Pharmacy Prior Authorization Criteria

Migraine Quantity Limit

Indications for Prior Authorization

Amerge (naratriptan), Frova (frovatriptan), Imitrex (sumatriptan) tablets and nasal spray, Onzetra (sumatriptan), Relpax (eletriptan), Tosymra (sumatriptan), Zembrace SymTouch (sumatriptan), Zomig (zolmitriptan) tablets, Zomig-ZMT (zolmitriptan)

• For diagnosis of Migraine Headaches
  Indicated for the acute treatment of migraine with or without aura in adults.

  Limitations of Use: Safety and effectiveness of respective triptan therapy have not been established for cluster headache (not applicable to Zembrace SymTouch). Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with therapy, reconsider the diagnosis of migraine before therapy is administered to treat any subsequent attacks. Therapy is not indicated for the prevention of migraine attacks.

Axert (almotriptan)

• For diagnosis of Migraine Headaches
  Indicated for the acute treatment of migraine attacks in adults with a history of migraine with or without aura. Indicated for the acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).

  Important Limitations: Only use where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with Axert, the diagnosis of migraine should be reconsidered before Axert is administered to treat any subsequent attacks. In adolescents age 12 to 17 years, efficacy of Axert on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. Axert is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of Axert have not been established for cluster headache which is present in an older, predominantly male population.

Maxalt (rizatriptan), Maxalt-MLT (rizatriptan)

• For diagnosis of Migraine headaches
  Indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.

  Limitations of Use: Maxalt should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with Maxalt, the diagnosis of migraine should be reconsidered before Maxalt is administered to treat any subsequent attacks. Maxalt is not indicated for use in the management of hemiplegic or basilar migraine. Maxalt is not indicated for the prevention of migraine attacks. Safety and effectiveness of Maxalt have not been established for cluster headache.

Migranal (dihydroergotamine mesylate)

• For diagnosis of Migraine Headaches
  Indicated 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.

Treximet (sumatriptan/naproxen)

• For diagnosis of Migraine Headaches
  Indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age or older.

  Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Treximet, reconsider the diagnosis of migraine before Treximet is administered to treat any subsequent attacks. Treximet is not indicated for the prevention of migraine attacks. Safety and effectiveness of Treximet have not been established for cluster headache.

Zomig (zolmitriptan) nasal spray

• For diagnosis of Migraine Headaches
  Indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.

  Limitations of Use: Only use Zomig if a clear diagnosis of migraine has been established. If a patient has no response to Zomig treatment for the first migraine attack, reconsider the diagnosis of migraine before Zomig is administered to treat any subsequent attacks. Zomig is not indicated for the prevention of migraine attacks. Safety and effectiveness of Zomig have not been established for cluster headache. Not recommended in patients with moderate or severe hepatic impairment.

D.H.E. 45 (dihydroergotamine mesylate) injection

• For diagnosis of Migraine Headache
  Indicated for the acute treatment of migraine headaches with or without aura.

• For diagnosis of Cluster Headaches
  Indicated for acute treatment of cluster headache episodes.

Imitrex (sumatriptan) injection

• For diagnosis of Migraine Headache
  Indicated in adults for the acute treatment of migraine, with or without aura.

  Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine headache attack treated with Imitrex injection, reconsider the diagnosis before Imitrex injection is administered to treat any subsequent attacks. Imitrex injection is not indicated for the prevention of migraine headache attacks.

• For diagnosis of Cluster Headaches
  Indicated in adults for the acute treatment of cluster headache.

  Limitations of Use: Use only if a clear diagnosis of cluster headache has been established. If a patient has no response to the first cluster headache attack treated with Imitrex injection, reconsider the diagnosis before Imitrex injection is administered to treat any subsequent attacks. Imitrex injection is not indicated for the prevention of cluster headache attacks.

Trudhesa (dihydroergotamine mesylate)

• For diagnosis of Migraine Headaches
  Indicated 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

Nurtec ODT (rimegepant sulfate)

• For diagnosis of Acute Treatment of Migraine
  Indicated for the acute treatment of migraine with or without aura in adults.

• For diagnosis of Preventive Treatment of Episodic Migraine
  Indicated for the preventive treatment of episodic migraine in adults.

Ubrelvy (ubrogepant)

• For diagnosis of Acute Treatment of Migraine
  Indicated for the acute treatment of migraine with or without aura in adults.

  Limitations of Use: Not indicated for the preventive treatment of migraine.

Zavzpret (zavegepant)

• For diagnosis of Acute Treatment of Migraine
  Indicated for the acute treatment of migraine with or without aura in adults.

  Limitations of Use: Not indicated for the preventive treatment of migraine.

Criteria

Brand Amerge, Generic naratriptan, Brand Axert, Generic almotriptan, Brand Frova, Generic frovatriptan, Brand Imitrex, Generic sumatriptan, Brand Maxalt, Generic rizatriptan, Onzetra, Brand Relpax, Generic eletriptan, Tosymra, Brand Treximet, Generic sumatriptan/naproxen, Zembrace SymTouch, Brand Zomig, Generic zolmitriptan, or Brand Zolmitriptan nasal spray

Quantity Limit

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Patient is experiencing 2 or more headaches per month [10-12]
AND
• Patient will not be treating 15 or more headache days per month
AND
• Currently receiving prophylactic therapy with at least one of the following: [A, 10, 24]
• An antidepressant (i.e., Elavil [amitriptyline] or Effexor [venlafaxine])
• An anticonvulsant (i.e., Depakote/Depakote ER [divalproex sodium] or Topamax [topiramate])
• A beta-blocker (i.e., atenolol, propranolol, nadolol, timolol, or metoprolol)
• An angiotensin receptor blocker (i.e., Atacand [candesartan])
• An angiotensin-converting enzyme (ACE) inhibitor (i.e., lisinopril)
AND
• Not used in combination with another triptan-containing product
AND
• One of the following: [B]
• Higher dose or quantity is supported in the Dosage and Administration section of the manufacturer’s prescribing information
OR
• Higher dose or quantity is supported by one of the following compendia:
• American Hospital Formulary Service Drug Information
• Micromedex DRUGDEX System

Brand D.H.E. 45, Generic dihydroergotamine mesylate injection, Brand Migranal, Generic dihydroergotamine mesylate nasal spray, Nurtec ODT, Trudhesa, Ubrelvy, Zavzpret

Quantity Limit

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• One of the following: [B]
• Higher dose or quantity is supported in the Dosage and Administration section of the manufacturer’s prescribing information
OR
• Higher dose or quantity is supported by one of the following compendia:
• American Hospital Formulary Service Drug Information
• Micromedex DRUGDEX System

P & T Revisions

2024-06-05, 2024-03-06, 2023-08-28, 2023-07-20, 2023-04-05, 2023-03-02, 2022-04-06, 2022-03-03, 2022-01-19, 2021-09-28, 2021-05-21, 2021-03-03, 2020-03-04

References

1. Amerge Prescribing Information. GlaxoSmithKline. Research Triangle Park, NC. October 2020.
2. Almotriptan Prescribing Information. Ajanta Pharma USA Inc. Bridgewater, NJ. March 2023.
3. Frova Prescribing Information. Endo Pharmaceuticals Inc. Malvern, PA. August 2018.
4. Imitrex Tablets Prescribing Information. GlaxoSmithKline. Research Triangle Park, NC. December 2020.
5. Imitrex Nasal Spray Prescribing Information. GlaxoSmithKline. Research Triangle Park, NC. December 2017.
6. Imitrex Injection Prescribing Information. GlaxoSmithKline. Durham, NC. February 2023.
7. Maxalt/Maxalt MLT Prescribing Information. Organon LLC. Jersey City, NJ. June 2021.
8. Migranal Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. September 2022.
9. Relpax Prescribing Information. Roerig. New York, NY. March 2020.
10. 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 the American Headache Society. Neurology. 2012;78:1337-1345.
11. Silberstein SD, Holland S, Freitag F, et al. Erratum to: 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 the American Headache Society. Neurology. 2013;80(9):871.
12. Snow V, Weiss K, Wall EM, Mottur-Pilson C; American Academy of Family Physicians; American College of Physicians-American Society of Internal Medicine. Pharmacologic management of acute attacks of migraine and prevention of migraine headache. Ann Intern Med. 2002;137:840-9.
13. Onzetra Xsail Prescribing Information. Currax Pharmaceuticals LLC. Morristown, NJ. December 2019.
14. Treximet Prescribing Information. Currax Pharmaceuticals LLC. Brentwood, TN. January 2024.
15. Zomig/Zomig ZMT Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, NJ. May 2019.
16. Zomig Nasal Spray Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, NJ. May 2019.
17. D.H.E. 45 Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. April 2022.
18. Loder E, Burch R, Rizzoli P. The 2012 AHS/AAN Guidelines for Prevention of Episodic Migraine: A Summary and Comparison with Other Recent Clinical Practice Guidelines. Headache 2012;52:930-945.
19. Zembrace SymTouch Prescribing Information. Upsher-Smith Laboratories, LLC. Maple Grove, MN. February 2021.
20. Tosymra Prescribing Information. Upsher-Smith Laboratories, LLC. Maple Grove, MN. February 2021.
21. Trudhesa Prescribing Information. Impel NeuroPharma Inc. Seattle, WA. August 2023.
22. Nurtec ODT Prescribing Information. Pfizer Inc. New York, NY April 2023.
23. Ubrelvy Prescribing Information. AbbVie Inc. North Chicago, IL. June 2023.
24. AHS Consensus Statement. Update on integrating new migraine treatments into clinical practice. Headache. 2021 Jul;61(7):1021-1039.
25. Zavzpret Prescribing Information. Pfizer Labs. New York, NY. March 2023.

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Revision History

• 2024-06-05: Removed prescriber requirement. Background updates.
• 2024-03-06: Annual review: Background updates.
• 2023-08-28: Removal of drug name, Sumavel Dosepro, from header in criteria section.
• 2023-07-20: Attached Zavzpret as target to guideline.
• 2023-04-05: Annual review: Added Nurtec ODT and Ubrelvy and updated criteria and background.
• 2023-03-02: Annual review: Added Nurtec ODT and Ubrelvy and updated criteria and background.
• 2022-04-06: Added ARBs as an additional prophylactic option.
• 2022-03-03: Annual review: Added Trudhesa and removed discontinued product (Brand Axert), includes background updates.
• 2022-01-19: Addition of EHB formulary to guideline, no changes to criteria
• 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-03: Added Brand Zolmitriptan nasal spray, Brand/Generic D.H.E. 45 injection, and Tosymra.
• 2020-03-04: Annual review: removed discontinued product and updated criteria and background.

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