Pharmacy Prior Authorization Criteria

5HT-1 Receptor Agonists (Triptans)

Indications for Prior Authorization

Onzetra Xsail (sumatriptan)

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

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

Tosymra (sumatriptan)

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

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

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 and 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.

Zembrace SymTouch (sumatriptan) injection solution

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

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

Criteria

Onzetra Xsail, Brand Treximet, Generic sumatriptan/naproxen, Tosymra, or Zembrace SymTouch

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply) or intolerance to two of the following generics [A, B]:
• Almotriptan tablet
• Eletriptan tablet
• Frovatriptan tablet
• Naratriptan tablet
• Rizatriptan tablet/rizatriptan orally dissolving tablet (ODT)
• Sumatriptan tablet/nasal spray
• Zolmitriptan tablet/zolmitriptan ODT

Zomig nasal spray or Brand Zolmitriptan nasal spray

Step Therapy

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:
• Both of the following:
• Patient is 12 to 17 years of age
AND
• Trial and failure (of a minimum 30-day supply) or intolerance to rizatriptan tablet/rizatriptan orally dissolving tablet (ODT)
OR
• Both of the following:
• Patient is 18 years of age or older
AND
• Trial and failure (of a minimum 30-day supply) or intolerance to two of the following generics [A, B]:
• Almotriptan tablet
• Eletriptan tablet
• Frovatriptan tablet
• Naratriptan tablet
• Rizatriptan tablet/rizatriptan orally dissolving tablet (ODT)
• Sumatriptan tablet/nasal spray
• Zolmitriptan tablet/zolmitriptan ODT

P & T Revisions

2024-03-06, 2023-03-27, 2023-03-02, 2022-10-26, 2022-10-11, 2022-03-03, 2021-03-03, 2020-09-02, 2020-04-01, 2019-11-26, 2019-10-29

References

1. Treximet Prescribing Information. Currax Pharmaceuticals LLC. Brentwood, TN. January 2024.
2. Onzetra Xsail Prescribing Information. Currax Pharmaceuticals LLC. Morristown, NJ. December 2019.
3. Drugs@FDA [internet database]. Rockville (MD): Food and Drug Administration (US), Center for Drug Evaluation and Research; Updated periodically. Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed January 23, 2024.
4. Schwedt TJ, Garza I. Acute treatment of migraine in adults. UpToDate. Available by subscription at: http://www.uptodate.com/. Accessed January 23, 2024.
5. Zomig Nasal Spray Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, NJ. May 2019.
6. Tosymra Prescribing Information. Upsher-Smith Laboratories, LLC. Maple Grove, MN. February 2021.
7. Zembrace SymTouch Prescribing Information. Upsher-Smith Laboratories, LLC. Maple Grove, MN. February 2021.

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End Notes

1. All triptans are FDA-approved for the acute treatment of migraines with or without aura in adults [3]. Those agents FDA-approved in pediatric patients include almotriptan, sumatriptan/naproxen, zolmitriptan nasal spray (for ≥12 years of age), and rizatriptan (for ≥6 years of age).
2. Triptans are a well established, effective treatment option for acute migraine [4]. There is limited head-to-head data available, which makes it difficult to recommend the use of one agent over another [4].

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Revision History

• 2024-03-06: Annual review: Background updates.
• 2023-03-27: Added Zembrace Symtouch to guideline. Updated background and references.
• 2023-03-02: Annual review: Updated criteria, background, and formatting.
• 2022-10-26: Addition of generic sumatriptan-naproxen as target drug
• 2022-10-11: Removed generic sumatriptan/naproxen from guideline
• 2022-03-03: Annual review: Updated criteria and background.
• 2021-03-03: Added Brand Zolmitriptan nasal spray to guideline.
• 2020-09-02: Updated number of alternatives required and added additional alternatives and age bypass.
• 2020-04-01: Annual review: background and cosmetic updates.
• 2019-11-26: Fixed UMCS search function, no change to criteria.
• 2019-10-29: Tosyma added as a step target.

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