dihydroergotamine agents (TRUDHESA)

Dihydroergotamine Agents:

TRUDHESA (dihydroergotamine mesylate)

Self-administration - nasal spray

Diagnosis considered for coverage:

• Migraine: Indicated for the acute treatment of migraine with or without aura in adults.
  • Limitations of Use: Not indicated for the preventative treatment of migraine or for the management of hemiplegic or basilar migraine.

Coverage Criteria:

For acute treatment of migraine:

• Diagnosis of migraine headaches with or without aura (not indicated for the management of hemiplegic or basilar migraine); AND
• Will be used for the acute treatment of migraine; AND
• Dose does not exceed two doses per day (i.e., 2.9 mg/day) or three doses per week (limit 12 doses per month); AND
• Patient is 18 years of age or older; AND
• Prescribed by or in consultation with one of the following specialists
  • Neurologist
  • Pain management specialist
  • Headache specialist; AND
• One of the following:
  • Documented trial and failure or intolerance to two triptan medications
  • Contraindication to all triptan medications; AND
• The average number of migraine headaches experienced per month is confirmed by medical records:
  • If the patient has 4 or more migraine headache days per month, then one of the following regarding the use of prophylactic medications for migraine headaches:
  • Experienced an inadequate response (minimum two-month trial) to at least TWO prophylactic medications each from a different pharmacologic class:
    • Antiepileptic drug: divalproex sodium, sodium valproate, topiramate, carbamazepine
    • Beta-blocker: metoprolol, propranolol, timolol, atenolol, nadolol, nebivolol, pindolol
    • Antidepressant: amitriptyline, venlafaxine
    • Blood pressure drug: lisinopril, candesartan
    • Alpha-agonist: clonidine, guanfacine
    • Antihistamine: cyproheptadine
    • CGRP-inhibitor: Emgality, Ajovy, Aimovig, Nurtec (taken every other day)
  • Currently being treated with one of the medications listed for migraine headache prophylaxis.
  • Contraindication to all medications listed for migraine headache prophylaxis; AND
• Not used in combination with another triptan or ergotamine-containing product.

Reauthorization Criteria:

For acute treatment of migraine:

• Documentation of positive clinical response to therapy (i.e., reduction in pain, photophobia, phonophobia, nausea)

Coverage Duration:

• 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

The American Academy of Neurology (AAN)-recommended first-line agents for the prevention of migraine headache are atenolol, metoprolol, nadolol, propranolol, timolol, amitriptyline, venlafaxine, topiramate, and divalproex sodium.

Policy Updates:

• 05/16/2023 – New policy approved by WHA P&T (5/16/23).

References:

1. American Family Physician. Acute Migraine Headache: Treatment Strategies. 2018 Feb; 97(4):243-251.
2. American Family Physician. Migraine Headache Prophylaxis. 2019 Jan;99(1):17-24.
3. American Headache Society Consensus Statement. Update on integrating new migraine treatments into clinical practice. Headache. 2021 Jul;61(7):1021-1039.
4. D.H.E. Mesylate Nasal Prescribing Information. Cipla USA Inc. Warren, NJ. May 2022.
5. Migranal Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. July 2019.
6. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and American Headache Society. Neurology. 2012 April;78(17):1337-1345.
7. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016 May 10;86(19):1818-26.
8. Trudhesa Prescribing Information. Impel NeuroPharma Inc. Seattle, WA. September 2021.
9. United Council for Neurologic Subspecialties website. www.ucns.org. Accessed February 25, 2023.