spray)

FDA Approved Use: 

• Migranal
  • For the acute treatment of migraine headaches with or without aura
  • Not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine
• D.H.E. 45
  • Indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes
• Trudhesa
  • For the acute treatment of migraine with or without aura in adults
  • Limitations of Use: not indicated for the preventive treatment of migraine or for the management of hemiplegic or basilar migraine

Criteria for Approval of Restricted Product(s):

1. The patient will be using dihydroergotamine mesylate inj (generic D.H.E. 45) for the acute treatment of cluster headaches; OR
2. The patient will be using the medication for the acute treatment of migraine; AND
   1. ONE of the following:
      1. The patient has failed therapy with TWO of the following classes of medications:
         1. Prescription NSAIDS/COX-2 Inhibitor (e.g., ibuprofen, naproxen, diclofenac, celecoxib, etc.)
         2. Other Ergotamine-containing products (e.g., Cafergot, Ergomar, etc.) 
         3. Serotonin 5-HT1 receptor agonists (“triptans”); OR
      2. The patient has a clinical contraindication/intolerance to the medication classes (above) that have not been trialed; AND
   2. The patient has tried and failed or has a clinical contraindication/intolerance to a CGRP product indicated for the acute treatment of migraine (e.g, Ubrelvy, Nurtect ODT, etc.); AND
   3. If the request is for Migranal, Trudhesa, or generic dihydroergotamine mesylate nasal spray:
      1. The patient has tried and failed or has a clinical contraindication/intolerance to generic dihydroergotamine injections; AND
      2. The patient will NOT be using the medication for hemiplegic or basilar migraine headaches; AND
3. The patient will NOT be using the requested agent in combination with another acute migraine therapy (e.g., 5HT-1F, acute use CGRP, Elyxyb, ergotamine, triptan); AND
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:  365 days (1 year)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. If the patient experiences greater than 4 migraine headaches per month, prophylactic therapy (e.g., amitriptyline, nortriptyline, topiramate, propranolol, divalproex) should have been given an adequate trial of at least 2 – 3 months; AND 
2. The possibility of medication-induced, rebound or chronic daily headache has been considered and ruled out; AND 
3. The requested medication is not used in combination with a "triptan" product or another ergotamine product due to the possibility of increased blood pressure effect; AND
4. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
   If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval:  365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Francis GJ, Becker WJ, and Pringsheim TM; Acute and preventive pharmacologic treatment of cluster headache. Neurology August 3, 2010, 75:5 463-473; 1526-632X

Silberstein SD, Holland S, Freitag F, Dodick DW,  Argoff C, Ashman E; Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults. Neurology April 24, 2012 vol. 78 no. 17 1337-1345.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

October 2024: Criteria change: Policy name change to NC Standard. Removed obsolete product, brand D.H.E. 45. Updated QL for dihydroergotamine mesylate injections (generic D.H.E. 45), Migranal, and Trudhesa.

July 2022: Criteria change: Policy name change to Enhanced/Essential. Added requirement that the requested product cannot be used in combination with another acute migraine therapy.

January 2022: Criteria change: Added required step through a CGRP product indicated for acute migraine.

October 2021: Criteria update: Added new to market product, Trudhesa; shortened approval length to 365 days.

October 2020: Criteria update: Applied criteria to Net Results formulary.

Apr 2020:  Criteria update:  Removed suggested alternatives and updated format.

Sep 2018:  Indication review for cluster headache diagnosis.

Nov 2017: Reformatted criteria; removed requirement for “Isometheptene/dichloralphenazone/acetaminophen (Ex. Midrin^®, etc.)” as they are approved by the FDA; indication review.

Aug 2016: Original utilization management criteria issued